Research Publications

Measuring atropisomers of BMS-986142 using 2DLC as an enabling technology.

Wang Q, He BL, Shackman JG.

J Pharm Biomed Anal. 2021 Jan 30;193:113730. doi: 10.1016/j.jpba.2020.113730. Epub 2020 Oct 31.

PMID: 33181427

 

Electron-Passing Neural Networks for Atomic Charge Prediction in Systems with Arbitrary Molecular Charge.

Metcalf DP, Jiang A, Spronk SA, Cheney DL, Sherrill CD.

J Chem Inf Model. 2021 Jan 25;61(1):115-122. doi: 10.1021/acs.jcim.0c01071. Epub 2020 Dec 16.

PMID: 33326247

 

3D printed bilayer tablet with dual controlled drug release for tuberculosis treatment.

Ghanizadeh Tabriz A, Nandi U, Hurt AP, Hui HW, Karki S, Gong Y, Kumar S, Douroumis D.

Int J Pharm. 2021 Jan 25;593:120147. doi: 10.1016/j.ijpharm.2020.120147. Epub 2020 Dec 3.

PMID: 33278493

 

High-Throughput Therapeutic Antibody Interference-Free High-Resolution Mass Spectrometry Assay for Monitoring M-Proteins in Multiple Myeloma.

Santockyte R, Puig O, Zheng N, Ouyang Z, Titsch C, Zhang YJ, Pillutla R, Zeng J.

Anal Chem. 2021 Jan 19;93(2):834-842. doi: 10.1021/acs.analchem.0c03357. Epub 2020 Dec 10.

PMID: 33300779

 

T4-mediated rescue of aortic malformations in hypothyroid rats indicates maternal thyroid status can affect great vessel development.

Augustine-Rauch K, Liaw JJ, Graziano M.

Toxicol Appl Pharmacol. 2021 Jan 15;411:115367. doi: 10.1016/j.taap.2020.115367. Epub 2020 Dec 17.

PMID: 33340518

 

Photocatalytic Dearomative Intermolecular [2 + 2] Cycloaddition of Heterocycles for Building Molecular Complexity.

Oderinde MS, Ramirez A, Dhar TGM, Cornelius LAM, Jorge C, Aulakh D, Sandhu B, Pawluczyk J, Sarjeant AA, Meanwell NA, Mathur A, Kempson J.

J Org Chem. 2021 Jan 15;86(2):1730-1747. doi: 10.1021/acs.joc.0c02547. Epub 2020 Dec 24.

PMID: 33356273

 

Neoadjuvant Therapy for Melanoma: A U.S. Food and Drug Administration-Melanoma Research Alliance Public Workshop.

Mueller KL, Theoret MR, Lemery SJ, Amiri-Kordestani L, Ariyan CE, Atkins MB, Berry DA, Blank CU, DeMichele AM, Forde PM, Ibrahim N, Keegan P, Mitchell TC, Moss RA, Robert C, Sridhara R, Taube JM, Tetzlaff MT, Wargo JA, Flaherty KT, Kaplan MJ, Topalian SL, Ward AF, Hurlbert MS.

Clin Cancer Res. 2021 Jan 15;27(2):394-401. doi: 10.1158/1078-0432.CCR-20-3285. Epub 2020 Nov 13.

PMID: 33188142 

 

Discovery of BMS-986202: A Clinical Tyk2 Inhibitor that Binds to Tyk2 JH2.

Liu C, Lin J, Langevine C, Smith D, Li J, Tokarski JS, Khan J, Ruzanov M, Strnad J, Zupa-Fernandez A, Cheng L, Gillooly KM, Shuster D, Zhang Y, Thankappan A, McIntyre KW, Chaudhry C, Elzinga PA, Chiney M, Chimalakonda A, Lombardo LJ, Macor JE, Carter PH, Burke JR, Weinstein DS.

J Med Chem. 2021 Jan 14;64(1):677-694. doi: 10.1021/acs.jmedchem.0c01698. Epub 2020 Dec 28.

PMID: 33370104

 

Quaternary Charge-Transfer Complex Enables Photoenzymatic Intermolecular Hydroalkylation of Olefins.

Page CG, Cooper SJ, DeHovitz JS, Oblinsky DG, Biegasiewicz KF, Antropow AH, Armbrust KW, Ellis JM, Hamann LG, Horn EJ, Oberg KM, Scholes GD, Hyster TK.

J Am Chem Soc. 2021 Jan 13;143(1):97-102. doi: 10.1021/jacs.0c11462. Epub 2020 Dec 28.

PMID: 33369395

 

Data-smart machine learning methods for predicting composition-dependent Young's modulus of pharmaceutical compacts.

Thomas S, Palahnuk H, Amini H, Akseli I.

Int J Pharm. 2021 Jan 5;592:120049. doi: 10.1016/j.ijpharm.2020.120049. Epub 2020 Nov 7.

PMID: 33171260

 

A methodology employing retention modeling for achieving control space in liquid chromatography method development using quality by design approach.

Jayaraman K, Rajendran AK, Kumar GS, Bhutani H.

J Chromatogr A. 2021 Jan 4;1635:461658. doi: 10.1016/j.chroma.2020.461658. Epub 2020 Nov 4.

PMID: 33333351

 

Discovery of Annulating Reagents Enabling the One-Step and Highly Stereoselective Synthesis of Cyclopentyl and Cyclohexyl Cores.

McDaniel J, Farley CA, Ramirez A, Sandhu B, Sarjeant A, Shi Q, Han A, Gallagher WP, Hynes J Jr, Dhar TGM, Gonzalez-Bobes F, Coombs JR, Marcoux D.

Org Lett. 2021 Jan 1;23(1):60-65. doi: 10.1021/acs.orglett.0c03695. Epub 2020 Dec 22.

PMID: 33351641

 

Sustainability Challenges and Opportunities in Oligonucleotide Manufacturing.

Andrews BI, Antia FD, Brueggemeier SB, Diorazio LJ, Koenig SG, Kopach ME, Lee H, Olbrich M, Watson AL.

J Org Chem. 2021 Jan 1;86(1):49-61. doi: 10.1021/acs.joc.0c02291. Epub 2020 Nov 30.

PMID: 33253568

 

Phase I Study of Alvocidib Followed by 7+3 (Cytarabine + Daunorubicin) in Newly Diagnosed Acute Myeloid Leukemia.

Zeidner JF, Lee DJ, Frattini M, Fine GD, Costas J, Kolibaba K, Anthony SP, Bearss D, Smith BD.

Clin Cancer Res. 2021 Jan 1;27(1):60-69. doi: 10.1158/1078-0432.CCR-20-2649. Epub 2020 Sep 30.

PMID: 32998965 

 

Using yeast surface display to engineer a soluble and crystallizable construct of hematopoietic progenitor kinase 1 (HPK1).

Lau WL, Pearce B, Malakian H, Rodrigo I, Xie D, Gao M, Marsilio F, Chang C, Ruzanov M, Muckelbauer JK, Newitt JA, Lipovšek D, Sheriff S.

Acta Crystallogr F Struct Biol Commun. 2021 Jan 1;77(Pt 1):22-28. doi: 10.1107/S2053230X20016015. Epub 2020 Dec 22.

PMID: 33439152

 

Profiling and targeting connective tissue remodeling in autoimmunity - A novel paradigm for diagnosing and treating chronic diseases.

Karsdal MA, Kraus VB, Shevell D, Bay-Jensen AC, Schattenberg J, Rambabu Surabattula R, Schuppan D.

Autoimmun Rev. 2021 Jan;20(1):102706. doi: 10.1016/j.autrev.2020.102706. Epub 2020 Nov 12.

PMID: 33188918 

 

Biomarkers of response to ibrutinib plus nivolumab in relapsed diffuse large B-cell lymphoma, follicular lymphoma, or Richter's transformation.

Hodkinson BP, Schaffer M, Brody JD, Jurczak W, Carpio C, Ben-Yehuda D, Avivi I, Forslund A, Özcan M, Alvarez J, Ceulemans R, Fourneau N, Younes A, Balasubramanian S.

Transl Oncol. 2021 Jan;14(1):100977. doi: 10.1016/j.tranon.2020.100977. Epub 2020 Dec 6.

PMID: 33395752                                                                                      

 

Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study.

Prager GW, Oehler L, Gerger A, Mlineritsch B, Andel J, Petzer A, Wilthoner K, Sliwa T, Pichler P, Winder T, Heibl S, Gruenberger B, Laengle F, Hubmann E, Korger M, Pecherstorfer M, Djanani A, Neumann HJ, Philipp-Abbrederis K, Wöll E, Trondl R, Arnold-Schrauf C, Eisterer W.

Eur J Cancer. 2021 Jan;143:101-112. doi: 10.1016/j.ejca.2020.11.003. Epub 2020 Dec 6.

PMID: 33296830 

 

Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations.

Peters T, Soanes N, Abbas M, Ahmad J, Delumeau JC, Herrero-Martinez E, Paramananda M, Piper J, Smail-Aoudia F, van der Spuij W, Veizovic T, Winstanley G;

EFPIA International Pharmacovigilance Group.Drug Saf. 2021 Jan;44(1):17-28. doi: 10.1007/s40264-020-01008-0. Epub 2020 Dec 8.

PMID: 33289904 

 

Real-World Effectiveness of Nivolumab Monotherapy After Prior Systemic Therapy in Advanced Non-Small-Cell Lung Cancer in the United States.

Stenehjem DD, Lubinga SJ, Gupte-Singh K, Zhang Y, Le TK, Penrod JR, Smith CB.

Clin Lung Cancer. 2021 Jan;22(1):e35-e47. doi: 10.1016/j.cllc.2020.07.009. Epub 2020 Jul 29.

PMID: 33187914 

 

Long-term safety and efficacy of patisiran for hereditary transthyretin-mediated amyloidosis with polyneuropathy: 12-month results of an open-label extension study.

Adams D, Polydefkis M, González-Duarte A, Wixner J, Kristen AV, Schmidt HH, Berk JL, Losada López IA, Dispenzieri A, Quan D, Conceição IM, Slama MS, Gillmore JD, Kyriakides T, Ajroud-Driss S, Waddington-Cruz M, Mezei MM, Planté-Bordeneuve V, Attarian S, Mauricio E, Brannagan TH 3rd, Ueda M, Aldinc E, Wang JJ, White MT, Vest J, Berber E, Sweetser MT, Coelho T; patisiran Global OLE study group.

Lancet Neurol. 2021 Jan;20(1):49-59. doi: 10.1016/S1474-4422(20)30368-9. Epub 2020 Nov 16.

PMID: 33212063  

Best practices for the development, analytical validation and clinical implementation of flow cytometric methods for chimeric antigen receptor T cell analyses.

Sarikonda G, Mathieu M, Natalia M, Pahuja A, Xue Q, Pierog PL, Trampont PC, Decman V, Reynolds S, Hanafi LA, Sun YS, Eck S, Hedrick MN, Stewart JJ, Tangri S, Litwin V, Dakappagari N.

Cytometry B Clin Cytom. 2020 Dec 29. doi: 10.1002/cyto.b.21985. Online ahead of print.

PMID: 33373096

 

Clinical Outcome Event Adjudication in a 10-Year Prospective Study of Nucleos(t)ide Analogue Therapy for Chronic Hepatitis B.

Lim JK, Chang AY, Zaman A, Martin P, Fernandez-Rodriguez CM, Korkmaz M, Rossi S, Ford JM, Noonan T, Cooney E, Navarro V, Colombato L.

J Clin Transl Hepatol. 2020 Dec 28;8(4):377-384. doi: 10.14218/JCTH.2020.00039. Epub 2020 Oct 10.

PMID: 33447520 

 

Therapeutic potential of TLR8 agonist GS-9688 (selgantolimod) in chronic hepatitis B: re-modelling of antiviral and regulatory mediators.

Amin OE, Colbeck EJ, Daffis S, Khan S, Ramakrishnan D, Pattabiraman D, Chu R, Micolochick Steuer H, Lehar S, Peiser L, Palazzo A, Frey C, Davies J, Javanbakht H, Rosenberg WMC, Fletcher SP, Maini MK, Pallett LJ.

Hepatology. 2020 Dec 25. doi: 10.1002/hep.31695. Online ahead of print.

PMID: 33368377

 

Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission.

Wei AH, Döhner H, Pocock C, Montesinos P, Afanasyev B, Dombret H, Ravandi F, Sayar H, Jang JH, Porkka K, Selleslag D, Sandhu I, Turgut M, Giai V, Ofran Y, Kizil Çakar M, Botelho de Sousa A, Rybka J, Frairia C, Borin L, Beltrami G, Čermák J, Ossenkoppele GJ, La Torre I, Skikne B, Kumar K, Dong Q, Beach CL, Roboz GJ; QUAZAR AML-001 Trial Investigators.

N Engl J Med. 2020 Dec 24;383(26):2526-2537. doi: 10.1056/NEJMoa2004444.

PMID: 33369355 

 

Urinary miRNA biomarkers of drug-induced kidney injury and their site specificity within the nephron.

Chorley B, Ellinger-Ziegelbauer H, Tackett M, Simutis FJ, Harrill AH, McDuffie J, Atabakhsh E, Nassirpour R, Whiteley LO, Léonard JF, Carswell GK, Harpur E, Chen CL, Gautier JC.

Toxicol Sci. 2020 Dec 24:kfaa181. doi: 10.1093/toxsci/kfaa181. Online ahead of print.

PMID: 33367795

 

Site-Selective Functionalization of Methionine Residues via Photoredox Catalysis.

Kim J, Li BX, Huang RY, Qiao JX, Ewing WR, MacMillan DWC.

J Am Chem Soc. 2020 Dec 23;142(51):21260-21266. doi: 10.1021/jacs.0c09926. Epub 2020 Dec 8.

PMID: 33290649

 

Engaging Patients in Real-World Evidence: An Atrial Fibrillation Patient Advisory Board Case Example.

Oehrlein EM, Luo X, Savone M, Lobban T, Kang A, Lee B, Gale R, Schoch S, Perfetto E.

Patient. 2020 Dec 23. doi: 10.1007/s40271-020-00479-8. Online ahead of print.

PMID: 33355917 

 

LXH254, a potent and selective ARAF-sparing inhibitor of BRAF and CRAF for the treatment of MAPK-driven tumors.

Monaco KA, Delach S, Yuan J, Mishina Y, Fordjour P, Labrot E, McKay D, Guo R, Higgins S, Wang HQ, Liang J, Bui K, Green J, Aspesi P, Ambrose J, Mapa F, Griner L, Jaskelioff M, Fuller J, Crawford K, Pardee G, Widger S, Hammerman PS, Engelman JA, Stuart DD, Cooke VG, Caponigro G.

Clin Cancer Res. 2020 Dec 22:clincanres.2563.2020. doi: 10.1158/1078-0432.CCR-20-2563. Online ahead of print.

PMID: 33355204 

 

Pharmacodynamics-based approach for efficacious human dose projection of BMS-986260, a small molecule transforming growth factor beta receptor 1 inhibitor.

Parrish KE, Swanson J, Cheng L, Luk E, Stetsko P, Smalley J, Shu YZ, Huang J, Pabalan JG, Sun Y, Zvyaga T, Cvijic ME, Burke J, Borzilleri R, Murtaza A, Augustine K, Yang Z.

Biopharm Drug Dispos. 2020 Dec 22. doi: 10.1002/bdd.2256. Online ahead of print.

PMID: 33354831

 

Comparability of European League Against Rheumatology-Recommended Pharmacological Treatments of Oral Ulcers Associated with Behçet's Disease: A Systematic Literature Review of Randomized Controlled Trials.

Nazareth T, Hart EM, Ronnebaum SM, Mehta S, Patel DA, Kötter I.

Open Access Rheumatol. 2020 Dec 21;12:323-335. doi: 10.2147/OARRR.S277036. eCollection 2020.

PMID: 33376418 

 

Analysis of the Role of Plasma 25-Hydroxyvitamin D Levels in Survival Outcomes in Patients from the Phase III MPACT Trial of Metastatic Pancreatic Cancer.

Von Hoff DD, Cridebring D, Tian OY, Han H, Bhore R, Franco T, Ondovik MS, Louis CU.

Oncologist. 2020 Dec 20. doi: 10.1002/onco.13645. Online ahead of print.

PMID: 33345430 

 

Cereblon Modulators Target ZBTB16 and Its Oncogenic Fusion Partners for Degradation via Distinct Structural Degrons.

Matyskiela ME, Zhu J, Baughman JM, Clayton T, Slade M, Wong HK, Danga K, Zheng X, Labow M, LeBrun L, Lu G, Chamberlain PP, Thompson JW.

ACS Chem Biol. 2020 Dec 18;15(12):3149-3158. doi: 10.1021/acschembio.0c00674. Epub 2020 Nov 18.

PMID: 33206504

 

Cost Effectiveness of Nivolumab in Patients with Advanced, Previously Treated Squamous and Non-squamous Non-small-cell Lung Cancer in England.

Rothwell B, Kiff C, Ling C, Brodtkorb TH.

Pharmacoecon Open. 2020 Dec 17. doi: 10.1007/s41669-020-00245-4. Online ahead of print.

PMID: 33332018 

 

A cross-industry collaboration to assess if acute oral toxicity (Q)SAR models are fit-for-purpose for GHS classification and labelling.

Bercu J, Masuda-Herrera MJ, Trejo-Martin A, Hasselgren C, Lord J, Graham J, Schmitz M, Milchak L, Owens C, Lal SH, Robinson RM, Whalley S, Bellion P, Vuorinen A, Gromek K, Hawkins WA, van de Gevel I, Vriens K, Kemper R, Naven R, Ferrer P, Myatt GJ.

Regul Toxicol Pharmacol. 2020 Dec 17;120:104843. doi: 10.1016/j.yrtph.2020.104843. Online ahead of print.

PMID: 33340644 

 

Leveraging the Value of CDISC SEND Data Sets for Cross-Study Analysis: Incidence of Microscopic Findings in Control Animals.

Carfagna MA, Anderson J, Eley C, Fukushima T, Horvath J, Houser W, Larsen B, Page T, Russo D, Sloan C, Snyder K, Thompson R, Ullmann G, Whittaker M.

Chem Res Toxicol. 2020 Dec 16. doi: 10.1021/acs.chemrestox.0c00317. Online ahead of print.

PMID: 33325690

 

Development and characterization of rat duodenal organoids for ADME and toxicology applications.

Hedrich WD, Panzica-Kelly JM, Chen SJ, Strassle B, Hasson C, Lecureux L, Wang L, Chen W, Sherry T, Gan J, Davis M.

Toxicology. 2020 Dec 15;446:152614. doi: 10.1016/j.tox.2020.152614. Epub 2020 Oct 24.

PMID: 33199268

 

Modulating target engagement of small molecules via drug delivery: approaches and applications in drug discovery and development.

Yang W, Bhattachar SN, Patel PJ, Landis M, Patel D, Reid DL, Duvnjak Romic M.

Drug Discov Today. 2020 Dec 14:S1359-6446(20)30526-2. doi: 10.1016/j.drudis.2020.12.008. Online ahead of print.

PMID: 33333320 

 

Concentration-QTc Modeling of Ozanimod's Major Active Metabolites in Adult Healthy Subjects.

Briggs E, Chapel S, Zhang P, Palmisano M, Tran JQ.

CPT Pharmacometrics Syst Pharmacol. 2020 Dec 12. doi: 10.1002/psp4.12580. Online ahead of print.

PMID: 33314790 

 

The Impact of Product and Process Related Critical Quality Attributes on Immunogenicity and Adverse Immunological Effects of Biotherapeutics.

Wen Y, Jawa V.

J Pharm Sci. 2020 Dec 11:S0022-3549(20)30781-4. doi: 10.1016/j.xphs.2020.12.003. Online ahead of print.

PMID: 33316242 

 

Aberrant interaction of FUS with the U1 snRNA provides a molecular mechanism of FUS induced amyotrophic lateral sclerosis.

Jutzi D, Campagne S, Schmidt R, Reber S, Mechtersheimer J, Gypas F, Schweingruber C, Colombo M, von Schroetter C, Loughlin FE, Devoy A, Hedlund E, Zavolan M, Allain FH, Ruepp MD.

Nat Commun. 2020 Dec 11;11(1):6341. doi: 10.1038/s41467-020-20191-3.

PMID: 33311468 

 

Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS.

DeLuca J, Schippling S, Montalban X, Kappos L, Cree BAC, Comi G, Arnold DL, Hartung HP, Sheffield JK, Liu H, Silva D, Cohen JA.

Mult Scler Relat Disord. 2020 Dec 10;48:102673. doi: 10.1016/j.msard.2020.102673. Online ahead of print.

PMID: 33454584 

 

Preclinical Rationale for Targeting the PD-1/PD-L1 Axis in Combination with a CD38 Antibody in Multiple Myeloma and Other CD38-Positive Malignancies.

Verkleij CPM, Jhatakia A, Broekmans MEC, Frerichs KA, Zweegman S, Mutis T, Bezman NA, van de Donk NWCJ.

Cancers (Basel). 2020 Dec 10;12(12):3713. doi: 10.3390/cancers12123713.

PMID: 33321969 

 

Synthesis and Structure-Activity Relationship of Tetra-Substituted Cyclohexyl Diol Inhibitors of Proviral Insertion of Moloney Virus (PIM) Kinases.

Han W, Ding Y, Chen Z, Langowski JL, Bellamacina C, Rico A, Nishiguchi GA, Lan J, Atallah G, Lindvall M, Lin S, Zang R, Feucht P, Zavorotinskaya T, Dai Y, Garcia P, Burger MT.

J Med Chem. 2020 Dec 10;63(23):14885-14904. doi: 10.1021/acs.jmedchem.0c01279. Epub 2020 Dec 1.

PMID: 33258605

 

Biologic-like In Vivo Efficacy with Small Molecule Inhibitors of TNFα Identified Using Scaffold Hopping and Structure-Based Drug Design Approaches.

Xiao HY, Li N, Duan JJ, Jiang B, Lu Z, Ngu K, Tino J, Kopcho LM, Lu H, Chen J, Tebben AJ, Sheriff S, Chang CY, Yanchunas J Jr, Calambur D, Gao M, Shuster DJ, Susulic V, Xie JH, Guarino VR, Wu DR, Gregor KR, Goldstine CB, Hynes J Jr, Macor JE, Salter-Cid L, Burke JR, Shaw PJ, Dhar TGM.

J Med Chem. 2020 Dec 10;63(23):15050-15071. doi: 10.1021/acs.jmedchem.0c01732. Epub 2020 Dec 1.

PMID: 33261314

 

Discovery of BMS-986144, a Third-Generation, Pan-Genotype NS3/4A Protease Inhibitor for the Treatment of Hepatitis C Virus Infection.

Sun LQ, Mull E, D'Andrea S, Zheng B, Hiebert S, Gillis E, Bowsher M, Kandhasamy S, Baratam VR, Puttaswamy S, Pulicharla N, Vishwakrishnan S, Reddy S, Trivedi R, Sinha S, Sivaprasad S, Rao A, Desai S, Ghosh K, Anumula R, Kumar A, Rajamani R, Wang YK, Fang H, Mathur A, Rampulla R, Zvyaga TA, Mosure K, Jenkins S, Falk P, Tagore DM, Chen C, Rendunchintala K, Loy J, Meanwell NA, McPhee F, Scola PM.

J Med Chem. 2020 Dec 10;63(23):14740-14760. doi: 10.1021/acs.jmedchem.0c01296. Epub 2020 Nov 23.

PMID: 33226226

 

Preclinical Characterization of Linrodostat Mesylate, a Novel, Potent, and Selective Oral Indoleamine 2,3-Dioxygenase 1 Inhibitor.

Balog A, Lin TA, Maley D, Gullo-Brown J, Kandoussi EH, Zeng J, Hunt JT.

Mol Cancer Ther. 2020 Dec 9:molcanther.0251.2020. doi: 10.1158/1535-7163.MCT-20-0251. Online ahead of print.

PMID: 33298590

 

Safety and effectiveness of apixaban compared with warfarin among clinically-relevant subgroups of venous thromboembolism patients in the United States Medicare population.

Guo JD, Hlavacek P, Rosenblatt L, Keshishian A, Russ C, Mardekian J, Ferri M, Poretta T, Yuce H, McBane R.

Thromb Res. 2020 Dec 8;198:163-170. doi: 10.1016/j.thromres.2020.11.039. Online ahead of print.

PMID: 33348190 

 

PBPK Model of Coproporphyrin I: Evaluation of the Impact of SLCO1B1 Genotype, Ethnicity, and Sex on its Inter-Individual Variability.

Takita H, Barnett S, Zhang Y, Ménochet K, Shen H, Ogungbenro K, Galetin A.

CPT Pharmacometrics Syst Pharmacol. 2020 Dec 8. doi: 10.1002/psp4.12582. Online ahead of print.

PMID: 33289952 

 

Model-Based Selection and Recommendation for Subcutaneous Abatacept Dose in Patients With Polyarticular Juvenile Idiopathic Arthritis.

Gandhi Y, Passarell JA, Roy A, Murthy B.

J Clin Pharmacol. 2020 Dec 7. doi: 10.1002/jcph.1797. Online ahead of print.

PMID: 33284480

 

Multiple SARS-CoV-2 Introductions Shaped the Early Outbreak in Central Eastern Europe: Comparing Hungarian Data to a Worldwide Sequence Data-Matrix.

Kemenesi G, Zeghbib S, Somogyi BA, Tóth GE, Bányai K, Solymosi N, Szabo PM, Szabó I, Bálint Á, Urbán P, Herczeg R, Gyenesei A, Nagy Á, Pereszlényi CI, Babinszky GC, Dudás G, Terhes G, Zöldi V, Lovas R, Tenczer S, Kornya L, Jakab F.

Viruses. 2020 Dec 6;12(12):1401. doi: 10.3390/v12121401.

PMID: 33291299 

 

Physiologically-Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective.

Heimbach T, Chen Y, Chen J, Dixit V, Parrott N, Peters SA, Poggesi I, Sharma P, Snoeys J, Shebley M, Tai G, Tse S, Upreti VV, Wang YH, Tsai A, Xia B, Zheng M, Zhu AZX, Hall S.

Clin Pharmacol Ther. 2020 Dec 3. doi: 10.1002/cpt.2125. Online ahead of print.

PMID: 33270249

Synthetic thick filaments: A new avenue for better understanding the myosin super-relaxed state in healthy, disease, and mavacamten-treated cardiac systems.

Gollapudi SK, Yu M, Gan QF, Nag S.

J Biol Chem. 2020 Dec 3:100114. doi: 10.1074/jbc.RA120.016506. Online ahead of print.

PMID: 33434580 

 

Patient experiences with hypertrophic cardiomyopathy: a conceptual model of symptoms and impacts on quality of life.

Zaiser E, Sehnert AJ, Duenas A, Saberi S, Brookes E, Reaney M.

J Patient Rep Outcomes. 2020 Dec 1;4(1):102. doi: 10.1186/s41687-020-00269-8.

PMID: 33259041 

 

Computational insights into O-glycosylation in a CTLA4 Fc-fusion protein linker and its impact on protein quality attributes.

Song Y, Qian Y, Huang Z, Khattak SF, Li ZJ.

Comput Struct Biotechnol J. 2020 Dec 1;18:3925-3935. doi: 10.1016/j.csbj.2020.11.037. eCollection 2020.

PMID: 33335689 

 

Updated Analysis of Complication Rates Associated With Invasive Diagnostic Procedures After Lung Cancer Screening.

Zhao H, Xu Y, Huo J, Burks AC, Ost DE, Shih YT.

JAMA Netw Open. 2020 Dec 1;3(12):e2029874. doi: 10.1001/jamanetworkopen.2020.29874.

PMID: 33326023 

 

Evaluate the Impact of Diabetes on RA-related outcomes in an Electronic Health Record-Based Rheumatology Registry.

Yun H, Xie F, Chen L, Yang S, Ferri L, Alemao E, Curtis J.

J Rheumatol. 2020 Dec 1:jrheum.200486. doi: 10.3899/jrheum.200486. Online ahead of print.

PMID: 33262304

 

Best practices for optimization and validation of flow cytometry-based receptor occupancy assays.

Hilt E, Sun YS, McCloskey TW, Eck S, McIntosh T, Grugan KD, Lanham DF, Standifer N, Green C, Litwin V, Stewart JJ.

Cytometry B Clin Cytom. 2020 Dec 1. doi: 10.1002/cyto.b.21970. Online ahead of print.

PMID: 33259706

 

Patterns of drug release as a function of drug loading from amorphous solid dispersions: A comparison of five different polymers.

Saboo S, Moseson DE, Kestur US, Taylor LS.

Eur J Pharm Sci. 2020 Dec 1;155:105514. doi: 10.1016/j.ejps.2020.105514. Epub 2020 Aug 15.

PMID: 32810579

 

In Silico Meets In Vitro Techniques in ADMET Profiling of Drug Discovery (Part I).

Kar S, Chatterjee S.

Curr Drug Metab. 2020 Dec;21(10):745. doi: 10.2174/138920022110201126153901.

PMID: 33327905 

 

SITC cancer immunotherapy resource document: a compass in the land of biomarker discovery.

Hu-Lieskovan S, Bhaumik S, Dhodapkar K, Grivel JJB, Gupta S, Hanks BA, Janetzki S, Kleen TO, Koguchi Y, Lund AW, Maccalli C, Mahnke YD, Novosiadly RD, Selvan SR, Sims T, Zhao Y, Maecker HT.

J Immunother Cancer. 2020 Dec;8(2):e000705. doi: 10.1136/jitc-2020-000705.

PMID: 33268350 

 

Treatment patterns, clinical outcomes, and healthcare resource use associated with advanced/metastatic lung cancer in China: protocol for a retrospective observational study.

Qiu B, Li G, Luo F, Cai X, Wu L, Chen J, Hu Y, Tang Z, Yang S, He J.

Transl Lung Cancer Res. 2020 Dec;9(6):2460-2468. doi: 10.21037/tlcr-20-1269.

PMID: 33489806 

 

Development of the first reference antibody panel for qualification and validation of cytokine release assay platforms - Report of an international collaborative study.

Vessillier S, Fort M, O'Donnell L, Hinton H, Nadwodny K, Piccotti J, Rigsby P, Staflin K, Stebbings R, Mekala D, Willingham A, Wolf B; participants of the study.

Cytokine X. 2020 Dec;2(4):100042. doi: 10.1016/j.cytox.2020.100042.

PMID: 33458650 

 

Reply.

Danese S, Chitkara D, Usiskin K.

Clin Gastroenterol Hepatol. 2020 Dec;18(13):3057-3058. doi: 10.1016/j.cgh.2020.03.023.

PMID: 33190745 

 

Cross-company evaluation of the human lymphocyte activation assay.

Collinge M, Schneider P, Li D, Parish S, Dumont C, Freebern W, Ghanime J, Guimont-Derochers F, Langenkamp A, Lebron J, Li N, Marban C, Plitnick L, Wheeler J.

J Immunotoxicol. 2020 Dec;17(1):51-58. doi: 10.1080/1547691X.2020.1725694.

PMID: 32124652

 

The hexosamine biosynthesis pathway is a targetable liability in KRAS/LKB1 mutant lung cancer.

Kim J, Lee HM, Cai F, Ko B, Yang C, Lieu EL, Muhammad N, Rhyne S, Li K, Haloul M, Gu W, Faubert B, Kaushik AK, Cai L, Kasiri S, Marriam U, Nham K, Girard L, Wang H, Sun X, Kim J, Minna JD, Unsal-Kacmaz K, DeBerardinis RJ.

Nat Metab. 2020 Dec;2(12):1401-1412. doi: 10.1038/s42255-020-00316-0. Epub 2020 Nov 30.

PMID: 33257855

 

Toxicologic Pathology Forum: Opinion on Obligatory Microscopic Examination of Intermediate-Dose Groups in Toxicity Studies With Biotherapeutics in Cynomolgus Monkeys.

Parrula C, Dincer Z, Geoly FJ, De Vera Mudry MC, Mysore J, Wuersch K.

Toxicol Pathol. 2020 Dec;48(8):939-943. doi: 10.1177/0192623320969098. Epub 2020 Nov 28.

PMID: 33252033

 

Real-Time Killing Assays to Assess the Potency of a New Anti-Simian Immunodeficiency Virus Chimeric Antigen Receptor T Cell.

Haeseleer F, Eichholz K, Tareen SU, Iwamoto N, Roederer M, Kirchhoff F, Park H, Okoye AA, Corey L.

AIDS Res Hum Retroviruses. 2020 Dec;36(12):998-1009. doi: 10.1089/AID.2020.0163. Epub 2020 Nov 5.

PMID: 32988211

 

Multiple-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites and the Pharmacodynamic and Pharmacokinetic Interactions with Pseudoephedrine, a Sympathomimetic Agent, in Healthy Subjects.

Tran JQ, Zhang P, Walker S, Ghosh A, Syto M, Wang X, Harris S, Palmisano M.

Adv Ther. 2020 Dec;37(12):4944-4958. doi: 10.1007/s12325-020-01500-0. Epub 2020 Oct 6.

PMID: 33025342

 

Impact of quercetin on pharmacokinetics of quetiapine: insights from in-vivo studies in wistar rats.

Bhutani P, Rajanna PK, Paul AT.

Xenobiotica. 2020 Dec;50(12):1483-1489. doi: 10.1080/00498254.2020.1792002. Epub 2020 Jul 14.

PMID: 32623931

 

Identification of extractables by liquid chromatography-high resolution mass spectrometry: A case study to understand the extraction profile of different disposable syringes.

Kurmi M, Prasad S, Panduranga NS, Jayaraman K, Bhutani H.

J Pharm Biomed Anal. 2020 Nov 30;191:113602. doi: 10.1016/j.jpba.2020.113602. Epub 2020 Sep 9.

PMID: 33010603

 

Rapid development of a bromochloropyridine regioisomer purity method enabled by strategic LC screening.

Borges-Muñoz A, Li L, Tattersall P.

J Pharm Biomed Anal. 2020 Nov 30;191:113594. doi: 10.1016/j.jpba.2020.113594. Epub 2020 Aug 28.

PMID: 32949956

 

Diverse crystal size effects in covalent organic frameworks.

Ma T, Wei L, Liang L, Yin S, Xu L, Niu J, Xue H, Wang X, Sun J, Zhang YB, Wang W.

Nat Commun. 2020 Nov 30;11(1):6128. doi: 10.1038/s41467-020-19858-8.

PMID: 33257671 

 

Comparison of online and face-to-face valuation of the EQ-5D-5L using composite time trade-off.

Jiang R, Shaw J, Mühlbacher A, Lee TA, Walton S, Kohlmann T, Norman R, Pickard AS.

Qual Life Res. 2020 Nov 28. doi: 10.1007/s11136-020-02712-1. Online ahead of print.

PMID: 33247810

 

A Comparison of Real-World Treatment Patterns and Clinical Outcomes in Patients Receiving First-Line Therapy for Unresectable Advanced Gastric or Gastroesophageal Junction Cancer Versus Esophageal Adenocarcinomas.

Shankaran V, Xiao H, Bertwistle D, Zhang Y, You M, Abraham P, Chau I.

Adv Ther. 2020 Nov 26. doi: 10.1007/s12325-020-01567-9. Online ahead of print.

PMID: 33244736

 

Author Correction: Blood-brain barrier permeable nano immunoconjugates induce local immune responses for glioma therapy.

Galstyan A, Markman JL, Shatalova ES, Chiechi A, Korman AJ, Patil R, Klymyshyn D, Tourtellotte WG, Israel LL, Braubach O, Ljubimov VA, Mashouf LA, Ramesh A, Grodzinski ZB, Penichet ML, Black KL, Holler E, Sun T, Ding H, Ljubimov AV, Ljubimova JY.

Nat Commun. 2020 Nov 26;11(1):6170. doi: 10.1038/s41467-020-20129-9.

PMID: 33243989 

 

Metabolomic and quality data for early and late passages of an antibody-producing industrial CHO cell line.

Sowa SW, Qian Y, Aron KL, Xu P, Langsdorf E, Warrack B, Aranibar N, Tremml G, Xu J, McVey D, Reily M, Khetan A, Borys MC, Li ZJ.

Data Brief. 2020 Nov 26;33:106591. doi: 10.1016/j.dib.2020.106591. eCollection 2020 Dec.

PMID: 33318978 

 

Axl and Mertk receptors cooperate to promote breast cancer progression by combined oncogenic signaling and evasion of host anti-tumor immunity.

Davra V, Kumar S, Geng K, Calianese D, Mehta D, Gadiyar V, Kasikara C, Lahey KC, Chang YJ, Wichroski M, Gao C, De Lorenzo MS, Kotenko SV, Bergsbaken T, Mishra PK, Gause WC, Quigley M, Spires TE, Birge RB.

Cancer Res. 2020 Nov 25:canres.2066.2020. doi: 10.1158/0008-5472.CAN-20-2066. Online ahead of print.

PMID: 33239426

 

Design, Synthesis, and Structure-Activity Relationships of Novel Tetrahydroisoquinolino Benzodiazepine Dimer Antitumor Agents and Their Application in Antibody-Drug Conjugates.

Chowdari NS, Zhang Y, McDonald I, Johnson W, Langley DR, Sivaprakasam P, Mate R, Huynh T, Kotapati S, Deshpande M, Pan C, Menezes D, Wang Y, Rao C, Sarma G, Warrack BM, Rangan VS, Mei-Chen S, Cardarelli P, Deshpande S, Passmore D, Rampulla R, Mathur A, Borzilleri R, Rajpal A, Vite G, Gangwar S.

J Med Chem. 2020 Nov 25;63(22):13913-13950. doi: 10.1021/acs.jmedchem.0c01385. Epub 2020 Nov 6.

PMID: 33155811

 

Development of a Platform for Near-Infrared Photoredox Catalysis.

Ravetz BD, Tay NES, Joe CL, Sezen-Edmonds M, Schmidt MA, Tan Y, Janey JM, Eastgate MD, Rovis T.

ACS Cent Sci. 2020 Nov 25;6(11):2053-2059. doi: 10.1021/acscentsci.0c00948. Epub 2020 Oct 20.

PMID: 33274281 

  

Aryl Amination Using Soluble Weak Base Enabled by a Water-Assisted Mechanism.

Lau SH, Yu P, Chen L, Madsen-Duggan CB, Williams MJ, Carrow BP.

J Am Chem Soc. 2020 Nov 25;142(47):20030-20039. doi: 10.1021/jacs.0c09275. Epub 2020 Nov 12.

PMID: 33179489

 

Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer: 2-year follow-up from a randomized, open-label, phase 3 study (CheckMate 078).

Lu S, Wang J, Cheng Y, Mok T, Chang J, Zhang L, Feng J, Tu HY, Wu L, Zhang Y, Luft A, Zhou JY, Ma Z, Lu Y, Hu C, Shi Y, Ying K, Zhong H, Poddubskaya E, Soo RA, Chia YH, Li A, Li A, Wu YL.

Lung Cancer. 2020 Nov 24;152:7-14. doi: 10.1016/j.lungcan.2020.11.013. Online ahead of print.

PMID: 33321441 

 

Epigenetic Signatures and Plasticity of Intestinal and Other Stem Cells.

Saxena M, Shivdasani RA.

Annu Rev Physiol. 2020 Nov 24. doi: 10.1146/annurev-physiol-021119-034520. Online ahead of print.

PMID: 33234018

 

Optimization of a transient antibody expression platform towards high titer and efficiency.

Greene E, Cazacu D, Tamot N, Castellano S, Datar A, Kronkaitis A, Gebhard D, Reed J, Mawson P, Florin L, Rossi N, Lauer A, Juckem L, Nixon A, Wenger T, Sen S.

Biotechnol J. 2020 Nov 23:e2000251. doi: 10.1002/biot.202000251. Online ahead of print.

PMID: 33226178

 

Synthetic thick filaments: A new avenue for better understanding the myosin super-relaxed state in healthy, disease, and mavacamten-treated cardiac systems.

Gollapudi SK, Yu M, Gan QF, Nag S.

J Biol Chem. 2020 Nov 23:jbc.RA120.016506. doi: 10.1074/jbc.RA120.016506. Online ahead of print.

PMID: 33234590 

 

Multiple Myeloma in Hispanics: Incidence, Characteristics, Survival, Results of Discovery, and Validation Using Real-World and Connect MM Registry Data.

Kaur G, Mejia Saldarriaga M, Shah N, Catamero DD, Yue L, Ashai N, Goradia N, Heisler J, Xiao Z, Ghalib N, Aaron T, Cole D, Foreman R, Mantzaris I, Derman O, Bachier L, Sica RA, Kornblum N, Braunschweig I, Shastri A, Goel S, Verma A, Janakiram M.

Clin Lymphoma Myeloma Leuk. 2020 Nov 21:S2152-2650(20)30636-4. doi: 10.1016/j.clml.2020.11.013. Online ahead of print.

PMID: 33339770

 

CITCO as an Adjuvant Facilitates CHOP-Based Lymphoma Treatment in hCAR-Transgenic Mice.

Kurian R, Hedrich W, Mackowiak B, Li L, Wang H.

Cells. 2020 Nov 21;9(11):2520. doi: 10.3390/cells9112520.

PMID: 33233444 

 

Real-world diagnostic testing patterns for assessment of ring sideroblasts and SF3B1 mutations in patients with newly diagnosed lower-risk myelodysplastic syndromes.

Patel JL, Abedi M, Cogle CR, Erba HP, Foucar K, Garcia-Manero G, Grinblatt DL, Komrokji RS, Kurtin SE, Maciejewski JP, Pollyea DA, Revicki DA, Roboz GJ, Savona MR, Scott BL, Sekeres MA, Steensma DP, Thompson MA, Dawn Flick E, Kiselev P, Louis CU, Nifenecker M, Swern AS, George TI.

Int J Lab Hematol. 2020 Nov 21. doi: 10.1111/ijlh.13400. Online ahead of print.

PMID: 33220019

 

Effectiveness and safety of nivolumab in patients with head and neck cancer in Japanese real-world clinical practice: a multicenter retrospective clinical study.

Hanai N, Shimizu Y, Kariya S, Yasumatsu R, Yokota T, Fujii T, Tsukahara K, Yoshida M, Hanyu K, Ueda T, Hirakawa H, Takahashi S, Ono T, Sano D, Yamauchi M, Watanabe A, Omori K, Yamazaki T, Monden N, Kudo N, Arai M, Sakurai D, Asakage T, Doi I, Yamada T, Homma A.

Int J Clin Oncol. 2020 Nov 21. doi: 10.1007/s10147-020-01829-0. Online ahead of print.

PMID: 33219460

 

Expression of T-Cell Exhaustion Molecules and Human Endogenous Retroviruses as Predictive Biomarkers for Response to Nivolumab in Metastatic Clear Cell Renal Cell Carcinoma.

Ficial M, Jegede OA, Sant'Angelo M, Hou Y, Flaifel A, Pignon JC, Braun DA, Wind-Rotolo M, Sticco-Ivins MA, Catalano PJ, Freeman GJ, Sharpe AH, Hodi FS, Motzer RJ, Wu CJ, Atkins MB, McDermott DF, Shukla SA, Choueiri TK, Signoretti S.

Clin Cancer Res. 2020 Nov 20. doi: 10.1158/1078-0432.CCR-20-3084. Online ahead of print.

PMID: 33219016

 

A review of global health technology assessments of non-VKA oral anticoagulants in non-valvular atrial fibrillation.

Lopes RD, Berger SE, Di Fusco M, Kang A, Russ C, Afriyie A, Earley A, Deshpande S, Mantovani LG.

Int J Cardiol. 2020 Nov 15;319:85-93. doi: 10.1016/j.ijcard.2020.06.061. Epub 2020 Jul 4.

PMID: 32634487 

 

Pharmacological Optimization for Successful Traumatic Brain Injury Drug Development.

Poloyac SM, Bertz RJ, McDermott LA, Marathe P.

J Neurotrauma. 2020 Nov 15;37(22):2435-2444. doi: 10.1089/neu.2018.6295. Epub 2019 Apr 10.

PMID: 30816062

 

Mavacamten Favorably Impacts Cardiac Structure in Obstructive Hypertrophic Cardiomyopathy: EXPLORER-HCM CMR Substudy Analysis.

Saberi S, Cardim N, Yamani MH, Schulz-Menger J, Li W, Florea V, Sehnert AJ, Kwong RY, Jerosch-Herold M, Masri A, Owens A, Lakdawala NK, Kramer CM, Sherrid M, Seidler T, Wang A, Sedaghat-Hamedani F, Meder B, Havakuk O, Jacoby D.

Circulation. 2020 Nov 15. doi: 10.1161/CIRCULATIONAHA.120.052359. Online ahead of print.

PMID: 33190524 

 

Derivation of DO-BITS, a score for predicting success on Love Island: a retrospective, observational cohort study.

Simpson A, Graham S, Sammon C, Leahy TP, Ramagopalan SV.

Future Sci OA. 2020 Nov 13;7(1):FSO658. doi: 10.2144/fsoa-2020-0168.

PMID: 33437509 

 

Effectiveness and Safety of Apixaban, Low-Molecular-Weight Heparin, and Warfarin among Venous Thromboembolism Patients with Active Cancer: A U.S. Claims Data Analysis.

Cohen A, Keshishian A, Lee T, Wygant G, Rosenblatt L, Hlavacek P, Mardekian J, Wiederkehr D, Sah J, Luo X.

Thromb Haemost. 2020 Nov 10. doi: 10.1055/s-0040-1718728. Online ahead of print.

PMID: 33171521 

 

Combined Oral 5-Azacytidine and Romidepsin are Highly Effective in Patients with PTCL: A Multicenter Phase 2 Study.

Falchi L, Ma H, Klein S, Lue JK, Montanari F, Marchi E, Deng C, Kim HA, Rada AM, Jacob AT, Kinahan C, Francescone M, Soderquist CR, Park DC, Bhagat G, Nandakumar R, Menezes DL, Scotto L, Sokol L, Shustov AR, O'Connor OA.

Blood. 2020 Nov 10:blood.2020009004. doi: 10.1182/blood.2020009004. Online ahead of print.

PMID: 33171487

 

Efficacy and safety of abatacept in active primary Sjögren's syndrome: results of a phase III, randomised, placebo-controlled trial.

Baer AN, Gottenberg JE, St Clair EW, Sumida T, Takeuchi T, Seror R, Foulks G, Nys M, Mukherjee S, Wong R, Ray N, Bootsma H.

Ann Rheum Dis. 2020 Nov 9:annrheumdis-2020-218599. doi: 10.1136/annrheumdis-2020-218599. Online ahead of print.

PMID: 33168545 

 

TIGIT blockade enhances functionality of peritoneal NK cells with altered expression of DNAM-1/TIGIT/CD96 checkpoint molecules in ovarian cancer.

Maas RJ, Hoogstad-van Evert JS, Van der Meer JM, Mekers V, Rezaeifard S, Korman AJ, de Jonge PK, Cany J, Woestenenk R, Schaap NP, Massuger LF, Jansen JH, Hobo W, Dolstra H.

Oncoimmunology. 2020 Nov 8;9(1):1843247. doi: 10.1080/2162402X.2020.1843247.

PMID: 33224630 

 

Outpatient management of patients presenting with venous thromboembolism: Retrospective cohort study at 11 community hospitals.

Khatib R, Nitti K, McDowell M, Szymialis R, Blair C, Glowacki N, Rhoades W.

J Thromb Thrombolysis. 2020 Nov 7. doi: 10.1007/s11239-020-02328-9. Online ahead of print.

PMID: 33161514

 

Novel Tricyclic Pyroglutamide Derivatives as Potent RORγt Inverse Agonists Identified using a Virtual Screening Approach.

Liu Q, Batt DG, Weigelt CA, Yip S, Wu DR, Ruzanov M, Sack JS, Wang J, Yarde M, Li S, Shuster DJ, Xie JH, Sherry T, Obermeier MT, Fura A, Stefanski K, Cornelius G, Khandelwal P, Tino JA, Macor JE, Salter-Cid L, Denton R, Zhao Q, Dhar TGM.

ACS Med Chem Lett. 2020 Nov 6;11(12):2510-2518. doi: 10.1021/acsmedchemlett.0c00496. eCollection 2020 Dec 10.

PMID: 33335675

 

The 2020 Nobel Prize in Physiology or Medicine.

Meanwell NA, Georg GI, Wang S.

J Med Chem. 2020 Nov 5. doi: 10.1021/acs.jmedchem.0c01877. Online ahead of print.

PMID: 33147952 

 

OX40 Agonist BMS-986178 Alone or in Combination With Nivolumab and/or Ipilimumab in Patients With Advanced Solid Tumors.

Gutierrez M, Moreno V, Heinhuis KM, Olszanski AJ, Spreafico A, Ong M, Chu QS, Carvajal RD, Trigo J, Ochoa de Olza M, Provencio M, De Vos F, de Braud F, Leong S, Lathers D, Wang R, Ravindran P, Feng Y, Aanur P, Melero I.

Clin Cancer Res. 2020 Nov 4:clincanres.1830.2020. doi: 10.1158/1078-0432.CCR-20-1830. Online ahead of print.

PMID: 33148673

 

Bone marrow microenvironments that contribute to patient outcomes in newly diagnosed multiple myeloma: A cohort study of patients in the Total Therapy clinical trials.

Danziger SA, McConnell M, Gockley J, Young MH, Rosenthal A, Schmitz F, Reiss DJ, Farmer P, Alapat DV, Singh A, Ashby C, Bauer M, Ren Y, Smith K, Couto SS, van Rhee F, Davies F, Zangari M, Petty N, Orlowski RZ, Dhodapkar MV, Copeland WB, Fox B, Hoering A, Fitch A, Newhall K, Barlogie B, Trotter MWB, Hershberg RM, Walker BA, Dervan AP, Ratushny AV, Morgan GJ.

PLoS Med. 2020 Nov 4;17(11):e1003323. doi: 10.1371/journal.pmed.1003323. eCollection 2020 Nov.

PMID: 33147277

 

Consensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug-Induced Liver Injury During Clinical Trials in Adults with Chronic Viral Hepatitis and Adults with Cirrhosis Secondary to Hepatitis B, C and Nonalcoholic Steatohepatitis.

Treem WR, Palmer M, Lonjon-Domanec I, Seekins D, Dimick-Santos L, Avigan MI, Marcinak JF, Dash A, Regev A, Maller E, Patwardhan M, Lewis JH, Rockey DC, Di Bisceglie AM, Freston JW, Andrade RJ, Chalasani N.

Drug Saf. 2020 Nov 3. doi: 10.1007/s40264-020-01014-2. Online ahead of print.

PMID: 33141341 

 

Comparative effectiveness of nivolumab versus standard of care for third-line patients with small-cell lung cancer.

Keeping ST, Cope S, Chan K, Wilson FR, Jansen JP, Penrod JR, Abraham P, Camidge DR, Korytowsky B, Gu T, Garcia AJ, Le TK, Yuan Y.

J Comp Eff Res. 2020 Nov 3. doi: 10.2217/cer-2020-0134. Online ahead of print.

PMID: 33140652

 

Antipeptide Immunocapture with In-Sample Calibration Curve Strategy for Sensitive and Robust LC-MS/MS Bioanalysis of Clinical Protein Biomarkers in Formalin-Fixed Paraffin-Embedded Tumor Tissues.

Zheng N, Taylor K, Gu H, Santockyte R, Wang XT, McCarty J, Adelakun O, Zhang YJ, Pillutla R, Zeng J.

Anal Chem. 2020 Nov 3;92(21):14713-14722. doi: 10.1021/acs.analchem.0c03271. Epub 2020 Oct 13.

PMID: 33047598

 

NMR-Based Assay for the Ex Vivo Determination of Soluble CD73 Activity in Serum.

He Y, Zhao Y, Nelson DM, Klippel A, Reily MD.

Anal Chem. 2020 Nov 3;92(21):14501-14508. doi: 10.1021/acs.analchem.0c02630. Epub 2020 Oct 19.

PMID: 32985862

 

Radiographic Read Paradigms and the Roles of the Central Imaging Laboratory in Neuro-Oncology Clinical Trials.

Ellingson BM, Brown MS, Boxerman JL, Gerstner ER, Kaufmann TJ, Cole PE, Bacha JA, Leung D, Barone A, Colman H, van den Bent MJ, Wen PY, Yung WKA, Cloughesy TF, Goldin JG.

Neuro Oncol. 2020 Nov 1:noaa253. doi: 10.1093/neuonc/noaa253. Online ahead of print.

PMID: 33130879

 

Design, synthesis and SAR study of novel C2-pyrazolopyrimidine amides and amide isosteres as allosteric integrase inhibitors.

Patel M, Cianci C, Allard CW, Parker DD, Simmermacher J, Jenkins S, Mcauliffe B, Minassian B, Discotto L, Krystal M, Meanwell NA, Naidu BN.

Bioorg Med Chem Lett. 2020 Nov 1;30(21):127516. doi: 10.1016/j.bmcl.2020.127516. Epub 2020 Aug 27.

PMID: 32860982

 

Immunomodulatory Activity of a Colony-stimulating Factor-1 Receptor Inhibitor in Patients with Advanced Refractory Breast or Prostate Cancer: A Phase I Study.

Autio KA, Klebanoff CA, Schaer D, Kauh JSW, Slovin SF, Adamow M, Blinder VS, Brahmachary M, Carlsen M, Comen E, Danila DC, Doman TN, Durack JC, Fox JJ, Gluskin JS, Hoffman DM, Kang S, Kang P, Landa J, McAndrew PF, Modi S, Morris MJ, Novosiadly R, Rathkopf DE, Sanford R, Chapman SC, Tate CM, Yu D, Wong P, McArthur HL.

Clin Cancer Res. 2020 Nov 1;26(21):5609-5620. doi: 10.1158/1078-0432.CCR-20-0855. Epub 2020 Aug 26.

PMID: 32847933

 

Identification of 5H-chromeno[3,4-c]pyridine and 6H-isochromeno[3,4-c]pyridine derivatives as potent and selective dual ROCK inhibitors.

Hu Z, Wang C, Sitkoff D, Cheadle NL, Xu S, Muckelbauer JK, Adam LP, Wexler RR, Quan ML.

Bioorg Med Chem Lett. 2020 Nov 1;30(21):127474. doi: 10.1016/j.bmcl.2020.127474. Epub 2020 Aug 15.

PMID: 32805407

 

Discovery of a phenylpyrazole amide ROCK inhibitor as a tool molecule for in vivo studies.

Hu Z, Wang C, Glunz PW, Li J, Cheadle NL, Chen AY, Chen XQ, Myers JE, Guarino VR, Rose A, Sack JS, Sitkoff D, Taylor DS, Xu S, Yan C, Zhang H, Zhang L, Hennan J, Adam LP, Wexler RR, Quan ML.

Bioorg Med Chem Lett. 2020 Nov 1;30(21):127495. doi: 10.1016/j.bmcl.2020.127495. Epub 2020 Aug 13.

PMID: 32798651

 

Applications of small molecules in modulating productivity and product quality of recombinant proteins produced using cell cultures.

Xu P, Xu S, He C, Khetan A.

Biotechnol Adv. 2020 Nov 1;43:107577. doi: 10.1016/j.biotechadv.2020.107577. Epub 2020 Jun 12.

PMID: 32540474 

 

Plasma Tenascin-C: a prognostic biomarker in heart failure with preserved ejection fraction.

Kanagala P, Arnold JR, Khan JN, Singh A, Gulsin GS, Chan DCS, Cheng ASH, Yang J, Li Z, Gupta P, Squire IB, McCann GP, Ng LL.

Biomarkers. 2020 Nov;25(7):556-565. doi: 10.1080/1354750X.2020.1810319. Epub 2020 Aug 28.

PMID: 32803990

 

In-Hospital Therapy for Heart Failure With Reduced Ejection Fraction in the United States.

Greene SJ, Triana TS, Ionescu-Ittu R, Burne RM, Guérin A, Borentain M, Kessler PD, Tugcu A, DeSouza MM, Felker GM, Chen L.

JACC Heart Fail. 2020 Nov;8(11):943-953. doi: 10.1016/j.jchf.2020.05.013. Epub 2020 Aug 12.

PMID: 32800512

 

IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 4: Prediction accuracy and software comparisons with improved data and modelling strategies.

Ahmad A, Pepin X, Aarons L, Wang Y, Darwich AS, Wood JM, Tannergren C, Karlsson E, Patterson C, Thörn H, Ruston L, Mattinson A, Carlert S, Berg S, Murphy D, Engman H, Laru J, Barker R, Flanagan T, Abrahamsson B, Budhdeo S, Franek F, Moir A, Hanisch G, Pathak SM, Turner D, Jamei M, Brown J, Good D, Vaidhyanathan S, Jackson C, Nicolas O, Beilles S, Nguefack JF, Louit G, Henrion L, Ollier C, Boulu L, Xu C, Heimbach T, Ren X, Lin W, Nguyen-Trung AT, Zhang J, He H, Wu F, Bolger MB, Mullin JM, van Osdol B, Szeto K, Korjamo T, Pappinen S, Tuunainen J, Zhu W, Xia B, Daublain P, Wong S, Varma MVS, Modi S, Schäfer KJ, Schmid K, Lloyd R, Patel A, Tistaert C, Bevernage J, Nguyen MA, Lindley D, Carr R, Rostami-Hodjegan A.

Eur J Pharm Biopharm. 2020 Nov;156:50-63. doi: 10.1016/j.ejpb.2020.08.006. Epub 2020 Aug 14.

PMID: 32805361

 

Advances of solid-state NMR spectroscopy in material sciences.

Abraham A, Salager E, Krishnan D, Su Y.

Magn Reson Chem. 2020 Nov;58(11):987. doi: 10.1002/mrc.5086.

PMID: 33006157 

  

Metabolic understanding of disulfide reduction during monoclonal antibody production.

Cura AJ, Xu X, Egan S, Aron K, Jenkins L, Hageman T, Huang Y, Chollangi S, Borys M, Ghose S, Li ZJ.

Appl Microbiol Biotechnol. 2020 Nov;104(22):9655-9669. doi: 10.1007/s00253-020-10916-1. Epub 2020 Sep 30.

PMID: 32997205

 

Paediatric Strategy Forum for medicinal product development of epigenetic modifiers for children: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.

Pearson AD, Stegmaier K, Bourdeaut F, Reaman G, Heenen D, Meyers ML, Armstrong SA, Brown P, De Carvalho D, Jabado N, Marshall L, Rivera M, Smith M, Adamson PC, Barone A, Baumann C, Blackman S, Buenger V, Donoghue M, Duncan AD, Fox E, Gadbaw B, Hattersley M, Ho P, Jacobs I, Kelly MJ, Kieran M, Lesa G, Ligas F, Ludwinski D, McDonough J, Nikolova Z, Norga K, Senderowicz A, Taube T, Weiner S, Karres D, Vassal G.

Eur J Cancer. 2020 Nov;139:135-148. doi: 10.1016/j.ejca.2020.08.014. Epub 2020 Sep 26.

PMID: 32992153 

 

Clinical and Proteomic Correlates of Plasma ACE2 (Angiotensin-Converting Enzyme 2) in Human Heart Failure.

Chirinos JA, Cohen JB, Zhao L, Hanff T, Sweitzer N, Fang J, Corrales-Medina V, Anmar R, Morley M, Zamani P, Bhattacharya P, Brandimarto J, Jia Y, Basso MD, Wang Z, Ebert C, Ramirez-Valle F, Schafer PH, Seiffert D, Gordon DA, Cappola T.

Hypertension. 2020 Nov;76(5):1526-1536. doi: 10.1161/HYPERTENSIONAHA.120.15829. Epub 2020 Sep 28.

PMID: 32981365

 

Nonclinical safety assessment of epigenetic modulatory drugs: Current status and industry perspective.

Reynolds VL, Butler P, Abernathy MM, Aschenbrenner L, Best DD, Blank J, Crosby M, Custer L, Escobar PA, Kolaja K, Moggs J, Shuey D, Snyder C, Van Vleet T, Zhou J, Hart TK.

Regul Toxicol Pharmacol. 2020 Nov;117:104746. doi: 10.1016/j.yrtph.2020.104746. Epub 2020 Sep 8.

PMID: 32911461

 

Antithrombotic Effects of Combined PAR (Protease-Activated Receptor)-4 Antagonism and Factor Xa Inhibition.

Meah MN, Raftis J, Wilson SJ, Perera V, Garonzik SM, Murthy B, Everlof JG, Aronson R, Luettgen J, Newby DE.

Arterioscler Thromb Vasc Biol. 2020 Nov;40(11):2678-2685. doi: 10.1161/ATVBAHA.120.314960. Epub 2020 Sep 10.

PMID: 32907366 

 

Dissolution testing of modified release products with biorelevant media: An OrBiTo ring study using the USP apparatus III and IV.

Reppas C, Vrettos NN, Dressman J, Andreas CJ, Miyaji Y, Brown J, Etherson K, Hanley S, Karkossa F, Karlsson E, Klein S, Maier GM, McAllister M, Mistry N, Rosenblatt K, Schäfer KJ, Smith KL, Tomaszewska I, Williams J, Winge F, Vertzoni M.

Eur J Pharm Biopharm. 2020 Nov;156:40-49. doi: 10.1016/j.ejpb.2020.08.025. Epub 2020 Aug 31.

PMID: 32882421

 

Synthesis of stable-isotope-labeled N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide and N-(3-dimethylaminopropyl)-N'-ethylurea.

Cao K, Brailsford JA, Bonacorsi SJ Jr.

J Labelled Comp Radiopharm. 2020 Nov;63(13):526-530. doi: 10.1002/jlcr.3877. Epub 2020 Sep 7.

PMID: 32845523

 

Persistent IL-2 Receptor Signaling by IL-2/CD25 Fusion Protein Controls Diabetes in NOD Mice by Multiple Mechanisms.

Ward NC, Lui JB, Hernandez R, Yu L, Struthers M, Xie J, Santos Savio A, Dwyer CJ, Hsiung S, Yu A, Malek TR.

Diabetes. 2020 Nov;69(11):2400-2413. doi: 10.2337/db20-0186. Epub 2020 Aug 25.

PMID: 32843568

 

Repolarization studies using human stem cell-derived cardiomyocytes: Validation studies and best practice recommendations.

Gintant G, Kaushik EP, Feaster T, Stoelzle-Feix S, Kanda Y, Osada T, Smith G, Czysz K, Kettenhofen R, Lu HR, Cai B, Shi H, Herron TJ, Dang Q, Burton F, Pang L, Traebert M, Abassi Y, Pierson JB, Blinova K.

Regul Toxicol Pharmacol. 2020 Nov;117:104756. doi: 10.1016/j.yrtph.2020.104756. Epub 2020 Aug 19.

PMID: 32822771 

 

Best practices for detection, assessment and management of suspected immune-mediated liver injury caused by immune checkpoint inhibitors during drug development.

Regev A, Avigan MI, Kiazand A, Vierling JM, Lewis JH, Omokaro SO, Di Bisceglie AM, Fontana RJ, Bonkovsky HL, Freston JW, Uetrecht JP, Miller ED, Pehlivanov ND, Haque SA, Harrison MJ, Kullak-Ublick GA, Li H, Patel NN, Patwardhan M, Price KD, Watkins PB, Chalasani NP.

J Autoimmun. 2020 Nov;114:102514. doi: 10.1016/j.jaut.2020.102514. Epub 2020 Aug 5.

PMID: 32768244 

 

Incidence and prevalence of venous thromboembolism in Norway 2010-2017.

Ghanima W, Brodin E, Schultze A, Shepherd L, Lambrelli D, Ulvestad M, Ramagopalan S, Halvorsen S.

Thromb Res. 2020 Nov;195:165-168. doi: 10.1016/j.thromres.2020.07.011. Epub 2020 Jul 7.

PMID: 32707359 

 

Soluble SLAMF7 is a predictive biomarker for elotuzumab therapy.

Suzuki A, Kakugawa S, Miyoshi M, Hori M, Suzuki K, Furukawa Y, Ohta K.

Leukemia. 2020 Nov;34(11):3088-3090. doi: 10.1038/s41375-020-0860-7. Epub 2020 May 12.

PMID: 32398792 

 

Solid state nuclear magnetic resonance studies of hydroxypropylmethylcellulose acetyl succinate polymer, a useful carrier in pharmaceutical solid dispersions.

Pugliese A, Hawarden LE, Abraham A, Tobyn M, Blanc F.

Magn Reson Chem. 2020 Nov;58(11):1036-1048. doi: 10.1002/mrc.4984. Epub 2020 Feb 3.

PMID: 31880823

 

Proposed Best Practice Guidelines for Scientific Response Documents: A Consensus Statement from phactMI.

Hermes-DeSantis ER, Johnson RM, Redlich A, Patel B, Flanigan-Minnick A, Wnorowski S, Cortes MM, Han CW, Vine E, Sarwar H, Haydar R, Jamil A, Huang T, Sandhu SK, Reilly P.

Ther Innov Regul Sci. 2020 Nov;54(6):1303-1311. doi: 10.1007/s43441-020-00151-1. Epub 2020 Apr 20.

PMID: 33258092 

 

Mechanistic insights into viral clearance during the chromatography steps in antibody processes by using virus surrogates.

Dyer R, Song Y, Chen J, Bigelow E, McGinnis J, Jenkins L, Ghose S, Li ZJ.

Biotechnol Prog. 2020 Nov;36(6):e3057. doi: 10.1002/btpr.3057. Epub 2020 Aug 21.

PMID: 33405373

 

Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial.

Albiges L, Tannir NM, Burotto M, McDermott D, Plimack ER, Barthélémy P, Porta C, Powles T, Donskov F, George S, Kollmannsberger CK, Gurney H, Grimm MO, Tomita Y, Castellano D, Rini BI, Choueiri TK, Saggi SS, McHenry MB, Motzer RJ.

ESMO Open. 2020 Nov;5(6):e001079. doi: 10.1136/esmoopen-2020-001079.

PMID: 33246931 

 

Treatment Patterns and Relapses Among Newly Treated Multiple Sclerosis Patients From a Retrospective Claims Analysis.

Kantor D, Mehta R, Pelletier C, Tian M, Noxon V, Johnson BH, Bonafede M.

Clin Ther. 2020 Nov;42(11):2136-2147.e3. doi: 10.1016/j.clinthera.2020.09.014. Epub 2020 Nov 5.

PMID: 33160682

 

Nivolumab + ipilimumab (N+I) vs sunitinib (S) dans le traitement de première ligne du carcinome rénal avancé (aRCC) dans l’étude CheckMate 214 : suivi à 4 ans et analyse en sous-groupe des patients (pts) non néphrectomisés.

Albiges L, Tannir N, Burotto M, Mcdermott D, Plimack E, Barthélémy P, Porta C, Powles T, Donskov F, George S, Kollmannsberger C, Gurney H, Grimm M, Tomita Y, Castellano D, Rini B, Choueiri T, Shally Saggi S, Mchenry M, Motzer R.

Prog Urol. 2020 Nov;30(13):785-786. doi: 10.1016/j.purol.2020.07.155.

PMID: 33157721  

 

Considerations for setting occupational exposure limits for novel pharmaceutical modalities.

Graham J, Hillegass J, Schulze G.

Regul Toxicol Pharmacol. 2020 Oct 31:104813. doi: 10.1016/j.yrtph.2020.104813. Online ahead of print.

PMID: 33144077 

 

A Novel Approach for the Treatment of T Cell Malignancies: Targeting T Cell Receptor Vβ Families.

Wang J, Urbanska K, Sharma P, Nejati R, Shaw L, Lim MS, Schuster SJ, Jr DJP.

Vaccines (Basel). 2020 Oct 31;8(4):E631. doi: 10.3390/vaccines8040631.

PMID: 33142718

 

Biomarkers for Risk Stratification in Patients With Previously Untreated Follicular Lymphoma Receiving Anti-CD20-based Biological Therapy.

Sohani AR, Maurer MJ, Giri S, Pitcher B, Chadburn A, Said JW, Bartlett NL, Czuczman MS, Martin P, Rosenbaum CA, Jung SH, Leonard JP, Cheson BD, Hsi ED.

Am J Surg Pathol. 2020 Oct 30. doi: 10.1097/PAS.0000000000001609. Online ahead of print.

PMID: 33136585

 

Transporter activity changes in non-alcoholic steatohepatitis: assessment with plasma coproporphyrin I and III.

Chatterjee S, Mukherjee S, Sivaprasad Lvj S, Naik T, Gautam SS, Murali BV, Hadambar AA, Gunti GR, Kuchibhotla V, Deyati A, Basavanthappa S, Ramarao M, Mariappan TT, Zinker BA, Zhang Y, Sinz M, Shen H.

J Pharmacol Exp Ther. 2020 Oct 30:JPET-AR-2020-000291. doi: 10.1124/jpet.120.000291. Online ahead of print.

PMID: 33127749 

 

Immunoaffinity microflow liquid chromatography/tandem mass spectrometry for the quantitation of PD1 and PD-L1 in human tumor tissues.

Zhu Y, Zalaznick J, Sleczka B, Parrish K, Yang Z, Olah T, Shipkova P.

Rapid Commun Mass Spectrom. 2020 Oct 30;34(20):e8896. doi: 10.1002/rcm.8896.

PMID: 32666620

 

The Value of Hope: Patients' and Physicians' Preferences for Survival in Advanced Non-Small Cell Lung Cancer.

Hauber B, Penrod JR, Gebben D, Musallam L.

Patient Prefer Adherence. 2020 Oct 30;14:2093-2104. doi: 10.2147/PPA.S248295. eCollection 2020.

PMID: 33154633 

 

Mutant Isocitrate Dehydrogenase 1 Inhibitor Ivosidenib in Combination With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia.

DiNardo CD, Stein AS, Stein EM, Fathi AT, Frankfurt O, Schuh AC, Döhner H, Martinelli G, Patel PA, Raffoux E, Tan P, Zeidan AM, de Botton S, Kantarjian HM, Stone RM, Frattini MG, Lersch F, Gong J, Gianolio DA, Zhang V, Franovic A, Fan B, Goldwasser M, Daigle S, Choe S, Wu B, Winkler T, Vyas P.

J Clin Oncol. 2020 Oct 29:JCO2001632. doi: 10.1200/JCO.20.01632. Online ahead of print.

PMID: 33119479

 

Effect of initial treatment on health-related quality of life in patients with newly diagnosed multiple myeloma without immediate stem cell transplant intent: results from the Connect^® MM Registry.

Abonour R, Rifkin RM, Gasparetto C, Toomey K, Durie BGM, Hardin JW, Terebelo HR, Jagannath S, Narang M, Ailawadhi S, Omel JL, Lee HC, Srinivasan S, Kitali A, Agarwal A, Wagner L; CONNECT MM Registry Investigators.

Br J Haematol. 2020 Oct 29. doi: 10.1111/bjh.17131. Online ahead of print.

PMID: 33118614

 

Misannotated multi-nucleotide variants in public cancer genomics datasets lead to inaccurate mutation calls with significant implications.

Srinivasan S, Kalinava N, Aldana R, Li Z, van Hagen S, Rodenburg SYA, Wind-Rotolo M, Qian X, Sasson AS, Tang H, Kirov S.

Cancer Res. 2020 Oct 28:canres.2151.2020. doi: 10.1158/0008-5472.CAN-20-2151. Online ahead of print.

PMID: 33115802

 

Economic evaluation of nivolumab combined with ipilimumab in the first-line treatment of advanced melanoma in Japan.

Paly VF, Hikichi Y, Baker T, Itakura E, Chandran N, Harrison J.

J Med Econ. 2020 Oct 28:1-11. doi: 10.1080/13696998.2020.1830781. Online ahead of print.

PMID: 33000994

 

An Industry Perspective on Compatibility Assessment of Closed System Drug-Transfer Devices for Biologics.

Besheer A, Burton L, Galas RJ Jr, Gokhale K, Goldbach P, Hu Q, Mathews L, Muthurania K, Narasimhan C, Singh SN, Stokes ES, Weiser S, Zamiri C, Zhou S.

J Pharm Sci. 2020 Oct 27:S0022-3549(20)30663-8. doi: 10.1016/j.xphs.2020.10.047. Online ahead of print.

PMID: 33127425

 

What Went Wrong with Anticancer Nanomedicine Design and How to Make It Right.

Sun D, Zhou S, Gao W.

ACS Nano. 2020 Oct 27;14(10):12281-12290. doi: 10.1021/acsnano.9b09713. Epub 2020 Oct 6.

PMID: 33021091

 

Use of the ZDF rat to model dietary fat induced hypercoagulability is limited by progressive and fatal nephropathy.

Pugsley MK, Brooks MB, Fishman CE, Katavolos P, Chiang AY, Parish ST, Schultze AE, Pierson JB.

J Pharmacol Toxicol Methods. 2020 Oct 26:106933. doi: 10.1016/j.vascn.2020.106933. Online ahead of print.

PMID: 33122074 

 

Evaluation of hepatic uptake of OATP1B substrates by short term-cultured plated human hepatocytes: Comparison with isolated suspended hepatocytes.

Yoshikado T, Lee W, Toshimoto K, Morita K, Kiriake A, Chu X, Lee N, Kimoto E, Varma MVS, Kikuchi R, Scialis RJ, Shen H, Ishiguro N, Lotz R, Li AP, Kazuya M, Kusuhara H, Sugiyama Y.

J Pharm Sci. 2020 Oct 26:S0022-3549(20)30633-X. doi: 10.1016/j.xphs.2020.10.041. Online ahead of print.

PMID: 33122051

 

Reply to Ethan B. Ludmir, Zachary R. McCaw, and Lee-Jen Wei's Letter to the Editor re: Karim Fizazi, Charles G. Drake, Tomasz M. Beer, et al. Final Analysis of the Ipilimumab Versus Placebo Following Radiotherapy Phase III Trial in Postdocetaxel Metastatic Castration-resistant Prostate Cancer Identifies an Excess of Long-term Survivors. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.07.032. Interpreting the Effect of Ipilimumab following Radiotherapy for Patients with Postdocetaxel Metastatic Castration-resistant Prostate Cancer.

McHenry MB, Drake CG, Fizazi K.

Eur Urol. 2020 Oct 26:S0302-2838(20)30789-2. doi: 10.1016/j.eururo.2020.10.012. Online ahead of print.

PMID: 33121826 

 

A Phase I Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Ipilimumab in Chinese Patients with Select Advanced Solid Tumors.

Sheng J, Zhang L, Ma Y, Fang W, Zhao H, Bathena SP, Tendolkar A.

Oncologist. 2020 Oct 26. doi: 10.1002/onco.13577. Online ahead of print.

PMID: 33105036 

 

Modeling performance of sample collection sites using whole exome sequencing metrics.

Kalinava N, Apfel A, Cartmell R, Srinivasan S, Chien MS, Kim KI, Golhar R, Bednarz KE, Pant S, Szustakowski J, Chasalow SD, Sasson A, Kirov S.

Biotechniques. 2020 Oct 26. doi: 10.2144/btn-2020-0086. Online ahead of print.

PMID: 33103912 

 

Writing Your Next Medicinal Chemistry Article: Journal Bibliometrics and Guiding Principles for Industrial Authors.

Hatley RJD, Procopiou PA, McLachlan SP, Westendorf LE, Meanwell NA, Ewing WR, Macdonald SJF.

J Med Chem. 2020 Oct 26. doi: 10.1021/acs.jmedchem.0c01159. Online ahead of print.

PMID: 33103431

  

Nivolumab treatment in advanced non-small cell lung cancer: real-world long-term outcomes within overall and special populations (the UNIVOC study).

Assié JB, Corre R, Levra MG, Calvet CY, Gaudin AF, Grumberg V, Jouaneton B, Cotté FE, Chouaïd C.

Ther Adv Med Oncol. 2020 Oct 26;12:1758835920967237. doi: 10.1177/1758835920967237. eCollection 2020.

PMID: 33403011 

 

Azacitidine is removed effectively by hemodialysis.                                    

Beer AGE, Laille E, Neuwirt H, Mayer G, Stauder R.

Leuk Lymphoma. 2020 Oct 25:1-3. doi: 10.1080/10428194.2020.1838505. Online ahead of print.

PMID: 33100080 

 

Land O'Lakes Workshop on Microsampling: Enabling Broader Adoption.

Wickremsinhe ER, Ji QC, Gleason CR, Anderson M, Booth BP.

AAPS J. 2020 Oct 23;22(6):135. doi: 10.1208/s12248-020-00524-2.

PMID: 33098040 

 

Realizing the Potential of the Patient Perspective.

Simon TA, Khouri MS, Kou TD, Gomez-Caminero A.

Patient Prefer Adherence. 2020 Oct 22;14:2001-2007. doi: 10.2147/PPA.S257355. eCollection 2020.

PMID: 33132698 

 

Impact of virus-antibody interactions on viral clearance in anion exchange chromatography.

Hung J, Lam SF, Tan Z, Choy D, Chennamsetty N, Lewandowski A, Qi W, Lynch M, Ghose S, Li ZJ.

J Chromatogr A. 2020 Oct 22;1633:461635. doi: 10.1016/j.chroma.2020.461635. Online ahead of print.

PMID: 33128974

 

Long-term outcomes in Chinese patients with chronic hepatitis B receiving nucleoside/nucleotide analogue therapy in real-world clinical practice: 5-year results from the EVOLVE study.

Jia J, Shang J, Tang H, Jiang J, Ning Q, Dou X, Zhang S, Zhang M, Han T, Tan D, Zhou X, Chen G, Sheng J, Su Z, Chen H, Dai E, Ye Y, Guo Y, Shen Y, Yuan J, Wei Z, Zhu S; EVOLVE Study Group.

Antivir Ther. 2020 Oct 22. doi: 10.3851/IMP3372. Online ahead of print.

PMID: 33090970

 

Authors' response.

LaGoy A, Evangelou EA, Somogyi T, DiGangi EA.

J Forensic Sci. 2020 Oct 21. doi: 10.1111/1556-4029.14593. Online ahead of print.

PMID: 33085776 

 

Increasing cancer risk over calendar year in people with multiple sclerosis: a case-control study.

Zecca C, Disanto G, Sacco R, MacLachlan S, Kuhle J, Ramagopalan SV, Gobbi C.

J Neurol. 2020 Oct 21. doi: 10.1007/s00415-020-10170-5. Online ahead of print.

PMID: 33084939

 

First-line immunotherapy versus targeted therapy in patients with BRAF-mutant advanced melanoma: a real-world analysis.

Pavlick AC, Zhao R, Lee CH, Ritchings C, Rao S.

Future Oncol. 2020 Oct 21. doi: 10.2217/fon-2020-0643. Online ahead of print.

PMID: 33084375 

 

Synthesis and Biological Evaluation of a Carbamate-Containing Tubulysin Antibody-Drug Conjugate.

Cheng H, Cong Q, Dervin D, Stevens A, Vemuri K, Huber M, Juliano J, Cuison S, Sung J, Passmore D, Chong C, Greenbaum M, Kwok E, Jiang J, Pan C, Rao-Naik C, Rangan V, Kempe T, Tatum A, Deshpande S, Cardarelli P, Vite G, Gangwar S.

Bioconjug Chem. 2020 Oct 21;31(10):2350-2361. doi: 10.1021/acs.bioconjchem.0c00429. Epub 2020 Sep 11.

PMID: 32881482

 

Expamers: a new technology to control T cell activation.

Poltorak MP, Graef P, Tschulik C, Wagner M, Cletiu V, Dreher S, Borjan B, Fraessle SP, Effenberger M, Turk M, Busch DH, Plitzko J, Kugler DG, Ragan S, Schmidt T, Stemberger C, Germeroth L.

Sci Rep. 2020 Oct 20;10(1):17832. doi: 10.1038/s41598-020-74595-8.

PMID: 33082362 

 

Experimental model of congestive heart failure induced by transverse aortic constriction in BALB/c mice.

Tannu S, Allocco J, Yarde M, Wong P, Ma X.

J Pharmacol Toxicol Methods. 2020 Oct 20;106:106935. doi: 10.1016/j.vascn.2020.106935. Online ahead of print.

PMID: 33096237 

 

Azepino-indazoles as calcitonin gene-related peptide (CGRP) receptor antagonists.

Mercer SE, Chaturvedula PV, Conway CM, Cook DA, Davis CD, Pin SS, Macci R, Schartman R, Signor LJ, Widmann KA, Whiterock VJ, Chen P, Xu C, Herbst JJ, Kostich WA, Thalody G, Macor JE, Dubowchik GM.

Bioorg Med Chem Lett. 2020 Oct 20:127624. doi: 10.1016/j.bmcl.2020.127624. Online ahead of print.

PMID: 33096162

 

Identification of undiagnosed atrial fibrillation patients using a machine learning risk prediction algorithm and diagnostic testing (PULsE-AI): Study protocol for a randomised controlled trial.

Hill NR, Arden C, Beresford-Hulme L, Camm AJ, Clifton D, Davies DW, Farooqui U, Gordon J, Groves L, Hurst M, Lawton S, Lister S, Mallen C, Martin AC, McEwan P, Pollock KG, Rogers J, Sandler B, Sugrue DM, Cohen AT.

Contemp Clin Trials. 2020 Oct 19;99:106191. doi: 10.1016/j.cct.2020.106191. Online ahead of print.

PMID: 33091585 

 

A phase I, multicenter, dose-escalation study of avadomide in adult Japanese patients with advanced malignancies.

Hatake K, Chou T, Doi T, Terui Y, Kato H, Hirose T, Seo S, Pourdehnad M, Ogaki Y, Fujimoto H, Hagner PR, Yamamoto K.

Cancer Sci. 2020 Oct 19. doi: 10.1111/cas.14704. Online ahead of print.

PMID: 33075165 

 

Total Synthesis of Meayamycin and O-Acyl Analogues.

Gartshore C, Tadano S, Chanda PB, Sarkar A, Chowdari NS, Gangwar S, Zhang Q, Vite GD, Momirov J, Boger DL.

Org Lett. 2020 Oct 19. doi: 10.1021/acs.orglett.0c03308. Online ahead of print.

PMID: 33074680

 

Evolving use of real-world evidence in the regulatory process: a focus on immuno-oncology treatment and outcomes.

O'Donnell JC, T Kim Le, Dobrin R, Higashi M, Pereira A, Wagner S, Yang A, Hukkelhoven M.

Future Oncol. 2020 Oct 19. doi: 10.2217/fon-2020-0591. Online ahead of print.

PMID: 33074018 

 

Utilization of anticoagulants and predictors of treatment among hospitalized patients with atrial fibrillation in the USA.

Deitelzweig S, Dhamane AD, Di Fusco M, Russ C, Rosenblatt L, Lingohr-Smith M, Lin J.

J Med Econ. 2020 Oct 19:1-12. doi: 10.1080/13696998.2020.1832099. Online ahead of print.

PMID: 33021129

 

SPARC promotes insulin secretion through down-regulation of RGS4 protein in pancreatic β cells.

Hu L, He F, Huang M, Zhao Q, Cheng L, Said N, Zhou Z, Liu F, Dai YS.

Sci Rep. 2020 Oct 16;10(1):17581. doi: 10.1038/s41598-020-74593-w.

PMID: 33067534 

 

A Cost per Responder Model for Abatacept versus Adalimumab Among Rheumatoid Arthritis Patients with Seropositivity.

Park SH, Han X, Lobo F, Nanji S, Patel D.

Clinicoecon Outcomes Res. 2020 Oct 15;12:589-594. doi: 10.2147/CEOR.S263903. eCollection 2020.

PMID: 33116698 

 

Decreased immune response in monkeys administered a human T-effector cell agonist (OX40) antibody.

Gamse JT, Freebern W, Haynes Ii R, Simutis F, Pazian M, Crona J, Haggerty HG, Graziano M, Bunch RT.

Toxicol Appl Pharmacol. 2020 Oct 15;409:115285. doi: 10.1016/j.taap.2020.115285. Online ahead of print.

PMID: 33069749 

 

Cell-to-Medium Concentration Ratio Overshoot in the Uptake of Statins by Human Hepatocytes in Suspension, but Not in Monolayer: Kinetic Analysis Suggesting a Partial Loss of Functional OATP1Bs.

Lee W, Koyama S, Morita K, Kiriake A, Kikuchi R, Chu X, Lee N, Scialis RJ, Shen H, Kimoto E, Tremaine L, Ishiguro N, Lotz R, Maeda K, Kusuhara H, Sugiyama Y.

AAPS J. 2020 Oct 15;22(6):133. doi: 10.1208/s12248-020-00512-6.

PMID: 33063163 

 

Outcomes of the European Federation of Pharmaceutical Industries and Associations Oligonucleotide Working Group Survey on Nonclinical Practices and Regulatory Expectations for Therapeutic Oligonucleotide Safety Assessment.

Tessier Y, Achanzar W, Mihalcik L, Amuzie C, Andersson P, Parry JD, Moggs J, Whiteley LO.

Nucleic Acid Ther. 2020 Oct 15. doi: 10.1089/nat.2020.0892. Online ahead of print.

PMID: 33054599

 

Phase I and Pharmacokinetic Study of Romidepsin in Patients with Cancer and Hepatic Dysfunction: A National Cancer Institute Organ Dysfunction Working Group Study.

Connolly RM, Laille E, Vaishampayan U, Chung V, Kelly K, Dowlati A, Alese OB, Harvey RD, Haluska P, Siu LL, Kummar S, Piekarz R, Ivy SP, Anders NM, Downs M, O'Connor A, Scardina A, Saunders J, Rosner GL, Carducci MA, Rudek MA; ETCTN-9008 Study Team.

Clin Cancer Res. 2020 Oct 15;26(20):5329-5337. doi: 10.1158/1078-0432.CCR-20-1412. Epub 2020 Aug 14.

PMID: 32816943

 

IL15 Stimulation with TIGIT Blockade Reverses CD155-mediated NK-Cell Dysfunction in Melanoma.

Chauvin JM, Ka M, Pagliano O, Menna C, Ding Q, DeBlasio R, Sanders C, Hou J, Li XY, Ferrone S, Davar D, Kirkwood JM, Johnston RJ, Korman AJ, Smyth MJ, Zarour HM.

Clin Cancer Res. 2020 Oct 15;26(20):5520-5533. doi: 10.1158/1078-0432.CCR-20-0575. Epub 2020 Jun 26.

PMID: 32591463

 

Effect of coating excipients on chemical stability of active coated tablets.

Kestur U, Desai D, Zong Z, Abraham A, Fiske J.

Pharm Dev Technol. 2020 Oct 14:1-7. doi: 10.1080/10837450.2020.1832520. Online ahead of print.

PMID: 33021427

 

Serine-Selective Bioconjugation.

Vantourout JC, Adusumalli SR, Knouse KW, Flood DT, Ramirez A, Padial NM, Istrate A, Maziarz K, deGruyter JN, Merchant RR, Qiao JX, Schmidt MA, Deery MJ, Eastgate MD, Dawson PE, Bernardes GJL, Baran PS.

J Am Chem Soc. 2020 Oct 14;142(41):17236-17242. doi: 10.1021/jacs.0c05595. Epub 2020 Oct 5.

PMID: 32965106

 

Selective Capture and Recovery of Monoclonal Antibodies by Self-Assembling Supramolecular Polymers of High Affinity for Protein Binding.

Li Y, Lock LL, Mills J, Ou BS, Morrow M, Stern D, Wang H, Anderson CF, Xu X, Ghose S, Li ZJ, Cui H.

Nano Lett. 2020 Oct 14;20(10):6957-6965. doi: 10.1021/acs.nanolett.0c01297. Epub 2020 Sep 3.

PMID: 32852220

 

Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report.

Parrott N, Suarez-Sharp S, Kesisoglou F, Pathak SM, Good D, Wagner C, Dallmann A, Mullin J, Patel N, Riedmaier AE, Mitra A, Raines K, Butler J, Kakhi M, Li M, Zhao Y, Tsakalozou E, Flanagan T, Dressman J, Pepin X.

J Pharm Sci. 2020 Oct 13:S0022-3549(20)30608-0. doi: 10.1016/j.xphs.2020.09.058. Online ahead of print.

PMID: 33058891

 

CD155 on Tumor Cells Drives Resistance to Immunotherapy by Inducing the Degradation of the Activating Receptor CD226 in CD8⁺ T Cells.

Braun M, Aguilera AR, Sundarrajan A, Corvino D, Stannard K, Krumeich S, Das I, Lima LG, Meza Guzman LG, Li K, Li R, Salim N, Jorge MV, Ham S, Kelly G, Vari F, Lepletier A, Raghavendra A, Pearson S, Madore J, Jacquelin S, Effern M, Quine B, Koufariotis LT, Casey M, Nakamura K, Seo EY, Hölzel M, Geyer M, Kristiansen G, Taheri T, Ahern E, Hughes BGM, Wilmott JS, Long GV, Scolyer RA, Batstone MD, Landsberg J, Dietrich D, Pop OT, Flatz L, Dougall WC, Veillette A, Nicholson SE, Möller A, Johnston RJ, Martinet L, Smyth MJ, Bald T.

Immunity. 2020 Oct 13;53(4):805-823.e15. doi: 10.1016/j.immuni.2020.09.010.

PMID: 33053330

 

Productivity Loss and Associated Costs Among Employed Patients Receiving Disease-Modifying Treatment for Multiple Sclerosis.

Bonafede M, Mehta R, Kim G, Sruti I, Tian M, Pelletier C, Goldfarb N.

Pharmacoecon Open. 2020 Oct 13. doi: 10.1007/s41669-020-00233-8. Online ahead of print.

PMID: 33051856   

 

Continuous lenalidomide and low-dose dexamethasone in patients with transplant-ineligible newly diagnosed MM: FIRST trial subanalysis of Canadian/US patients.

Belch A, Bahlis N, White D, Cheung M, Chen C, Shustik C, Song K, Tosikyan A, Dispenzieri A, Anderson K, Brown D, Robinson S, Srinivasan S, Facon T.

Cancer Med. 2020 Oct 13. doi: 10.1002/cam4.3511. Online ahead of print.

PMID: 33049118 

 

Endogenous Coproporphyrin I and III Are Altered in Multidrug Resistance-Associated Protein 2-Deficient (TR^-) Rats.

Bezençon J, Saran C, Hussner J, Beaudoin JJ, Zhang Y, Shen H, Fallon JK, Smith PC, Meyer Zu Schwabedissen HE, Brouwer KLR.

J Pharm Sci. 2020 Oct 12:S0022-3549(20)30607-9. doi: 10.1016/j.xphs.2020.10.017. Online ahead of print.

PMID: 33058892

 

Combinations with allosteric SHP2 inhibitor TNO155 to block receptor tyrosine kinase signaling.

Hao HX, Liu C, Lu H, Wang H, Loo A, Zhang X, Yang G, Kowal C, Delach S, Wang Y, Goldoni S, Hastings WD, Wong K, Gao H, Meyer MJ, Moody S, LaMarche MJ, Engelman JA, Williams JA, Hammerman PS, Abrams TJ, Mohseni M, Caponigro G.

Clin Cancer Res. 2020 Oct 12:clincanres.2718.2020. doi: 10.1158/1078-0432.CCR-20-2718. Online ahead of print.

PMID: 33046519

 

Phase I Study of Lysine-Specific Demethylase-1 Inhibitor CC-90011 in Patients With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma.

Hollebecque A, Salvagni S, Plummer R, Isambert N, Niccoli P, Capdevila J, Curigliano G, Moreno V, Martin-Romano P, Baudin E, Arias M, Mora S, de Alvaro J, Di Martino J, Parra-Palau JL, Sánchez-Pérez T, Aronchik I, Filvaroff EH, Lamba M, Nikolova Z, de Bono JS.

Clin Cancer Res. 2020 Oct 12:clincanres.2380.2020. doi: 10.1158/1078-0432.CCR-20-2380. Online ahead of print.

PMID: 33046517 

 

Effects of azacitidine in 93 patients with IDH1/2 mutated acute myeloid leukemia/myelodysplastic syndromes: a French retrospective multicenter study.

Willekens C, Rahme R, Duchmann M, Vidal V, Saada V, Broutin S, Delahousse J, Renneville A, Marceau A, Clappier E, Uzunov M, Rossignol J, Pascal L, Simon L, Micol JB, Pasquier F, Raffoux E, Preudhomme C, Quivoron C, Itzykson R, Penard-Lacronique V, Paci A, Fenaux P, Attar EC, Frattini M, Braun T, Ades L, De Botton S.

Leuk Lymphoma. 2020 Oct 12:1-8. doi: 10.1080/10428194.2020.1832661. Online ahead of print.

PMID: 33043739

 

Nivolumab Plus Ipilimumab for Metastatic Castration-Resistant Prostate Cancer: Preliminary Analysis of Patients in the CheckMate 650 Trial.

Sharma P, Pachynski RK, Narayan V, Fléchon A, Gravis G, Galsky MD, Mahammedi H, Patnaik A, Subudhi SK, Ciprotti M, Simsek B, Saci A, Hu Y, Han GC, Fizazi K.

Cancer Cell. 2020 Oct 12;38(4):489-499.e3. doi: 10.1016/j.ccell.2020.08.007. Epub 2020 Sep 10.

PMID: 32916128

 

Conserved Interferon-γ Signaling Drives Clinical Response to Immune Checkpoint Blockade Therapy in Melanoma.

Grasso CS, Tsoi J, Onyshchenko M, Abril-Rodriguez G, Ross-Macdonald P, Wind-Rotolo M, Champhekar A, Medina E, Torrejon DY, Shin DS, Tran P, Kim YJ, Puig-Saus C, Campbell K, Vega-Crespo A, Quist M, Martignier C, Luke JJ, Wolchok JD, Johnson DB, Chmielowski B, Hodi FS, Bhatia S, Sharfman W, Urba WJ, Slingluff CL Jr, Diab A, Haanen JBAG, Algarra SM, Pardoll DM, Anagnostou V, Topalian SL, Velculescu VE, Speiser DE, Kalbasi A, Ribas A.

Cancer Cell. 2020 Oct 12;38(4):500-515.e3. doi: 10.1016/j.ccell.2020.08.005. Epub 2020 Sep 10.

PMID: 32916126

 

Clinical Characteristics of Acute Hepatitis E and Their Correlation with HEV Genotype 3 Subtypes in Italy.

Minosse C, Biliotti E, Lapa D, Rianda A, Marchili M, Luzzitelli I, Capobianchi MR, McPhee F, Garbuglia AR, D'Offizi G.

Pathogens. 2020 Oct 11;9(10):E832. doi: 10.3390/pathogens9100832.

PMID: 33050666 

 

An assessment of the hospital exemption landscape across European Member States: regulatory frameworks, use and impact.

Hills A, Awigena-Cook J, Genenz K, Ostertag M, Butler S, Eggimann AV, Hubert A.

Cytotherapy. 2020 Oct 9:S1465-3249(20)30847-1. doi: 10.1016/j.jcyt.2020.08.011. Online ahead of print.

PMID: 33046395

 

Discovery of CC-90011: A Potent and Selective Reversible Inhibitor of Lysine Specific Demethylase 1 (LSD1).

Kanouni T, Severin C, Cho RW, Yuen NY, Xu J, Shi L, Lai C, Del Rosario JR, Stansfield RK, Lawton LN, Hosfield D, O'Connell S, Kreilein MM, Tavares-Greco P, Nie Z, Kaldor SW, Veal JM, Stafford JA, Chen YK.

J Med Chem. 2020 Oct 9. doi: 10.1021/acs.jmedchem.0c00978. Online ahead of print.

PMID: 33034194

 

Population Pharmacokinetic Analysis of BMS-986166, a Novel Selective Sphingosine-1-Phosphate-1 Receptor Modulator, and Exposure-Response Assessment of Lymphocyte Counts and Heart Rate in Healthy Participants.

Bihorel S, Singhal S, Shevell D, Sun H, Xie J, Basdeo S, Liu A, Dutta S, Ludwig E, Huang H, Lin KJ, Fura A, Throup J, Girgis IG.

Clin Pharmacol Drug Dev. 2020 Oct 8. doi: 10.1002/cpdd.878. Online ahead of print.

PMID: 33090733

 

A Detailed Protocol for Generation of Therapeutic Antibodies with Galactosylated Glycovariants at Laboratory Scale Using In-Vitro Glycoengineering Technology.

Voruganti S, Xu J, Li X, Balakrishnan G, Singh SM, Kar SR, Das TK.

J Pharm Sci. 2020 Oct 8:S0022-3549(20)30590-6. doi: 10.1016/j.xphs.2020.09.056. Online ahead of print.

PMID: 33039440

 

Appropriate Analysis of Duration of Response Data in Cancer Trials-Reply.

Weller M, Tatsuoka K, Reardon DA.

JAMA Oncol. 2020 Oct 8. doi: 10.1001/jamaoncol.2020.4664. Online ahead of print.

PMID: 33030510 

 

Abatacept: A Review of the Treatment of Polyarticular-Course Juvenile Idiopathic Arthritis.

Brunner HI, Wong R, Nys M, Kou TD, Dominique A, Martini A, Lovell DJ, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG).

Paediatr Drugs. 2020 Oct 8. doi: 10.1007/s40272-020-00422-2. Online ahead of print.

PMID: 33029724 

 

Strategies for Setting Patient-Centric Commercial Specifications for Biotherapeutic Products.

Ruesch MN, Benetti L, Berkay E, Cirelli DJ, Frantz N, Gastens MH, Kelley WP, Kretsinger J, Lewis M, Novick S, Rellahan B, Pack L, Stroop CJM, Subashi A, Yin P, Zeng M, Stults J.

J Pharm Sci. 2020 Oct 7:S0022-3549(20)30579-7. doi: 10.1016/j.xphs.2020.09.048. Online ahead of print.

PMID: 33035537 

 

Tazemetostat in advanced epithelioid sarcoma with loss of INI1/SMARCB1: an international, open-label, phase 2 basket study.

Gounder M, Schöffski P, Jones RL, Agulnik M, Cote GM, Villalobos VM, Attia S, Chugh R, Chen TW, Jahan T, Loggers ET, Gupta A, Italiano A, Demetri GD, Ratan R, Davis LE, Mir O, Dileo P, Van Tine BA, Pressey JG, Lingaraj T, Rajarethinam A, Sierra L, Agarwal S, Stacchiotti S.

Lancet Oncol. 2020 Oct 6:S1470-2045(20)30451-4. doi: 10.1016/S1470-2045(20)30451-4. Online ahead of print.

PMID: 33035459

 

Use of Drug Release Testing to Evaluate the Retention of Abuse-Deterrent Properties of Polyethylene Oxide Matrix Tablets.

Meruva S, Rezaei L, Thool P, Donovan MD.

AAPS PharmSciTech. 2020 Oct 6;21(7):270. doi: 10.1208/s12249-020-01804-y.

PMID: 33025237

 

Comparative effectiveness study of chemotherapy in follicular lymphoma patients in the rituximab era: a Japanese claims database study.

Tsutsué S, Tobinai K, Yi J, Crawford B.

Future Oncol. 2020 Oct 6. doi: 10.2217/fon-2020-0832. Online ahead of print.

PMID: 33021099 

 

Ultrahigh-Throughput and Chromatography-Free Bioanalysis of Polar Analytes with Acoustic Ejection Mass Spectrometry.

Wagner A, Zhang J, Liu C, Covey TR, Olah TV, Weller HBN, Shou WZ.

Anal Chem. 2020 Oct 6;92(19):13525-13531. doi: 10.1021/acs.analchem.0c03006. Epub 2020 Sep 25.

PMID: 32926623

 

Control of leached beta-glucan levels from depth filters by an improved depth filtration flush strategy.

Holstein M, Jang D, Urrea C, Botta LS, Grimm W, Ghose S, Li ZJ.

Biotechnol Prog. 2020 Oct 5:e3086. doi: 10.1002/btpr.3086. Online ahead of print.

PMID: 33016571

 

Long-Term Treatment with Apixaban in Patients with Atrial Fibrillation: Outcomes during the Open-Label Extension following AVERROES.

Benz AP, Eikelboom JW, Yusuf S, Hohnloser SH, Kahl A, Beresh H, Balasubramanian K, Healey JS, Connolly SJ.

Thromb Haemost. 2020 Oct 4. doi: 10.1055/s-0040-1717115. Online ahead of print.

PMID: 33011964 

 

Effectiveness and Safety of Oral Anticoagulants Among Non-Valvular Atrial FibrillationPatients with Polypharmacy.

Lip GYH, Keshishian A, Kang A, Dhamane AD, Luo X, Klem C, Rosenblatt L, Mardekian J, Jiang J, Yuce H, Deitelzweig S.

Eur Heart J Cardiovasc Pharmacother. 2020 Oct 3:pvaa117. doi: 10.1093/ehjcvp/pvaa117. Online ahead of print.

PMID: 33010157

 

Defining and Manipulating B Cell Immunodominance Hierarchies to Elicit Broadly Neutralizing Antibody Responses against Influenza Virus.

Amitai A, Sangesland M, Barnes RM, Rohrer D, Lonberg N, Lingwood D, Chakraborty AK.

Cell Syst. 2020 Oct 2:S2405-4712(20)30335-5. doi: 10.1016/j.cels.2020.09.005. Online ahead of print.

PMID: 33031741

 

Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib: The CheckMate 040 Randomized Clinical Trial.

Yau T, Kang YK, Kim TY, El-Khoueiry AB, Santoro A, Sangro B, Melero I, Kudo M, Hou MM, Matilla A, Tovoli F, Knox JJ, Ruth He A, El-Rayes BF, Acosta-Rivera M, Lim HY, Neely J, Shen Y, Wisniewski T, Anderson J, Hsu C.

JAMA Oncol. 2020 Oct 1:e204564. doi: 10.1001/jamaoncol.2020.4564. Online ahead of print.

PMID: 33001135 

 

Defining the clinical, molecular and imaging spectrum of adaptor protein complex 4-associated hereditary spastic paraplegia.

Ebrahimi-Fakhari D, Teinert J, Behne R, Wimmer M, D'Amore A, Eberhardt K, Brechmann B, Ziegler M, Jensen DM, Nagabhyrava P, Geisel G, Carmody E, Shamshad U, Dies KA, Yuskaitis CJ, Salussolia CL, Ebrahimi-Fakhari D, Pearson TS, Saffari A, Ziegler A, Kölker S, Volkmann J, Wiesener A, Bearden DR, Lakhani S, Segal D, Udwadia-Hegde A, Martinuzzi A, Hirst J, Perlman S, Takiyama Y, Xiromerisiou G, Vill K, Walker WO, Shukla A, Dubey Gupta R, Dahl N, Aksoy A, Verhelst H, Delgado MR, Kremlikova Pourova R, Sadek AA, Elkhateeb NM, Blumkin L, Brea-Fernández AJ, Dacruz-Álvarez D, Smol T, Ghoumid J, Miguel D, Heine C, Schlump JU, Langen H, Baets J, Bulk S, Darvish H, Bakhtiari S, Kruer MC, Lim-Melia E, Aydinli N, Alanay Y, El-Rashidy O, Nampoothiri S, Patel C, Beetz C, Bauer P, Yoon G, Guillot M, Miller SP, Bourinaris T, Houlden H, Robelin L, Anheim M, Alamri AS, Mahmoud AAH, Inaloo S, Habibzadeh P, Faghihi MA, Jansen AC, Brock S, Roubertie A, Darras BT, Agrawal PB, Santorelli FM, Gleeson J, Zaki MS, Sheikh SI, Bennett JT, Sahin M.

Brain. 2020 Oct 1;143(10):2929-2944. doi: 10.1093/brain/awz307.

PMID: 32979048

Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab in Untreated Oral Cavity Squamous Cell Carcinoma: A Phase 2 Open-Label Randomized Clinical Trial.

Schoenfeld JD, Hanna GJ, Jo VY, Rawal B, Chen YH, Catalano PS, Lako A, Ciantra Z, Weirather JL, Criscitiello S, Luoma A, Chau N, Lorch J, Kass JI, Annino D, Goguen L, Desai A, Ross B, Shah HJ, Jacene HA, Margalit DN, Tishler RB, Wucherpfennig KW, Rodig SJ, Uppaluri R, Haddad RI.

JAMA Oncol. 2020 Oct 1;6(10):1563-1570. doi: 10.1001/jamaoncol.2020.2955.

PMID: 32852531 

 

Annulation reaction enables the identification of an exocyclic amide tricyclic chemotype as retinoic acid Receptor-Related orphan receptor gamma (RORγ/RORc) inverse agonists.

Marcoux D, Bertrand MB, Weigelt CA, Yip S, Galella M, Park H, Wu DR, Wang J, Yarde M, Cvijic ME, Li S, Hynes J Jr, Tino JA, Zhao Q, Dhar TGM.

Bioorg Med Chem Lett. 2020 Oct 1;30(19):127466. doi: 10.1016/j.bmcl.2020.127466. Epub 2020 Aug 5.

PMID: 32763309

 

Discovery of 2,6-difluorobenzyl ether series of phenyl ((R)-3-phenylpyrrolidin-3-yl)sulfones as surprisingly potent, selective and orally bioavailable RORγt inverse agonists.

Duan JJ, Jiang B, Lu Z, Stachura S, Weigelt CA, Sack JS, Khan J, Ruzanov M, Wu DR, Yarde M, Shen DR, Zhao Q, Salter-Cid LM, Carter PH, Murali Dhar TG.

Bioorg Med Chem Lett. 2020 Oct 1;30(19):127441. doi: 10.1016/j.bmcl.2020.127441. Epub 2020 Jul 29.

PMID: 32736080

 

Nivolumab in Patients with Advanced Platinum-resistant Urothelial Carcinoma: Efficacy, Safety, and Biomarker Analyses with Extended Follow-up from CheckMate 275.

Galsky MD, Saci A, Szabo PM, Han GC, Grossfeld G, Collette S, Siefker-Radtke A, Necchi A, Sharma P.

Clin Cancer Res. 2020 Oct 1;26(19):5120-5128. doi: 10.1158/1078-0432.CCR-19-4162. Epub 2020 Jun 12.

PMID: 32532789

 

Low-dose radiation treatment enhances systemic antitumor immune responses by overcoming the inhibitory stroma.

Barsoumian HB, Ramapriyan R, Younes AI, Caetano MS, Menon H, Comeaux NI, Cushman TR, Schoenhals JE, Cadena AP, Reilly TP, Chen D, Masrorpour F, Li A, Hong DS, Diab A, Nguyen QN, Glitza I, Ferrarotto R, Chun SG, Cortez MA, Welsh J.

J Immunother Cancer. 2020 Oct;8(2):e000537. doi: 10.1136/jitc-2020-000537.

PMID: 33106386 

 

Evolving impact of long-term survival results on metastatic melanoma treatment.

Michielin O, Atkins MB, Koon HB, Dummer R, Ascierto PA.

J Immunother Cancer. 2020 Oct;8(2):e000948. doi: 10.1136/jitc-2020-000948.

PMID: 33037115 

 

Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study.

Wysham CH, Rosenstock J, Vetter ML, Wang H, Hardy E, Iqbal N.

BMJ Open Diabetes Res Care. 2020 Oct;8(1):e000773. doi: 10.1136/bmjdrc-2019-000773.

PMID: 33037036 

 

Accelerating protein biomarker discovery and translation from proteomics research for clinical utility.

Chen J, Zheng N.

Bioanalysis. 2020 Oct;12(20):1469-1481. doi: 10.4155/bio-2020-0198. Epub 2020 Oct 2.

PMID: 33006485

 

Immunoaffinity enrichment LC-MS/MS quantitation of CDH17 in tissues.

Caporuscio C, Holmes D, Olah TV, Shipkova P.

Bioanalysis. 2020 Oct;12(20):1439-1447. doi: 10.4155/bio-2020-0162. Epub 2020 Oct 2.

PMID: 33006478

 

Technology outlook for real-time quality attribute and process parameter monitoring in biopharmaceutical development-A review.

Wasalathanthri DP, Rehmann MS, Song Y, Gu Y, Mi L, Shao C, Chemmalil L, Lee J, Ghose S, Borys MC, Ding J, Li ZJ.

Biotechnol Bioeng. 2020 Oct;117(10):3182-3198. doi: 10.1002/bit.27461. Epub 2020 Jul 1.

PMID: 32946122 

 

Physiologically based pharmacokinetic modeling to assess metabolic drug-drug interaction risks and inform the drug label for fedratinib.

Wu F, Krishna G, Surapaneni S.

Cancer Chemother Pharmacol. 2020 Oct;86(4):461-473. doi: 10.1007/s00280-020-04131-y. Epub 2020 Sep 4.

PMID: 32886148 

 

Single-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites Alone and in Combination with Gemfibrozil, Itraconazole, or Rifampin in Healthy Subjects: A Randomized, Parallel-Group, Open-Label Study.

Tran JQ, Zhang P, Ghosh A, Liu L, Syto M, Wang X, Palmisano M.

Adv Ther. 2020 Oct;37(10):4381-4395. doi: 10.1007/s12325-020-01473-0. Epub 2020 Aug 28.

PMID: 32857315

 

Phenome-wide Mendelian randomization mapping the influence of the plasma proteome on complex diseases.

Zheng J, Haberland V, Baird D, Walker V, Haycock PC, Hurle MR, Gutteridge A, Erola P, Liu Y, Luo S, Robinson J, Richardson TG, Staley JR, Elsworth B, Burgess S, Sun BB, Danesh J, Runz H, Maranville JC, Martin HM, Yarmolinsky J, Laurin C, Holmes MV, Liu JZ, Estrada K, Santos R, McCarthy L, Waterworth D, Nelson MR, Smith GD, Butterworth AS, Hemani G, Scott RA, Gaunt TR.

Nat Genet. 2020 Oct;52(10):1122-1131. doi: 10.1038/s41588-020-0682-6. Epub 2020 Sep 7.

PMID: 32895551

 

Current status and future opportunities for incorporation of dissolution data in PBPK modeling for pharmaceutical development and regulatory applications: OrBiTo consortium commentary.

Jamei M, Abrahamsson B, Brown J, Bevernage J, Bolger MB, Heimbach T, Karlsson E, Kotzagiorgis E, Lindahl A, McAllister M, Mullin JM, Pepin X, Tistaert C, Turner DB, Kesisoglou F.

Eur J Pharm Biopharm. 2020 Oct;155:55-68. doi: 10.1016/j.ejpb.2020.08.005. Epub 2020 Aug 8.

PMID: 32781025

 

IL-1 induces mitochondrial translocation of IRAK2 to suppress oxidative metabolism in adipocytes.

Zhou H, Wang H, Yu M, Schugar RC, Qian W, Tang F, Liu W, Yang H, McDowell RE, Zhao J, Gao J, Dongre A, Carman JA, Yin M, Drazba JA, Dent R, Hine C, Chen YR, Smith JD, Fox PL, Brown JM, Li X.

Nat Immunol. 2020 Oct;21(10):1219-1231. doi: 10.1038/s41590-020-0750-1. Epub 2020 Aug 10.

PMID: 32778760

 

Corrigendum to "Effectiveness and Safety of Oral Anticoagulants in Adults with Non-valvular Atrial Fibrillation Patients and Concomitant Coronary/Peripheral Artery Disease" American Journal of Medicine 131:09 (2018): 1074-1085.e4.

Lopes RD, Steffel J, Di Fusco M, Keshishian A, Luo X, Li X, Masseria C, Hamilton M, Friend K, Gupta K, Mardekian J, Pan X, Baser O, Jones WS.

Am J Med. 2020 Oct;133(10):1229-1238. doi: 10.1016/j.amjmed.2020.06.003. Epub 2020 Aug 5.

PMID: 32771226

 

Infections in patients with multiple sclerosis: A national cohort study in Sweden.

Castelo-Branco A, Chiesa F, Conte S, Bengtsson C, Lee S, Minton N, Niemcryk S, Lindholm A, Rosenlund M, Piehl F, Montgomery S.

Mult Scler Relat Disord. 2020 Oct;45:102420. doi: 10.1016/j.msard.2020.102420. Epub 2020 Jul 23.

PMID: 32736217 

 

Detection of Weak Organic Anion-Transporting Polypeptide 1B Inhibition by Probenecid with Plasma-Based Coproporphyrin in Humans.

Zhang Y, Holenarsipur VK, Kandoussi H, Zeng J, Mariappan TT, Sinz M, Shen H.

Drug Metab Dispos. 2020 Oct;48(10):841-848. doi: 10.1124/dmd.120.000076. Epub 2020 Jul 28.

PMID: 32723847

 

Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design.

Khushalani NI, Diab A, Ascierto PA, Larkin J, Sandhu S, Sznol M, Koon HB, Jarkowski A, Zhou M, Statkevich P, Geese WJ, Long GV.

Future Oncol. 2020 Oct;16(28):2165-2175. doi: 10.2217/fon-2020-0351. Epub 2020 Jul 29.

PMID: 32723187 

  

Absence of OATP1B (Organic Anion-Transporting Polypeptide) Induction by Rifampin in Cynomolgus Monkeys: Determination Using the Endogenous OATP1B Marker Coproporphyrin and Tissue Gene Expression.

Zhang Y, Chen C, Chen SJ, Chen XQ, Shuster DJ, Puszczalo PD, Fancher RM, Yang Z, Sinz M, Shen H.

J Pharmacol Exp Ther. 2020 Oct;375(1):139-151. doi: 10.1124/jpet.120.000139. Epub 2020 Jul 27.

PMID: 32719071

 

Correction to: Real-World Recurrence Rates and Economic Burden in Patients with Resected Early-Stage Melanoma.

Jang S, Poretta T, Bhagnani T, Harshaw Q, Burke M, Rao S.

Dermatol Ther (Heidelb). 2020 Oct;10(5):1001. doi: 10.1007/s13555-020-00422-7.

PMID: 32683664 

 

Impact of adverse event reports from marketing authorization holder-sponsored patient support programs on the performance of signal detection in pharmacovigilance.

Lee I, Lee TA, Crawford SY, Kilpatrick RD, Calip GS, Jokinen JD.

Expert Opin Drug Saf. 2020 Oct;19(10):1357-1366. doi: 10.1080/14740338.2020.1792883. Epub 2020 Jul 27.

PMID: 32662668

 

Human ileal organoid model recapitulates clinical incidence of diarrhea associated with small molecule drugs.

Belair DG, Visconti RJ, Hong M, Marella M, Peters MF, Scott CW, Kolaja KL.

Toxicol In Vitro. 2020 Oct;68:104928. doi: 10.1016/j.tiv.2020.104928. Epub 2020 Jul 3.

PMID: 32622998 

  

Skin sensitization in silico protocol.

Johnson C, Ahlberg E, Anger LT, Beilke L, Benigni R, Bercu J, Bobst S, Bower D, Brigo A, Campbell S, Cronin MTD, Crooks I, Cross KP, Doktorova T, Exner T, Faulkner D, Fearon IM, Fehr M, Gad SC, Gervais V, Giddings A, Glowienke S, Hardy B, Hasselgren C, Hillegass J, Jolly R, Krupp E, Lomnitski L, Magby J, Mestres J, Milchak L, Miller S, Muster W, Neilson L, Parakhia R, Parenty A, Parris P, Paulino A, Paulino AT, Roberts DW, Schlecker H, Stidl R, Suarez-Rodrigez D, Szabo DT, Tice RR, Urbisch D, Vuorinen A, Wall B, Weiler T, White AT, Whritenour J, Wichard J, Woolley D, Zwickl C, Myatt GJ.

Regul Toxicol Pharmacol. 2020 Oct;116:104688. doi: 10.1016/j.yrtph.2020.104688. Epub 2020 Jul 1.

PMID: 32621976 

 

A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide.

Gamberi B, Berthou C, Hernandez M, Semenzato G, Tholouli E, Hájek R, Caers J, Dimopoulos M, Minnema MC, Andreasson B, Parreira J, Crotty G, Remes K, Kueenburg E, Rosettani B, Di Micco A, Peters S, Bacon P, Blau IW.

Clin Lymphoma Myeloma Leuk. 2020 Oct;20(10):e629-e644. doi: 10.1016/j.clml.2020.05.006. Epub 2020 May 13.

PMID: 32605897

 

Analysis of real-world PD-L1 IHC 28-8 and 22C3 pharmDx assay utilisation, turnaround times and analytical concordance across multiple tumour types.

Krigsfeld GS, Prince EA, Pratt J, Chizhevsky V, William Ragheb J, Novotny J Jr, Huron D.

J Clin Pathol. 2020 Oct;73(10):656-664. doi: 10.1136/jclinpath-2020-206466. Epub 2020 Jun 26.

PMID: 32591352 

 

Real-World Recurrence Rates and Economic Burden in Patients with Resected Early-Stage Melanoma.

Jang S, Poretta T, Bhagnani T, Harshaw Q, Burke M, Rao S.

Dermatol Ther (Heidelb). 2020 Oct;10(5):985-999. doi: 10.1007/s13555-020-00404-9. Epub 2020 Jun 16.

PMID: 32548707 

 

Quality by design (QbD) approach to match tablet glossiness.

Mansuri N, Patel K, Mehta M, Vyas G, Reddy JP, Shah T, Steinbach D, Desai D.

Pharm Dev Technol. 2020 Oct;25(8):1010-1017. doi: 10.1080/10837450.2020.1772291. Epub 2020 Jun 12.

PMID: 32432492

 

Creating E-Labeling Platforms: An Industry Vision.

Roberts K, Thakkar R, Autor D, Bisordi F, Fitton H, Garner C, Garvin M, Honig P, Hukkelhoven M, Kowalski R, Milligan S, O'Dowd L, Olmstead S, Reilly E, Robertson AS, Rohrer M, Stewart J, Taisey M, Van Baelen K, Wegner M.

Clin Pharmacol Ther. 2020 Oct;108(4):716-718. doi: 10.1002/cpt.1865. Epub 2020 May 19.

PMID: 32337707 

 

Integration of Acoustic Liquid Handling into Quantitative Analysis of Biological Matrix Samples.

Wang L, Dalglish G, Ouyang Z, David-Brown DG, Chiriac C, Duo J, Kozhich A, Ji QC, Peterson JE.

SLAS Technol. 2020 Oct;25(5):463-473. doi: 10.1177/2472630320915844. Epub 2020 Apr 30.

PMID: 32351162

 

Age-dependent cut-offs for pathological deep gray matter and thalamic volume loss using Jacobian integration.

Opfer R, Krüger J, Spies L, Hamann M, Wicki CA, Kitzler HH, Gocke C, Silva D, Schippling S.

Neuroimage Clin. 2020 Oct;28:102478. doi: 10.1016/j.nicl.2020.102478. Epub 2020 Oct 27.

PMID: 33269702 

 

Single-Dose Pharmacokinetics, Safety, and Tolerability of Avadomide (CC-122) in Subjects With Mild, Moderate, or Severe Renal Impairment.

Li Y, MacGorman K, Liu L, Chen J, Hoffmann M, Palmisano M, Zhou S.

Clin Pharmacol Drug Dev. 2020 Oct;9(7):785-796. doi: 10.1002/cpdd.760. Epub 2019 Dec 31.

PMID: 31891240

  

Nivolumab in Advanced Hepatocellular Carcinoma: Safety Profile and Select Treatment-Related Adverse Events From the CheckMate 040 Study.

Julien K, Leung HT, Fuertes C, Mori M, Wang MJ, Teo J, Weiss L, Hamilton S, DiFebo H, Noh YJ, Galway A, Koh J, Brutcher E, Zhao H, Shen Y, Tschaika M, To YY.

Oncologist. 2020 Oct;25(10):e1532-e1540. doi: 10.1634/theoncologist.2019-0591. Epub 2020 Aug 24.

PMID: 33400305 

 

Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review.

Bolden J, Knutsen C, Levin J, Milne C, Morris T, Mozier N, Spreitzer I, von Wintzingerode F.

PDA J Pharm Sci Technol. 2020 Sep-Oct;74(5):602-611. doi: 10.5731/pdajpst.2020.012187. Epub 2020 Aug 14.

PMID: 32817324

 

Healthcare utilization and total costs of care among patients with advanced metastatic gastric and esophageal cancer.

Abraham P, Wang L, Jiang Z, Gricar J, Tan H, Kelly RJ.

Future Oncol. 2020 Sep 30. doi: 10.2217/fon-2020-0516. Online ahead of print.

PMID: 32996811 

 

Cobalt-Catalyzed C(sp²)-C(sp³) Suzuki-Miyaura Cross Coupling.

Ludwig JR, Simmons EM, Wisniewski SR, Chirik PJ.

Org Lett. 2020 Sep 30. doi: 10.1021/acs.orglett.0c02934. Online ahead of print.

PMID: 32996312

 

Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma.

Robert C, Long GV, Brady B, Dutriaux C, Di Giacomo AM, Mortier L, Rutkowski P, Hassel JC, McNeil CM, Kalinka EA, Lebbé C, Charles J, Hernberg MM, Savage KJ, Chiarion-Sileni V, Mihalcioiu C, Mauch C, Arance A, Cognetti F, Ny L, Schmidt H, Schadendorf D, Gogas H, Zoco J, Re S, Ascierto PA, Atkinson V.

J Clin Oncol. 2020 Sep 30:JCO2000995. doi: 10.1200/JCO.20.00995. Online ahead of print.

PMID: 32997575

 

COVID-19: A Catalyst to Accelerate Global Regulatory Transformation.

Stewart J, Honig P, AlJuburi L, Autor D, Berger S, Brady P, Fitton H, Garner C, Garvin M, Hukkelhoven M, Kowalski R, Milligan S, O'Dowd L, Reilly E, Roberts K, Robertson AS, Taisey M, Thakkar R, Van Baelen K, Wegner M.

Clin Pharmacol Ther. 2020 Sep 29:10.1002/cpt.2046. doi: 10.1002/cpt.2046. Online ahead of print.

PMID: 32990986 

 

Treatment patterns and clinical outcomes of tyrosine kinase inhibitors in chronic-phase CML in clinical practice: 3-year European SIMPLICITY data.

Gambacorti-Passerini C, Chen C, Davis C, Sen GP, Guyan C, Hehlmann R, Michallet M, Paquette R, Goldberg SL.

Eur J Haematol. 2020 Sep 28. doi: 10.1111/ejh.13524. Online ahead of print.

PMID: 32989776

 

Impact of polysorbate 80 grade on the interfacial properties and interfacial stress induced subvisible particle formation in monoclonal antibodies.

Vaclaw C, Merritt K, Pringle V, Whitaker N, Gokhale M, Carvalho T, Pan D, Liu Z, Bindra D, Khossravi M, Bolgar M, Volkin DB, Ogunyankin MO, Dhar P.

J Pharm Sci. 2020 Sep 25:S0022-3549(20)30565-7. doi: 10.1016/j.xphs.2020.09.035. Online ahead of print.

PMID: 32987092

 

Drug-induced cholestasis assay in primary hepatocytes.

Van Brantegem P, Chatterjee S, De Bruyn T, Annaert P, Deferm N.

MethodsX. 2020 Sep 25;7:101080. doi: 10.1016/j.mex.2020.101080. eCollection 2020.

PMID: 33088729 

 

Reverse-phase HPLC purification for an extremely unstable glucuronide metabolite.

Sun D, Wu DR, Li P, Yip H, Mathur A.

J Pharm Biomed Anal. 2020 Sep 25;192:113651. doi: 10.1016/j.jpba.2020.113651. Online ahead of print.

PMID: 33010500

 

Development of low dose micro-tablets by high shear wet granulation process.

Gupta S, Thool P, Meruva S, Li J, Patel J, Agrawal A, Karki S, Bowen W, Mitra B.

Int J Pharm. 2020 Sep 25;587:119571. doi: 10.1016/j.ijpharm.2020.119571. Epub 2020 Jul 9.

PMID: 32652180

 

To Maintain Formulation Composition Similarity of Coated Tablets of Different Strengths: Should Coating be Based on Core Tablet Weight or Surface Area?

Reddy JP, Vyas G, Patel R, Rana S, Mansuri N, Dimuthu J, Shah T, Desai D.

Pharm Res. 2020 Sep 24;37(10):201. doi: 10.1007/s11095-020-02926-5.

PMID: 32968862

 

Collaborations between Clinical Pharmacologists in Japan and in the United States - Report from the IQ CPLG and JPMA CPTF Meeting in Tokyo, Japan.

Zhu T, Kayama M, Girish S, Sinha V, Bello A, Kawaguchi A, Czerniak R, Nagao L.

Clin Transl Sci. 2020 Sep 24. doi: 10.1111/cts.12853. Online ahead of print.

PMID: 32969589

 

First-in-Human, Single- and Multiple-Ascending-Dose Studies in Healthy Subjects to Assess Pharmacokinetics, Pharmacodynamics, and Safety/Tolerability of Iberdomide, a Novel Cereblon E3 Ligase Modulator.

Ye Y, Gaudy A, Schafer P, Thomas M, Weiss D, Chen N, Liu L, Xue Y, Carayannopoulos L, Palmisano M.

Clin Pharmacol Drug Dev. 2020 Sep 23. doi: 10.1002/cpdd.869. Online ahead of print.

PMID: 32969202

 

Cost and burden of poor anticoagulation control with vitamin K antagonists in patients with nonvalvular atrial fibrillation in Spain.

Barrios V, Cinza-Sanjurjo S, Gavín O, Egocheaga I, Burgos-Pol R, Soto J, Polanco C, Suárez J, Casado MÁ.

Rev Esp Cardiol (Engl Ed). 2020 Sep 23:S1885-5857(20)30372-8. doi: 10.1016/j.rec.2020.06.033. Online ahead of print.

PMID: 32980294 

 

Evaluation of iberdomide and cytochrome p450 drug-drug interaction potential in vitro and in a phase 1 study in healthy subjects.

Gaudy A, Atsriku C, Ye Y, MacGorman K, Liu L, Xue Y, Surapaneni S, Palmisano M.

Eur J Clin Pharmacol. 2020 Sep 23. doi: 10.1007/s00228-020-03004-w. Online ahead of print.

PMID: 32965548

 

Chemical Modification of Linkers Provides Stable Linker-Payloads for the Generation of Antibody-Drug Conjugates.

Poudel YB, Chowdari NS, Cheng H, Iwuagwu CI, King HD, Kotapati S, Passmore D, Rampulla R, Mathur A, Vite G, Gangwar S.

ACS Med Chem Lett. 2020 Sep 22;11(11):2190-2194. doi: 10.1021/acsmedchemlett.0c00325. eCollection 2020 Nov 12.

PMID: 33214828

 

Hydrophobic property of cation-exchange resins affects monoclonal antibody aggregation.

Huang C, Wang Y, Xu X, Mills J, Jin W, Ghose S, Li ZJ.

J Chromatogr A. 2020 Sep 20;1631:461573. doi: 10.1016/j.chroma.2020.461573. Online ahead of print.

PMID: 33010710

 

Genome-Wide Somatic Alterations in Multiple Myeloma Reveal a Superior Outcome Group.

Samur MK, Aktas Samur A, Fulciniti M, Szalat R, Han T, Shammas M, Richardson P, Magrangeas F, Minvielle S, Corre J, Moreau P, Thakurta A, Anderson KC, Parmigiani G, Avet-Loiseau H, Munshi NC.

J Clin Oncol. 2020 Sep 20;38(27):3107-3118. doi: 10.1200/JCO.20.00461. Epub 2020 Jul 20.

PMID: 32687451

 

Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study.

Abramson JS, Palomba ML, Gordon LI, Lunning MA, Wang M, Arnason J, Mehta A, Purev E, Maloney DG, Andreadis C, Sehgal A, Solomon SR, Ghosh N, Albertson TM, Garcia J, Kostic A, Mallaney M, Ogasawara K, Newhall K, Kim Y, Li D, Siddiqi T.

Lancet. 2020 Sep 19;396(10254):839-852. doi: 10.1016/S0140-6736(20)31366-0. Epub 2020 Sep 1.

PMID: 32888407 

 

Nanoparticle Albumin-bound Paclitaxel Plus Carboplatin Induction Followed by Nanoparticle Albumin-bound Paclitaxel Maintenance in Squamous Non-Small-cell Lung Cancer (ABOUND.sqm): A Phase III Randomized Clinical Trial.

Spigel DR, Jotte RM, Aix SP, Gressot L, Morgensztern D, McCleod M, Socinski MA, Daniel D, Juan-Vidal O, Mileham KF, West H, Page R, Reinmuth N, Knoble J, Chen T, Bhore R, Wolfsteiner M, Ong TJ, Gridelli C, Thomas M; ABOUND.sqm Investigators.

Clin Lung Cancer. 2020 Sep 18:S1525-7304(20)30270-9. doi: 10.1016/j.cllc.2020.09.007. Online ahead of print.

PMID: 33097414

 

Imaging of the Effect of Alcohol-Containing Media on the Performance of Hypromellose Hydrophilic Matrix Tablets: Comparison of Direct Compression and Regular Grades of Polymer.

Mawla N, Hanley S, Walton K, Kaialy W, Hussain T, Ward A, Brown J, Conway BR, Timmins P, Asare-Addo K.

Pharmaceutics. 2020 Sep 18;12(9):889. doi: 10.3390/pharmaceutics12090889.

PMID: 32961942 

 

Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial.

Ascierto PA, Del Vecchio M, Mandalá M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Márquez-Rodas I, Butler MO, Maio M, Middleton MR, de la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Lobo M, de Pril V, Loffredo J, Larkin J, Weber J.

Lancet Oncol. 2020 Sep 18:S1470-2045(20)30494-0. doi: 10.1016/S1470-2045(20)30494-0. Online ahead of print.

PMID: 32961119

 

Consensus recommendations on the use of ¹⁸F-FDG PET/CT in lung disease.

Chen DL, Ballout S, Chen L, Cheriyan J, Choudhury G, Denis-Bacelar AM, Emond E, Erlandsson K, Fisk M, Fraioli F, Groves AM, Gunn RN, Hatazawa J, Holeman BF, Hutton BF, Iida H, Lee S, MacNee W, Matsunaga K, Mohan D, Parr D, Rashidnasab A, Rizzo G, Subramanian D, Tal-Singer R, Thielemans K, Tregay N, Van Beek EJR, Vass L, Vidal Melo MF, Wellen JW, Wilkinson I, Wilson FJ, Winkler T.

J Nucl Med. 2020 Sep 18:jnumed.120.244780. doi: 10.2967/jnumed.120.244780. Online ahead of print.

PMID: 32948678

 

Premature permanent discontinuation of apixaban or warfarin in patients with atrial fibrillation.

Carnicelli AP, Al-Khatib SM, Xavier D, Dalgaard F, Merrill PD, Wojdyla DM, Lewis BS, Hanna M, Alexander JH, Lopes RD, Wallentin L, Granger CB.

Heart. 2020 Sep 16:heartjnl-2020-317229. doi: 10.1136/heartjnl-2020-317229. Online ahead of print.

PMID: 32938772

 

Leveraging Automation toward Development of a High-Throughput Gene Expression Profiling Platform.

Chen J, Futran A, Crithary A, Li S, Wolicki A, Fogarty K, Baldick J, Chase P, Arey BJ, Lippy J.

SLAS Discov. 2020 Sep 16:2472555220956593. doi: 10.1177/2472555220956593. Online ahead of print.

PMID: 32935608

 

Driving Potency with Rotationally Stable Atropisomers: Discovery of Pyridopyrimidinedione-Carbazole Inhibitors of BTK.

Srivastava AS, Ko S, Watterson SH, Pattoli MA, Skala S, Cheng L, Obermeier MT, Vickery R, Discenza LN, D'Arienzo CJ, Gillooly KM, Taylor TL, Pulicicchio C, McIntyre KW, Yip S, Li P, Sun D, Wu DR, Dai J, Wang C, Zhang Y, Wang B, Pawluczyk J, Kempson J, Zhao R, Hou X, Rampulla R, Mathur A, Galella MA, Salter-Cid L, Barrish JC, Carter PH, Fura A, Burke JR, Tino JA.

ACS Med Chem Lett. 2020 Sep 16;11(11):2195-2203. doi: 10.1021/acsmedchemlett.0c00335. eCollection 2020 Nov 12.

PMID: 33214829

 

Dysregulated Ribosome Biogenesis Reveals Therapeutic Liabilities in Cancer.

Bursać S, Prodan Y, Pullen N, Bartek J, Volarević S.

Trends Cancer. 2020 Sep 15:S2405-8033(20)30235-1. doi: 10.1016/j.trecan.2020.08.003. Online ahead of print.

PMID: 32948502 

 

Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicentre, observer-blind, randomised, controlled trial.

de Bruyn G, Gordon DL, Steiner T, Tambyah P, Cosgrove C, Martens M, Bassily E, Chan ES, Patel D, Chen J, Torre-Cisneros J, Fernando De Magalhães Francesconi C, Gesser R, Jeanfreau R, Launay O, Laot T, Morfin-Otero R, Oviedo-Orta E, Park YS, Piazza FM, Rehm C, Rivas E, Self S, Gurunathan S.

Lancet Infect Dis. 2020 Sep 15:S1473-3099(20)30331-5. doi: 10.1016/S1473-3099(20)30331-5. Online ahead of print.

PMID: 32946836

 

Intact Protein Mass Spectrometry for Therapeutic Protein Quantitation, Pharmacokinetics, and Biotransformation in Preclinical and Clinical Studies: An Industry Perspective.

Kellie JF, Tran JC, Jian W, Jones B, Mehl JT, Ge Y, Henion J, Bateman KP.

J Am Soc Mass Spectrom. 2020 Sep 15. doi: 10.1021/jasms.0c00270. Online ahead of print.

PMID: 32869982

 

Open-label, Phase I Study of Nivolumab Combined with nab-Paclitaxel Plus Gemcitabine in Advanced Pancreatic Cancer.

Wainberg ZA, Hochster HS, Kim EJ, George B, Kaylan A, Chiorean EG, Waterhouse DM, Guiterrez M, Parikh A, Jain R, Carrizosa DR, Soliman HH, Lila T, Reiss DJ, Pierce DW, Bhore R, Banerjee S, Lyons L, Louis CU, Ong TJ, O'Dwyer PJ.

Clin Cancer Res. 2020 Sep 15;26(18):4814-4822. doi: 10.1158/1078-0432.CCR-20-0099. Epub 2020 Jun 18.

PMID: 32554514 

 

Immunomodulation in Pomalidomide, Dexamethasone, and Daratumumab-Treated Patients with Relapsed/Refractory Multiple Myeloma.

Pierceall WE, Amatangelo MD, Bahlis NJ, Siegel DS, Rahman A, Van Oekelen O, Neri P, Young M, Chung W, Serbina N, Parekh S, Agarwal A, Thakurta A.

Clin Cancer Res. 2020 Sep 14. doi: 10.1158/1078-0432.CCR-20-1781. Online ahead of print.

PMID: 32928795 

 

Health-related quality of life of long-term advanced melanoma survivors treated with anti-CTLA-4 immune checkpoint inhibition compared to matched controls.

Boekhout AH, Rogiers A, Jozwiak K, Boers-Sonderen MJ, van den Eertwegh AJ, Hospers GA, de Groot JWB, Aarts MJB, Kapiteijn E, Ten Tije AJ, Piersma D, Vreugdenhil G, van der Veldt AA, Suijkerbuijk KPM, Rozeman EA, Neyns B, Janssen KJ, van de Poll-Franse LV, Blank CU.

Acta Oncol. 2020 Sep 14:1-9. doi: 10.1080/0284186X.2020.1818823. Online ahead of print.

PMID: 32924708

Cost-Utility Analysis of Nivolumab in Adjuvant Treatment of Melanoma in France.

Bregman B, Teitsson S, Orsini I, Cotté FE, Amadi A, Moshyk A, Roze S, Gaudin AF.

Dermatol Ther (Heidelb). 2020 Sep 13. doi: 10.1007/s13555-020-00446-z. Online ahead of print.

PMID: 32920709

 

Preclinical optimization of an enterotoxigenic Escherichia coli adjuvanted subunit vaccine using response surface design of experiments.

Poncet D, Hessler C, Liang H, Gautheron S, Sergent M, Rintala ND, Seydoux E, Huang PD, Argilla D, Ruiz S, Heinrichs J, Maciel M Jr, Orr MT.

NPJ Vaccines. 2020 Sep 11;5:83. doi: 10.1038/s41541-020-00228-w. eCollection 2020.

PMID: 32983577 

 

Body Composition, Natriuretic Peptides, and Adverse Outcomes in Heart Failure With Preserved and Reduced Ejection Fraction.

Selvaraj S, Kim J, Ansari BA, Zhao L, Cvijic ME, Fronheiser M, Mohan-Rao Vanjarapu J, Kumar AA, Suri A, Yenigalla S, Satija V, Ans AH, Narvaez-Guerra O, Herrera-Enriquez K, Obeid MJ, Lee JJ, Jehangir Q, Seiffert DA, Car BD, Gordon DA, Chirinos JA.

JACC Cardiovasc Imaging. 2020 Sep 11:S1936-878X(20)30647-1. doi: 10.1016/j.jcmg.2020.07.022. Online ahead of print.

PMID: 32950445

 

Exploring the Health-Related Quality of Life of Patients Treated With Immune Checkpoint Inhibitors: Social Media Study.

Cotté FE, Voillot P, Bennett B, Falissard B, Tzourio C, Foulquié P, Gaudin AF, Lemasson H, Grumberg V, McDonald L, Faviez C, Schück S.

J Med Internet Res. 2020 Sep 11;22(9):e19694. doi: 10.2196/19694.

PMID: 32915159 

 

Real-world treatment patterns and survival outcomes for advanced non-small cell lung cancer in the pre-immunotherapy era in Portugal: a retrospective analysis from the I-O Optimise initiative.

Soares M, Antunes L, Redondo P, Borges M, Hermans R, Patel D, Grimson F, Munro R, Chaib C, Lacoin L, Daumont M, Penrod JR, O'Donnell JC, Bento MJ, Rocha Gonçalves F.

BMC Pulm Med. 2020 Sep 10;20(1):240. doi: 10.1186/s12890-020-01270-z.

PMID: 32912174 

 

Divalent N^I Compounds: Identifying new Carbocyclic Carbenes to Design Nitreones using Quantum Chemical Methods.

Patel N, Arfeen M, Singh T, Bhagat S, Sakhare A, Bharatam PV.

J Comput Chem. 2020 Sep 10. doi: 10.1002/jcc.26417. Online ahead of print.

PMID: 32964506

 

Continuous Versus 1-Year Fixed-Duration Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: CheckMate 153.

Waterhouse DM, Garon EB, Chandler J, McCleod M, Hussein M, Jotte R, Horn L, Daniel DB, Keogh G, Creelan B, Einhorn LH, Baker J, Kasbari S, Nikolinakos P, Babu S, Couture F, Leighl NB, Reynolds C, Blumenschein G Jr, Gunuganti V, Li A, Aanur N, Spigel DR.

J Clin Oncol. 2020 Sep 10:JCO2000131. doi: 10.1200/JCO.20.00131. Online ahead of print.

PMID: 32910710

 

Pharmacodynamic analysis of apremilast in Japanese patients with moderate to severe psoriasis: Results from a phase 2b randomized trial.

Imafuku S, Nemoto O, Okubo Y, Komine M, Schafer P, Petric R, Ohtsuki M.

J Dermatol. 2020 Sep 10. doi: 10.1111/1346-8138.15596. Online ahead of print.

PMID: 32909643

 

Discovery of BMS-986235/LAR-1219: A Potent Formyl Peptide Receptor 2 (FPR2) Selective Agonist for the Prevention of Heart Failure.

Asahina Y, Wurtz NR, Arakawa K, Carson N, Fujii K, Fukuchi K, Garcia R, Hsu MY, Ishiyama J, Ito B, Kick E, Lupisella J, Matsushima S, Ohata K, Ostrowski J, Saito Y, Tsuda K, Villarreal F, Yamada H, Yamaoka T, Wexler R, Gordon D, Kohno Y.

J Med Chem. 2020 Sep 10;63(17):9003-9019. doi: 10.1021/acs.jmedchem.9b02101. Epub 2020 May 24.

PMID: 32407089

 

Pomalidomide, bortezomib, and dexamethasone for multiple myeloma previously treated with lenalidomide (OPTIMISMM): outcomes by prior treatment at first relapse.

Dimopoulos M, Weisel K, Moreau P, Anderson LD Jr, White D, San-Miguel J, Sonneveld P, Engelhardt M, Jenner M, Corso A, Dürig J, Pavic M, Salomo M, Casal E, Srinivasan S, Yu X, Nguyen TV, Biyukov T, Peluso T, Richardson P.

Leukemia. 2020 Sep 7. doi: 10.1038/s41375-020-01021-3. Online ahead of print.

PMID: 32895455 

 

Triggering interferon signaling in T cells with avadomide sensitizes CLL to anti-PD-L1/PD-1 immunotherapy.

Ioannou N, Hagner PR, Stokes M, Gandhi AK, Apollonio B, Fanous M, Papazoglou D, Sutton LA, Rosenquist R, Amini RM, Chiu H, Lopez-Girona A, Janardhanan P, Awan FT, Jones JA, Kay NE, Shanafelt TD, Tallman MS, Stamatopoulos K, Patten PE, Vardi A, Ramsay AG.

Blood. 2020 Sep 6:blood.2020006073. doi: 10.1182/blood.2020006073. Online ahead of print.

PMID: 33024998

 

Ivosidenib or enasidenib combined with intensive chemotherapy in patients with newly diagnosed AML: a phase 1 study.

Stein EM, DiNardo CD, Fathi AT, Mims AS, Pratz KW, Savona MR, Stein AS, Stone RM, Winer ES, Seet CS, Döhner H, Pollyea DA, McCloskey J, Odenike O, Löwenberg B, Ossenkoppele GJ, Patel PA, Roshal M, Frattini MG, Lersch F, Franovic A, Nabhan S, Fan B, Choe S, Wang H, Wu B, Hua L, Almon C, Cooper M, Kantarjian HM, Tallman MS.

Blood. 2020 Sep 5:blood.2020007233. doi: 10.1182/blood.2020007233. Online ahead of print.

PMID: 33024987

 

Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study.

Dimopoulos MA, Lonial S, White D, Moreau P, Weisel K, San-Miguel J, Shpilberg O, Grosicki S, Špička I, Walter-Croneck A, Magen H, Mateos MV, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Röllig C, Einsele H, Matsumoto M, Wu KL, Anderson KC, Jou YM, Ganetsky A, Singhal AK, Richardson PG.

Blood Cancer J. 2020 Sep 4;10(9):91. doi: 10.1038/s41408-020-00357-4.

PMID: 32887873 

 

Synthesis of Differentially Protected Azatryptophan Analogs via Pd₂(dba)₃/XPhos Catalyzed Negishi Coupling of N-Ts Azaindole Halides with Zinc Derivative from Fmoc-Protected tert-Butyl (R)-2-Amino-3-iodopropanoate.

Nimje RY, Vytla D, Kuppusamy P, Velayuthaperumal R, Jarugu LB, Reddy CA, Chikkananjaiah NK, Rampulla RA, Cavallaro CL, Li J, Mathur A, Gupta A, Roy A.

J Org Chem. 2020 Sep 4;85(17):11519-11530. doi: 10.1021/acs.joc.0c00973. Epub 2020 Aug 25.

PMID: 32786620

 

Rapid fingerprinting of a highly glycosylated fusion protein by microfluidic chip-based capillary electrophoresis-mass spectrometry.

Deyanova EG, Huang RY, Madia PA, Nandi P, Gudmundsson O, Chen G.

Electrophoresis. 2020 Sep 3. doi: 10.1002/elps.202000132. Online ahead of print.

PMID: 32885501

 

Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development.

Bhagat R, Bojarski L, Chevalier S, Görtz DR, Le Meignen S, Makowski M, Nadolny P, Pillwein M, Suprin M, Turri S.

Ther Innov Regul Sci. 2020 Sep 3. doi: 10.1007/s43441-020-00209-0. Online ahead of print.

PMID: 32885397

 

Synthesis of functionalized derivatives of the gamma-secretase modulator BMS-932481 and identification of its major metabolite.

Zhang Y, Boy KM, Wu YJ, Ramirez A, Toyn JH, Ahlijanian MK, Albright CF, Zhuo X, Johnson BM, Denton RR, Olson RE, Thompson LA 3rd, Macor JE.

Bioorg Med Chem Lett. 2020 Sep 2;30(22):127530. doi: 10.1016/j.bmcl.2020.127530. Online ahead of print.

PMID: 32890687

 

Structure-based amelioration of PXR transactivation in a novel series of macrocyclic allosteric inhibitors of HIV-1 integrase.

Sivaprakasam P, Wang Z, Meanwell NA, Khan JA, Langley DR, Johnson SR, Li G, Pendri A, Connolly TP, Gao M, Camac DM, Klakouski C, Zvyaga T, Cianci C, McAuliffe B, Ding B, Discotto L, Krystal MR, Jenkins S, Peese KM, Narasimhulu Naidu B.

Bioorg Med Chem Lett. 2020 Sep 2;30(22):127531. doi: 10.1016/j.bmcl.2020.127531. Online ahead of print.

PMID: 32890685

 

Standardizing Health Outcomes for Lung Cancer. Adaptation of the International Consortium for Health Outcomes Measurement Set to the Spanish Setting.

Escudero-Vilaplana V, Calles A, Collado-Borrell R, Belén Marzal-Alfaro M, Polanco C, Garrido C, Suarez J, Ortiz A, Appierto M, Comellas M, Lizán L.

Front Oncol. 2020 Sep 2;10:1645. doi: 10.3389/fonc.2020.01645. eCollection 2020.

PMID: 32984036 

 

High-resolution purification of a therapeutic PEGylated protein using a cuboid packed-bed device.

Chen G, Umatheva U, Pagano J, Yu D, Ghose S, Li Z, Ghosh R.

J Chromatogr A. 2020 Sep 2;1630:461524. doi: 10.1016/j.chroma.2020.461524. Online ahead of print.

PMID: 32920248

 

Modified Goldilocks Design with strict type I error control in confirmatory clinical trials.

Zhan T, Zhang H, Hartford A, Mukhopadhyay S.

J Biopharm Stat. 2020 Sep 2;30(5):821-833. doi: 10.1080/10543406.2020.1744620. Epub 2020 Apr 16.

PMID: 32297825

 

Discovery and structure activity relationships of 7-benzyl triazolopyridines as stable, selective, and reversible inhibitors of myeloperoxidase.

Shaw SA, Vokits BP, Dilger AK, Viet A, Clark CG, Abell LM, Locke GA, Duke G, Kopcho LM, Dongre A, Gao J, Krishnakumar A, Jusuf S, Khan J, Spronk SA, Basso MD, Zhao L, Cantor GH, Onorato JM, Wexler RR, Duclos F, Kick EK.

Bioorg Med Chem. 2020 Sep 1;28(22):115723. doi: 10.1016/j.bmc.2020.115723. Online ahead of print.

PMID: 33007547

 

Quantifying drug tissue biodistribution by integrating high content screening with deep-learning analysis.

Li Z, Xiao Y, Peng J, Locke D, Holmes D, Li L, Hamilton S, Cook E, Myer L, Vanderwall D, Cloutier N, Siddiqui AM, Whitehead P, Bishop R, Zhao L, Cvijic ME.

Sci Rep. 2020 Sep 1;10(1):14408. doi: 10.1038/s41598-020-71347-6.

PMID: 32873881 

 

Efficacy and Safety of Nivolumab Plus Ipilimumab versus Sunitinib in First-line Treatment of Patients with Advanced Sarcomatoid Renal Cell Carcinoma.

Tannir NM, Signoretti S, Choueiri TK, McDermott DF, Motzer RJ, Flaifel A, Pignon JC, Ficial M, Frontera OA, George S, Powles T, Donskov F, Harrison MR, Barthélémy P, Tykodi SS, Kocsis J, Ravaud A, Rodriguez-Cid JR, Pal SK, Murad AM, Ishii Y, Saggi SS, McHenry MB, Rini BI.

Clin Cancer Res. 2020 Sep 1. doi: 10.1158/1078-0432.CCR-20-2063. Online ahead of print.

PMID: 32873572

 

Spatial Signatures Identify Immune Escape via PD-1 as a Defining Feature of T-cell/Histiocyte-rich Large B-cell Lymphoma.

Griffin GK, Weirather JL, Roemer M, Lipschitz M, Kelley A, Chen PH, Gusenleitner D, Jeter E, Gjini E, Chapuy B, Rosenthal M, Xu J, Chen BJ, Sohani A, Lovitch SB, Abramson J, Ishizuka JJ, Kim AI, Jacobson CA, LaCasce AS, Fletcher CDM, Neuberg D, Freeman GJ, Hodi FS, Wright K, Ligon AH, Jacobsen ED, Armand P, Shipp MA, Rodig SJ.

Blood. 2020 Sep 1:blood.2020006464. doi: 10.1182/blood.2020006464. Online ahead of print.

PMID: 32871584

 

Pancreatic ductal adenocarcinoma progression is restrained by stromal matrix.

Jiang H, Torphy RJ, Steiger K, Hongo H, Ritchie AJ, Kriegsmann M, Horst D, Umetsu SE, Joseph NM, McGregor K, Pishvaian MJ, Blais EM, Lu B, Li M, Hollingsworth M, Stashko C, Volmar K, Yeh JJ, Weaver VM, Wang ZJ, Tempero MA, Weichert W, Collisson EA.

J Clin Invest. 2020 Sep 1;130(9):4704-4709. doi: 10.1172/JCI136760.

PMID: 32749238 

 

Discovery of (3S,4S)-3-methyl-3-(4-fluorophenyl)-4-(4-(1,1,1,3,3,3-hexafluoro-2-hydroxyprop-2-yl)phenyl)pyrrolidines as novel RORγt inverse agonists.

Jiang B, Duan JJ, Stachura S, Karmakar A, Hemagiri H, Raut DK, Gupta AK, Weigelt CA, Khan J, Sack JS, Wu DR, Yarde M, Shen DR, Galella MA, Mathur A, Zhao Q, Salter-Cid LM, Carter PH, Dhar TGM.

Bioorg Med Chem Lett. 2020 Sep 1;30(17):127392. doi: 10.1016/j.bmcl.2020.127392. Epub 2020 Jul 10.

PMID: 32738966

 

Enhancement of covalent aggregate quantification of protein therapeutics by non-reducing capillary gel electrophoresis using sodium hexadecyl sulfate (CE-SHS).

Guan Q, Knihtila R, Atsma J, Tulsan R, Singh S, Kar S, Beckman J, Ding J, Li ZJ.

J Chromatogr B Analyt Technol Biomed Life Sci. 2020 Sep 1;1152:122230. doi: 10.1016/j.jchromb.2020.122230. Epub 2020 Jun 10.

PMID: 32585496

 

Cross-linking of poly (vinyl alcohol) films under acidic and thermal stress.

Desai SD, Kundu I, Swamy NP, Crull GB, Pan D, Zhao J, Shah RP, Venkatesh C, Vig B, Varia SA, Badawy SIF, Desikan S, Bhutani H.

Eur J Pharm Sci. 2020 Sep 1;152:105429. doi: 10.1016/j.ejps.2020.105429. Epub 2020 Jun 17.

PMID: 32561460

 

A phase II study of pomalidomide, daily oral cyclophosphamide, and dexamethasone in relapsed/refractory multiple myeloma.

Van Oekelen O, Parekh S, Cho HJ, Vishnuvardhan N, Madduri D, Richter J, Ip C, Lau K, Florendo E, Mancia IS, Thomas J, Verina D, Chan E, Zarychta K, La L, Strumolo G, Melnekoff DT, Leshchenko VV, Kim-Schulze S, Couto S, Wang M, Pierceall WE, Thakurta A, Laganà A, Jagannath S, Chari A.

Leuk Lymphoma. 2020 Sep;61(9):2208-2215. doi: 10.1080/10428194.2020.1805111. Epub 2020 Aug 19.

PMID: 32812822

 

A peptide immunoaffinity LC-MS/MS strategy for quantifying the GPCR protein, S1PR1 in human colon biopsies.

Zhang H, Ciccimaro E, Zalaznick J, Sleczka BG, Menard L, Olah TV, Shipkova P.

Bioanalysis. 2020 Sep;12(18):1311-1324. doi: 10.4155/bio-2020-0115. Epub 2020 Sep 18.

PMID: 32945691

 

Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung Cancer.

Bonomi P, Stuccio N, Delgra CJ, Chuk MK, Spira A, Deitz AC, Blumenthal GM, Ferris A, Gong Y, He J, Basu Roy U, Selig W.

Ther Innov Regul Sci. 2020 Sep;54(5):1208-1214. doi: 10.1007/s43441-020-00145-z. Epub 2020 Mar 26.

PMID: 32865803

 

Secondary stroke prevention with apixaban in nonvalvular atrial fibrillation: A subgroup analysis of the STANDARD study.

Yasaka M, Umeyama M, Kataoka H, Inoue H.

J Stroke Cerebrovasc Dis. 2020 Sep;29(9):105034. doi: 10.1016/j.jstrokecerebrovasdis.2020.105034. Epub 2020 Jun 24.

PMID: 32807446 

 

 Evaluating the potential of relapse-free survival as a surrogate for overall survival in the adjuvant therapy of melanoma with checkpoint inhibitors.

Coart E, Suciu S, Squifflet P, Saad ED, Moshyk A, de Schaetzen G, Buyse M, Weber JS, Eggermont A, Kotapati S.

Eur J Cancer. 2020 Sep;137:171-174. doi: 10.1016/j.ejca.2020.07.011. Epub 2020 Aug 7.

PMID: 32777716

 

Avadomide plus obinutuzumab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (CC-122-NHL-001): a multicentre, dose escalation and expansion phase 1 study.

Michot JM, Bouabdallah R, Vitolo U, Doorduijn JK, Salles G, Chiappella A, Zinzani PL, Bijou F, Kersten MJ, Sarmiento R, Mosulen S, Mendez C, Uttamsingh S, Pourdehnad M, Hege K, Chen T, Klein C, Hagner PR, Nikolova Z, Ribrag V.

Lancet Haematol. 2020 Sep;7(9):e649-e659. doi: 10.1016/S2352-3026(20)30208-8. Epub 2020 Aug 3.

PMID: 32758434 

 

Melanoma brain metastases - Interdisciplinary management recommendations 2020.

Gutzmer R, Vordermark D, Hassel JC, Krex D, Wendl C, Schadendorf D, Sickmann T, Rieken S, Pukrop T, Höller C, Eigentler TK, Meier F.

Cancer Treat Rev. 2020 Sep;89:102083. doi: 10.1016/j.ctrv.2020.102083. Epub 2020 Jul 18.

PMID: 32736188 

Paediatric Strategy Forum for medicinal product development for acute myeloid leukaemia in children and adolescents: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.

Pearson ADJ, Zwaan CM, Kolb EA, Karres D, Guillot J, Kim SY, Marshall L, Tasian SK, Smith M, Cooper T, Adamson PC, Barry E, Benettaib B, Binlich F, Borgman A, Brivio E, Capdeville R, Delgado D, Faller D, Fogelstrand L, Fraenkel PG, Hasle H, Heenen D, Kaspers G, Kieran M, Klusmann JH, Lesa G, Ligas F, Mappa S, Mohamed H, Moore A, Morris J, Nottage K, Reinhardt D, Scobie N, Simko S, Winkler T, Norga K, G, Vassal G.

Eur J Cancer. 2020 Sep;136:116-129. doi: 10.1016/j.ejca.2020.04.038. Epub 2020 Jul 17.

PMID: 32688206 

 

Genome-wide transcriptome analysis identifies novel dysregulated genes implicated in Alzheimer's pathology.

Nho K, Nudelman K, Allen M, Hodges A, Kim S, Risacher SL, Apostolova LG, Lin K, Lunnon K, Wang X, Burgess JD, Ertekin-Taner N, Petersen RC, Wang L, Qi Z, He A, Neuhaus I, Patel V, Foroud T, Faber KM, Lovestone S, Simmons A, Weiner MW, Saykin AJ;

Alzheimer's Disease Neuroimaging Initiative.Alzheimers Dement. 2020 Sep;16(9):1213-1223. doi: 10.1002/alz.12092. Epub 2020 Aug 5.

PMID: 32755048 

 

Application of the Gyrolab microfluidic platform to measure picomolar affinity of a PD-L1-binding Adnectin™ radioligand for positron emission tomography.

Dai Z, Juneja J, Schneeweis L, Cohen D, Marsilio F, Morin P, DasGupta R.

Biotechniques. 2020 Sep;69(3):200-205. doi: 10.2144/btn-2020-0080. Epub 2020 Jul 16.

PMID: 32672060 

 

Toward further simplification of elotuzumab therapy by subcutaneous administration.

Shimura Y, Tsukamoto T, Yamaguchi J, Kuwahara-Ota S, Isa R, Nishiyama D, Kobayashi T, Horiike S, Suzuki A, Kuroda J.

Int J Hematol. 2020 Sep;112(3):427-428. doi: 10.1007/s12185-020-02942-6. Epub 2020 Jul 13.

PMID: 32656639 

 

Up to 5-year retention of abatacept in Belgian patients with moderate-to-severe rheumatoid arthritis: a sub-analysis of the international, observational ACTION study.

Westhovens R, Connolly SE, Margaux J, Vanden Berghe M, Maertens M, Van den Berghe M, Elbez Y, Chartier M, Baeke F, Robert S, Malaise M.

Rheumatol Int. 2020 Sep;40(9):1409-1421. doi: 10.1007/s00296-020-04619-z. Epub 2020 Jun 17.

PMID: 32556473 

 

Ozanimod induction therapy for patients with moderate to severe Crohn's disease: a single-arm, phase 2, prospective observer-blinded endpoint study.

Feagan BG, Sandborn WJ, Danese S, Wolf DC, Liu WJ, Hua SY, Minton N, Olson A, D'Haens G.

Lancet Gastroenterol Hepatol. 2020 Sep;5(9):819-828. doi: 10.1016/S2468-1253(20)30188-6. Epub 2020 Jun 15.

PMID: 32553149 

 

Hallmarks of NLRP3 inflammasome activation are observed in organotypic hippocampal slice culture.

Hoyle C, Redondo-Castro E, Cook J, Tzeng TC, Allan SM, Brough D, Lemarchand E.

Immunology. 2020 Sep;161(1):39-52. doi: 10.1111/imm.13221. Epub 2020 Jun 22.

PMID: 32445196 

 

Comparison of infection-related hospitalization risk and costs in tumor necrosis factor inhibitor-experienced patients with rheumatoid arthritis (RA) treated with abatacept or other targeted disease-modifying anti-rheumatic drugs (tDMARDs).

Paul D, Patil D, McDonald L, Patel V, Lobo F.

J Med Econ. 2020 Sep;23(9):1025-1031. doi: 10.1080/13696998.2020.1772271. Epub 2020 Jun 13.

PMID: 32427547

 

Enhanced alcoholic liver disease in mice with intestine-specific farnesoid X receptor deficiency.

Huang M, Kong B, Zhang M, Rizzolo D, Armstrong LE, Schumacher JD, Chow MD, Lee YH, Joseph LB, Stofan M, Zhang L, Guo GL.

Lab Invest. 2020 Sep;100(9):1158-1168. doi: 10.1038/s41374-020-0439-y. Epub 2020 May 13.

PMID: 32404932 

 

Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View.

Parab AA, Mehta P, Vattikola A, Denney CK, Cherry M, Maniar RM, Kjaer J.

Ther Innov Regul Sci. 2020 Sep;54(5):1141-1151. doi: 10.1007/s43441-020-00138-y. Epub 2020 Mar 3.

PMID: 32128701 

 

Cost-Effectiveness Analysis of Apixaban Versus Edoxaban in Patients with Atrial Fibrillation for Stroke Prevention.

Oyagüez I, Suárez C, López-Sendón JL, González-Juanatey JR, de Andrés-Nogales F, Suárez J, Polanco C, Soto J.

Pharmacoecon Open. 2020 Sep;4(3):485-497. doi: 10.1007/s41669-019-00186-7.

PMID: 31673882 

 

Development of Resilience Among Rheumatoid Arthritis Patients: A Qualitative Study.

Shaw Y, Bradley M, Zhang C, Dominique A, Michaud K, McDonald D, Simon TA.

Arthritis Care Res (Hoboken). 2020 Sep;72(9):1257-1265. doi: 10.1002/acr.24024.

PMID: 31282121

 

Efficacy and safety results from CheckMate 140, a phase 2 study of nivolumab for relapsed/refractory follicular lymphoma.

Armand P, Janssens AM, Gritti G, Radford J, Timmerman JM, Pinto A, Mercadal Vilchez S, Johnson PWM, Cunningham D, Leonard JP, Rodig SJ, Martín-Regueira P, Sumbul A, Samakoglu S, Tang H, Ansell SM.

Blood. 2020 Aug 31:blood.2019004753. doi: 10.1182/blood.2019004753. Online ahead of print.

PMID: 32870269

 

Time for a Fully Integrated Nonclinical-Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective.

Vargas HM, Rolf MG, Wisialowski TA, Achanzar W, Bahinski A, Bass A, Benson CT, Chaudhary KW, Couvreur N, Dota C, Engwall MJ, Michael Foley C, Gallacher D, Greiter-Wilke A, Guillon JM, Guth B, Himmel HM, Hegele-Hartung C, Ito M, Jenkinson S, Chiba K, Lagrutta A, Levesque P, Martel E, Okai Y, Peri R, Pointon A, Qu Y, Teisman A, Traebert M, Yoshinaga T, Gintant GA, Leishman DJ, Valentin JP.

Clin Pharmacol Ther. 2020 Aug 31. doi: 10.1002/cpt.2029. Online ahead of print.

PMID: 32866317

 

Tricyclic sulfones as potent, selective and efficacious RORγt inverse agonists - Exploring C6 and C8 SAR using late-stage functionalization.

Shi Q, Xiao Z, Yang MG, Marcoux D, Cherney RJ, Yip S, Li P, Wu DR, Weigelt CA, Sack J, Khan J, Ruzanov M, Wang J, Yarde M, Ellen Cvijic M, Li S, Shuster DJ, Xie J, Sherry T, Obermeier M, Fura A, Stefanski K, Cornelius G, Chacko S, Shu YZ, Khandelwal P, Hynes J Jr, Tino JA, Salter-Cid L, Denton R, Zhao Q, Dhar TGM.

Bioorg Med Chem Lett. 2020 Aug 31;30(23):127521. doi: 10.1016/j.bmcl.2020.127521. Online ahead of print.

PMID: 32882417

 

Cyclic tailor-made amino acids in the design of modern pharmaceuticals.

Liu J, Han J, Izawa K, Sato T, White S, Meanwell NA, Soloshonok VA.

Eur J Med Chem. 2020 Aug 31;208:112736. doi: 10.1016/j.ejmech.2020.112736. Online ahead of print.

PMID: 32966895 

 

Impact of the column on effluent pH in cation exchange pH gradient chromatography, a practical study.

Farsang E, Horváth K, Beck A, Wang Q, Lauber M, Guillarme D, Fekete S.

J Chromatogr A. 2020 Aug 30;1626:461350. doi: 10.1016/j.chroma.2020.461350. Epub 2020 Jun 17.

PMID: 32797830 

 

Advancing stereoisomeric separation of an atropisomeric Bruton's tyrosine kinase inhibitor by using sub-2 µm immobilized polysaccharide-based chiral columns in supercritical fluid chromatography.

He BL, Kleinsorge NG, Zhang L, Kleintop B.

J Chromatogr A. 2020 Aug 30;1626:461320. doi: 10.1016/j.chroma.2020.461320. Epub 2020 Jun 7.

PMID: 32797816

 

Model-Based Meta-Analysis Compares DAS28 Rheumatoid Arthritis Treatment Effects and Suggests an Expedited Trial Design for Early Clinical Development.

Leil TA, Lu Y, Bouillon-Pichault M, Wong R, Nowak M.

Clin Pharmacol Ther. 2020 Aug 29. doi: 10.1002/cpt.2023. Online ahead of print.

PMID: 32860421

 

Increasing respondent engagement in composite time trade-off tasks by imposing three minimum trade-offs to improve data quality.

Jiang R, Kohlmann T, Lee TA, Mühlbacher A, Shaw J, Walton S, Pickard AS.

Eur J Health Econ. 2020 Aug 28. doi: 10.1007/s10198-020-01224-6. Online ahead of print.

PMID: 32860093

 

High rates of therapeutic changes in patients with psoriatic arthritis receiving treatment with disease-modifying antirheumatic drugs: a cross-sectional study.

Behrens F, Rech J, Thaçi D, Zinke S, Rothnie KJ, Oefner Daamen C, Leipe J.

Mod Rheumatol. 2020 Aug 28:1-23. doi: 10.1080/14397595.2020.1816597. Online ahead of print.

PMID: 32856975

 

Effects of Manipulating Fibroblast Growth Factor Expression on Sindbis Virus Replication In Vitro and in Aedes aegypti Mosquitoes.

Wu W, Simmons CA, Moffitt J, Clem RJ, Passarelli AL.

Viruses. 2020 Aug 26;12(9):943. doi: 10.3390/v12090943.

PMID: 32858937 

 

Outcomes of patients with relapsed or refractory acute myeloid leukemia: a population-based real-world study.

Brandwein JM, Saini L, Geddes MN, Yusuf D, Liu F, Schwann K, Billawala A, Westcott C, Kurniawan JA, Cheung WY.

Am J Blood Res. 2020 Aug 25;10(4):124-133. eCollection 2020.

PMID: 32923092 

 

A Single Human V_H-gene Allows for a Broad-Spectrum Antibody Response Targeting Bacterial Lipopolysaccharides in the Blood.

Sangesland M, Yousif AS, Ronsard L, Kazer SW, Zhu AL, Gatter GJ, Hayward MR, Barnes RM, Quirindongo-Crespo M, Rohrer D, Lonberg N, Kwon D, Shalek AK, Lingwood D.

Cell Rep. 2020 Aug 25;32(8):108065. doi: 10.1016/j.celrep.2020.108065.

PMID: 32846123 

 

Identifying collagen VI as a target of fibrotic diseases regulated by CREBBP/EP300.

Williams LM, McCann FE, Cabrita MA, Layton T, Cribbs A, Knezevic B, Fang H, Knight J, Zhang M, Fischer R, Bonham S, Steenbeek LM, Yang N, Sood M, Bainbridge C, Warwick D, Harry L, Davidson D, Xie W, Sundstrӧm M, Feldmann M, Nanchahal J.

Proc Natl Acad Sci U S A. 2020 Aug 25;117(34):20753-20763. doi: 10.1073/pnas.2004281117. Epub 2020 Aug 5.

PMID: 32759223 

 

Fit-for-purpose protein biomarker assay validation strategies using hybrid immunocapture-liquid chromatography-tandem-mass spectrometry platform: Quantitative analysis of total soluble cluster of differentiation 73.

Zhao Y, Gu H, Postelnek J, DeMichele M, Yuan L, Zhang YJ, Zeng J.

Anal Chim Acta. 2020 Aug 22;1126:144-153. doi: 10.1016/j.aca.2020.06.023. Epub 2020 Jun 18.

PMID: 32736718

 

(Carbonyl)oxyalkyl linker-based amino acid prodrugs of the HIV-1 protease inhibitor atazanavir that enhance oral bioavailability and plasma trough concentration.

Subbaiah MAM, Ramar T, Subramani L, Desai SD, Sinha S, Mandlekar S, Jenkins SM, Krystal MR, Subramanian M, Sridhar S, Padmanabhan S, Bhutani P, Arla R, Kadow JF, Meanwell NA.

Eur J Med Chem. 2020 Aug 21;207:112749. doi: 10.1016/j.ejmech.2020.112749. Online ahead of print.

PMID: 33065417

 

Synthesis of 1-(tert-Butyl) 4-Methyl (1R,2S,4R)-2-Methylcyclohexane-1,4-dicarboxylate from Hagemann's tert-Butyl Ester for an Improved Synthesis of BMS-986251.

Cornelius LAM, Li J, Smith D, Krishnananthan S, Yip S, Wu DR, Pawluczyk J, Aulakh D, Sarjeant AA, Kempson J, Tino JA, Mathur A, Murali Dhar TG, Cherney RJ.

J Org Chem. 2020 Aug 21;85(16):10988-10993. doi: 10.1021/acs.joc.0c01169. Epub 2020 Aug 7.

PMID: 32687358

 

Pd- and Ni-Based Systems for the Catalytic Borylation of Aryl (Pseudo)halides with B₂(OH)₄.

Munteanu C, Spiller TE, Qiu J, DelMonte AJ, Wisniewski SR, Simmons EM, Frantz DE.

J Org Chem. 2020 Aug 21;85(16):10334-10349. doi: 10.1021/acs.joc.0c00929. Epub 2020 Jul 22.

PMID: 32662636

 

Single-step purification of a small non-mAb biologic by peptide-ELP-based affinity precipitation.

Mullerpatan A, Kane E, Ghosh R, Nascimento A, Andersen H, Cramer S, Karande P.

Biotechnol Bioeng. 2020 Aug 19. doi: 10.1002/bit.27539. Online ahead of print.

PMID: 32813285

 

Nationwide claims database analysis of treatment patterns, costs and survival of Japanese patients with diffuse large B-cell lymphoma.

Tsutsué S, Tobinai K, Yi J, Crawford B.

PLoS One. 2020 Aug 18;15(8):e0237509. doi: 10.1371/journal.pone.0237509. eCollection 2020.

PMID: 32810157 

 

Future perspectives and challenges with CDK4/6 inhibitors in hormone receptor-positive metastatic breast cancer.

Bayraktar S, Batoo S, Al-Hattab E, Basu S, Okuno S, Glück S.

Future Oncol. 2020 Aug 17. doi: 10.2217/fon-2020-0234. Online ahead of print.

PMID: 32805138

 

OX40 agonistic antibody reverses immune suppression and improves survival in sepsis.

Unsinger J, Walton AH, Blood T, Tenney DJ, Quigley M, Drewry AM, Hotchkiss RS.

J Leukoc Biol. 2020 Aug 17. doi: 10.1002/JLB.5HI0720-043R. Online ahead of print.

PMID: 33264454

 

Model based strategies towards protein A resin lifetime optimization and supervision.

Feidl F, Luna MF, Podobnik M, Vogg S, Angelo J, Potter K, Wiggin E, Xu X, Ghose S, Li ZJ, Morbidelli M, Butté A.

J Chromatogr A. 2020 Aug 16;1625:461261. doi: 10.1016/j.chroma.2020.461261. Epub 2020 May 25.

PMID: 32709318

 

Rapid and efficient chiral method development for lamivudine and tenofovir disoproxil fumarate fixed dose combination using ultra-high performance supercritical fluid chromatography: A design of experiment approach.

Kurmi M, Jayaraman K, Natarajan S, Kumar GS, Bhutani H, Bajpai L.

J Chromatogr A. 2020 Aug 16;1625:461257. doi: 10.1016/j.chroma.2020.461257. Epub 2020 Jun 2.

PMID: 32709317

 

Final Analysis of the Ipilimumab Versus Placebo Following Radiotherapy Phase III Trial in Postdocetaxel Metastatic Castration-resistant Prostate Cancer Identifies an Excess of Long-term Survivors.

Fizazi K, Drake CG, Beer TM, Kwon ED, Scher HI, Gerritsen WR, Bossi A, den Eertwegh AJMV, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Danielli R, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengeløv L, Hansen S, McHenry MB, Chen A, Logothetis C; CA184-043, Investigators.

Eur Urol. 2020 Aug 15:S0302-2838(20)30604-7. doi: 10.1016/j.eururo.2020.07.032. Online ahead of print.

PMID: 32811715

 

Non-infectious comorbidity in patients with multiple sclerosis: A national cohort study in Sweden.

Castelo-Branco A, Chiesa F, Bengtsson CE, Lee S, Minton NN, Niemcryk S, Lindholm A, Rosenlund M, Piehl F, Montgomery S.

Mult Scler J Exp Transl Clin. 2020 Aug 14;6(3):2055217320947761. doi: 10.1177/2055217320947761. eCollection 2020 Jul-Sep.

PMID: 32864156 

 

Targeting activated PI3K/mTOR signaling overcomes acquired resistance to CDK4/6-based therapies in preclinical models of hormone receptor-positive breast cancer.

O'Brien NA, McDermott MSJ, Conklin D, Luo T, Ayala R, Salgar S, Chau K, DiTomaso E, Babbar N, Su F, Gaither A, Hurvitz SA, Linnartz R, Rose K, Hirawat S, Slamon DJ.

Breast Cancer Res. 2020 Aug 14;22(1):89. doi: 10.1186/s13058-020-01320-8.

PMID: 32795346 

 

Urinary CD80 Discriminates Among Glomerular Disease Types and Reflects Disease Activity.

Gonzalez Guerrico AM, Lieske J, Klee G, Kumar S, Lopez-Baez V, Wright AM, Bobart S, Shevell D, Maldonado M, Troost JP, Hogan MC; Nephrotic Syndrome Study Network Consortium (NEPTUNE).

Kidney Int Rep. 2020 Aug 14;5(11):2021-2031. doi: 10.1016/j.ekir.2020.08.001. eCollection 2020 Nov.

PMID: 33163723 

 

Detecting undiagnosed atrial fibrillation in UK primary care: Validation of a machine learning prediction algorithm in a retrospective cohort study.

Sekelj S, Sandler B, Johnston E, Pollock KG, Hill NR, Gordon J, Tsang C, Khan S, Ng FS, Farooqui U.

Eur J Prev Cardiol. 2020 Aug 13:2047487320942338. doi: 10.1177/2047487320942338. Online ahead of print.

PMID: 32787456

 

Aryl Ether-Derived Sphingosine-1-Phosphate Receptor (S1P₁) Modulators: Optimization of the PK, PD, and Safety Profiles.

Xiao Z, Yang MG, Dhar TGM, Xiao HY, Gilmore JL, Marcoux D, McIntyre KW, Taylor TL, Shi H, Levesque PC, Marino AM, Cornelius G, Mathur A, Shen DR, Cvijic ME, Lehman-McKeeman LD, Sun H, Xie JH, Carter PH, Dyckman AJ.

ACS Med Chem Lett. 2020 Aug 11;11(9):1766-1772. doi: 10.1021/acsmedchemlett.0c00333. eCollection 2020 Sep 10.

PMID: 32944145

 

RECENT ADVANCES IN INSTRUMENTAL APPROACHES TO TIME-OF-FLIGHT MASS SPECTROMETRY.

Brais CJ, Ibañez JO, Schwartz AJ, Ray SJ.

Mass Spectrom Rev. 2020 Aug 10. doi: 10.1002/mas.21650. Online ahead of print.

PMID: 32779281 

 

To use or not to use propensity score matching?

Wang J.

Pharm Stat. 2020 Aug 10. doi: 10.1002/pst.2051. Online ahead of print.

PMID: 32776719

 

Real-time monitoring of quality attributes by in-line Fourier transform infrared spectroscopic sensors at ultrafiltration and diafiltration of bioprocess.

Wasalathanthri DP, Feroz H, Puri N, Hung J, Lane G, Holstein M, Chemmalil L, Both D, Ghose S, Ding J, Li ZJ.

Biotechnol Bioeng. 2020 Aug 10. doi: 10.1002/bit.27532. Online ahead of print.

PMID: 32776504

 

meta-Selective C-H Arylation of Fluoroarenes and Simple Arenes.

Liu LY, Qiao JX, Yeung KS, Ewing WR, Yu JQ.

Angew Chem Int Ed Engl. 2020 Aug 10;59(33):13831-13835. doi: 10.1002/anie.202002865. Epub 2020 Jul 9.

PMID: 32333462

 

The catalytic domain of the histone methyltransferase NSD2/MMSET is required for the generation of B1 cells in mice.

Dobenecker MW, Marcello J, Becker A, Rudensky E, Bhanu NV, Carrol T, Garcia BA, Prinjha R, Yurchenko V, Tarakhovsky A.

FEBS Lett. 2020 Aug 9. doi: 10.1002/1873-3468.13903. Online ahead of print.

PMID: 32862441

 

Spliceosome mutations are common in persons with myeloproliferative neoplasm-associated myelofibrosis with RBC-transfusion-dependence and correlate with response to pomalidomide.

Chowdhury O, O'Sullivan J, Barkas N, Wang G, Buck G, Hamblin A, Tefferi A, Al-Ali HK, Barosi G, Devos T, Gisslinger H, Jiang Q, Kiladjian JJ, Mesa R, Passamonti F, Ribrag V, Schiller G, Vannucchi AM, Zhou D, McMullin MF, Zhong J, Gale RP, Mead AJ; RESUME trialists.

Leukemia. 2020 Aug 7. doi: 10.1038/s41375-020-0979-6. Online ahead of print.

PMID: 32770086 

 

Geographic Variation in Knowledge of Palliative Care Among US Adults: Findings From 2018 Health Information National Trends Survey.

Chen G, Hong YR, Wilkie DJ, Kittleson S, Huo J, Bian J.

Am J Hosp Palliat Care. 2020 Aug 6:1049909120946266. doi: 10.1177/1049909120946266. Online ahead of print.

PMID: 32757758

 

Strategies and Recommendations for Using a Data-Driven and Risk-Based Approach in the Selection of First-in-Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment.

Leach MW, Clarke DO, Dudal S, Han C, Li C, Yang Z, Brennan FR, Bailey WJ, Chen Y, Deslandes A, Loberg LI, Mayawala K, Rogge MC, Todd M, Chemuturi NV.

Clin Pharmacol Ther. 2020 Aug 5. doi: 10.1002/cpt.2009. Online ahead of print.

PMID: 32757299

 

Multiple Cereblon genetic changes associate with acquired resistance to Lenalidomide or Pomalidomide in Multiple Myeloma.

Gooding S, Ansari-Pour N, Towfic F, Ortiz Estevez M, Chamberlain PP, Tsai KT, Flynt E, Hirst M, Rozelle D, Dhiman P, Neri P, Ramasamy K, Bahlis NJ, Vyas P, Thakurta A.

Blood. 2020 Aug 4:blood.2020007081. doi: 10.1182/blood.2020007081. Online ahead of print.

PMID: 32750105

 

Integrated Approach for Characterizing Bispecific Antibody/Antigens Complexes and Mapping Binding Epitopes with SEC/MALS, Native Mass Spectrometry, and Protein Footprinting.

Huang RY, Wang F, Wheeler M, Wang Y, Langish R, Chau B, Dong J, Morishige W, Bezman N, Strop P, Rajpal A, Gudmundsson O, Chen G.

Anal Chem. 2020 Aug 4;92(15):10709-10716. doi: 10.1021/acs.analchem.0c01876. Epub 2020 Jul 22.

PMID: 32639723

 

Enhancing Host-Cell Protein Detection in Protein Therapeutics Using HILIC Enrichment and Proteomic Analysis.

Wang Q, Slaney TR, Wu W, Ludwig R, Tao L, Leone A.

Anal Chem. 2020 Aug 4;92(15):10327-10335. doi: 10.1021/acs.analchem.0c00360. Epub 2020 Jul 17.

PMID: 32614163

 

Ewing sarcoma family of tumors-derived small extracellular vesicle proteomics identify potential clinical biomarkers.

Samuel G, Crow J, Klein JB, Merchant ML, Nissen E, Koestler DC, Laurence K, Liang X, Neville K, Staggs V, Ahmed A, Atay S, Godwin AK.

Oncotarget. 2020 Aug 4;11(31):2995-3012. doi: 10.18632/oncotarget.27678. eCollection 2020 Aug 4.

PMID: 32821345 

 

MethylResolver-a method for deconvoluting bulk DNA methylation profiles into known and unknown cell contents.

Arneson D, Yang X, Wang K.

Commun Biol. 2020 Aug 3;3(1):422. doi: 10.1038/s42003-020-01146-2.

PMID: 32747663 

 

Determining the Impact of Roller Compaction Processing Conditions on Granule and API Properties.

Clarke J, Gamble JF, Jones JW, Tobyn M, Dawson N, Davies C, Ingram A, Greenwood R.

AAPS PharmSciTech. 2020 Aug 2;21(6):218. doi: 10.1208/s12249-020-01773-2.

PMID: 32743765

 

LC/MS/MS-based quantitation of pig and human S100A1 protein in cardiac tissues: Application to gene therapy.

Sleczka BG, Levesque PC, Adam LP, Olah TV, Shipkova P.

Anal Biochem. 2020 Aug 1;602:113766. doi: 10.1016/j.ab.2020.113766. Epub 2020 May 8.

PMID: 32389692

 

Neoadjuvant Nivolumab for Patients With Resectable Merkel Cell Carcinoma in the CheckMate 358 Trial.

Topalian SL, Bhatia S, Amin A, Kudchadkar RR, Sharfman WH, Lebbé C, Delord JP, Dunn LA, Shinohara MM, Kulikauskas R, Chung CH, Martens UM, Ferris RL, Stein JE, Engle EL, Devriese LA, Lao CD, Gu J, Li B, Chen T, Barrows A, Horvath A, Taube JM, Nghiem P.

J Clin Oncol. 2020 Aug 1;38(22):2476-2487. doi: 10.1200/JCO.20.00201. Epub 2020 Apr 23.

PMID: 32324435

 

Disease activity measures at baseline predict structural damage progression: data from the randomized, controlled AMPLE and AVERT trials.

Keystone EC, Ahmad HA, Yazici Y, Bergman MJ.

Rheumatology (Oxford). 2020 Aug 1;59(8):2090-2098. doi: 10.1093/rheumatology/kez455.

PMID: 31819995 

 

Canadian cohort expanded-access program of nivolumab plus ipilimumab in advanced melanoma.

Hogg D, Monzon JG, Ernst S, Song X, McWhirter E, Savage KJ, Skinn B, Romeyer F, Smylie M.

Curr Oncol. 2020 Aug;27(4):204-214. doi: 10.3747/co.27.5985. Epub 2020 Aug 1.

PMID: 32905202 

 

Excretion balance and pharmacokinetics following a single oral dose of [¹⁴C]-fedratinib in healthy subjects.

Ogasawara K, Xu C, Kanamaluru V, Siebers N, Surapaneni S, Ridoux L, Palmisano M, Krishna G.

Cancer Chemother Pharmacol. 2020 Aug;86(2):307-314. doi: 10.1007/s00280-020-04121-0. Epub 2020 Aug 3.

PMID: 32748109

 

Qualified method for the estimation of di-18:1 bis(monoacylglycero)phosphate in urine, a noninvasive biomarker to monitor drug-induced phospholipidosis.

Murali BV, Kurawattimath V, Bhutani P, Onorato J, Naikodi SB, Kole P, Rajanna PK.

Bioanalysis. 2020 Aug;12(15):1049-1059. doi: 10.4155/bio-2020-0114. Epub 2020 Jul 31.

PMID: 32735140

 

Recent advances in inhibitors of C-terminal SRC kinase.

P O'Malley D.

Future Med Chem. 2020 Aug;12(16):1447-1449. doi: 10.4155/fmc-2020-0125. Epub 2020 Jul 8.

PMID: 32638626 

 

Real-world switch patterns and healthcare costs in biologic-naive psoriasis patients initiating apremilast or biologics.

Wu JJ, Pelletier C, Ung B, Tian M, Khilfeh I, Curtis JR.

J Comp Eff Res. 2020 Aug;9(11):767-779. doi: 10.2217/cer-2020-0045. Epub 2020 Jul 8.

PMID: 32638609 

 

Viral myocarditis involves the generation of autoreactive T cells with multiple antigen specificities that localize in lymphoid and non-lymphoid organs in the mouse model of CVB3 infection.

Basavalingappa RH, Arumugam R, Lasrado N, Yalaka B, Massilamany C, Gangaplara A, Riethoven JJ, Xiang SH, Steffen D, Reddy J.

Mol Immunol. 2020 Aug;124:218-228. doi: 10.1016/j.molimm.2020.06.017. Epub 2020 Jun 29.

PMID: 32615275

 

Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities.

Al-Huniti N, Feng Y, Yu JJ, Lu Z, Nagase M, Zhou D, Sheng J.

CPT Pharmacometrics Syst Pharmacol. 2020 Aug;9(8):419-427. doi: 10.1002/psp4.12542. Epub 2020 Jul 22.

PMID: 32589767 

 

Phase II results from a phase I/II study to assess the safety and efficacy of weekly nab-paclitaxel in paediatric patients with recurrent or refractory solid tumours: A collaboration with the European Innovative Therapies for Children with Cancer Network.

Amoroso L, Castel V, Bisogno G, Casanova M, Marquez-Vega C, Chisholm JC, Doz F, Moreno L, Ruggiero A, Gerber NU, Fagioli F, Hingorani P, Melcón SG, Slepetis R, Chen N, le Bruchec Y, Simcock M, Vassal G.

Eur J Cancer. 2020 Aug;135:89-97. doi: 10.1016/j.ejca.2020.04.031. Epub 2020 Jun 15.

PMID: 32554315

 

A multicenter retrospective study of nivolumab monotherapy in previously treated metastatic renal cell carcinoma patients: interim analysis of Japanese real-world data.

Hinata N, Yonese J, Masui S, Nakai Y, Shirotake S, Tatsugami K, Inamoto T, Nozawa M, Ueda K, Etsunaga T, Osawa T, Uemura M, Kimura G, Numakura K, Yamana K, Miyake H, Fukasawa S, Ochi K, Kaneko H, Uemura H.

Int J Clin Oncol. 2020 Aug;25(8):1533-1542. doi: 10.1007/s10147-020-01692-z. Epub 2020 Jun 9.

PMID: 32519026 

 

Real-world safety and efficacy data of ipilimumab in Japanese radically unresectable malignant melanoma patients: A postmarketing surveillance.

Yamazaki N, Kiyohara Y, Uhara H, Tsuchida T, Maruyama K, Shakunaga N, Itakura E, Komoto A.

J Dermatol. 2020 Aug;47(8):834-848. doi: 10.1111/1346-8138.15388. Epub 2020 Jun 8.

PMID: 32515086 

 

Absorption and Disposition of Coproporphyrin I (CPI) in Cynomolgus Monkeys and Mice: Pharmacokinetic Evidence to Support the Use of CPI to Inform the Potential for Organic Anion-Transporting Polypeptide Inhibition.

Gu X, Wang L, Gan J, Fancher RM, Tian Y, Hong Y, Lai Y, Sinz M, Shen H.

Drug Metab Dispos. 2020 Aug;48(8):724-734. doi: 10.1124/dmd.120.090670. Epub 2020 Jun 1.

PMID: 32482623

 

Comparative Clinical and Economic Outcomes Associated with Warfarin Versus Apixaban in the Treatment of Patients with Venous Thromboembolism in a Large U.S. Commercial Claims Database.

Guo JD, Rajpura J, Hlavacek P, Keshishian A, Sah J, Delinger R, Mu Q, Mardekian J, Russ C, Okano GJ, Rosenblatt L.

J Manag Care Spec Pharm. 2020 Aug;26(8):1017-1026. doi: 10.18553/jmcp.2020.19311. Epub 2020 May 26.

PMID: 32452277

 

Disease activity and patient-reported outcomes in patients with rheumatoid arthritis and Sjögren's syndrome enrolled in a large observational US registry.

Harrold LR, Shan Y, Rebello S, Kramer N, Connolly SE, Alemao E, Kelly S, Kremer JM, Rosenstein ED.

Rheumatol Int. 2020 Aug;40(8):1239-1248. doi: 10.1007/s00296-020-04602-8. Epub 2020 May 24.

PMID: 32449040 

 

An anti-IL-13 antibody reverses epithelial-mesenchymal transition biomarkers in eosinophilic esophagitis: Phase 2 trial results.

Gann PH, Deaton RJ, McMahon N, Collins MH, Dellon ES, Hirano I, Hua SY, Rodriguez C, Harris S.

J Allergy Clin Immunol. 2020 Aug;146(2):367-376.e3. doi: 10.1016/j.jaci.2020.03.045. Epub 2020 May 11.

PMID: 32407835 

 

Incident depression in patients diagnosed with multiple sclerosis: a multi-database study.

Persson R, Lee S, Yood MU, Wagner MR, Minton N, Niemcryk S, Lindholm A, Evans AM, Jick S.

Eur J Neurol. 2020 Aug;27(8):1556-1560. doi: 10.1111/ene.14314. Epub 2020 Jun 8.

PMID: 32397001

 

Mitochondrial Complex 1, Sigma 1, and Synaptic Vesicle 2A in Early Drug-Naive Parkinson's Disease.

Wilson H, Pagano G, de Natale ER, Mansur A, Caminiti SP, Polychronis S, Middleton LT, Price G, Schmidt KF, Gunn RN, Rabiner EA, Politis M.

Mov Disord. 2020 Aug;35(8):1416-1427. doi: 10.1002/mds.28064. Epub 2020 Apr 29.

PMID: 32347983

 

The importance and future of biochemical engineering.

Whitehead TA, Banta S, Bentley WE, Betenbaugh MJ, Chan C, Clark DS, Hoesli CA, Jewett MC, Junker B, Koffas M, Kshirsagar R, Lewis A, Li CT, Maranas C, Terry Papoutsakis E, Prather KLJ, Schaffer S, Segatori L, Wheeldon I.

Biotechnol Bioeng. 2020 Aug;117(8):2305-2318. doi: 10.1002/bit.27364. Epub 2020 May 29.

PMID: 32343367

 

Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma.

Weisel K, Dimopoulos M, Moreau P, Yagci M, Larocca A, Kanate AS, Vural F, Cascavilla N, Basu S, Johnson P, Byeff P, Hus M, Rodríguez-Otero P, Muelduer E, Anttila P, Hayden PJ, Krauth MT, Lucio P, Ben-Yehuda D, Mendeleeva L, Guo S, Yu X, Grote L, Biyukov T, Dhanasiri S, Richardson P.

Leuk Lymphoma. 2020 Aug;61(8):1850-1859. doi: 10.1080/10428194.2020.1747066. Epub 2020 Apr 9.

PMID: 32268815

 

Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study.

Cortes JE, Jiang Q, Wang J, Weng J, Zhu H, Liu X, Hochhaus A, Kim DW, Radich J, Savona M, Martin-Regueira P, Sy O, Gurnani R, Saglio G.

Leukemia. 2020 Aug;34(8):2064-2073. doi: 10.1038/s41375-020-0805-1. Epub 2020 Apr 7.

PMID: 32265500 

 

Multiplexed ion beam imaging (MIBI) for characterization of the tumor microenvironment across tumor types.

Ptacek J, Locke D, Finck R, Cvijic ME, Li Z, Tarolli JG, Aksoy M, Sigal Y, Zhang Y, Newgren M, Finn J.

Lab Invest. 2020 Aug;100(8):1111-1123. doi: 10.1038/s41374-020-0417-4. Epub 2020 Mar 23.

PMID: 32203152 

 

Population Pharmacokinetics and Exposure Response Analysis of Pomalidomide in Subjects With Relapsed or Refractory Multiple Myeloma From the Novel Combination Treatment of Pomalidomide, Bortezomib, and Low-Dose Dexamethasone.

Li Y, Kassir N, Wang X, Palmisano M, Zhou S.

J Clin Pharmacol. 2020 Aug;60(8):1061-1075. doi: 10.1002/jcph.1602. Epub 2020 Mar 13.

PMID: 32168381

 

Modeling and Simulation of the Pharmacokinetics and Target Engagement of an Antagonist Monoclonal Antibody to Interferon-γ-Induced Protein 10, BMS-986184, in Healthy Participants to Guide Therapeutic Dosing.

Cai W, Leil TA, Gibiansky L, Krishna M, Zhang H, Gu H, Sun H, Throup J, Banerjee S, Girgis I.

Clin Pharmacol Drug Dev. 2020 Aug;9(6):689-698. doi: 10.1002/cpdd.784. Epub 2020 Feb 18.

PMID: 32068354 

 

Inpatient and outpatient treatment patterns of cancer-associated thrombosis in the United States.

Guo JD, Hlavacek P, Poretta T, Wygant G, Lane D, Gorritz M, Wang X, Chen CC, Wade RL, Pan X, Rajpura J, Stwalley B, Rosenblatt L.

J Thromb Thrombolysis. 2020 Aug;50(2):386-394. doi: 10.1007/s11239-019-02032-3.

PMID: 31955338 

 

Cost-Effectiveness of Extended and One-Time Screening Versus No Screening for Non-Valvular Atrial Fibrillation in the USA.

Oguz M, Lanitis T, Li X, Wygant G, Singer DE, Friend K, Hlavacek P, Nikolaou A, Mattke S.

Appl Health Econ Health Policy. 2020 Aug;18(4):533-545. doi: 10.1007/s40258-019-00542-y.

PMID: 31849021 

 

Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS

Harris S, Tran JQ, Southworth H, Spencer  CM, Cree  BAC,  Zamvil SS. 

Neurol Neuroimmunol Neuroinflamm 2020 Jul 31;7(5):e839. doi: 10.1212/NXI.0000000000000839. Print 2020 Sep.

PMID: 32737072 

 

TP53 mutations in myelodysplastic syndromes and secondary AML confer an immunosuppressive phenotype.

Sallman DA, McLemore AF, Aldrich AL, Komrokji RS, McGraw KL, Dhawan A, Geyer S, Hou HA, Eksioglu EA, Sullivan A, Warren S, MacBeth KJ, Meggendorfer M, Haferlach T, Boettcher S, Ebert BL, Al-Ali N, Lancet JE, Cleveland JL, Padron E, List AF.

Blood. 2020 Jul 30:blood.2020006158. doi: 10.1182/blood.2020006158. Online ahead of print.

PMID: 32730593

 

Symptoms and impacts in anemia of chronic kidney disease.

Mathias SD, Blum SI, Sikirica V, Johansen KL, Colwell HH, Okoro T.

J Patient Rep Outcomes. 2020 Jul 29;4(1):64. doi: 10.1186/s41687-020-00215-8.

PMID: 32728779 

 

Discovery of Potent and Orally Bioavailable Small Molecule Antagonists of Toll-like Receptors 7/8/9 (TLR7/8/9).

Mussari CP, Dodd DS, Sreekantha RK, Pasunoori L, Wan H, Posy SL, Critton D, Ruepp S, Subramanian M, Watson A, Davies P, Schieven GL, Salter-Cid LM, Srivastava R, Tagore DM, Dudhgaonkar S, Poss MA, Carter PH, Dyckman AJ.

ACS Med Chem Lett. 2020 Jul 29;11(9):1751-1758. doi: 10.1021/acsmedchemlett.0c00264. eCollection 2020 Sep 10.

PMID: 32944143

 

AP-Net: An atomic-pairwise neural network for smooth and transferable interaction potentials.

Glick ZL, Metcalf DP, Koutsoukas A, Spronk SA, Cheney DL, Sherrill CD.

J Chem Phys. 2020 Jul 28;153(4):044112. doi: 10.1063/5.0011521.

PMID: 32752707

 

Clinical characteristics and treatment patterns of patients with venous thromboembolism (VTE) transitioning from hospital to post-discharge settings.

Burton T, Hlavacek P, Guo JD, Rosenblatt L, Mardekian J, Ferri M, Russ C, Kline JA.

Hosp Pract (1995). 2020 Jul 28:1-10. doi: 10.1080/21548331.2020.1769988. Online ahead of print.

PMID: 32720816

 

Exploring Completeness of Adverse Event Reports as a Tool for Signal Detection in Pharmacovigilance.

Lee I, Jokinen JD, Crawford SY, Calip GS, Kilpatrick RD, Lee TA.

Ther Innov Regul Sci. 2020 Jul 27. doi: 10.1007/s43441-020-00199-z. Online ahead of print.

PMID: 32720297

 

Lymphatic Distribution of Etanercept Following Intravenous and Subcutaneous Delivery to Rats.

Gao X, Voronin G, Generaux C, Rose A, Kozhich A, Dalglish G, Rosa R, Oh S, Kagan L.

Pharm Res. 2020 Jul 27;37(8):155. doi: 10.1007/s11095-020-02860-6.

PMID: 32720159

 

Long-Term Safety and Tolerability of Apremilast Versus Placebo in Psoriatic Arthritis: A Pooled Safety Analysis of Three Phase III, Randomized, Controlled Trials.

Mease PJ, Gladman DD, Gomez-Reino JJ, Hall S, Kavanaugh A, Lespessailles E, Schett G, Paris M, Delev N, Teng L, Wollenhaupt J.

ACR Open Rheumatol. 2020 Jul 25;2(8):459-70. doi: 10.1002/acr2.11156. Online ahead of print.

PMID: 32710493 

 

Characterization of individuals with selected muscular dystrophies from the expanded pilot of the Muscular Dystrophy Surveillance, Tracking and Research Network (MD STARnet) in the United States.

Wallace B, Smith KT, Thomas S, Conway KM, Westfield C, Andrews JG, Weinert RO, Do TQN, Street N;

Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STARnet).Birth Defects Res. 2020 Jul 24. doi: 10.1002/bdr2.1764. Online ahead of print.

PMID: 32710484

 

Association between race and treatment patterns and survival outcomes in multiple myeloma: A Connect MM Registry analysis.

Ailawadhi S, Jagannath S, Lee HC, Narang M, Rifkin RM, Terebelo HR, Durie BGM, Toomey K, Hardin JW, Gasparetto CJ, Wagner L, Omel JL, He M, Yue L, Flick ED, Agarwal A, Abonour R; Connect MM Registry Investigators.

Cancer. 2020 Jul 24;126(19):4332-40. doi: 10.1002/cncr.33089. Online ahead of print.

PMID: 32706404 

 

Molecular Underpinnings of Severe Coronavirus Disease 2019.

Plenge RM.

JAMA. 2020 Jul 24. doi: 10.1001/jama.2020.14015. Online ahead of print.

PMID: 32706364 

 

Framework and case study for establishing impactful global health programs through academia - biopharmaceutical industry partnerships.

Pastakia SD, Tran DN, Manji I, Schellhase E, Karwa R, Miller ML, Aruasa W, Khan ZM.

Res Social Adm Pharm. 2020 Jul 24:S1551-7411(20)30162-5. doi: 10.1016/j.sapharm.2020.07.018. Online ahead of print.

PMID: 32792324

 

Transition-Metal-Catalyzed Cycloaddition Reactions to Access Seven-Membered Rings.

Trost BM, Zuo Z, Schultz JE.

Chemistry. 2020 Jul 23. doi: 10.1002/chem.202002713. Online ahead of print.

PMID: 32705722 

 

Lenalidomide as maintenance treatment for patients with multiple myeloma after autologous stem cell transplantation: A pharmaco-economic assessment.

Uyl-de Groot CA, Ramsden R, Lee D, Boersma J, Zweegman S, Dhanasiri S.

Eur J Haematol. 2020 Jul 23;105(5):635-45. doi: 10.1111/ejh.13497. Online ahead of print.

PMID: 32705720 

 

Risperidone- and paliperidone-induced hepatotoxicity: Case report and review of literature.

Khorassani F, Sousonis F, Lopez LV.

Am J Health Syst Pharm. 2020 Jul 23:zxaa224. doi: 10.1093/ajhp/zxaa224. Online ahead of print.

PMID: 32699878

 

A minority of T cells recognizing tumor-associated antigens presented in self-HLA can provoke antitumor reactivity.

Roex MCJ, Hageman L, Veld SAJ, van Egmond E, Hoogstraten C, Stemberger C, Germeroth L, Einsele H, Falkenburg JHF, Jedema I.

Blood. 2020 Jul 23;136(4):455-467. doi: 10.1182/blood.2019004443.

PMID: 32483595

 

Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments.

Gottlieb K, Daperno M, Usiskin K, Sands BE, Ahmad H, Howden CW, Karnes W, Oh YS, Modesto I, Marano C, Stidham RW, Reinisch W.

Gut. 2020 Jul 22:gutjnl-2020-320690. doi: 10.1136/gutjnl-2020-320690. Online ahead of print.

PMID: 32699100 

 

The use of UK primary care databases in health technology assessments carried out by the National Institute for health and care excellence (NICE).

Leahy TP, Ramagopalan S, Sammon C.

BMC Health Serv Res. 2020 Jul 22;20(1):675. doi: 10.1186/s12913-020-05529-3.

PMID: 32698805 

 

Association of inflammatory biomarkers with clinical outcomes in nivolumab-treated patients with advanced hepatocellular carcinoma.

Sangro B, Melero I, Wadhawan S, Finn RS, Abou-Alfa GK, Cheng AL, Yau T, Furuse J, Park JW, Boyd Z, Tang HT, Shen Y, Tschaika M, Neely J, El-Khoueiry A.

J Hepatol. 2020 Jul 22:S0168-8278(20)30479-7. doi: 10.1016/j.jhep.2020.07.026. Online ahead of print.

PMID: 32710922 

 

Population Pharmacokinetics and Exposure-Response Relationship of Luspatercept, an Erythroid Maturation Agent, in Anemic Patients With β-Thalassemia.

Chen N, Kassir N, Laadem A, Giuseppi AC, Shetty J, Maxwell SE, Sriraman P, Ritland S, Linde PG, Budda B, Reynolds JG, Zhou S, Palmisano M.

J Clin Pharmacol. 2020 Jul 21. doi: 10.1002/jcph.1696. Online ahead of print.

PMID: 32696522

 

Strategies for high-concentration drug substance manufacturing to facilitate subcutaneous administration: A review.

Holstein M, Hung J, Feroz H, Ranjan S, Du C, Ghose S, Li ZJ.

Biotechnol Bioeng. 2020 Jul 20. doi: 10.1002/bit.27510. Online ahead of print.

PMID: 32687221 

 

Switch Rates and Total Cost of Care Associated with Apremilast and Biologic Therapies in Biologic-Naive Patients with Plaque Psoriasis.

Kaplan DL, Ung BL, Pelletier C, Udeze C, Khilfeh I, Tian M.

Clinicoecon Outcomes Res. 2020 Jul 17;12:369-377. doi: 10.2147/CEOR.S251775. eCollection 2020.

PMID: 32765022 

 

Treatment patterns and health outcomes in metastatic renal cell carcinoma patients treated with targeted systemic therapies in the UK.

Hawkins R, Fife K, Hurst M, Wang M, Naicker N, Nolasco S, Eisen T, Matakidou A, Gordon J.

BMC Cancer. 2020 Jul 17;20(1):670. doi: 10.1186/s12885-020-07154-z.

PMID: 32680483 

 

A novel semi-mechanistic tumor growth fraction model for translation of preclinical efficacy of anti-glypican 3 antibody drug conjugate to human.

Singh R, Kozhich A, Pan C, Lee F, Cardarelli P, Vangipuram R, Iyer R, Marathe P.

Biopharm Drug Dispos. 2020 Jul 17. doi: 10.1002/bdd.2249. Online ahead of print.

PMID: 32678919

 

Evaluation of the Potential for QTc Prolongation With Repeated Oral Doses of Fedratinib in Patients With Advanced Solid Tumors.

Ogasawara K, Xu C, Yin J, Darpo B, Carayannopoulos L, Xue H, Palmisano M, Krishna G.

Clin Pharmacol Drug Dev. 2020 Jul 16. doi: 10.1002/cpdd.850. Online ahead of print.

PMID: 32673446

 

Nivolumab versus everolimus in patients with advanced renal cell carcinoma: Updated results with long-term follow-up of the randomized, open-label, phase 3 CheckMate 025 trial.

Motzer RJ, Escudier B, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Plimack ER, Procopio G, McDermott DF, Castellano D, Choueiri TK, Donskov F, Gurney H, Oudard S, Richardet M, Peltola K, Alva AS, Carducci M, Wagstaff J, Chevreau C, Fukasawa S, Tomita Y, Gauler TC, Kollmannsberger CK, Schutz FA, Larkin J, Cella D, McHenry MB, Saggi SS, Tannir NM.

Cancer. 2020 Jul 16. doi: 10.1002/cncr.33033. Online ahead of print.

PMID: 32673417

 

A CFD model for predicting protein aggregation in low-pH virial inactivation for mAb production.

Xing Z, Jin W, Xu X, Song Y, Huang C, Borys MC, Ghose S, Li ZJ.

Biotechnol Bioeng. 2020 Jul 16. doi: 10.1002/bit.27505. Online ahead of print.

PMID: 32672835

 

Publisher Correction: Cross-site and cross-platform variability of automated patch clamp assessments of drug effects on human cardiac currents in recombinant cells.

Kramer J, Himmel HM, Lindqvist A, Stoelzle-Feix S, Chaudhary KW, Li D, Bohme GA, Bridgland-Taylor M, Hebeisen S, Fan J, Renganathan M, Imredy J, Humphries ESA, Brinkwirth N, Strassmaier T, Ohtsuki A, Danker T, Vanoye C, Polonchuk L, Fermini B, Pierson JB, Gintant G.

Sci Rep. 2020 Jul 14;10(1):11884. doi: 10.1038/s41598-020-68819-0.

PMID: 32665705 

 

Impact of somatic mutations on response to lenalidomide in lower-risk non-del(5q) myelodysplastic syndromes patients.

Santini V, Fenaux P, Giagounidis A, Platzbecker U, List AF, Haferlach T, Zhong J, Wu C, Mavrommatis K, Beach CL, MacBeth KJ, Almeida A.

Leukemia. 2020 Jul 13. doi: 10.1038/s41375-020-0961-3. Online ahead of print.

PMID: 32661294 

 

Model-Based Determination of Elotuzumab Pharmacokinetics in Japanese Patients With Multiple Myeloma Incorporating Time-Varying M Protein.

Ide T, Roy A, Imai Y, Vezina HE.

J Clin Pharmacol. 2020 Jul 12. doi: 10.1002/jcph.1698. Online ahead of print.

PMID: 32656777

 

Quality of life of patients with metastatic pancreatic adenocarcinoma initiating first-line chemotherapy in routine practice.

Laquente B, Macarulla T, Bugés C, Martín M, García C, Pericay C, Merino S, Visa L, Martín T, Pedraza M, Carnero B, Guardeño R, Verdaguer H, Mut A, Vilanova D, García A.

BMC Palliat Care. 2020 Jul 10;19(1):103. doi: 10.1186/s12904-020-00610-4.

PMID: 32650765 

 

IL-31 transgenic mice show reduced allergen-induced lung inflammation.

Neuper T, Neureiter D, Sarajlic M, Strandt H, Bauer R, Schwarz H, Suchanek P, Korotchenko E, Dillon SR, Hammerl P, Stoecklinger A, Weiss R, Horejs-Hoeck J.

Eur J Immunol. 2020 Jul 10. doi: 10.1002/eji.202048547. Online ahead of print.

PMID: 32648940

 

Discovery of a High Affinity, Orally Bioavailable Macrocyclic FXIa Inhibitor with Antithrombotic Activity in Preclinical Species.

Yang W, Wang Y, Lai A, Clark CG, Corte JR, Fang T, Gilligan PJ, Jeon Y, Pabbisetty KB, Rampulla RA, Mathur A, Kaspady M, Neithnadka PR, Arumugam A, Raju S, Rossi KA, Myers JE Jr, Sheriff S, Lou Z, Zheng JJ, Chacko SA, Bozarth JM, Wu Y, Crain EJ, Wong PC, Seiffert DA, Luettgen JM, Lam PYS, Wexler RR, Ewing WR.

J Med Chem. 2020 Jul 9;63(13):7226-7242. doi: 10.1021/acs.jmedchem.0c00464. Epub 2020 Jun 17.

PMID: 32456431

 

Discovery of CRBN E3 Ligase Modulator CC-92480 for the Treatment of Relapsed and Refractory Multiple Myeloma.

Hansen JD, Correa M, Nagy MA, Alexander M, Plantevin V, Grant V, Whitefield B, Huang D, Kercher T, Harris R, Narla RK, Leisten J, Tang Y, Moghaddam M, Ebinger K, Piccotti J, Havens CG, Cathers B, Carmichael J, Daniel T, Vessey R, Hamann LG, Leftheris K, Mendy D, Baculi F, LeBrun LA, Khambatta G, Lopez-Girona A.

J Med Chem. 2020 Jul 9;63(13):6648-6676. doi: 10.1021/acs.jmedchem.9b01928. Epub 2020 Mar 19.

PMID: 32130004

 

Interferon-independent STING signaling promotes resistance to HSV-1 in vivo.

Yamashiro LH, Wilson SC, Morrison HM, Karalis V, Chung JJ, Chen KJ, Bateup HS, Szpara ML, Lee AY, Cox JS, Vance RE.

Nat Commun. 2020 Jul 7;11(1):3382. doi: 10.1038/s41467-020-17156-x.

PMID: 32636381 

 

Conducting Clinical Research During the COVID-19 Pandemic: Protecting Scientific Integrity.

Fleming TR, Labriola D, Wittes J.

JAMA. 2020 Jul 7;324(1):33-34. doi: 10.1001/jama.2020.9286.

PMID: 32463422 

 

Epitope and Paratope Mapping of PD-1/Nivolumab by Mass Spectrometry-Based Hydrogen-Deuterium Exchange, Cross-linking, and Molecular Docking.

Zhang MM, Huang RY, Beno BR, Deyanova EG, Li J, Chen G, Gross ML.

Anal Chem. 2020 Jul 7;92(13):9086-9094. doi: 10.1021/acs.analchem.0c01291. Epub 2020 Jun 10.

PMID: 32441507

 

Recent Advances in Co-processed APIs and Proposals for Enabling Commercialization of These Transformative Technologies.

Schenck L, Erdemir D, Saunders Gorka L, Merritt JM, Marziano I, Ho R, Lee M, Bullard J, Boukerche M, Ferguson S, Florence AJ, Khan SA, Sun CC.

Mol Pharm. 2020 Jul 6;17(7):2232-2244. doi: 10.1021/acs.molpharmaceut.0c00198. Epub 2020 Jun 10.

PMID: 32392068

 

Assessment of impact of daily huddles and visual displays on medication delivery timeliness in a large academic medical center.

Smith AJF, Ahern SP, Shermock KM, Feller TT, Hill JD.

Am J Health Syst Pharm. 2020 Jul 4:zxaa210. doi: 10.1093/ajhp/zxaa210. Online ahead of print.

PMID: 32620969

 

Assessment of technical errors and validation processes in economic models submitted by the company for NICE technology appraisals.

Radeva D, Hopkin G, Mossialos E, Borrill J, Osipenko L, Naci H.

Int J Technol Assess Health Care. 2020 Jul 3:1-6. doi: 10.1017/S0266462320000422. Online ahead of print.

PMID: 32618536

 

Amplifying the Voice of the Patient in Clinical Research: Development of Toolkits for Use in Designing and Conducting Patient-Centered Clinical Studies.

TransCelerate Biopharma Toolkits Core Team, Elmer M, Florek C, Gabryelski L, Greene A, Inglis AM, Johnson KL, Keiper T, Ludlam S, Sharpe TJ, Shay K, Somers F, Sutherland C, Teufel M, Yates S.

Ther Innov Regul Sci. 2020 Jul 2. doi: 10.1007/s43441-020-00176-6. Online ahead of print.

PMID: 32617912

 

A generalizable data-driven multicellular model of pancreatic ductal adenocarcinoma.

Aguilar B, Gibbs DL, Reiss DJ, McConnell M, Danziger SA, Dervan A, Trotter M, Bassett D, Hershberg R, Ratushny AV, Shmulevich I.

Gigascience. 2020 Jul 1;9(7):giaa075. doi: 10.1093/gigascience/giaa075.

PMID: 32696951 

 

Pharmacokinetic Disposition Difference Between Cyclosporine and Voclosporin Drives Their Distinct Efficacy and Safety Profiles in Clinical Studies.

Li Y, Palmisano M, Sun D, Zhou S.

Clin Pharmacol. 2020 Jul 1;12:83-96. doi: 10.2147/CPAA.S255789. eCollection 2020.

PMID: 32669879 

 

Effect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: The CheckMate 143 Phase 3 Randomized Clinical Trial.

Reardon DA, Brandes AA, Omuro A, Mulholland P, Lim M, Wick A, Baehring J, Ahluwalia MS, Roth P, Bähr O, Phuphanich S, Sepulveda JM, De Souza P, Sahebjam S, Carleton M, Tatsuoka K, Taitt C, Zwirtes R, Sampson J, Weller M.

JAMA Oncol. 2020 Jul 1;6(7):1003-1010. doi: 10.1001/jamaoncol.2020.1024.

PMID: 32437507 

 

Design, synthesis and SAR study of bridged tricyclic pyrimidinone carboxamides as HIV-1 integrase inhibitors.

Patel M, Naidu BN, Dicker I, Higley H, Lin Z, Terry B, Protack T, Krystal M, Jenkins S, Parker D, Panja C, Rampulla R, Mathur A, Meanwell NA, Walker MA.

Bioorg Med Chem. 2020 Jul 1;28(13):115541. doi: 10.1016/j.bmc.2020.115541. Epub 2020 May 4.

PMID: 32389483

 

Factors associated with non-prescription of oral anticoagulant treatment in non-valvular atrial fibrillation patients with dementia: a CPRD-HES study.

Besford M, Graham S, Sammon C, Mehmud F, Allan V, Alikhan R, Ramagopalan S.

Age Ageing. 2020 Jul 1;49(4):679-682. doi: 10.1093/ageing/afaa045.

PMID: 32242616

 

Treatment Patterns Among Patients with Multiple Sclerosis Initiating Second-Line Disease-Modifying Therapy.

Bowen J, Mehta R, Pelletier C, Tian M, Noxon V, Johnson BH, Bonafede M.

Adv Ther. 2020 Jul;37(7):3163-3177. doi: 10.1007/s12325-020-01367-1. Epub 2020 May 20.

PMID: 32436028 

 

Nivolumab treatment of elderly Japanese patients with non-small cell lung cancer: subanalysis of a real-world retrospective observational study (CA209-9CR).

Okishio K, Morita R, Shimizu J, Saito H, Sakai H, Kim YH, Hataji O, Yomota M, Nishio M, Aoe K, Kanai O, Kumagai T, Kibata K, Tsukamoto H, Oizumi S, Fujimoto D, Tanaka H, Mizuno K, Masuda T, Kozuki T, Haku T, Suzuki H, Okamoto I, Hoshiyama H, Yada N, Ohe Y.

ESMO Open. 2020 Jul;5(4):e000656. doi: 10.1136/esmoopen-2019-000656.

PMID: 32690620 

 

Interrogating the immune-modulating roles of radiation therapy for a rational combination with immune-checkpoint inhibitors in treating pancreatic cancer.

Fujiwara K, Saung MT, Jing H, Herbst B, Zarecki M, Muth S, Wu A, Bigelow E, Chen L, Li K, Jurcak N, Blair AB, Ding D, Wichroski M, Blum J, Cheadle N, Koenitzer J, Zheng L.

J Immunother Cancer. 2020 Jul;8(2):e000351. doi: 10.1136/jitc-2019-000351.

PMID: 32675194 

 

Survival outcomes and independent response assessment with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma: 42-month follow-up of a randomized phase 3 clinical trial.

Motzer RJ, Escudier B, McDermott DF, Arén Frontera O, Melichar B, Powles T, Donskov F, Plimack ER, Barthélémy P, Hammers HJ, George S, Grünwald V, Porta C, Neiman V, Ravaud A, Choueiri TK, Rini BI, Salman P, Kollmannsberger CK, Tykodi SS, Grimm MO, Gurney H, Leibowitz-Amit R, Geertsen PF, Amin A, Tomita Y, McHenry MB, Saggi SS, Tannir NM.

J Immunother Cancer. 2020 Jul;8(2):e000891. doi: 10.1136/jitc-2020-000891.

PMID: 32661118 

 

Current challenges for assessing the long-term clinical benefit of cancer immunotherapy: a multi-stakeholder perspective.

Quinn C, Garrison LP, Pownell AK, Atkins MB, de Pouvourville G, Harrington K, Ascierto PA, McEwan P, Wagner S, Borrill J, Wu E.

J Immunother Cancer. 2020 Jul;8(2):e000648. doi: 10.1136/jitc-2020-000648.

PMID: 32661115 

 

Population Pharmacokinetics and Exposure-Response of Luspatercept, an Erythroid Maturation Agent, in Anemic Patients With Myelodysplastic Syndromes.

Chen N, Kassir N, Laadem A, Maxwell SE, Sriraman P, Giuseppi AC, Ritland S, Linde PG, Budda B, Reynolds JG, Zhou S, Palmisano M.

CPT Pharmacometrics Syst Pharmacol. 2020 Jul;9(7):395-404. doi: 10.1002/psp4.12521. Epub 2020 Jun 30.

PMID: 32602651 

 

Nomogram for Estimating Overall Survival in Patients With Metastatic Pancreatic Cancer.

Goldstein D, Von Hoff DD, Chiorean EG, Reni M, Tabernero J, Ramanathan RK, Botteman M, Aly A, Margunato-Debay S, Lu B, Louis CU, McGovern D, Lee CK.

Pancreas. 2020 Jul;49(6):744-750. doi: 10.1097/MPA.0000000000001563.

PMID: 32541630 

 

Comparative Safety and Effectiveness of Oral Anticoagulants in Nonvalvular Atrial Fibrillation: The NAXOS Study.

Van Ganse E, Danchin N, Mahé I, Hanon O, Jacoud F, Nolin M, Dalon F, Lefevre C, Cotté FE, Gollety S, Falissard B, Belhassen M, Steg PG.

Stroke. 2020 Jul;51(7):2066-2075. doi: 10.1161/STROKEAHA.120.028825. Epub 2020 Jun 16.

PMID: 32539675 

 

Assessment of effects of repeated oral doses of fedratinib on inhibition of cytochrome P450 activities in patients with solid tumors using a cocktail approach.

Ogasawara K, LoRusso PM, Olszanski AJ, Rixe O, Xu C, Yin J, Palmisano M, Krishna G.

Cancer Chemother Pharmacol. 2020 Jul;86(1):87-95. doi: 10.1007/s00280-020-04102-3. Epub 2020 Jun 14.

PMID: 32537715

Real-World Treatment Patterns and Outcomes in Patients Receiving Second-Line Therapy for Advanced/Metastatic Esophageal Squamous Cell Carcinoma.

Abraham P, Gricar J, Zhang Y, Shankaran V.

Adv Ther. 2020 Jul;37(7):3392-3403. doi: 10.1007/s12325-020-01394-y. Epub 2020 Jun 12.

PMID: 32533533 

 

Causal inference and adjustment for reference-arm risk in indirect treatment comparison meta-analysis.

Swallow E, Patterson-Lomba O, Ayyagari R, Pelletier C, Mehta R, Signorovitch J.

J Comp Eff Res. 2020 Jul;9(10):737-750. doi: 10.2217/cer-2020-0042. Epub 2020 Jun 3.

PMID: 32490682 

 

Large-scale implementation of a pragmatic atrial fibrillation screening program in Canadian community practice.

Andrade JG, Godin R, Nault I.

Pacing Clin Electrophysiol. 2020 Jul;43(7):768-769. doi: 10.1111/pace.13966. Epub 2020 Jun 11.

PMID: 32460368 

 

A Novel Peptidylarginine Deiminase 4 (PAD4) Inhibitor BMS-P5 Blocks Formation of Neutrophil Extracellular Traps and Delays Progression of Multiple Myeloma.

Li M, Lin C, Deng H, Strnad J, Bernabei L, Vogl DT, Burke JJ, Nefedova Y.

Mol Cancer Ther. 2020 Jul;19(7):1530-1538. doi: 10.1158/1535-7163.MCT-19-1020. Epub 2020 May 5.

PMID: 32371579

 

Minimization of artifact protein aggregation using tetradecyl sulfate and hexadecyl sulfate in capillary gel electrophoresis under reducing conditions.

Guan Q, Atsma J, Tulsan R, Voronov S, Ding J, Beckman J, Li ZJ.

Electrophoresis. 2020 Jul;41(13-14):1245-1252. doi: 10.1002/elps.201900435. Epub 2020 May 17.

PMID: 32297333

 

 Poor prognostic factors in predicting abatacept response in a phase III randomized controlled trial in psoriatic arthritis.

Mease PJ, McInnes IB, Strand V, FitzGerald O, Ahmad HA, Elbez Y, Banerjee S.

Rheumatol Int. 2020 Jul;40(7):1021-1028. doi: 10.1007/s00296-020-04564-x. Epub 2020 Apr 30.

PMID: 32356115 

 

The economic burden to payers of patients with diffuse large B-cell lymphoma during the treatment period by line of therapy.

Tkacz J, Garcia J, Gitlin M, McMorrow D, Snyder S, Bonafede M, Chung KC, Maziarz RT.

Leuk Lymphoma. 2020 Jul;61(7):1601-1609. doi: 10.1080/10428194.2020.1734592. Epub 2020 Apr 9.

PMID: 32270727

 

Intermittent dosing of the transforming growth factor beta receptor 1 inhibitor, BMS-986260, mitigates class-based cardiovascular toxicity in dogs but not rats.

Rak GD, White MR, Augustine-Rauch K, Newsome C, Graziano MJ, Schulze GE.

J Appl Toxicol. 2020 Jul;40(7):931-946. doi: 10.1002/jat.3954. Epub 2020 Feb 15.

PMID: 32061184

 

Multiple Myeloma DREAM Challenge reveals epigenetic regulator PHF19 as marker of aggressive disease.

Mason MJ, Schinke C, Eng CLP, Towfic F, Gruber F, Dervan A, White BS, Pratapa A, Guan Y, Chen H, Cui Y, Li B, Yu T, Chaibub Neto E, Mavrommatis K, Ortiz M, Lyzogubov V, Bisht K, Dai HY, Schmitz F, Flynt E, Dan Rozelle, Danziger SA, Ratushny A; Multiple Myeloma DREAM Consortium, Dalton WS, Goldschmidt H, Avet-Loiseau H, Samur M, Hayete B, Sonneveld P, Shain KH, Munshi N, Auclair D, Hose D, Morgan G, Trotter M, Bassett D, Goke J, Walker BA, Thakurta A, Guinney J.

Leukemia. 2020 Jul;34(7):1866-1874. doi: 10.1038/s41375-020-0742-z. Epub 2020 Feb 14.

PMID: 32060406 

 

Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: Results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study.

Van Voorhees AS, Stein Gold L, Lebwohl M, Strober B, Lynde C, Tyring S, Cauthen A, Sofen H, Zhang Z, Paris M, Wang Y.

J Am Acad Dermatol. 2020 Jul;83(1):96-103. doi: 10.1016/j.jaad.2020.01.072. Epub 2020 Feb 4.

PMID: 32032692 

 

Recommended Practices for Macerating Human Thyroid Cartilage.

LaGoy A, Evangelou EA, Somogyi T, DiGangi EA.

J Forensic Sci. 2020 Jul;65(4):1266-1273. doi: 10.1111/1556-4029.14289. Epub 2020 Feb 7.

PMID: 32031684

 

Feeding tricarboxylic acid cycle intermediates improves lactate consumption and antibody production in Chinese hamster ovary cell cultures.

Zhang X, Jiang R, Lin H, Xu S.

Biotechnol Prog. 2020 Jul;36(4):e2975. doi: 10.1002/btpr.2975. Epub 2020 Feb 21.

PMID: 32012447

 

Baseline Objective Inflammation by Magnetic Resonance Imaging as a Predictor of Therapeutic Benefit in Early Rheumatoid Arthritis With Poor Prognosis.

Ahmad HA, Baker JF, Østergaard M, Emery P, Durez P, Ye J, Banerjee S, Conaghan PG.

Arthritis Care Res (Hoboken). 2020 Jul;72(7):959-964. doi: 10.1002/acr.24072. Epub 2020 May 26.

PMID: 31549793 

 

Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis.

Arroyo R, Bury DP, Guo JD, Margolin DH, Melanson M, Daizadeh N, Cella D.

Mult Scler. 2020 Jul;26(8):955-963. doi: 10.1177/1352458519849796. Epub 2019 May 30.

PMID: 31144568 

 

T-Cell Dependent Immunogenicity of Protein Therapeutics Pre-clinical Assessment and Mitigation-Updated Consensus and Review 2020.

Jawa V, Terry F, Gokemeijer J, Mitra-Kaushik S, Roberts BJ, Tourdot S, De Groot AS.

Front Immunol. 2020 Jun 30;11:1301. doi: 10.3389/fimmu.2020.01301. eCollection 2020.

PMID: 32695107 

 

Oral anticoagulants for nonvalvular atrial fibrillation in frail elderly patients: insights from the ARISTOPHANES study.

Lip GYH, Keshishian AV, Kang AL, Dhamane AD, Luo X, Li X, Balachander N, Rosenblatt L, Mardekian J, Pan X, Di Fusco M, Garcia Reeves AB, Yuce H, Deitelzweig S.

J Intern Med. 2020 Jun 30. doi: 10.1111/joim.13140. Online ahead of print.

PMID: 32602228

 

A phase 1b study of dual PD-1 and CTLA-4 or KIR blockade in patients with relapsed/refractory lymphoid malignancies.

Armand P, Lesokhin A, Borrello I, Timmerman J, Gutierrez M, Zhu L, Popa McKiver M, Ansell SM.

Leukemia. 2020 Jun 29. doi: 10.1038/s41375-020-0939-1. Online ahead of print.

PMID: 32601377 

 

Real-World Experience with Apremilast in the Treatment of Adults with Moderate to Severe Plaque Psoriasis in Québec: A Claims-Based Analysis of Drug Utilization and Healthcare Resource Utilization.

Poulin Y, Beauchemin C, Royer C, Gaudreau AJ, Yim C, Liu FF, Lachaine J.

J Cutan Med Surg. 2020 Jun 29:1203475420936652. doi: 10.1177/1203475420936652. Online ahead of print.

PMID: 32597685

 

Background Glucocorticoid Therapy Has No Impact on Efficacy and Safety of Abatacept or Adalimumab in Patients with Rheumatoid Arthritis.

Degboé Y, Schiff M, Weinblatt M, Fleischmann R, Ahmad HA, Constantin A.

J Clin Med. 2020 Jun 26;9(6):2017. doi: 10.3390/jcm9062017.

PMID: 32604962 

 

The Universal Patient Language: A Set of Resources and Tools to Design Patient Communications That Support Better Health Literacy.

Bartlett S, Dezii C, Sandt K.

Stud Health Technol Inform. 2020 Jun 25;269:264-274. doi: 10.3233/SHTI200041.

PMID: 32594001

 

Metabolic and Pharmaceutical Aspects of Fluorinated Compounds.

Johnson BM, Shu YZ, Zhuo X, Meanwell NA.

J Med Chem. 2020 Jun 25;63(12):6315-6386. doi: 10.1021/acs.jmedchem.9b01877. Epub 2020 Mar 17.

PMID: 32182061

 

Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141).

Yen CJ, Kiyota N, Hanai N, Takahashi S, Yokota T, Iwae S, Shimizu Y, Hong RL, Goto M, Kang JH, Li WSK, Ferris RL, Gillison M, Endo T, Jayaprakash V, Tahara M.

Head Neck. 2020 Jun 24;42(10):2852-62. doi: 10.1002/hed.26331. Online ahead of print.

PMID: 32583557 

 

Author Correction: Cellular census of human fibrosis defines functionally distinct stromal cell types and states.

Layton TB, Williams L, McCann F, Zhang M, Fritzsche M, Colin-York H, Cabrita M, Ng MTH, Feldmann M, Sansom SN, Furniss D, Xie W, Nanchahal J.

Nat Commun. 2020 Jun 24;11(1):3275. doi: 10.1038/s41467-020-17073-z.

PMID: 32581254 

 

Potentiation of rifampin activity in a mouse model of tuberculosis by activation of host transcription factor EB.

Bryk R, Mundhra S, Jiang X, Wood M, Pfau D, Weber E, Park S, Zhang L, Wilson C, Van der Westhuyzen R, Street L, Chibale K, Zimmerman M, Dartois V, Pastore N, Ballabio A, Hawryluk N, Canan S, Khetani V, Camardo J, Nathan C.

PLoS Pathog. 2020 Jun 23;16(6):e1008567. doi: 10.1371/journal.ppat.1008567. eCollection 2020 Jun.

PMID: 32574211 

 

Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative.

Mikita JS, Mitchel J, Gatto NM, Laschinger J, Tcheng JE, Zeitler EP, Swern AS, Flick ED, Dowd C, Lystig T, Calvert SB.

Ther Innov Regul Sci. 2020 Jun 22. doi: 10.1007/s43441-020-00185-5. Online ahead of print.

PMID: 32572772

 

Correction to: Comparative clinical outcomes between direct oral anticoagulants and warfarin among elderly patients with non-valvular atrial fibrillation in the CMS Medicare population.

Amin A, Keshishian A, Dina O, Dhamane A, Nadkarni A, Carda E, Russ C, Rosenblatt L, Mardekian J, Yuce H, Baker CL.

J Thromb Thrombolysis. 2020 Jun 20. doi: 10.1007/s11239-020-02161-0. Online ahead of print.

PMID: 32564179

 

Quantifying Target Occupancy of Small Molecules Within Living Cells.

Robers MB, Friedman-Ohana R, Huber KVM, Kilpatrick L, Vasta JD, Berger BT, Chaudhry C, Hill S, Müller S, Knapp S, Wood KV.

Annu Rev Biochem. 2020 Jun 20;89:557-581. doi: 10.1146/annurev-biochem-011420-092302. Epub 2020 Mar 24.

PMID: 32208767

 

Pediatric cancer research: Surviving COVID-19.

Auletta JJ, Adamson PC, Agin JE, Kearns P, Kennedy S, Kieran MW, Ludwinski DM, Knox LJ, McKay K, Rhiner P, Thiele CJ, Cripe TP.

Pediatr Blood Cancer. 2020 Jun 18:e28435. doi: 10.1002/pbc.28435. Online ahead of print.

PMID: 32558190 

 

ARID1A mutation plus CXCL13 expression act as combinatorial biomarkers to predict responses to immune checkpoint therapy in mUCC.

Goswami S, Chen Y, Anandhan S, Szabo PM, Basu S, Blando JM, Liu W, Zhang J, Natarajan SM, Xiong L, Guan B, Yadav SS, Saci A, Allison JP, Galsky MD, Sharma P.

Sci Transl Med. 2020 Jun 17;12(548):eabc4220. doi: 10.1126/scitranslmed.abc4220.

PMID: 32554706

 

Benchmarking Patient Recruitment and Retention Practices.

Lamberti MJ, Smith Z, Henry R, Howe D, Goodwin M, Williams A, Getz K.

Ther Innov Regul Sci. 2020 Jun 16. doi: 10.1007/s43441-020-00186-4. Online ahead of print.

PMID: 32548703

 

Osmolality as a lever to modulate the N-glycolylneuraminicacid (Neu5Gc) level of a recombinant glycoprotein produced in Chinese hamster ovary cells.

Xu S, Borys M, Khetan A, Pla I.

Biotechnol Prog. 2020 Jun 15:e3038. doi: 10.1002/btpr.3038. Online ahead of print.

PMID: 32542945

 

Dendritic Cell Maturation Defines Immunological Responsiveness of Tumors to Radiation Therapy.

Blair TC, Bambina S, Alice AF, Kramer GF, Medler TR, Baird JR, Broz ML, Tormoen GW, Troesch V, Crittenden MR, Gough MJ.

J Immunol. 2020 Jun 15;204(12):3416-3424. doi: 10.4049/jimmunol.2000194. Epub 2020 Apr 27.

PMID: 32341058

 

Substituted benzyloxytricyclic compounds as retinoic acid-related orphan receptor gamma t (RORγt) agonists.

Harikrishnan LS, Gill P, Kamau MG, Qin LY, Ruan Z, O'Malley D, Huynh T, Stachura S, Cavallaro CL, Lu Z, J-W Duan J, Weigelt CA, Sack JS, Ruzanov M, Khan J, Gururajan M, Wong JJ, Huang Y, Yarde M, Li Z, Chen C, Sun H, Borowski V, Murtaza A, Fink BE.

Bioorg Med Chem Lett. 2020 Jun 15;30(12):127204. doi: 10.1016/j.bmcl.2020.127204. Epub 2020 Apr 20.

PMID: 32334911

 

Characterization of a novel hydroxypropyl methylcellulose (HPMC) direct compression grade excipient for pharmaceutical tablets.

Allenspach C, Timmins P, Sharif S, Minko T.

Int J Pharm. 2020 Jun 15;583:119343. doi: 10.1016/j.ijpharm.2020.119343. Epub 2020 Apr 17.

PMID: 32305364

 

Safety and Efficacy of Nivolumab in Patients With Advanced Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study.

McFarlane JJ, Kochenderfer MD, Olsen MR, Bauer TM, Molina A, Hauke RJ, Reeves JA, Babu S, Van Veldhuizen P, Somer B, Gunuganti V, Schnadig I, George S, Page RD, Arrowsmith E, Jain RK, Zhang J, McHenry MB, Johansen JL, Vogelzang NJ.

Clin Genitourin Cancer. 2020 Jun 14:S1558-7673(20)30141-5. doi: 10.1016/j.clgc.2020.06.002. Online ahead of print.

PMID: 32641261 

 

The Role of Cocrystallization-Mediated Altered Crystallographic Properties on the Tabletability of Rivaroxaban and Malonic Acid.

Kale DP, Puri V, Kumar A, Kumar N, Bansal AK.

Pharmaceutics. 2020 Jun 12;12(6):546. doi: 10.3390/pharmaceutics12060546.

PMID: 32545503 

 

Sericin: A Versatile Protein Biopolymer with Therapeutic Significance.

Suryawanshi R, Kanoujia J, Parashar P, Saraf SA.

Curr Pharm Des. 2020 Jun 12. doi: 10.2174/1381612826666200612165253. Online ahead of print.

PMID: 32532189

 

Catalytic α-Hydroarylation of Acrylates and Acrylamides via an Interrupted Hydrodehalogenation Reaction.

Vasquez AM, Gurak JA Jr, Joe CL, Cherney EC, Engle KM.

J Am Chem Soc. 2020 Jun 10;142(23):10477-10484. doi: 10.1021/jacs.0c03040. Epub 2020 May 28.

PMID: 32379433

 

The Roles of Signaling in Cytoskeletal Changes, Random Movement, Direction-Sensing and Polarization of Eukaryotic Cells.

Cheng Y, Felix B, Othmer HG.

Cells. 2020 Jun 10;9(6):1437. doi: 10.3390/cells9061437.

PMID: 32531876 

 

Optimization of Nicotinamides as Potent and Selective IRAK4 Inhibitors with Efficacy in a Murine Model of Psoriasis.

Nair S, Kumar SR, Paidi VR, Sistla R, Kantheti D, Polimera SR, Thangavel S, Mukherjee AJ, Das M, Bhide RS, Pitts WJ, Murugesan N, Dudhgoankar S, Nagar J, Subramani S, Mazumder D, Carman JA, Holloway DA, Li X, Fereshteh MP, Ruepp S, Palanisamy K, Mariappan TT, Maddi S, Saxena A, Elzinga P, Chimalakonda A, Ruan Q, Ghosh K, Bose S, Sack J, Yan C, Kiefer SE, Xie D, Newitt JA, Saravanakumar SP, Rampulla RA, Barrish JC, Carter PH, Hynes J Jr.

ACS Med Chem Lett. 2020 Jun 10;11(7):1402-1409. doi: 10.1021/acsmedchemlett.0c00082. eCollection 2020 Jul 9.

PMID: 32676146

 

Pd^II -Catalyzed Enantioselective C(sp³ )-H Arylation of Cyclobutyl Ketones Using a Chiral Transient Directing Group.

Xiao LJ, Hong K, Luo F, Hu L, Ewing WR, Yeung KS, Yu JQ.

Angew Chem Int Ed Engl. 2020 Jun 8;59(24):9594-9600. doi: 10.1002/anie.202000532. Epub 2020 Apr 1.

PMID: 32155313

 

Medical biotechnology as a paradigm for forest restoration and introduction of the transgenic American chestnut.

Aucott M, Parker RA.

Conserv Biol. 2020 Jun 7. doi: 10.1111/cobi.13566. Online ahead of print.

PMID: 32506503

 

Prevalence of co-existing autoimmune disease in juvenile idiopathic arthritis: a cross-sectional study.

Simon TA, Harikrishnan GP, Kawabata H, Singhal S, Brunner HI, Lovell DJ.

Pediatr Rheumatol Online J. 2020 Jun 5;18(1):43. doi: 10.1186/s12969-020-00426-9.

PMID: 32503658 

 

Distributed Regression Analysis Application in Large Distributed Data Networks: Analysis of Precision and Operational Performance.

Her Q, Malenfant J, Zhang Z, Vilk Y, Young J, Tabano D, Hamilton J, Johnson R, Raebel M, Boudreau D, Toh S.

JMIR Med Inform. 2020 Jun 4;8(6):e15073. doi: 10.2196/15073.

PMID: 32496200 

 

International prognostic indices in diffuse large B-cell lymphoma: a comparison of IPI, R-IPI, and NCCN-IPI.

Ruppert AS, Dixon JG, Salles G, Wall A, Cunningham D, Poeschel V, Haioun C, Tilly H, Ghesquieres H, Ziepert M, Flament J, Flowers C, Shi Q, Schmitz N.

Blood. 2020 Jun 4;135(23):2041-2048. doi: 10.1182/blood.2019002729.

PMID: 32232482

 

Pd-Catalyzed γ-C(sp³)-H Fluorination of Free Amines.

Chen YQ, Singh S, Wu Y, Wang Z, Hao W, Verma P, Qiao JX, Sunoj RB, Yu JQ.

J Am Chem Soc. 2020 Jun 3;142(22):9966-9974. doi: 10.1021/jacs.9b13537. Epub 2020 May 18.

PMID: 32363869

 

Cellular census of human fibrosis defines functionally distinct stromal cell types and states.

Layton TB, Williams L, McCann F, Zhang M, Fritzsche M, Colin-York H, Cabrita M, Ng MTH, Feldmann M, Sansom SN, Furniss D, Xie W, Nanchahal J.

Nat Commun. 2020 Jun 2;11(1):2768. doi: 10.1038/s41467-020-16264-y.

PMID: 32488016 

 

KLK6 expression in skin induces PAR1-mediated psoriasiform dermatitis and inflammatory joint disease.

Billi AC, Ludwig JE, Fritz Y, Rozic R, Swindell WR, Tsoi LC, Gruzska D, Abdollahi-Roodsaz S, Xing X, Diaconu D, Uppala R, Camhi MI, Klenotic PA, Sarkar MK, Husni ME, Scher JU, McDonald C, Kahlenberg JM, Midura RJ, Gudjonsson JE, Ward NL.

J Clin Invest. 2020 Jun 1;130(6):3151-3157. doi: 10.1172/JCI133159.

PMID: 32155135 

 

Defining the path ahead for NOAC use in the pediatric population: A Cardiac Safety Research Consortium Think Tank.

Seltzer JH, Farrell A, Goldenberg N, Hornik C, Keene D, Krucoff MW, Lipardi C, Massicotte P, Mentzer D, Monagle P, Thornburg C, Revkin JH, Walker S, Gajjar D.

Am Heart J. 2020 Jun;224:138-147. doi: 10.1016/j.ahj.2020.02.012. Epub 2020 Feb 28.

PMID: 32388153 

 

Indirect treatment comparison of nivolumab versus placebo for the adjuvant treatment of melanoma.

Hemstock M, Amadi A, Kupas K, Roskell N, Kotapati S, Gooden K, Middleton MR, Schadendorf D.

Eur J Cancer. 2020 Jun;132:176-186. doi: 10.1016/j.ejca.2020.03.011. Epub 2020 May 4.

PMID: 32380428 

 

New genetic predictors for abacavir tolerance in HLA-B*57:01 positive individuals.

Pavlos R, Deshpande P, Chopra A, Leary S, Strautins K, Nolan D, Thorborn D, Shaefer M, Rauch A, Dunn D, Montaner J, Rachlis A, Almeida CA, Choo L, James I, Redwood AJ, Li Y, Gaudieri S, Mallal SA, Phillips EJ.

Hum Immunol. 2020 Jun;81(6):300-304. doi: 10.1016/j.humimm.2020.02.011. Epub 2020 Mar 12.

PMID: 32173028 

 

Pomalidomide-bortezomib-dexamethasone in relapsed or refractory multiple myeloma: Japanese subset analysis of OPTIMISMM.

Sunami K, Matsue K, Suzuki K, Takezako N, Shinagawa A, Sakurai S, Tamakoshi H, Biyukov T, Peluso T, Richardson P.

Cancer Sci. 2020 Jun;111(6):2116-2122. doi: 10.1111/cas.14415. Epub 2020 May 13.

PMID: 32297407 

 

A Phase 1, Open-Label Study in Healthy Subjects to Evaluate the Absolute Bioavailability of AG-221 by a Microtracer Approach.

Wang X, Chen J, Reyes J, Zhou S, Palmisano M, Li Y.

Oncol Ther. 2020 Jun;8(1):91-102. doi: 10.1007/s40487-019-0097-7. Epub 2019 Jul 19.

PMID: 32700065 

 

Software-aided detection and structural characterization of cyclic peptide metabolites in biological matrix by high-resolution mass spectrometry.

Yao M, Cai T, Duchoslav E, Ma L, Guo X, Zhu M.

J Pharm Anal. 2020 Jun;10(3):240-246. doi: 10.1016/j.jpha.2020.05.012. Epub 2020 May 26.

PMID: 32612870 

 

Current status and future directions of high-throughput ADME screening in drug discovery.

Shou WZ.

J Pharm Anal. 2020 Jun;10(3):201-208. doi: 10.1016/j.jpha.2020.05.004. Epub 2020 May 23.

PMID: 32612866 

 

Developing Biotherapeutics in the New Decade.

Meng WS, Sahin E, Wen Y.

J Pharm Innov. 2020 Jun;15(2):201. doi: 10.1007/s12247-020-09454-0. Epub 2020 May 29.

PMID: 32582399 

 

Serum interleukin-6 and C-reactive protein are associated with survival in melanoma patients receiving immune checkpoint inhibition.

Laino AS, Woods D, Vassallo M, Qian X, Tang H, Wind-Rotolo M, Weber J.

J Immunother Cancer. 2020 Jun;8(1):e000842. doi: 10.1136/jitc-2020-000842. Epub 2020 Jun 23.

PMID: 32581042 

 

Recommendations for singlet-based approach in ligand binding assays: an IQ Consortium perspective.

Pillutla R, Gorovits B, Gleason C, Quiroz J, Christopher D, Braun M, Brockus C, Donaldson D, Haslberger T, He L, Qian M, Sydor J, Wickremsinhe E, Williams L.

Bioanalysis. 2020 Jun;12(12):823-834. doi: 10.4155/bio-2020-0094. Epub 2020 Jun 19.

PMID: 32558588

 

Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma.

Ascierto PA, Del Vecchio M, Mackiewicz A, Robert C, Chiarion-Sileni V, Arance A, Lebbé C, Svane IM, McNeil C, Rutkowski P, Loquai C, Mortier L, Hamid O, Bastholt L, Dreno B, Schadendorf D, Garbe C, Nyakas M, Grob JJ, Thomas L, Liszkay G, Smylie M, Hoeller C, Ferraresi V, Grange F, Gutzmer R, Pikiel J, Hosein F, Simsek B, Maio M.

J Immunother Cancer. 2020 Jun;8(1):e000391. doi: 10.1136/jitc-2019-000391.

PMID: 32503946 

 

Interplay of somatic alterations and immune infiltration modulates response to PD-1 blockade in advanced clear cell renal cell carcinoma.

Braun DA, Hou Y, Bakouny Z, Ficial M, Sant' Angelo M, Forman J, Ross-Macdonald P, Berger AC, Jegede OA, Elagina L, Steinharter J, Sun M, Wind-Rotolo M, Pignon JC, Cherniack AD, Lichtenstein L, Neuberg D, Catalano P, Freeman GJ, Sharpe AH, McDermott DF, Van Allen EM, Signoretti S, Wu CJ, Shukla SA, Choueiri TK.

Nat Med. 2020 Jun;26(6):909-918. doi: 10.1038/s41591-020-0839-y. Epub 2020 May 29.

PMID: 32472114

 

Pharmacokinetics and tolerability of fedratinib, an oral, selective Janus kinase 2 inhibitor, in subjects with renal or hepatic impairment.

Ogasawara K, Smith WB, Xu C, Yin J, Palmisano M, Krishna G.

Cancer Chemother Pharmacol. 2020 Jun;85(6):1109-1117. doi: 10.1007/s00280-020-04084-2. Epub 2020 May 24.

PMID: 32449142

 

Linking process indicators and clinical/safety outcomes to assess the effectiveness of abatacept (ORENCIA) patient alert cards in patients with rheumatoid arthritis.

Artime E, Kahlon R, Méndez I, Kou T, Garrido-Estepa M, Qizilbash N.

Pharmacoepidemiol Drug Saf. 2020 Jun;29(6):664-674. doi: 10.1002/pds.5012. Epub 2020 May 12.

PMID: 32394485

 

Propensity score matching and inverse probability of treatment weighting to address confounding by indication in comparative effectiveness research of oral anticoagulants.

Allan V, Ramagopalan SV, Mardekian J, Jenkins A, Li X, Pan X, Luo X.

J Comp Eff Res. 2020 Jun;9(9):603-614. doi: 10.2217/cer-2020-0013. Epub 2020 Mar 18.

PMID: 32186922 

 

Inoculum size and traits of the infecting clinical strain define the protection level against Mycobacterium tuberculosis infection in a rabbit model.

Tsenova L, Fallows D, Kolloli A, Singh P, O'Brien P, Kushner N, Kaplan G, Subbian S.

Eur J Immunol. 2020 Jun;50(6):858-872. doi: 10.1002/eji.201948448. Epub 2020 Mar 20.

PMID: 32130727

 

Prevalence of Sjögren's syndrome associated with rheumatoid arthritis in the USA: an observational study from the Corrona registry.

Harrold LR, Shan Y, Rebello S, Kramer N, Connolly SE, Alemao E, Kelly S, Kremer JM, Rosenstein ED.

Clin Rheumatol. 2020 Jun;39(6):1899-1905. doi: 10.1007/s10067-020-05004-8. Epub 2020 Mar 4.

PMID: 32130579 

 

Fedratinib in patients with myelofibrosis previously treated with ruxolitinib: An updated analysis of the JAKARTA2 study using stringent criteria for ruxolitinib failure.

Harrison CN, Schaap N, Vannucchi AM, Kiladjian JJ, Jourdan E, Silver RT, Schouten HC, Passamonti F, Zweegman S, Talpaz M, Verstovsek S, Rose S, Shen J, Berry T, Brownstein C, Mesa RA.

Am J Hematol. 2020 Jun;95(6):594-603. doi: 10.1002/ajh.25777. Epub 2020 Apr 17.

PMID: 32129512 

 

Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation.

Prior H, Baldrick P, Beken S, Booler H, Bower N, Brooker P, Brown P, Burlinson B, Burns-Naas LA, Casey W, Chapman M, Clarke D, de Haan L, Doehr O, Downes N, Flaherty M, Gellatly N, Moesgaard SG, Harris J, Holbrook M, Hui J, Jones D, Jones K, Kedar H, Mahl A, Manninen A, McGuire A, Mortimer-Cassen E, Peraza M, Pugsley MK, Richard J, Roberts R, Roosen W, Rothfuss A, Schoenmakers A, Sewell F, Weaver R, Weir L, Wolfreys A, Kimber I.

Regul Toxicol Pharmacol. 2020 Jun;113:104624. doi: 10.1016/j.yrtph.2020.104624. Epub 2020 Feb 29.

PMID: 32126256 

 

Scientific Regulatory Policy Committee Points to Consider*: Nuisance Factors, Block Effects, and Batch Effects in Nonclinical Safety Assessment Studies.

Schultze AE, Bennet B, Rae JC, Chiang AY, Frazier K, Katavolos P, McKinney L, Patrick DJ, Tripathi N.

Toxicol Pathol. 2020 Jun;48(4):537-548. doi: 10.1177/0192623320906385. Epub 2020 Mar 3.

PMID: 32122253

 

Health-related quality of life results from the IFM 2009 trial: treatment with lenalidomide, bortezomib, and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma.

Roussel M, Hebraud B, Hulin C, Perrot A, Caillot D, Stoppa AM, Macro M, Escoffre M, Arnulf B, Belhadj K, Karlin L, Garderet L, Facon T, Guo S, Weng J, Dhanasiri S, Leleu X, Moreau P, Attal M.

Leuk Lymphoma. 2020 Jun;61(6):1323-1333. doi: 10.1080/10428194.2020.1719091. Epub 2020 Feb 22.

PMID: 32090636

 

A budget impact analysis for making treatment decisions based on anti-cyclic citrullinated peptide (anti-CCP) testing in rheumatoid arthritis.

Park SH, Han X, Lobo F, Kratochvil D, Patel D.

J Med Econ. 2020 Jun;23(6):624-630. doi: 10.1080/13696998.2020.1732991. Epub 2020 May 19.

PMID: 32075453

 

Infections in patients diagnosed with multiple sclerosis: A multi-database study.

Persson R, Lee S, Ulcickas Yood M, Wagner Usn Mc CM, Minton N, Niemcryk S, Lindholm A, Evans AM, Jick SS.

Mult Scler Relat Disord. 2020 Jun;41:101982. doi: 10.1016/j.msard.2020.101982. Epub 2020 Feb 4.

PMID: 32070858

 

Achievement of red blood cell transfusion independence in red blood cell transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes correlates with serum erythropoietin levels.

Santini V, Almeida A, Giagounidis A, Skikne B, Beach CL, Weaver J, Tu N, Fenaux P.

Leuk Lymphoma. 2020 Jun;61(6):1475-1483. doi: 10.1080/10428194.2020.1719088. Epub 2020 Feb 17.

PMID: 32064987

 

Cell-Based In Vitro Assay Automation: Balancing Technology and Data Reproducibility/Predictability.

Thomas-Fowlkes B, Cifelli S, Souza S, Visconti R, Struck A, Weinglass A, Wildey MJ.

SLAS Technol. 2020 Jun;25(3):276-285. doi: 10.1177/2472630320902095. Epub 2020 Jan 31.

PMID: 32003291

 

Efficacy and safety of dapagliflozin plus saxagliptin versus insulin glargine over 52 weeks as add-on to metformin with or without sulphonylurea in patients with type 2 diabetes: A randomized, parallel-design, open-label, Phase 3 trial.

Vilsbøll T, Ekholm E, Johnsson E, Garcia-Sanchez R, Dronamraju N, Jabbour SA, Lind M.

Diabetes Obes Metab. 2020 Jun;22(6):957-968. doi: 10.1111/dom.13981. Epub 2020 Feb 23.

PMID: 32003150 

 

The value of immunotherapy for survivors of stage IV non-small cell lung cancer: patient perspectives on quality of life.

Park R, Shaw JW, Korn A, McAuliffe J.

J Cancer Surviv. 2020 Jun;14(3):363-376. doi: 10.1007/s11764-020-00853-3. Epub 2020 Jan 16.

PMID: 31950409 

 

Prospective Study Evaluating Changes in Bone Quality in Premenopausal Women With Breast Cancer Undergoing Adjuvant Chemotherapy.

Hopson MB, Onishi M, Awad D, Buono D, Maurer M, Crew KD, Shane E, Hershman DL, Kalinsky K.

Clin Breast Cancer. 2020 Jun;20(3):e327-e333. doi: 10.1016/j.clbc.2019.12.001. Epub 2019 Dec 5.

PMID: 31926840

 

Treatment-to-Target With Apremilast in Psoriatic Arthritis: The Probability of Achieving Targets and Comprehensive Control of Disease Manifestations.

Mease PJ, Gladman DD, Ogdie A, Coates LC, Behrens F, Kavanaugh A, McInnes I, Queiro R, Guerette B, Brunori M, Teng L, Smolen JS.

Arthritis Care Res (Hoboken). 2020 Jun;72(6):814-821. doi: 10.1002/acr.24134. Epub 2020 May 8.

PMID: 31909868 

 

Trajectories of health-related quality of life among renal transplant patients associated with graft failure and symptom distress: Analysis of the BENEFIT and BENEFIT-EXT trials.

Purnajo I, Beaumont JL, Polinsky M, Alemao E, Everly MJ.

Am J Transplant. 2020 Jun;20(6):1650-1658. doi: 10.1111/ajt.15757. Epub 2020 Jan 11.

PMID: 31874117

 

Nonhomologous end-joining repair is likely involved in the repair of double-stranded DNA breaks induced by riluzole in melanoma cells.

Cerchio R Jr, Marinaro C, Foo TK, Xia B, Chen S.

Melanoma Res. 2020 Jun;30(3):303-308. doi: 10.1097/CMR.0000000000000652.

PMID: 31855905

 

Modelling Survival of Patients Treated with Adjuvant Nivolumab Who Have Melanoma with Lymph Node Involvement or Metastatic Disease After Complete Resection.

Batteson R, Hart R, Hemstock M, Gooden K, Kotapati S, Roze S, Lee D, Amadi A.

Pharmacoecon Open. 2020 Jun;4(2):343-351. doi: 10.1007/s41669-019-00181-y.

PMID: 31587138 

 

Hepatocyte spheroids as a viable in vitro model for recapitulation of complex in vivo metabolism pathways of loratadine in humans.

Chacko SA, Ly VT, Christopher LJ, Gan J.

Xenobiotica. 2020 Jun;50(6):621-629. doi: 10.1080/00498254.2019.1675100. Epub 2019 Oct 10.

PMID: 31566996

 

Presence of anti-cyclic citrullinated peptide antibodies is associated with better treatment response to abatacept but not to TNF inhibitors in patients with rheumatoid arthritis: a meta-analysis.

Alemao E, Postema R, Elbez Y, Mamane C, Finckh A.

Clin Exp Rheumatol. 2020 May-Jun;38(3):455-466. Epub 2019 Nov 16.

PMID: 31770089 

 

Tg.rasH2 Mouse Model for Assessing Carcinogenic Potential of Pharmaceuticals: Industry Survey of Current Practices.

Bogdanffy MS, Lesniak J, Mangipudy R, Sistare FD, Colman K, Garcia-Tapia D, Monticello T, Blanset D.

Int J Toxicol. 2020 May/Jun;39(3):198-206. doi: 10.1177/1091581820919896. Epub 2020 May 6.

PMID: 32372678

 

Practical Applications of Biofluorescent Particle Counting in Environmental Monitoring Investigations.

Prasad A, Milling A, Hauschild J, Ruh AC, Horsch J, Weber J, Yan L, Plourde L, Claassen M, Villari P, IJzerman-Boon P, Forng RY, Henry RB, Portmann R, Shereefa S, Urwyler S, Dassu D.

PDA J Pharm Sci Technol. 2020 May-Jun;74(3):318-323. doi: 10.5731/pdajpst.2019.009969. Epub 2019 Dec 16.

PMID: 31843986

 

Effectiveness and Safety of Oral Anticoagulants among NVAF Patients with Obesity: Insights from the ARISTOPHANES Study.

Deitelzweig S, Keshishian A, Kang A, Dhamane AD, Luo X, Li X, Balachander N, Rosenblatt L, Mardekian J, Pan X, Fusco MD, Garcia Reeves AB, Yuce H, Lip GYH.

J Clin Med. 2020 May 28;9(6):1633. doi: 10.3390/jcm9061633.

PMID: 32481607 

 

Core outcome set measurement for future clinical trials in acute myeloid leukemia: the HARMONY study protocol using a multi-stakeholder consensus-based Delphi process and a final consensus meeting.

Lang KM, Harrison KL, Williamson PR, Huntly BJP, Ossenkoppele G, Geissler J, Bereczky T, Hernández-Rivas JM, Chevrou-Séverac H, Goodbody R, Schulze-Rath R, Bullinger L.

Trials. 2020 May 27;21(1):437. doi: 10.1186/s13063-020-04384-1.

PMID: 32460828 

 

Population Pharmacokinetics and Exposure-Response Analysis of nab-Paclitaxel in Pediatric Patients With Recurrent or Refractory Solid Tumors.

Li Y, Kassir N, Chen N, Wang X, Palmisano M, Zhou S.

Clin Pharmacol Drug Dev. 2020 May 27. doi: 10.1002/cpdd.803. Online ahead of print.

PMID: 32459889

 

Sesquiterpenoids from Cultures of the Basidiomycetes Irpex lacteus.

Wang M, Du JX, Hui-Xiang Y, Dai Q, Liu YP, He J, Wang Y, Li ZH, Feng T, Liu JK.

J Nat Prod. 2020 May 22;83(5):1524-1531. doi: 10.1021/acs.jnatprod.9b01177. Epub 2020 Apr 21.

PMID: 32315183

 

Nucleophilic (Radio)Fluorination of Redox-Active Esters via Radical-Polar Crossover Enabled by Photoredox Catalysis.

Webb EW, Park JB, Cole EL, Donnelly DJ, Bonacorsi SJ, Ewing WR, Doyle AG.

J Am Chem Soc. 2020 May 20;142(20):9493-9500. doi: 10.1021/jacs.0c03125. Epub 2020 May 7.

PMID: 32378889

 

Non-Small Cell Lung Cancer Patient Preferences for First-Line Treatment: A Discrete Choice Experiment.

MacEwan JP, Gupte-Singh K, Zhao LM, Reckamp KL.

MDM Policy Pract. 2020 May 21;5(1):2381468320922208. doi: 10.1177/2381468320922208. eCollection 2020 Jan-Jun.

PMID: 32548305 

 

Re-challenge of Platinum-based Chemotherapy for Platinum-refractory Patients with Recurrent or Metastatic Head and Neck Cancer: Claims Data Analysis in Japan.

Tahara M, Doi I, Murata T, Mishina S, Takai S, Kaneko H.

J Health Econ Outcomes Res. 2020 May 20;7(1):43-51. doi: 10.36469/jheor.2020.12853. eCollection 2020.

PMID: 32685597 

 

Correction to: A window-of-opportunity trial of the CXCR1/2 inhibitor reparixin in operable HER-2-negative breast cancer.

Goldstein LJ, Perez RP, Yardley D, Han LK, Reuben JM, Gao H, McCanna S, Butler B, Ruffini PA, Liu Y, Rosato RR, Chang JC.

Breast Cancer Res. 2020 May 20;22(1):52. doi: 10.1186/s13058-020-01294-7.

PMID: 32434589 

 

CXCR1 and CXCR2 Chemokine Receptor Agonists Produced by Tumors Induce Neutrophil Extracellular Traps that Interfere with Immune Cytotoxicity.

Teijeira Á, Garasa S, Gato M, Alfaro C, Migueliz I, Cirella A, de Andrea C, Ochoa MC, Otano I, Etxeberria I, Andueza MP, Nieto CP, Resano L, Azpilikueta A, Allegretti M, de Pizzol M, Ponz-Sarvisé M, Rouzaut A, Sanmamed MF, Schalper K, Carleton M, Mellado M, Rodriguez-Ruiz ME, Berraondo P, Perez-Gracia JL, Melero I.

Immunity. 2020 May 19;52(5):856-871.e8. doi: 10.1016/j.immuni.2020.03.001. Epub 2020 Apr 13.

PMID: 32289253

 

Risk/Benefit Tradeoff of Antithrombotic Therapy in Patients With Atrial Fibrillation Early and Late After an Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From AUGUSTUS.

Alexander JH, Wojdyla D, Vora AN, Thomas L, Granger CB, Goodman SG, Aronson R, Windecker S, Mehran R, Lopes RD.

Circulation. 2020 May 19;141(20):1618-1627. doi: 10.1161/CIRCULATIONAHA.120.046534. Epub 2020 Mar 29.

PMID: 32223444

 

Rapid and cost-effective LC-MS/MS method for determination of hydroxycitric acid in plasma: Application in the determination of pharmacokinetics in commercial Garcinia preparations.

Bhutani P, U R, H N S, Ranjanna PK, Paul AT.

Biomed Chromatogr. 2020 May 19:e4902. doi: 10.1002/bmc.4902. Online ahead of print.

PMID: 32428251

 

Costs and Cost Drivers of Providing Option B+ Services to Mother-Baby Pairs for PMTCT of HIV in Health Centre IV Facilities in Jinja District, Uganda.

Mukose AD, Kebede S, Muhumuza C, Makumbi F, Komakech H, Bayiga E, Busobozi D, Musinguzi J, Kuznik A, Stegman P, Forsythe S, Kagaayi J.

Biomed Res Int. 2020 May 18;2020:2875864. doi: 10.1155/2020/2875864. eCollection 2020.

PMID: 32550228 

 

Safety and Efficacy of Nivolumab in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study.

Vogelzang NJ, Olsen MR, McFarlane JJ, Arrowsmith E, Bauer TM, Jain RK, Somer B, Lam ET, Kochenderfer MD, Molina A, Doshi G, Lingerfelt B, Hauke RJ, Gunuganti V, Schnadig I, Van Veldhuizen P, Fleming M, Galamaga R, Gupta M, Hool H, Hutson T, Zhang J, McHenry MB, Johansen JL, Tykodi SS.

Clin Genitourin Cancer. 2020 May 16:S1558-7673(20)30104-X. doi: 10.1016/j.clgc.2020.05.006. Online ahead of print.

PMID: 32718906 

 

Germline variant burden in cancer genes correlates with age at diagnosis and somatic mutation burden.

Qing T, Mohsen H, Marczyk M, Ye Y, O'Meara T, Zhao H, Townsend JP, Gerstein M, Hatzis C, Kluger Y, Pusztai L.

Nat Commun. 2020 May 15;11(1):2438. doi: 10.1038/s41467-020-16293-7.

PMID: 32415133 

 

Ligand-Enabled Pd(II)-Catalyzed C(sp³)-H Lactonization Using Molecular Oxygen as Oxidant.

Qian S, Li ZQ, Li M, Wisniewski SR, Qiao JX, Richter JM, Ewing WR, Eastgate MD, Chen JS, Yu JQ.

Org Lett. 2020 May 15;22(10):3960-3963. doi: 10.1021/acs.orglett.0c01243. Epub 2020 Apr 24.

PMID: 32330054

 

Corrigendum to "A systematic strategy for estimating hERG block potency and its implications in a new cardiac safety paradigm" [Toxicology and Applied Pharmacology volume 394C (2020) 114961].

Ridder BJ, Leishman DJ, Bridgland-Taylor M, Samieegohar M, Han X, Wu WW, Randolph A, Tran P, Sheng J, Danker T, Lindqvist A, Konrad D, Hebeisen S, Polonchuk L, Gissinger E, Renganathan M, Koci B, Wei H, Fan J, Levesque P, Kwagh J, Imredy J, Zhai J, Rogers M, Humphries E, Kirby R, Stoelzle-Feix S, Brinkwirth N, Rotordam MG, Becker N, Friis S, Rapedius M, Goetze TA, Strassmaier T, Okeyo G, Kramer J, Kuryshev Y, Wu C, Himmel H, Mirams GR, Strauss DG, Bardenet R, Li Z.

Toxicol Appl Pharmacol. 2020 May 15;395:114983. doi: 10.1016/j.taap.2020.114983. Epub 2020 Apr 2.

PMID: 32247767 

 

BRAF and DIS3 Mutations Associate with Adverse Outcome in a Long-term Follow-up of Patients with Multiple Myeloma.

Boyle EM, Ashby C, Tytarenko RG, Deshpande S, Wang H, Wang Y, Rosenthal A, Sawyer J, Tian E, Flynt E, Hoering A, Johnson SK, Rutherford MW, Wardell CP, Bauer MA, Dumontet C, Facon T, Thanendrarajan S, Schinke CD, Zangari M, van Rhee F, Barlogie B, Cairns D, Jackson G, Thakurta A, Davies FE, Morgan GJ, Walker BA.

Clin Cancer Res. 2020 May 15;26(10):2422-2432. doi: 10.1158/1078-0432.CCR-19-1507. Epub 2020 Jan 27.

PMID: 31988198

 

Rapid Compound Integrity Assessment for High-Throughput Screening Hit Triaging.

Shou WZ, Gerritz SW, Harden D, Lawrence RM, Chase P, Chin J, Surti N, Lippy JS, Weller HN, Nielsen J, Weerakoon D.

SLAS Discov. 2020 May 13:2472555220919097. doi: 10.1177/2472555220919097. Online ahead of print.

PMID: 32400264

 

Retrospective observational cohort study on innovation in oncology and progress in survival: How far have we gotten in the two decades of treating patients with advanced non-small cell lung cancer as a single population?

Justo N, Nilsson J, Korytowsky B, Dalen J, Madison T, McGuire A.

PLoS One. 2020 May 12;15(5):e0232669. doi: 10.1371/journal.pone.0232669. eCollection 2020.

PMID: 32396541 

 

Symptom burden and its functional impact in patients with "symptomatic" relapsed or refractory multiple myeloma.

Kamal M, Wang XS, Shi Q, Zyczynski TM, Davis C, Williams LA, Lin HK, Garcia-Gonzalez A, Cleeland CS, Orlowski R.

Support Care Cancer. 2020 May 11. doi: 10.1007/s00520-020-05493-y. Online ahead of print.

PMID: 32390093

 

Pharmacological inhibition of RORC2 enhances human Th17-Treg stability and function.

Boardman DA, Garcia RV, Ivison SM, Bressler B, Dhar TM, Zhao Q, Levings MK.

Eur J Immunol. 2020 May 10. doi: 10.1002/eji.201948435. Online ahead of print.

PMID: 32388860

 

Bridging size and charge variants of a therapeutic monoclonal antibody by two-dimensional liquid chromatography.

Chen Z, Zeng M, Park SJ, Balakrishnan G, Zhou K, Pan D, Das TK.

J Pharm Biomed Anal. 2020 May 10;183:113178. doi: 10.1016/j.jpba.2020.113178. Epub 2020 Feb 14.

PMID: 32086124

 

Feasibility and efficacy of CD19-targeted CAR T cells with concurrent ibrutinib for CLL after ibrutinib failure.

Gauthier J, Hirayama AV, Purushe J, Hay KA, Lymp J, Li DH, Yeung CCS, Sheih A, Pender BS, Hawkins RM, Vakil A, Phi TD, Steinmetz RN, Shadman M, Riddell SR, Maloney DG, Turtle CJ.

Blood. 2020 May 7;135(19):1650-1660. doi: 10.1182/blood.2019002936.

PMID: 32076701

 

Pomalidomide, dexamethasone, and daratumumab in relapsed refractory multiple myeloma after lenalidomide treatment.

Siegel DS, Schiller GJ, Samaras C, Sebag M, Berdeja J, Ganguly S, Matous J, Song K, Seet CS, Talamo G, Acosta-Rivera M, Bar M, Quick D, Anz B, Fonseca G, Reece D, Pierceall WE, Chung W, Zafar F, Agarwal A, Bahlis NJ.

Leukemia. 2020 May 6. doi: 10.1038/s41375-020-0813-1. Online ahead of print.

PMID: 32376855 

 

Economic Evaluation of Single versus Combination Immuno-Oncology Therapies: Application of a Novel Modelling Approach in Metastatic Melanoma.

Gibson EJ, Begum N, Koblbauer I, Dranitsaris G, Liew D, McEwan P, Yuan Y, Juarez-Garcia A, Tyas D, Pritchard C.

Clinicoecon Outcomes Res. 2020 May 6;12:241-252. doi: 10.2147/CEOR.S238725. eCollection 2020.

PMID: 32440174 

 

Reduced Apolipoprotein M and Adverse Outcomes Across the Spectrum of Human Heart Failure.

Chirinos JA, Zhao L, Jia Y, Frej C, Adamo L, Mann D, Shewale SV, Millar JS, Rader DJ, French B, Brandimarto J, Margulies KB, Parks JS, Wang Z, Seiffert DA, Fang J, Sweitzer N, Chistoffersen C, Dahlbäck B, Car BD, Gordon DA, Cappola TP, Javaheri A.

Circulation. 2020 May 5;141(18):1463-1476. doi: 10.1161/CIRCULATIONAHA.119.045323. Epub 2020 Apr 2.

PMID: 32237898

 

Ni(COD)(DQ): An Air-Stable 18-Electron Nickel(0)-Olefin Precatalyst.

Tran VT, Li ZQ, Apolinar O, Derosa J, Joannou MV, Wisniewski SR, Eastgate MD, Engle KM.

Angew Chem Int Ed Engl. 2020 May 4;59(19):7409-7413. doi: 10.1002/anie.202000124. Epub 2020 Mar 18.

PMID: 32065839

 

Tailor-Made Amino Acids and Fluorinated Motifs as Prominent Traits in Modern Pharmaceuticals.

Mei H, Han J, White S, Graham DJ, Izawa K, Sato T, Fustero S, Meanwell NA, Soloshonok VA.

Chemistry. 2020 May 2. doi: 10.1002/chem.202000617. Online ahead of print.

PMID: 32359086 

 

A systematic strategy for estimating hERG block potency and its implications in a new cardiac safety paradigm.

Ridder BJ, Leishman DJ, Bridgland-Taylor M, Samieegohar M, Han X, Wu WW, Randolph A, Tran P, Sheng J, Danker T, Lindqvist A, Konrad D, Hebeisen S, Polonchuk L, Gissinger E, Renganathan M, Koci B, Wei H, Fan J, Levesque P, Kwagh J, Imredy J, Zhai J, Rogers M, Humphries E, Kirby R, Stoelzle-Feix S, Brinkwirth N, Rotordam MG, Becker N, Friis S, Rapedius M, Goetze TA, Strassmaier T, Okeyo G, Kramer J, Kuryshev Y, Wu C, Himmel H, Mirams GR, Strauss DG, Bardenet R, Li Z.

Toxicol Appl Pharmacol. 2020 May 1;394:114961. doi: 10.1016/j.taap.2020.114961. Epub 2020 Mar 21.

PMID: 32209365 

 

Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics.

Dercle L, Fronheiser M, Lu L, Du S, Hayes W, Leung DK, Roy A, Wilkerson J, Guo P, Fojo AT, Schwartz LH, Zhao B.

Clin Cancer Res. 2020 May 1;26(9):2151-2162. doi: 10.1158/1078-0432.CCR-19-2942. Epub 2020 Mar 20.

PMID: 32198149

 

Response to "Letter to the Editor concerning: 'A systematic review of network meta-analyses among patients with nonvalvular atrial fibrillation: A comparison of efficacy and safety following treatment with direct oral anticoagulants'".

Cohen AT, Hill NR, Luo X, Masseria C, Abariga SA, Ashaye AO.

Int J Cardiol. 2020 May 1;306:101. doi: 10.1016/j.ijcard.2019.11.141. Epub 2019 Nov 28.

PMID: 31898985 

 

Elevated serum interleukin-8 is associated with enhanced intratumor neutrophils and reduced clinical benefit of immune-checkpoint inhibitors.

Schalper KA, Carleton M, Zhou M, Chen T, Feng Y, Huang SP, Walsh AM, Baxi V, Pandya D, Baradet T, Locke D, Wu Q, Reilly TP, Phillips P, Nagineni V, Gianino N, Gu J, Zhao H, Perez-Gracia JL, Sanmamed MF, Melero I.

Nat Med. 2020 May;26(5):688-692. doi: 10.1038/s41591-020-0856-x. Epub 2020 May 11.

PMID: 32405062

 

Challenges and recommendations in developing LC-MS/MS bioanalytical assays of labile glucuronides and parent compounds in the presence of glucuronide metabolites.

Yuan L, Sophia Xu X, Ji QC.

Bioanalysis. 2020 May;12(9):615-624. doi: 10.4155/bio-2020-0055. Epub 2020 May 22.

PMID: 32441529

 

The Society for Immunotherapy of Cancer statement on best practices for multiplex immunohistochemistry (IHC) and immunofluorescence (IF) staining and validation.

Taube JM, Akturk G, Angelo M, Engle EL, Gnjatic S, Greenbaum S, Greenwald NF, Hedvat CV, Hollmann TJ, Juco J, Parra ER, Rebelatto MC, Rimm DL, Rodriguez-Canales J, Schalper KA, Stack EC, Ferreira CS, Korski K, Lako A, Rodig SJ, Schenck E, Steele KE, Surace MJ, Tetzlaff MT, von Loga K, Wistuba II, Bifulco CB; Society for Immunotherapy of Cancer (SITC) Pathology Task Force.

J Immunother Cancer. 2020 May;8(1):e000155. doi: 10.1136/jitc-2019-000155.

PMID: 32414858 

 

MR Imaging Correlates for Molecular and Mutational Analyses in Children with Diffuse Intrinsic Pontine Glioma.

Jaimes C, Vajapeyam S, Brown D, Kao PC, Ma C, Greenspan L, Gupta N, Goumnerova L, Bandopahayay P, Dubois F, Greenwald NF, Zack T, Shapira O, Beroukhim R, Ligon KL, Chi S, Kieran MW, Wright KD, Poussaint TY.

AJNR Am J Neuroradiol. 2020 May;41(5):874-881. doi: 10.3174/ajnr.A6546. Epub 2020 May 7.

PMID: 32381545

 

Effectiveness and Safety of Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation and Diabetes Mellitus.

Lip GYH, Keshishian AV, Kang AL, Li X, Dhamane AD, Luo X, Balachander N, Rosenblatt L, Mardekian J, Nadkarni A, Pan X, Di Fusco M, Garcia Reeves AB, Yuce H, Deitelzweig SB.

Mayo Clin Proc. 2020 May;95(5):929-943. doi: 10.1016/j.mayocp.2019.05.032.

PMID: 32370854 

A Real-World Observational Study of Hospitalization and Health Care Costs Among Nonvalvular Atrial Fibrillation Patients Prescribed Oral Anticoagulants in the U.S. Medicare Population.

Amin A, Keshishian A, Trocio J, Dina O, Le H, Rosenblatt L, Liu X, Mardekian J, Zhang Q, Baser O, Nadkarni A, Vo L.

J Manag Care Spec Pharm. 2020 May;26(5):639-651. doi: 10.18553/jmcp.2020.26.5.639.

PMID: 32347184

 

Viral contamination in biologic manufacture and implications for emerging therapies.

Barone PW, Wiebe ME, Leung JC, Hussein ITM, Keumurian FJ, Bouressa J, Brussel A, Chen D, Chong M, Dehghani H, Gerentes L, Gilbert J, Gold D, Kiss R, Kreil TR, Labatut R, Li Y, Müllberg J, Mallet L, Menzel C, Moody M, Monpoeho S, Murphy M, Plavsic M, Roth NJ, Roush D, Ruffing M, Schicho R, Snyder R, Stark D, Zhang C, Wolfrum J, Sinskey AJ, Springs SL.

Nat Biotechnol. 2020 May;38(5):563-572. doi: 10.1038/s41587-020-0507-2. Epub 2020 Apr 27.

PMID: 32341561 

 

A phase I study of the effect of repeated oral doses of pantoprazole on the pharmacokinetics of a single dose of fedratinib in healthy male subjects.

Ogasawara K, Vince B, Xu C, Zhang M, Palmisano M, Krishna G.

Cancer Chemother Pharmacol. 2020 May;85(5):995-1001. doi: 10.1007/s00280-020-04074-4. Epub 2020 Apr 22.

PMID: 32318809

 

Effects of repeated oral doses of ketoconazole on a sequential ascending single oral dose of fedratinib in healthy subjects.

Ogasawara K, Xu C, Kanamaluru V, Palmisano M, Krishna G.

Cancer Chemother Pharmacol. 2020 May;85(5):899-906. doi: 10.1007/s00280-020-04067-3. Epub 2020 Apr 4.

PMID: 32248324

 

Correction to: Evaluation of the bioequivalence and food effect on the bioavailability of CC-486 (oral azacitidine) tablets in adult patients with cancer.

Babiker HM, Milhem M, Aisner J, Edenfield W, Shepard D, Savona M, Iyer S, Abdelrahim M, Beach CL, Skikne B, Laille E, Tsai KT, Ho T.

Cancer Chemother Pharmacol. 2020 May;85(5):1009-1010. doi: 10.1007/s00280-020-04056-6.

PMID: 32215699

 

Immunosuppression and the risk of readmission and mortality in patients with rheumatoid arthritis undergoing hip fracture, abdominopelvic and cardiac surgery.

George MD, Baker JF, Winthrop KL, Goldstein SD, Alemao E, Chen L, Wu Q, Xie F, Curtis JR.

Ann Rheum Dis. 2020 May;79(5):573-580. doi: 10.1136/annrheumdis-2019-216802. Epub 2020 Mar 24.

PMID: 32209540

 

Accelerating the development of innovative cellular therapy products for the treatment of cancer.

Stewart MD, Keane A, Butterfield LH, Levine BL, Thompson B, Xu Y, Ramsborg C, Lee A, Kalos M, Koerner C, Moore T, Markovic I, Lasiter L, Ibrahim R, Bluestone J, Sigal E, Allen J.

Cytotherapy. 2020 May;22(5):239-246. doi: 10.1016/j.jcyt.2020.01.014. Epub 2020 Mar 18.

PMID: 32199724 

 

Relationship between remission, disease activity and patient-reported outcome measures in patients with recent-onset systemic lupus erythematosus.

Heijke R, Björk M, Frodlund M, McDonald L, Alemao E, Sjöwall C.

Lupus. 2020 May;29(6):625-630. doi: 10.1177/0961203320912338. Epub 2020 Mar 18.

PMID: 32188304 

 

Human papillomavirus type 16 infection activates the host serine arginine protein kinase 1 (SRPK1) - splicing factor axis.

Mole S, Faizo AAA, Hernandez-Lopez H, Griffiths M, Stevenson A, Roberts S, Graham SV.

J Gen Virol. 2020 May;101(5):523-532. doi: 10.1099/jgv.0.001402. Epub 2020 Mar 13.

PMID: 32182205 

 

Approaches for the identification of chronic kidney disease in CPRD-HES-linked studies.

Ramagopalan S, Leahy TP, Stamp E, Sammon C.

J Comp Eff Res. 2020 May;9(7):441-446. doi: 10.2217/cer-2019-0190. Epub 2020 Mar 9.

PMID: 32148084 

 

Treatment Journeys of Patients With Newly Diagnosed Multiple Myeloma (NDMM): Results From The Connect MM Registry.

Jagannath S, Rifkin RM, Gasparetto CJ, Toomey K, Durie BGM, Hardin JW, Terebelo HR, Wagner L, Narang M, Ailawadhi S, Omel JL, Srinivasan S, He M, Ung B, Kitali A, Flick ED, Agarwal A, Abonour R; CONNECT MM Registry Investigators.

Clin Lymphoma Myeloma Leuk. 2020 May;20(5):272-276. doi: 10.1016/j.clml.2019.10.002. Epub 2019 Oct 14.

PMID: 32144027 

 

Treatment Switch Patterns and Healthcare Costs in Biologic-Naive Patients with Psoriatic Arthritis.

Wu JJ, Pelletier C, Ung B, Tian M, Khilfeh I, Curtis JR.

Adv Ther. 2020 May;37(5):2098-2115. doi: 10.1007/s12325-020-01262-9. Epub 2020 Mar 5.

PMID: 32141018 

 

Disruptive innovation in rheumatology: new networks of global public-private partnerships are needed to take advantage of scientific progress.

Huizinga TW, Holers VM, Anolik J, Brenner MB, Buckley CD, Bykerk V, Connolly SE, Deane KD, Guo J, Hodge M, Hoffmann S, Nestle F, Pitzalis C, Raychaudhuri S, Yamamoto K, Li Z, Klareskog L.

Ann Rheum Dis. 2020 May;79(5):553-555. doi: 10.1136/annrheumdis-2019-216846. Epub 2020 Mar 5.

PMID: 32139419 

 

Urelumab alone or in combination with rituximab in patients with relapsed or refractory B-cell lymphoma.

Timmerman J, Herbaux C, Ribrag V, Zelenetz AD, Houot R, Neelapu SS, Logan T, Lossos IS, Urba W, Salles G, Ramchandren R, Jacobson C, Godwin J, Carpio C, Lathers D, Liu Y, Neely J, Suryawanshi S, Koguchi Y, Levy R.

Am J Hematol. 2020 May;95(5):510-520. doi: 10.1002/ajh.25757. Epub 2020 Feb 29.

PMID: 32052473 

 

Patient-reported outcome measures in studies of myelodysplastic syndromes and acute myeloid leukemia: Literature review and landscape analysis.

Stauder R, Lambert J, Desruol-Allardin S, Savre I, Gaugler L, Stojkov I, Siebert U, Chevrou-Séverac H.

Eur J Haematol. 2020 May;104(5):476-487. doi: 10.1111/ejh.13389. Epub 2020 Mar 3.

PMID: 31985078 

 

A novel approach enables imaged capillary isoelectric focusing analysis of PEGylated proteins.

Zhang X, Chemmalil L, Ding J, Li Z.

Electrophoresis. 2020 May;41(9):735-742. doi: 10.1002/elps.201900406. Epub 2020 Feb 3.

PMID: 31967659

 

Effective temperature shift strategy development and scale confirmation for simultaneous optimization of protein productivity and quality in Chinese hamster ovary cells.

McHugh KP, Xu J, Aron KL, Borys MC, Li ZJ.

Biotechnol Prog. 2020 May;36(3):e2959. doi: 10.1002/btpr.2959. Epub 2020 Jan 17.

PMID: 31930722

 

Cost-effectiveness analysis of nivolumab for the treatment of squamous cell carcinoma of the head and neck in the United States.

Haddad R, Cohen EEW, Venkatachalam M, Young K, Singh P, Shaw JW, Korytowsky B, Abraham P, Harrington KJ.

J Med Econ. 2020 May;23(5):442-447. doi: 10.1080/13696998.2020.1715414. Epub 2020 Jan 29.

PMID: 31928375

 

Antitumor Potency of an Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, Lisocabtagene Maraleucel in Combination With Ibrutinib or Acalabrutinib.

Qin JS, Johnstone TG, Baturevych A, Hause RJ, Ragan SP, Clouser CR, Jones JC, Ponce R, Krejsa CM, Salmon RA, Ports MO.

J Immunother. 2020 May;43(4):107-120. doi: 10.1097/CJI.0000000000000307.

PMID: 31899702 

 

Covariate adjustment for randomized controlled trials revisited.

Wang J.

Pharm Stat. 2020 May;19(3):255-261. doi: 10.1002/pst.1988. Epub 2019 Dec 21.

PMID: 31863636

 

Mongersen (GED-0301) for Active Crohn's Disease: Results of a Phase 3 Study.

Sands BE, Feagan BG, Sandborn WJ, Schreiber S, Peyrin-Biroulet L, Frédéric Colombel J, Rossiter G, Usiskin K, Ather S, Zhan X, DʼHaens G.

Am J Gastroenterol. 2020 May;115(5):738-745. doi: 10.14309/ajg.0000000000000493.

PMID: 31850931 

 

Response to: Olry de Labry Lima A et al., Cost-effectiveness of lenalidomide maintenance in patients with multiple myeloma who have undergone autologous transplant hematopoietic progenitor cells.

Dhanasiri S.

Bone Marrow Transplant. 2020 May;55(5):987-988. doi: 10.1038/s41409-019-0749-0. Epub 2019 Nov 21.

PMID: 31754250 

 

Persistence of Inflammatory Phenotype in Residual Psoriatic Plaques in Patients on Effective Biologic Therapy.

Mashiko S, Edelmayer RM, Bi Y, Olson LM, Wetter JB, Wang J, Maari C, Saint-Cyr Proulx E, Kaimal V, Li X, Salte K, Garcet S, Kannan AK, Huang SM, Cao X, Liu Z, Krueger JG, Sarfati M, Bissonnette R, Smith KM.

J Invest Dermatol. 2020 May;140(5):1015-1025.e4. doi: 10.1016/j.jid.2019.09.027. Epub 2019 Nov 9.

PMID: 31715177

 

Physiologically-Based Pharmacokinetic Models for Evaluating Membrane Transporter Mediated Drug-Drug Interactions: Current Capabilities, Case Studies, Future Opportunities, and Recommendations.

Taskar KS, Pilla Reddy V, Burt H, Posada MM, Varma M, Zheng M, Ullah M, Emami Riedmaier A, Umehara KI, Snoeys J, Nakakariya M, Chu X, Beneton M, Chen Y, Huth F, Narayanan R, Mukherjee D, Dixit V, Sugiyama Y, Neuhoff S.

Clin Pharmacol Ther. 2020 May;107(5):1082-1115. doi: 10.1002/cpt.1693. Epub 2019 Dec 31.

PMID: 31628859 

 

Characterizing heart failure with preserved and reduced ejection fraction: An imaging and plasma biomarker approach.

Kanagala P, Arnold JR, Singh A, Chan DCS, Cheng ASH, Khan JN, Gulsin GS, Yang J, Zhao L, Gupta P, Squire IB, Ng LL, McCann GP.

PLoS One. 2020 Apr 29;15(4):e0232280. doi: 10.1371/journal.pone.0232280. eCollection 2020.

PMID: 32349122 

 

Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Advanced Chronic Kidney Disease.

Stanifer JW, Pokorney SD, Chertow GM, Hohnloser SH, Wojdyla DM, Garonzik S, Byon W, Hijazi Z, Lopes RD, Alexander JH, Wallentin L, Granger CB.

Circulation. 2020 Apr 28;141(17):1384-1392. doi: 10.1161/CIRCULATIONAHA.119.044059. Epub 2020 Mar 12.

PMID: 32160801

 

Comparison of readmissions among hospitalized nonvalvular atrial fibrillation patients treated with oral anticoagulants in the United States.

Deitelzweig S, Baker CL, Dhamane AD, Mardekian J, Dina O, Rosenblatt L, Russ C, Poretta T, Lingohr-Smith M, Lin J.

J Drug Assess. 2020 Apr 24;9(1):87-96. doi: 10.1080/21556660.2020.1750418. eCollection 2020.

PMID: 32489717

 

Nickel/Photoredox-Catalyzed Methylation of (Hetero)aryl Chlorides Using Trimethyl Orthoformate as a Methyl Radical Source.

Kariofillis SK, Shields BJ, Tekle-Smith MA, Zacuto MJ, Doyle AG.

J Am Chem Soc. 2020 Apr 22;142(16):7683-7689. doi: 10.1021/jacs.0c02805. Epub 2020 Apr 10.

PMID: 32275411

 

Clonal Evolution and Heterogeneity of Osimertinib Acquired Resistance Mechanisms in EGFR Mutant Lung Cancer.

Roper N, Brown AL, Wei JS, Pack S, Trindade C, Kim C, Restifo O, Gao S, Sindiri S, Mehrabadi F, El Meskini R, Ohler ZW, Maity TK, Venugopalan A, Cultraro CM, Akoth E, Padiernos E, Chen H, Kesarwala A, Smart DK, Nilubol N, Rajan A, Piotrowska Z, Xi L, Raffeld M, Panchenko AR, Sahinalp C, Hewitt S, Hoang CD, Khan J, Guha U.

Cell Rep Med. 2020 Apr 21;1(1):100007. doi: 10.1016/j.xcrm.2020.100007.

PMID: 32483558 

 

Characterization of BAY 1905254, an immune checkpoint inhibitor targeting the immunoglobulin-like domain containing receptor 2 (ILDR2).

Huetter J, Gritzan U, Gutcher I, Doecke WD, Luetke-Eversloh MV, Golfier S, Roider HG, Frisk AL, Hunter J, Pow A, Drake A, Levine Z, Levy O, Azulay M, Barbiro I, Cojocaru G, Vaknin I, Kreft B, Roese L.

Cancer Immunol Res. 2020 Apr 20. pii: canimm.0321.2019. doi: 10.1158/2326-6066.CIR-19-0321. [Epub ahead of print]

PMID: 32312711

 

Comparative efficacy and safety of current therapies for early rheumatoid arthritis: a systematic literature review and network meta-analysis.

Paul D, Fazeli MS, Mintzer L, Duarte L, Gupta K, Ferri L.

Clin Exp Rheumatol. 2020 Apr 17. [Epub ahead of print] Review.

PMID: 32301430

 

Is aspirin a substrate of MDR1/P-glycoprotein?

Singh R, Naik T, Nigam A, Chatterjee S, Rajanna P, Shen H, Iyer R.

Xenobiotica. 2020 Apr 17:1-26. doi: 10.1080/00498254.2020.1757785. [Epub ahead of print]

PMID: 32302241

 

High-Throughput Platform to Identify Antibody Conjugation Sites from Antibody-Drug Conjugate Libraries.

Yamazoe S, Hogan JM, West SM, Deng XA, Kotapati S, Shao X, Holder P, Lamba V, Huber M, Qiang C, Gangwar S, Rao C, Dollinger G, Rajpal A, Strop P.

Bioconjug Chem. 2020 Apr 15;31(4):1199-1208. doi: 10.1021/acs.bioconjchem.0c00146. Epub 2020 Mar 27.

PMID: 32178516

 

The Unfolded Protein Response Mediator PERK Governs Myeloid Cell-Driven Immunosuppression in Tumors through Inhibition of STING Signaling.

Mohamed E, Sierra RA, Trillo-Tinoco J, Cao Y, Innamarato P, Payne KK, de Mingo Pulido A, Mandula J, Zhang S, Thevenot P, Biswas S, Abdalla SK, Costich TL, Hänggi K, Anadon CM, Flores ER, Haura EB, Mehrotra S, Pilon-Thomas S, Ruffell B, Munn DH, Cubillos-Ruiz JR, Conejo-Garcia JR, Rodriguez PC.

Immunity. 2020 Apr 14;52(4):668-682.e7. doi: 10.1016/j.immuni.2020.03.004.

PMID: 32294407

 

The Connect CLL Registry: final analysis of 1494 patients with chronic lymphocytic leukemia across 199 US sites.

Mato A, Nabhan C, Lamanna N, Kay NE, Grinblatt DL, Flowers CR, Farber CM, Davids MS, Swern AS, Sullivan K, Flick ED, Gressett Ussery SM, Gharibo M, Kiselev P, Sharman JP.

Blood Adv. 2020 Apr 14;4(7):1407-1418. doi: 10.1182/bloodadvances.2019001145.

PMID: 32271900 

 

Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study.

Barlesi F, Dixmier A, Debieuvre D, Raspaud C, Auliac JB, Benoit N, Bombaron P, Moro-Sibilot D, Audigier-Valette C, Asselain B, Egenod T, Rabeau A, Fayette J, Sanchez ML, Labourey JL, Westeel V, Lamoureux P, Cotte FE, Allan V, Daumont M, Dumanoir J, Reynaud D, Calvet CY, Ozan N, Pérol M.

Oncoimmunology. 2020 Apr 12;9(1):1744898. doi: 10.1080/2162402X.2020.1744898.

PMID: 33457089 

 

Characteristics and outcomes of patients treated with apremilast in the real world: results from the APPRECIATE study.

Augustin M, Kleyn CE, Conrad C, Sator PG, Ståhle M, Eyerich K, Radtke MA, Bundy C, Mellars L, Greggio C, Cordey M, Koscielny V, Griffiths CEM.

J Eur Acad Dermatol Venereol. 2020 Apr 11. doi: 10.1111/jdv.16431. Online ahead of print.

PMID: 32279378

 

Macrofilaricides: An Unmet Medical Need for Filarial Diseases.

Hawryluk NA.

ACS Infect Dis. 2020 Apr 10;6(4):662-671. doi: 10.1021/acsinfecdis.9b00469. Epub 2020 Mar 5.

PMID: 32091199

 

An Improved P^III/P^V═O-Catalyzed Reductive C-N Coupling of Nitroaromatics and Boronic Acids by Mechanistic Differentiation of Rate- and Product-Determining Steps.

Li G, Nykaza TV, Cooper JC, Ramirez A, Luzung MR, Radosevich AT.

J Am Chem Soc. 2020 Apr 8;142(14):6786-6799. doi: 10.1021/jacs.0c01666. Epub 2020 Mar 25.

PMID: 32178514 

 

Congruent Release of Drug and Polymer from Amorphous Solid Dispersions: Insights into the Role of Drug-Polymer Hydrogen Bonding, Surface Crystallization, and Glass Transition.

Saboo S, Kestur US, Flaherty DP, Taylor LS.

Mol Pharm. 2020 Apr 6;17(4):1261-1275. doi: 10.1021/acs.molpharmaceut.9b01272. Epub 2020 Mar 17.

PMID: 32134677

 

Investigation of Within-Tablet Dynamics for Extended Release of a Poorly Soluble Basic Drug from Hydrophilic Matrix Tablets Using ATR-FTIR Imaging.

Zahoor FD, Mader KT, Timmins P, Brown J, Sammon C.

Mol Pharm. 2020 Apr 6;17(4):1090-1099. doi: 10.1021/acs.molpharmaceut.9b01063. Epub 2020 Mar 2.

PMID: 32069060

 

Disruption of Glycogen Utilization Markedly Improves the Efficacy of Carboplatin against Preclinical Models of Clear Cell Ovarian Carcinoma.

Khan T, He Y, Kryza T, Harrington BS, Gunter JH, Sullivan MA, Cuda T, Rogers R, Davies CM, Broomfield A, Gough M, Wu AC, McGann T, Weroha SJ, Haluska P, Forbes JM, Armes JE, Barry SC, Coward JI, Jagasia N, Chetty N, Snell CE, Lourie R, Perrin LC, Hooper JD.

Cancers (Basel). 2020 Apr 3;12(4):869. doi: 10.3390/cancers12040869.

PMID: 32260077 

 

Safety and effectiveness of non-vitamin K oral anticoagulants versus warfarin in real-world patients with non-valvular atrial fibrillation: a retrospective analysis of contemporary Japanese administrative claims data.

Kohsaka S, Katada J, Saito K, Jenkins A, Li B, Mardekian J, Terayama Y.

Open Heart. 2020 Apr 1;7(1):e001232. doi: 10.1136/openhrt-2019-001232. eCollection 2020.

PMID: 32341789 

 

Economic Evaluation of Chimeric Antigen Receptor T-Cell Therapy by Site of Care Among Patients With Relapsed or Refractory Large B-Cell Lymphoma.

Lyman GH, Nguyen A, Snyder S, Gitlin M, Chung KC.

JAMA Netw Open. 2020 Apr 1;3(4):e202072. doi: 10.1001/jamanetworkopen.2020.2072.

PMID: 32250433 

 

Circulating and tissue matricellular RNA and protein expression in calcific aortic valve disease.

Kossar AP, Anselmo W, Grau JB, Liu Y, Small A, Carter SL, Salvador L, Zhao L, Cvijic ME, Li Z, Yarde M, Rioux N, Rader DJ, Levy RJ, Ferrari G.

Physiol Genomics. 2020 Apr 1;52(4):191-199. doi: 10.1152/physiolgenomics.00104.2019. Epub 2020 Feb 24.

PMID: 32089075

 

Discovery and SAR of aryl hydroxy pyrimidinones as potent small molecule agonists of the GPCR APJ.

Myers MC, Bilder DM, Cavallaro CL, Chao HJ, Su S, Burford NT, Nayeem A, Wang T, Yan M, Langish RA, Dabros M, Li YX, Rose AV, Behnia K, Onorato JM, Gargalovic PS, Wexler RR, Lawrence RM.

Bioorg Med Chem Lett. 2020 Apr 1;30(7):126955. doi: 10.1016/j.bmcl.2020.126955. Epub 2020 Jan 22.

PMID: 32035698

 

Comparative safety of biologic versus conventional synthetic DMARDs in rheumatoid arthritis with COPD: a real-world population study.

Hudson M, Dell'Aniello S, Shen S, Simon TA, Ernst P,

Suissa S.Rheumatology (Oxford). 2020 Apr 1;59(4):820-827. doi: 10.1093/rheumatology/kez359.

PMID: 31504972 

  

Cost-effectiveness of targeted screening for the identification of patients with atrial fibrillation: evaluation of a machine learning risk prediction algorithm.

Hill NR, Sandler B, Mokgokong R, Lister S, Ward T, Boyce R, Farooqui U, Gordon J.

J Med Econ. 2020 Apr;23(4):386-393. doi: 10.1080/13696998.2019.1706543. Epub 2020 Jan 10.

PMID: 31855091

 

Efficacy of Nivolumab plus Ipilimumab According to Number of IMDC Risk Factors in CheckMate 214.

Escudier B, Motzer RJ, Tannir NM, Porta C, Tomita Y, Maurer MA, McHenry MB, Rini BI.

Eur Urol. 2020 Apr;77(4):449-453. doi: 10.1016/j.eururo.2019.10.025. Epub 2019 Nov 13.

PMID: 31732098

 

A Machine-Learning Approach to Identify a Prognostic Cytokine Signature That Is Associated With Nivolumab Clearance in Patients With Advanced Melanoma.

Wang R, Shao X, Zheng J, Saci A, Qian X, Pak I, Roy A, Bello A, Rizzo JI, Hosein F, Moss RA, Wind-Rotolo M, Feng Y.

Clin Pharmacol Ther. 2020 Apr;107(4):978-987. doi: 10.1002/cpt.1724. Epub 2019 Dec 19.

PMID: 31721173 

 

Iberdomide (CC-220) is a potent cereblon E3 ligase modulator with antitumor and immunostimulatory activities in lenalidomide- and pomalidomide-resistant multiple myeloma cells with dysregulated CRBN.

Bjorklund CC, Kang J, Amatangelo M, Polonskaia A, Katz M, Chiu H, Couto S, Wang M, Ren Y, Ortiz M, Towfic F, Flynt JE, Pierceall W, Thakurta A.

Leukemia. 2020 Apr;34(4):1197-1201. doi: 10.1038/s41375-019-0620-8. Epub 2019 Nov 12.

PMID: 31719682 

 

Lenalidomide maintenance for diffuse large B-cell lymphoma patients responding to R-CHOP: quality of life, dosing, and safety results from the randomised controlled REMARC study.

Thieblemont C, Howlett S, Casasnovas RO, Mounier N, Perrot A, Morschhauser F, Fruchart C, Daguindau N, van Eygen K, Obéric L, Bouabdallah R, Pica GM, Nicolas-Virezelier E, Abraham J, Fitoussi O, Snauwaert S, Eisenmann JC, Lionne-Huyghe P, Bron D, Tricot S, Deeren D, Gonzalez H, Costello R, Le Du K, da Silva MG, Grosicki S, Trotman J, Catalano J, Caballero D, Greil R, Cohen AM, Gaulard P, Roulin L, Takeshita K, Casadebaig ML, Tilly H, Coiffier B.

Br J Haematol. 2020 Apr;189(1):84-96. doi: 10.1111/bjh.16300. Epub 2019 Nov 8.

PMID: 31702836 

 

Abatacept retention and clinical outcomes in Austrian patients with rheumatoid arthritis: real-world data from the 2-year ACTION study.

Peichl P, Alten R, Galeazzi M, Lorenz HM, Nüßlein H, Navarro F, Elbez Y, Chartier M, Hackl R, Rauch C, Connolly SE.

Wien Med Wochenschr. 2020 Apr;170(5-6):132-140. doi: 10.1007/s10354-019-00710-8. Epub 2019 Oct 25.

PMID: 31654156 

 

Microhomology-mediated end joining drives complex rearrangements and overexpression of MYC and PVT1 in multiple myeloma.

Mikulasova A, Ashby C, Tytarenko RG, Qu P, Rosenthal A, Dent JA, Ryan KR, Bauer MA, Wardell CP, Hoering A, Mavrommatis K, Trotter M, Deshpande S, Yaccoby S, Tian E, Keats J, Auclair D, Jackson GH, Davies FE, Thakurta A, Morgan GJ, Walker BA.

Haematologica. 2020 Apr;105(4):1055-1066. doi: 10.3324/haematol.2019.217927. Epub 2019 Jun 20.

PMID: 31221783 

 

Fast understanding of phases and phase separation in liquid crystal drug delivery systems using deuterium solid-state NMR.

Abraham A, Chan E, Park H.

Solid State Nucl Magn Reson. 2020 Apr;106:101642. doi: 10.1016/j.ssnmr.2020.101642. Epub 2020 Jan 11.

PMID: 32035327

                                                                                                                    

Strategies for method comparison when changes in the immunogenicity method are needed within a clinical program.

Mora JR, White JT, Chilewski SD, Qu Q, Stocker D, Luo L, Lavelle A.

Bioanalysis. 2020 Apr;12(7):431-443. doi: 10.4155/bio-2019-0300. Epub 2020 Apr 28.

PMID: 32343147 

 

Interspecies prediction of pharmacokinetics and tissue distribution of doxorubicin by physiologically-based pharmacokinetic modeling.

Lee JB, Zhou S, Chiang M, Zang X, Kim TH, Kagan L.

Biopharm Drug Dispos. 2020 Apr;41(4-5):192-205. doi: 10.1002/bdd.2229. Epub 2020 May 16.

PMID: 32342986

 

STK11 and KEAP1 mutations as prognostic biomarkers in an observational real-world lung adenocarcinoma cohort.

Papillon-Cavanagh S, Doshi P, Dobrin R, Szustakowski J, Walsh AM.

ESMO Open. 2020 Apr;5(2):e000706. doi: 10.1136/esmoopen-2020-000706.

PMID: 32312757 

 

The safety and pharmacokinetics of a novel, selective S1P1R modulator in healthy participants.

Singhal S, Girgis IG, Xie J, Dutta S, Shevell DE, Throup J.

Expert Opin Investig Drugs. 2020 Apr;29(4):411-422. doi: 10.1080/13543784.2020.1742322.

PMID: 32306792

 

Crystal structure of the SALL4-pomalidomide-cereblon-DDB1 complex.

Matyskiela ME, Clayton T, Zheng X, Mayne C, Tran E, Carpenter A, Pagarigan B, McDonald J, Rolfe M, Hamann LG, Lu G, Chamberlain PP.

Nat Struct Mol Biol. 2020 Apr;27(4):319-322. doi: 10.1038/s41594-020-0405-9. Epub 2020 Apr 6.

PMID: 32251415

 

Quality of life with second or third line nab-paclitaxel-based regimens in advanced non-small-cell lung cancer.

Ponce Aix S, Talbot D, Govindan R, Dols MC, Postmus PE, Lewanski C, Bennouna J, Fischer JR, Juan-Vidal O, Stewart DJ, Ardizzoni A, Bhore R, Wolfsteiner M, Reck M, Ong TJ, Morgensztern D.

Future Oncol. 2020 Apr;16(12):749-762. doi: 10.2217/fon-2019-0796. Epub 2020 Mar 31.

PMID: 32228198 

 

Reverse TCR repertoire evolution toward dominant low-affinity clones during chronic CMV infection.

Schober K, Voit F, Grassmann S, Müller TR, Eggert J, Jarosch S, Weißbrich B, Hoffmann P, Borkner L, Nio E, Fanchi L, Clouser CR, Radhakrishnan A, Mihatsch L, Lückemeier P, Leube J, Dössinger G, Klein L, Neuenhahn M, Oduro JD, Cicin-Sain L, Buchholz VR, Busch DH.

Nat Immunol. 2020 Apr;21(4):434-441. doi: 10.1038/s41590-020-0628-2. Epub 2020 Mar 16.

PMID: 32205883

 

Late-stage oxidative C(sp³)-H methylation.

Feng K, Quevedo RE, Kohrt JT, Oderinde MS, Reilly U, White MC.

Nature. 2020 Apr;580(7805):621-627. doi: 10.1038/s41586-020-2137-8. Epub 2020 Mar 16.

PMID: 32179876

 

Enasidenib in patients with mutant IDH2 myelodysplastic syndromes: a phase 1 subgroup analysis of the multicentre, AG221-C-001 trial.

Stein EM, Fathi AT, DiNardo CD, Pollyea DA, Roboz GJ, Collins R, Sekeres MA, Stone RM, Attar EC, Frattini MG, Tosolini A, Xu Q, See WL, MacBeth KJ, de Botton S, Tallman MS, Kantarjian HM.

Lancet Haematol. 2020 Apr;7(4):e309-e319. doi: 10.1016/S2352-3026(19)30284-4. Epub 2020 Mar 5.

PMID: 32145771

 

The path to a better biomarker: application of a risk management framework for the implementation of PD-L1 and TILs as immuno-oncology biomarkers in breast cancer clinical trials and daily practice.

Gonzalez-Ericsson PI, Stovgaard ES, Sua LF, Reisenbichler E, Kos Z, Carter JM, Michiels S, Le Quesne J, Nielsen TO, Laenkholm AV, Fox SB, Adam J, Bartlett JM, Rimm DL, Quinn C, Peeters D, Dieci MV, Vincent-Salomon A, Cree I, Hida AI, Balko JM, Haynes HR, Frahm I, Acosta-Haab G, Balancin M, Bellolio E, Yang W, Kirtani P, Sugie T, Ehinger A, Castaneda CA, Kok M, McArthur H, Siziopikou K, Badve S, Fineberg S, Gown A, Viale G, Schnitt SJ, Pruneri G, Penault-Llorca F, Hewitt S, Thompson EA, Allison KH, Symmans WF, Bellizzi AM, Brogi E, Moore DA, Larsimont D, Dillon DA, Lazar A, Lien H, Goetz MP, Broeckx G, El Bairi K, Harbeck N, Cimino-Mathews A, Sotiriou C, Adams S, Liu SW, Loibl S, Chen IC, Lakhani SR, Juco JW, Denkert C, Blackley EF, Demaria S, Leon-Ferre R, Gluz O, Zardavas D, Emancipator K, Ely S, Loi S, Salgado R, Sanders M; International Immuno-Oncology Biomarker Working Group.

J Pathol. 2020 Apr;250(5):667-684. doi: 10.1002/path.5406. Epub 2020 Apr 9.

PMID: 32129476 

 

Nonindependence of patient data in the clinical practice research datalink: a case study in atrial fibrillation patients.

Sammon CJ, Leahy TP, Ramagopalan S.

J Comp Eff Res. 2020 Apr;9(6):395-403. doi: 10.2217/cer-2019-0191. Epub 2020 Feb 14.

PMID: 32056446

 

Pharmacokinetics and Clinical Pharmacology of Monoclonal Antibodies in Pediatric Patients.

Temrikar ZH, Suryawanshi S, Meibohm B.

Paediatr Drugs. 2020 Apr;22(2):199-216. doi: 10.1007/s40272-020-00382-7.

PMID: 32052309

 

Investigating Overlap in Signals from EVDAS, FAERS, and VigiBase^®.

Vogel U, van Stekelenborg J, Dreyfus B, Garg A, Habib M, Hosain R, Wisniewski A.

Drug Saf. 2020 Apr;43(4):351-362. doi: 10.1007/s40264-019-00899-y.

PMID: 32020559 

 

Collagen biology and non-invasive biomarkers of liver fibrosis.

Karsdal MA, Daniels SJ, Holm Nielsen S, Bager C, Rasmussen DGK, Loomba R, Surabattula R, Villesen IF, Luo Y, Shevell D, Gudmann NS, Nielsen MJ, George J, Christian R, Leeming DJ, Schuppan D.

Liver Int. 2020 Apr;40(4):736-750. doi: 10.1111/liv.14390. Epub 2020 Feb 19.

PMID: 31997561 

 

Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.

Bines J, Procter M, Restuccia E, Viale G, Zardavas D, Suter T, Arahmani A, Van Dooren V, Baselga J, Clark E, Eng-Wong J, Gelber RD, Piccart M, Mobus V, de Azambuja E; APHINITY Steering Committee and Investigators.

Clin Breast Cancer. 2020 Apr;20(2):174-181.e3. doi: 10.1016/j.clbc.2019.06.016. Epub 2019 Sep 5.

PMID: 31924513

 

A Case Study Examining the Usefulness of Cure Modelling for the Prediction of Survival Based on Data Maturity.

Grant TS, Burns D, Kiff C, Lee D.

Pharmacoeconomics. 2020 Apr;38(4):385-395. doi: 10.1007/s40273-019-00867-5.

PMID: 31848900

 

Risk Assessment Approach to Microbiological Controls of Cell Therapies.

Cundell T, Drummond S, Ford I, Reber D, Singer D; members of the Pharmaceutical Microbiology Expert Discussion Group.

PDA J Pharm Sci Technol. 2020 Mar-Apr;74(2):229-248. doi: 10.5731/pdajpst.2019.010546. Epub 2020 Jan 15.

PMID: 31941793

A 15-gene immune, stromal and proliferation gene signature that significantly associates with poor survival in patients with pancreatic ductal adenocarcinoma.

Kandimalla R, Tomihara H, Banwait JK, Yamamura K, Singh G, Baba H, Goel A.

Clin Cancer Res. 2020 Mar 31. pii: clincanres.4044.2019. doi: 10.1158/1078-0432.CCR-19-4044. [Epub ahead of print]

PMID: 32234757

 

Discovery of BMS-986251: A Clinically Viable, Potent, and Selective RORγt Inverse Agonist.

Cherney RJ, Cornelius LAM, Srivastava A, Weigelt CA, Marcoux D, Duan JJ, Shi Q, Batt DG, Liu Q, Yip S, Wu DR, Ruzanov M, Sack J, Khan J, Wang J, Yarde M, Cvijic ME, Mathur A, Li S, Shuster D, Khandelwal P, Borowski V, Xie J, Obermeier M, Fura A, Stefanski K, Cornelius G, Tino JA, Macor JE, Salter-Cid L, Denton R, Zhao Q, Carter PH, Dhar TGM.

ACS Med Chem Lett. 2020 Mar 31;11(6):1221-1227. doi: 10.1021/acsmedchemlett.0c00063. eCollection 2020 Jun 11.

PMID: 32551004

 

Phase I study of CC-90010, a reversible, oral BET inhibitor in patients with advanced solid tumors and relapsed/refractory non-Hodgkin's lymphoma.

Moreno V, Sepulveda JM, Vieito M, Hernández-Guerrero T, Doger B, Saavedra O, Ferrero O, Sarmiento R, Arias M, De Alvaro J, Di Martino J, Zuraek M, Sanchez-Pérez T, Aronchik I, Filvaroff EH, Lamba M, Hanna B, Nikolova Z, Braña I.

Ann Oncol. 2020 Mar 30:S0923-7534(20)36381-X. doi: 10.1016/j.annonc.2020.03.294. Online ahead of print.

PMID: 32240793 

 

Impact of Expansion of PGY1 Pharmacy Residency Program From 2 to 4 Residents.

Brophy A, Bente J, Sobolewski K, DeStefano D, Costello J.

J Pharm Pract. 2020 Mar 27:897190020912934. doi: 10.1177/0897190020912934. [Epub ahead of print]

PMID: 32216571

 

Cross-site and cross-platform variability of automated patch clamp assessments of drug effects on human cardiac currents in recombinant cells.

Kramer J, Himmel HM, Lindqvist A, Stoelzle-Feix S, Chaudhary KW, Li D, Bohme GA, Bridgland-Taylor M, Hebeisen S, Fan J, Renganathan M, Imredy J, Humphries ESA, Brinkwirth N, Strassmaier T, Ohtsuki A, Danker T, Vanoye C, Polonchuk L, Fermini B, Pierson JB, Gintant G.

Sci Rep. 2020 Mar 27;10(1):5627. doi: 10.1038/s41598-020-62344-w.

PMID: 32221320 

 

Impact of Expansion of PGY1 Pharmacy Residency Program From 2 to 4 Residents.

Brophy A, Bente J, Sobolewski K, DeStefano D, Costello J.

J Pharm Pract. 2020 Mar 27:897190020912934. doi: 10.1177/0897190020912934. Online ahead of print.

PMID: 32216571

 

A Phase 3 Trial of Luspatercept in Patients with Transfusion-Dependent β-Thalassemia.

Cappellini MD, Viprakasit V, Taher AT, Georgiev P, Kuo KHM, Coates T, Voskaridou E, Liew HK, Pazgal-Kobrowski I, Forni GL, Perrotta S, Khelif A, Lal A, Kattamis A, Vlachaki E, Origa R, Aydinok Y, Bejaoui M, Ho PJ, Chew LP, Bee PC, Lim SM, Lu MY, Tantiworawit A, Ganeva P, Gercheva L, Shah F, Neufeld EJ, Thompson A, Laadem A, Shetty JK, Zou J, Zhang J, Miteva D, Zinger T, Linde PG, Sherman ML, Hermine O, Porter J, Piga A; BELIEVE Investigators.

N Engl J Med. 2020 Mar 26;382(13):1219-1231. doi: 10.1056/NEJMoa1910182.

PMID: 32212518 

 

Prevalence of chronic kidney disease in the community using data from OxRen: a UK population-based cohort study.

Hirst JA, Hill N, O'Callaghan CA, Lasserson D, McManus RJ, Ogburn E, Mena JMO, Shine B, Taylor CJ, Vazquez-Montes MD, Yang Y, Hobbs FR.

Br J Gen Pract. 2020 Mar 26;70(693):e285-e293. doi: 10.3399/bjgp20X708245. Print 2020 Apr.

PMID: 32041766 

 

Leveraging gene expression subgroups to classify DLBCL patients and select for clinical benefit from a novel agent.

Risueño A, Hagner PR, Towfic F, Fontanillo C, Djebbari A, Parker JS, Drew CP, Nowakowski GS, Maurer MJ, Cerhan JR, Wei X, Ren Y, Lee CW, Couto S, Wang M, Pourdehnad M, Gandhi AK, Trotter MWB.

Blood. 2020 Mar 26;135(13):1008-1018. doi: 10.1182/blood.2019002414.

PMID: 31977005 

 

Avadomide monotherapy in relapsed/refractory DLBCL: safety, efficacy, and a predictive gene classifier.

Carpio C, Bouabdallah R, Ysebaert L, Sancho JM, Salles G, Cordoba R, Pinto A, Gharibo M, Rasco D, Panizo C, Lopez-Martin JA, Santoro A, Salar A, Damian S, Martin A, Verhoef G, Van den Neste E, Wang M, Couto S, Carrancio S, Weng A, Wang X, Schmitz F, Wei X, Hege K, Trotter MWB, Risueño A, Buchholz TJ, Hagner PR, Gandhi AK, Pourdehnad M, Ribrag V.

Blood. 2020 Mar 26;135(13):996-1007. doi: 10.1182/blood.2019002395.

PMID: 31977002 

 

Enantiodivergent Formation of C-P Bonds: Synthesis of P-Chiral Phosphines and Methylphosphonate Oligonucleotides.

Xu D, Rivas-Bascón N, Padial NM, Knouse KW, Zheng B, Vantourout JC, Schmidt MA, Eastgate MD, Baran PS.

J Am Chem Soc. 2020 Mar 25;142(12):5785-5792. doi: 10.1021/jacs.9b13898. Epub 2020 Mar 16.

PMID: 32109356

 

Triggers of Inflammatory Heart Disease.

Lasrado N, Yalaka B, Reddy J.

Front Cell Dev Biol. 2020 Mar 24;8:192. doi: 10.3389/fcell.2020.00192. eCollection 2020.

PMID: 32266270 

 

Multiple Plasma Biomarkers for Risk Stratification in Patients With Heart Failure and Preserved Ejection Fraction.

Chirinos JA, Orlenko A, Zhao L, Basso MD, Cvijic ME, Li Z, Spires TE, Yarde M, Wang Z, Seiffert DA, Prenner S, Zamani P, Bhattacharya P, Kumar A, Margulies KB, Car BD, Gordon DA, Moore JH, Cappola TP.

J Am Coll Cardiol. 2020 Mar 24;75(11):1281-1295. doi: 10.1016/j.jacc.2019.12.069.

PMID: 32192654

 

Single cell force profiling of human myofibroblasts reveals a biophysical spectrum of cell states.

Layton TB, Williams L, Colin-York H, McCann FE, Cabrita M, Feldmann M, Brown C, Xie W, Fritzsche M, Furniss D, Nanchahal J.

Biol Open. 2020 Mar 24;9(3):bio049809. doi: 10.1242/bio.049809.

PMID: 32139395 

 

Long-Term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis.

Dellon ES, Collins MH, Rothenberg ME, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer A, Straumann A, Safroneeva E, Rodriguez C, Minton N, Hua SY, Hirano I.

Clin Gastroenterol Hepatol. 2020 Mar 21:S1542-3565(20)30348-7. doi: 10.1016/j.cgh.2020.03.036. Online ahead of print.

PMID: 32205221 

 

Safety, pharmacokinetics and pharmacodynamics of branebrutinib (BMS-986195), a covalent, irreversible inhibitor of Bruton's tyrosine kinase: Randomised phase I, placebo-controlled trial in healthy participants.

Catlett IM, Nowak M, Kundu S, Zheng N, Liu A, He B, Girgis IG, Grasela DM.

Br J Clin Pharmacol. 2020 Mar 21;86(9):1849-59. doi: 10.1111/bcp.14290. Online ahead of print.

PMID: 32198939 

 

Iridium(I)-Catalyzed α-C(sp³)-H Alkylation of Saturated Azacycles.

Verma P, Richter JM, Chekshin N, Qiao JX, Yu JQ.

J Am Chem Soc. 2020 Mar 18;142(11):5117-5125. doi: 10.1021/jacs.9b12320. Epub 2020 Mar 9.

PMID: 32098471

 

Rational Development of Remote C-H Functionalization of Biphenyl: Experimental and Computational Studies.

Fan Z, Bay KL, Chen X, Zhuang Z, Park HS, Yeung KS, Houk KN, Yu JQ.

Angew Chem Int Ed Engl. 2020 Mar 16;59(12):4770-4777. doi: 10.1002/anie.201915624. Epub 2020 Feb 12.

PMID: 31943648

 

Role of wetting agents and disintegrants in development of danazol nanocrystalline tablets.

Meruva S, Thool P, Gong Y, Karki S, Bowen W, Kumar S.

Int J Pharm. 2020 Mar 15;577:119026. doi: 10.1016/j.ijpharm.2020.119026. Epub 2020 Jan 12.

PMID: 31940456 

 

Assessment of Glucose Control Metrics by Discriminant Ratio.

Moscardó V, Herrero P, Reddy M, Hill N, Georgiou P, Oliver N.

Diabetes Technol Ther. 2020 Mar 12. doi: 10.1089/dia.2019.0415. [Epub ahead of print]

PMID: 32163723

 

New genetic predictors for abacavir tolerance in HLA-B*57:01 positive individuals.

Pavlos R, Deshpande P, Chopra A, Leary S, Strautins K, Nolan D, Thorborn D, Shaefer M, Rauch A, Dunn D, Montaner J, Rachlis A, Almeida CA, Choo L, James I, Redwood AJ, Li Y, Gaudieri S, Mallal SA, Phillips EJ.

Hum Immunol. 2020 Mar 12. pii: S0198-8859(19)31410-7. doi: 10.1016/j.humimm.2020.02.011. [Epub ahead of print]

PMID: 32173028

A roadmap to using historical controls in clinical trials - by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG).

Ghadessi M, Tang R, Zhou J, Liu R, Wang C, Toyoizumi K, Mei C, Zhang L, Deng CQ, Beckman RA.

Orphanet J Rare Dis. 2020 Mar 12;15(1):69. doi: 10.1186/s13023-020-1332-x.

PMID: 32164754 

 

Discovery and Optimization of Novel Pyrazolopyrimidines as Potent and Orally Bioavailable Allosteric HIV-1 Integrase Inhibitors.

Li G, Meanwell NA, Krystal MR, Langley DR, Naidu BN, Sivaprakasam P, Lewis H, Kish K, Khan JA, Ng A, Trainor GL, Cianci C, Dicker IB, Walker MA, Lin Z, Protack T, Discotto L, Jenkins S, Gerritz SW, Pendri A.

J Med Chem. 2020 Mar 12;63(5):2620-2637. doi: 10.1021/acs.jmedchem.9b01681. Epub 2020 Feb 21.

PMID: 32081010

 

Targeting the Wnt signaling pathway through R-spondin 3 identifies an anti-fibrosis treatment strategy for multiple organs.

Zhang M, Haughey M, Wang NY, Blease K, Kapoun AM, Couto S, Belka I, Hoey T, Groza M, Hartke J, Bennett B, Cain J, Gurney A, Benish B, Castiglioni P, Drew C, Lachowicz J, Carayannopoulos L, Nathan SD, Distler J, Brenner DA, Hariharan K, Cho H, Xie W.

PLoS One. 2020 Mar 11;15(3):e0229445. doi: 10.1371/journal.pone.0229445. eCollection 2020.

PMID: 32160239 

 

Proteomic Modulation in the Dorsal Spinal Cord Following Spinal Cord Stimulation Therapy in an In Vivo Neuropathic Pain Model.

Tilley DM, Lietz CB, Cedeno DL, Kelley CA, Li L, Vallejo R.

Neuromodulation. 2020 Mar 10:10.1111/ner.13103. doi: 10.1111/ner.13103. Online ahead of print.

PMID: 32157770

 

Investigation on the Effect of Capillary Microsampling on Hematologic and Toxicokinetic Evaluation in Regulatory Safety Studies in Mice.

Wang B, Wang L, Batog A, Brodie T, Ramaiah L, Chadwick KD, Su T, Mangipudy R, Pilutla RC, Ji QC.

AAPS J. 2020 Mar 9;22(2):55. doi: 10.1208/s12248-020-00438-z.

PMID: 32152888

 

Allele-Selective Knockdown of MYH7 Using Antisense Oligonucleotides.

Anderson BR, Jensen ML, Hagedorn PH, Little SC, Olson RE, Ammar R, Kienzle B, Thompson J, McDonald I, Mercer S, Vikesaa J, Nordbo B, Iben L, Cao Y, Natale J, Dalton-Kay G, Cacace A, Hansen BR, Hedtjärn M, Koch T, Bristow LJ.

Mol Ther Nucleic Acids. 2020 Mar 6;19:1290-1298. doi: 10.1016/j.omtn.2020.01.012. Epub 2020 Jan 21.

PMID: 32092825 

 

Discovery of Selective, Covalent FGFR4 Inhibitors with Antitumor Activity in Models of Hepatocellular Carcinoma.

Liu H, Niu D, Tham Sjin RT, Dubrovskiy A, Zhu Z, McDonald JJ, Fahnoe K, Wang Z, Munson M, Scholte A, Barrague M, Fitzgerald M, Liu J, Kothe M, Sun F, Murtie J, Ge J, Rocnik J, Harvey D, Ospina B, Perron K, Zheng G, Shehu E, D'Agostino LA.

ACS Med Chem Lett. 2020 Mar 6;11(10):1899-1904. doi: 10.1021/acsmedchemlett.9b00601. eCollection 2020 Oct 8.

PMID: 33062171

 

Targeting of inflammatory pathways with R2CHOP in high-risk DLBCL.

Hartert KT, Wenzl K, Krull JE, Manske M, Sarangi V, Asmann Y, Larson MC, Maurer MJ, Slager S, Macon WR, King RL, Feldman AL, Gandhi AK, Link BK, Habermann TM, Yang ZZ, Ansell SM, Cerhan JR, Witzig TE, Nowakowski GS, Novak AJ.

Leukemia. 2020 Mar 5:10.1038/s41375-020-0766-4. doi: 10.1038/s41375-020-0766-4. Online ahead of print.

PMID: 32139889 

 

PIKES Analysis Reveals Response to Degraders and Key Regulatory Mechanisms of the CRL4 Network.

Reichermeier KM, Straube R, Reitsma JM, Sweredoski MJ, Rose CM, Moradian A, den Besten W, Hinkle T, Verschueren E, Petzold G, Thomä NH, Wertz IE, Deshaies RJ, Kirkpatrick DS.

Mol Cell. 2020 Mar 5;77(5):1092-1106.e9. doi: 10.1016/j.molcel.2019.12.013. Epub 2020 Jan 20.

PMID: 31973889

 

Stent Thrombosis in Patients With Atrial Fibrillation Undergoing Coronary Stenting in the AUGUSTUS Trial.

Lopes RD, Leonardi S, Wojdyla DM, Vora AN, Thomas L, Storey RF, Vinereanu D, Granger CB, Goodman SG, Aronson R, Windecker S, Thiele H, Valgimigli M, Mehran R, Alexander JH.

Circulation. 2020 Mar 3;141(9):781-783. doi: 10.1161/CIRCULATIONAHA.119.044584. Epub 2019 Nov 11.

PMID: 31707833 

 

A conserved intratumoral regulatory T cell signature identifies 4-1BB as a pan-cancer target.

Freeman ZT, Nirschl TR, Hovelson DH, Johnston RJ, Engelhardt JJ, Selby MJ, Kochel CM, Lan RY, Zhai J, Ghasemzadeh A, Gupta A, Skaist AM, Wheelan SJ, Jiang H, Pearson AT, Snyder LA, Korman AJ, Tomlins SA, Yegnasubramanian S, Drake CG.

J Clin Invest. 2020 Mar 2;130(3):1405-1416. doi: 10.1172/JCI128672.

PMID: 32015231 

 

Absence of GP130 cytokine receptor signaling causes extended Stüve-Wiedemann syndrome.

Chen YH, Grigelioniene G, Newton PT, Gullander J, Elfving M, Hammarsjö A, Batkovskyte D, Alsaif HS, Kurdi WIY, Abdulwahab F, Shanmugasundaram V, Devey L, Bacrot S, Brodszki J, Huber C, Hamel B, Gisselsson D, Papadogiannakis N, Jedrycha K, Gürtl-Lackner B, Chagin AS, Nishimura G, Aschenbrenner D, Alkuraya FS, Laurence A, Cormier-Daire V, Uhlig HH.

 

J Exp Med. 2020 Mar 2;217(3):e20191306. doi: 10.1084/jem.20191306.

PMID: 31914175 

 

Hybrid mode of hydrophobic interaction chromatography of monoclonal antibodies and related biomolecules: Influence of elution conditions on chromatographic performance using poly (alkyl aspartamide) silica columns.

Srikoti M, Bolgar MS, Kazakevich Y.

J Chromatogr B Analyt Technol Biomed Life Sci. 2020 Mar 1;1140:121984. doi: 10.1016/j.jchromb.2020.121984. Epub 2020 Jan 28.

PMID: 32014662

 

Regional variation in clinical characteristics and outcomes in patients with atrial fibrillation: Findings from the ARISTOTLE trial.

Bahit MC, Granger CB, Alexander JH, Mulder H, Wojdyla DM, Hanna M, Goto S, Xavier D, Verheugt FWA, Lanas F, Hijazi Z, Wallentin L, Lopes RD.

Int J Cardiol. 2020 Mar 1;302:53-58. doi: 10.1016/j.ijcard.2019.12.060. Epub 2019 Dec 30.

PMID: 31932116

 

Survival, costs, and health care resource use by line of therapy in US Medicare patients with newly diagnosed glioblastoma: a retrospective observational study.

Aly A, Singh P, Korytowsky B, Ling YL, Kale HP, Dastani HB, Botteman MF, Norden AD.

Neurooncol Pract. 2020 Mar;7(2):164-175. doi: 10.1093/nop/npz042. Epub 2019 Sep 30.

PMID: 32626585

 

Induction of Human Intestinal and Hepatic Organic Anion Transporting Polypeptides: Where Is the Evidence for Its Relevance in Drug-Drug Interactions?

Rodrigues AD, Lai Y, Shen H, Varma MVS, Rowland A, Oswald S.

Drug Metab Dispos. 2020 Mar;48(3):205-216. doi: 10.1124/dmd.119.089615. Epub 2019 Dec 26.

PMID: 31879282

 

Analysis of Japanese patients from the AUGMENT phase III study of lenalidomide + rituximab (R2) vs. rituximab + placebo in relapsed/refractory indolent non-Hodgkin lymphoma.

Izutsu K, Minami Y, Fukuhara N, Terui Y, Jo T, Yamamoto G, Ishikawa T, Kobayashi T, Kiguchi T, Nagai H, Ohtsu T, Kalambakas S, Fustier P, Midorikawa S, Tobinai K.

Int J Hematol. 2020 Mar;111(3):409-416. doi: 10.1007/s12185-019-02802-y. Epub 2019 Dec 19.

PMID: 31858429 

 

Real-world Treatment Patterns and Clinical Outcomes Across Lines of Therapy in Patients With Advanced/Metastatic Gastric or Gastroesophageal Junction Cancer.

Le DT, Ott PA, Korytowsky B, Le H, Le TK, Zhang Y, Maglinte GA, Abraham P, Patel D, Shangguan T, Chau I.

Clin Colorectal Cancer. 2020 Mar;19(1):32-38.e3. doi: 10.1016/j.clcc.2019.09.001. Epub 2019 Sep 24.

PMID: 31813769 

 

Letter to the Editor concerning "Bacteria: back pain, leg pain and Modic sign: a surgical multicenter comparative study" by Fritzell, P., Welinder-Olsson, C., Jönsson, B. et al. Eur Spine J (2019).

Capoor MN, McDowell A, Birkenmaier C, Ahmed FS, Coscia E, Raz A, Mavrommatis K, Fischetti VA, Slaby O.

Eur Spine J. 2020 Mar;29(3):628-630. doi: 10.1007/s00586-019-06237-1. Epub 2019 Dec 3.

PMID: 31797137 

 

Understanding mAb aggregation during low pH viral inactivation and subsequent neutralization.

Wälchli R, Ressurreição M, Vogg S, Feidl F, Angelo J, Xu X, Ghose S, Jian Li Z, Le Saoût X, Souquet J, Broly H, Morbidelli M.

Biotechnol Bioeng. 2020 Mar;117(3):687-700. doi: 10.1002/bit.27237. Epub 2019 Dec 11.

PMID: 31784982

 

Evaluating REMS Burden: A Comparative Time Analysis of 3 Channels for REMS Stakeholders to Perform Mandatory REMS Tasks.

Chapman J, Freeman J, Hechavarria J, Dodeja P, Sheehan P.

Ther Innov Regul Sci. 2020 Mar;54(2):318-323. doi: 10.1007/s43441-019-00060-y. Epub 2020 Jan 6.

PMID: 32072583

 

Evaluation of the bioequivalence and food effect on the bioavailability of CC-486 (oral azacitidine) tablets in adult patients with cancer.

Babiker HM, Milhem M, Aisner J, Edenfield W, Shepard D, Savona M, Iyer S, Abdelrahim M, Beach CL, Skikne B, Laille E, Tsai KT, Ho T.

Cancer Chemother Pharmacol. 2020 Mar;85(3):621-626. doi: 10.1007/s00280-020-04037-9. Epub 2020 Feb 8.

PMID: 32036412 

 

CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations.

Felip E, Ardizzoni A, Ciuleanu T, Cobo M, Laktionov K, Szilasi M, Califano R, Carcereny E, Griffiths R, Paz-Ares L, Duchnowska R, Garcia MA, Isla D, Jassem J, Appel W, Milanowski J, Van Meerbeeck JP, Wolf J, Li A, Acevedo A, Popat S.

Eur J Cancer. 2020 Mar;127:160-172. doi: 10.1016/j.ejca.2019.11.019. Epub 2020 Feb 3.

PMID: 32028209 

 

Mapping binding epitopes of monoclonal antibodies targeting major histocompatibility complex class I chain-related A (MICA) with hydrogen/deuterium exchange and electron-transfer dissociation mass spectrometry.

Huang RY, Kuhne M, Deshpande S, Rangan V, Srinivasan M, Wang Y, Chen G.

Anal Bioanal Chem. 2020 Mar;412(7):1693-1700. doi: 10.1007/s00216-020-02409-x. Epub 2020 Jan 29.

PMID: 31993727

 

ACCELERATE and European Medicines Agency Paediatric Strategy Forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients.

Pearson ADJ, Rossig C, Lesa G, Diede SJ, Weiner S, Anderson J, Gray J, Geoerger B, Minard-Colin V, Marshall LV, Smith M, Sondel P, Bajars M, Baldazzi C, Barry E, Blackman S, Blanc P, Capdeville R, Caron H, Cole PD, Jiménez JC, Demolis P, Donoghue M, Elgadi M, Gajewski T, Galluzzo S, Ilaria R Jr, Jenkner A, Karres D, Kieran M, Ligas F, Lowy I, Meyers M, Oprea C, Peddareddigari VGR, Sterba J, Stockman PK, Suenaert P, Tabori U, van Tilburg C, Yancey T, Weigel B, Norga K, Reaman G, Vassal G.

Eur J Cancer. 2020 Mar;127:52-66. doi: 10.1016/j.ejca.2019.12.029. Epub 2020 Jan 24.

PMID: 31986450 

 

Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study.

Philip PA, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Manzano Mozo JL, Kim EJ, Dowden S, Zakari A, Borg C, Terrebonne E, Rivera F, Sastre J, Bathini V, López-Trabada D, Asselah J, Saif MW, Shiansong Li J, Ong TJ, Nydam T, Hammel P.

Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294. doi: 10.1016/S2468-1253(19)30327-9. Epub 2020 Jan 14.

PMID: 31953079 

 

Defining tumor resistance to PD-1 pathway blockade: recommendations from the first meeting of the SITC Immunotherapy Resistance Taskforce.

Kluger HM, Tawbi HA, Ascierto ML, Bowden M, Callahan MK, Cha E, Chen HX, Drake CG, Feltquate DM, Ferris RL, Gulley JL, Gupta S, Humphrey RW, LaVallee TM, Le DT, Hubbard-Lucey VM, Papadimitrakopoulou VA, Postow MA, Rubin EH, Sharon E, Taube JM, Topalian SL, Zappasodi R, Sznol M, Sullivan RJ.

J Immunother Cancer. 2020 Mar;8(1):e000398. doi: 10.1136/jitc-2019-000398.

PMID: 32238470 

 

Establishing guidelines to harmonize tumor mutational burden (TMB): in silico assessment of variation in TMB quantification across diagnostic platforms: phase I of the Friends of Cancer Research TMB Harmonization Project.

Merino DM, McShane LM, Fabrizio D, Funari V, Chen SJ, White JR, Wenz P, Baden J, Barrett JC, Chaudhary R, Chen L, Chen WS, Cheng JH, Cyanam D, Dickey JS, Gupta V, Hellmann M, Helman E, Li Y, Maas J, Papin A, Patidar R, Quinn KJ, Rizvi N, Tae H, Ward C, Xie M, Zehir A, Zhao C, Dietel M, Stenzinger A, Stewart M, Allen J; TMB Harmonization Consortium.

J Immunother Cancer. 2020 Mar;8(1):e000147. doi: 10.1136/jitc-2019-000147.

PMID: 32217756 

 

ILC2s amplify PD-1 blockade by activating tissue-specific cancer immunity.

Moral JA, Leung J, Rojas LA, Ruan J, Zhao J, Sethna Z, Ramnarain A, Gasmi B, Gururajan M, Redmond D, Askan G, Bhanot U, Elyada E, Park Y, Tuveson DA, Gönen M, Leach SD, Wolchok JD, DeMatteo RP, Merghoub T, Balachandran VP.

Nature. 2020 Mar;579(7797):130-135. doi: 10.1038/s41586-020-2015-4. Epub 2020 Feb 19.

PMID: 32076273 

 

Comparative safety and efficacy of ozanimod versus fingolimod for relapsing multiple sclerosis.

Swallow E, Patterson-Lomba O, Yin L, Mehta R, Pelletier C, Kao D, Sheffield JK, Stonehouse T, Signorovitch J.

J Comp Eff Res. 2020 Mar;9(4):275-285. doi: 10.2217/cer-2019-0169. Epub 2020 Jan 17.

PMID: 31948278 

 

Kinetic modeling of Chinese hamster ovary cell culture: factors and principles.

Tang P, Xu J, Louey A, Tan Z, Yongky A, Liang S, Li ZJ, Weng Y, Liu S.

Crit Rev Biotechnol. 2020 Mar;40(2):265-281. doi: 10.1080/07388551.2019.1711015. Epub 2020 Jan 12.

PMID: 31928250

 

Clinical Phenogroups in Heart Failure With Preserved Ejection Fraction: Detailed Phenotypes, Prognosis, and Response to Spironolactone.

Cohen JB, Schrauben SJ, Zhao L, Basso MD, Cvijic ME, Li Z, Yarde M, Wang Z, Bhattacharya PT, Chirinos DA, Prenner S, Zamani P, Seiffert DA, Car BD, Gordon DA, Margulies K, Cappola T, Chirinos JA.

JACC Heart Fail. 2020 Mar;8(3):172-184. doi: 10.1016/j.jchf.2019.09.009. Epub 2020 Jan 8.

PMID: 31926856

 

Multiplex immunofluorescence staining and image analysis assay for diffuse large B cell lymphoma.

Lee CW, Ren YJ, Marella M, Wang M, Hartke J, Couto SS.

J Immunol Methods. 2020 Mar;478:112714. doi: 10.1016/j.jim.2019.112714. Epub 2019 Nov 26.

PMID: 31783023 

 

Clinical outcomes with fixed-duration therapy (UK real-world data) compared with continuous lenalidomide and low-dose dexamethasone therapy (FIRST trial; MM-020) for transplant-ineligible patients with newly-diagnosed multiple myeloma.

Sharpley FA, Djebbari F, Fourali S, Kothari J, Lynes JA, McLain-Smith S, Ramasamy K.

Leuk Lymphoma. 2020 Mar;61(3):732-736. doi: 10.1080/10428194.2019.1683737. Epub 2019 Nov 27.

PMID: 31771382 

 

Evaluation of correlation between bioanalytical methods.

Gleason CR, Ji QC, Wickremsinhe ER.

Bioanalysis. 2020 Mar;12(6):419-426. doi: 10.4155/bio-2020-0019. Epub 2020 Apr 14.

PMID: 32285680

 

Spebrutinib (CC-292) Affects Markers of B Cell Activation, Chemotaxis, and Osteoclasts in Patients with Rheumatoid Arthritis: Results from a Mechanistic Study.

Schafer PH, Kivitz AJ, Ma J, Korish S, Sutherland D, Li L, Azaryan A, Kosek J, Adams M, Capone L, Hur EM, Hough DR, Ringheim GE.

Rheumatol Ther. 2020 Mar;7(1):101-119. doi: 10.1007/s40744-019-00182-7. Epub 2019 Nov 13.

PMID: 31721017 

 

Immunogenicity in Clinical Practice and Drug Development: When is it Significant?

Shakhnovich V, Meibohm B, Rosenberg A, Kierzek AM, Hasenkamp R, Funk RS, Thalhauser CJ, van der Graaf PH, Wang YC, Hamuro L.

Clin Transl Sci. 2020 Mar;13(2):219-223. doi: 10.1111/cts.12717. Epub 2019 Nov 25.

PMID: 31762152 

 

SEND harmonization & cross-study analysis: A proposal to better harvest the value from SEND data.

Carfagna MA, Bjerregaard TG, Fukushima T, Houser W, Sloan C, Snyder K, Anderson J, Page T.

Regul Toxicol Pharmacol. 2020 Mar;111:104542. doi: 10.1016/j.yrtph.2019.104542. Epub 2019 Nov 20.

PMID: 31756353 

 

Relative efficacy of treatment options in transplant-ineligible newly diagnosed multiple myeloma: results from a systematic literature review and network meta-analysis.

Ramasamy K, Dhanasiri S, Thom H, Buchanan V, Robinson S, D'Souza VK, Weisel K.

Leuk Lymphoma. 2020 Mar;61(3):668-679. doi: 10.1080/10428194.2019.1683736. Epub 2019 Nov 11.

PMID: 31709875

 

Does recall period matter? Comparing PROMIS® physical function with no recall, 24-hr recall, and 7-day recall.

Condon DM, Chapman R, Shaunfield S, Kallen MA, Beaumont JL, Eek D, Mitra D, Benjamin KL, McQuarrie K, Liu J, Shaw JW, Martin Nguyen A, Keating K, Cella D.

Qual Life Res. 2020 Mar;29(3):745-753. doi: 10.1007/s11136-019-02344-0. Epub 2019 Nov 7.

PMID: 31701432

 

A Bayesian zero-inflated binomial regression and its application in dose-finding study.

Wanitjirattikal P, Shi C.

J Biopharm Stat. 2020 Mar;30(2):322-333. doi: 10.1080/10543406.2019.1684313. Epub 2019 Nov 6.

PMID: 31693441

 

Dasatinib discontinuation in patients with chronic-phase chronic myeloid leukemia and stable deep molecular response: the DASFREE study.

Shah NP, García-Gutiérrez V, Jiménez-Velasco A, Larson S, Saussele S, Rea D, Mahon FX, Levy MY, Gómez-Casares MT, Pane F, Nicolini FE, Mauro MJ, Sy O, Martin-Regueira P, Lipton JH.

Leuk Lymphoma. 2020 Mar;61(3):650-659. doi: 10.1080/10428194.2019.1675879. Epub 2019 Oct 24.

PMID: 31647335

 

Ceritinib plus Nivolumab in Patients with Advanced ALK-Rearranged Non-Small Cell Lung Cancer: Results of an Open-Label, Multicenter, Phase 1B Study.

Felip E, de Braud FG, Maur M, Loong HH, Shaw AT, Vansteenkiste JF, John T, Liu G, Lolkema MP, Selvaggi G, Giannone V, Cazorla P, Baum J, Balbin OA, Wang LV, Lau YY, Scott JW, Tan DS.

J Thorac Oncol. 2020 Mar;15(3):392-403. doi: 10.1016/j.jtho.2019.10.006. Epub 2019 Oct 18.

PMID: 31634667 

 

Nivolumab Monotherapy and Nivolumab Plus Ipilimumab in Recurrent Small Cell Lung Cancer: Results From the CheckMate 032 Randomized Cohort.

Ready NE, Ott PA, Hellmann MD, Zugazagoitia J, Hann CL, de Braud F, Antonia SJ, Ascierto PA, Moreno V, Atmaca A, Salvagni S, Taylor M, Amin A, Camidge DR, Horn L, Calvo E, Li A, Lin WH, Callahan MK, Spigel DR.

J Thorac Oncol. 2020 Mar;15(3):426-435. doi: 10.1016/j.jtho.2019.10.004. Epub 2019 Oct 17.

PMID: 31629915 

 

Generation and infusion of multi-antigen-specific T cells to prevent complications early after T-cell depleted allogeneic stem cell transplantation-a phase I/II study.

Roex MCJ, van Balen P, Germeroth L, Hageman L, van Egmond E, Veld SAJ, Hoogstraten C, van Liempt E, Zwaginga JJ, de Wreede LC, Meij P, Vossen ACTM, Danhof S, Einsele H, Schaafsma MR, Veelken H, Halkes CJM, Jedema I, Falkenburg JHF.

Leukemia. 2020 Mar;34(3):831-844. doi: 10.1038/s41375-019-0600-z. Epub 2019 Oct 17.

PMID: 31624377 

 

Evaluation of Therapeutics for Severely Debilitating or Life-Threatening Diseases or Conditions: Defining Scope to Enable Global Guidance Development.

Liu M, Fields FO, Prescott JS, Bello A, Bower N, Darakjy S, Hartke J, Kadambi V, Lapadula D, Stoch A, Derzi M.

Clin Pharmacol Ther. 2020 Mar;107(3):514-520. doi: 10.1002/cpt.1673. Epub 2019 Nov 22.

PMID: 31608984 

 

Treatment Patterns and Economic Burden by Lines of Therapy Among Patients with Advanced Hepatocellular Carcinoma Treated with Systemic Cancer Therapy.

Bonafede MM, Korytowsky B, Singh P, Cai Q, Cappell K, Jariwala-Parikh K, Sill B, Parikh ND.

J Gastrointest Cancer. 2020 Mar;51(1):217-226. doi: 10.1007/s12029-019-00230-z.

PMID: 31011982 

 

Analysis of Japanese patients from the AUGMENT phase III study of lenalidomide + rituximab (R2) vs. rituximab + placebo in relapsed/refractory indolent non-Hodgkin lymphoma.

Izutsu K, Minami Y, Fukuhara N, Terui Y, Jo T, Yamamoto G, Ishikawa T, Kobayashi T, Kiguchi T, Nagai H, Ohtsu T, Kalambakas S, Fustier P, Midorikawa S, Tobinai K.

Int J Hematol. 2020 Mar;111(3):409-416. doi: 10.1007/s12185-019-02802-y. Epub 2019 Dec 19.

PMID: 31858429

 

New Technologies to Image Tumors.

McNamara G, Lucas J, Beeler JF, Basavanhally A, Lee G, Hedvat CV, Baxi VA, Locke D, Borowsky A, Levenson R.

Cancer Treat Res. 2020 Mar;180:51-94. doi: 10.1007/978-3-030-38862-1_2.

PMID: 32215866

 

Discovery of New Immune Checkpoints: Family Grows Up.

Kong X.

Adv Exp Med Biol. 2020 Mar;1248:61-82. doi: 01007/978-981-15-3266-5_4. Review.

PMID: 32185707

 

i-Move, a personalised exercise intervention for patients with advanced melanoma receiving immunotherapy: a randomised feasibility trial protocol.

Hyatt A, Gough K, Murnane A, Au-Yeung G, Dawson T, Pearson E, Dhillon H, Sandhu S, Williams N, Paton E, Billett A, Traill A, Andersen H, Beedle V, Milne D.

BMJ Open. 2020 Feb 28;10(2):e036059. doi: 10.1136/bmjopen-2019-036059.

PMID: 32114479 

  

Armoring the Interface with Surfactants to Prevent the Adsorption of Monoclonal Antibodies.

Kanthe AD, Krause M, Zheng S, Ilott A, Li J, Bu W, Bera MK, Lin B, Maldarelli C, Tu RS.

ACS Appl Mater Interfaces. 2020 Feb 26;12(8):9977-9988. doi: 10.1021/acsami.9b21979. Epub 2020 Feb 17.

PMID: 32013386

 

Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2-5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept.

Brunner HI, Tzaribachev N, Cornejo GV, Joos R, Gervais E, Cimaz R, Calvo Penadés I, Cuttica R, Lutz T, Quartier P, Gandhi Y, Nys M, Wong R, Martini A, Lovell DJ, Ruperto N; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation.

Pediatr Rheumatol Online J. 2020 Feb 22;18(1):19. doi: 10.1186/s12969-020-0410-x.

PMID: 32087715

 

Approaches for machine learning intermolecular interaction energies and application to energy components from symmetry adapted perturbation theory.

Metcalf DP, Koutsoukas A, Spronk SA, Claus BL, Loughney DA, Johnson SR, Cheney DL, Sherrill CD.

J Chem Phys. 2020 Feb 21;152(7):074103. doi: 10.1063/1.5142636.

PMID: 32087645

 

Differential RNA splicing as a potentially important driver mechanism in multiple myeloma.

Bauer MA, Ashby C, Wardell C, Boyle EM, Ortiz M, Flynt E, Thakurta A, Morgan G, Walker BA.

Haematologica. 2020 Feb 20. pii: haematol.2019.235424. doi: 10.3324/haematol.2019.235424. [Epub ahead of print]

PMID: 32079689

 

Effect of restricted dissolved oxygen on expression of Clostridium difficile toxin A subunit from E. coli.

Sharma AK, Phue J, Khatipov E, Dalal N, Anderson ED, Shiloach J.

Sci Rep. 2020 Feb 20;10(1):3059. doi: 10.1038/s41598-020-59978-1.

PMID: 32080292

 

Thalidomide Inhibits Human iPSC Mesendoderm Differentiation by Modulating CRBN-dependent Degradation of SALL4.

Belair DG, Lu G, Waller LE, Gustin JA, Collins ND, Kolaja KL.

Sci Rep. 2020 Feb 18;10(1):2864. doi: 10.1038/s41598-020-59542-x.

PMID: 32071327

 

Estimated susceptibility of Canadian meningococcal B isolates to a meningococcal serogroup B vaccine (MenB-FHbp).

Bettinger JA, Liberator P, Halperin SA, Vaudry W, Sadarangani M, Hao L, Lambert N, Jansen KU, Anderson AS, Tsang R; members of the Canadian Immunization Monitoring Program, Active (IMPACT).

Vaccine. 2020 Feb 18;38(8):2026-2033. doi: 10.1016/j.vaccine.2019.12.051. Epub 2020 Jan 23.

PMID: 31983586

 

Achievement of red blood cell transfusion independence in red blood cell transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes correlates with serum erythropoietin levels.

Santini V, Almeida A, Giagounidis A, Skikne B, Beach CL, Weaver J, Tu N, Fenaux P.

Leuk Lymphoma. 2020 Feb 17:1-9. doi: 10.1080/10428194.2020.1719088. [Epub ahead of print]

PMID:

 

Effect of Serum Albumin Levels in Patients With Heart Failure With Preserved Ejection Fraction (from the TOPCAT Trial).

Prenner SB, Kumar A, Zhao L, Cvijic ME, Basso M, Spires T, Li Z, Yarde M, Bhattacharya P, Zamani P, Mazurek J, Wang Z, Seiffert D, Gordon DA, Chirinos JA.

Am J Cardiol. 2020 Feb 15;125(4):575-582. doi: 10.1016/j.amjcard.2019.11.006. Epub 2019 Nov 19.

PMID: 31843232

 

Orally bioavailable amine-linked macrocyclic inhibitors of factor XIa.

Fang T, Corte JR, Gilligan PJ, Jeon Y, Osuna H, Rossi KA, Myers JE Jr, Sheriff S, Lou Z, Zheng JJ, Harper TW, Bozarth JM, Wu Y, Luettgen JM, Seiffert DA, Wexler RR, Lam PYS.

Bioorg Med Chem Lett. 2020 Feb 15;30(4):126949. doi: 10.1016/j.bmcl.2020.126949. Epub 2020 Jan 7.

PMID: 31932224

 

Quantification of PD-L1 expression with [18F]BMS-986192 PET/CT in patients with advanced stage non-small-cell lung cancer.

Huisman M, Niemeijer AL, Windhorst B, Schuit R, Leung D, Hayes W, Poot A, Bahce I, Radonic T, Oprea-Lager D, Hoekstra O, Thunnissen E, Hendrikse H, Smit E, De Langen J, Boellaard R.

J Nucl Med. 2020 Feb 14. pii: jnumed.119.240895. doi: 10.2967/jnumed.119.240895. [Epub ahead of print]

PMID: 32060213

 

Herpes Zoster, Hepatitis C, and Tuberculosis Risk with Apremilast Compared to Biologics, DMARDs and Corticosteroids to Treat Psoriasis and Psoriatic Arthritis.

Hagberg KW, Persson R, Vasilakis-Scaramozza C, Niemcryk S, Peng M, Paris M, Lindholm A, Jick S.

Clin Epidemiol. 2020 Feb 12;12:153-161. doi: 10.2147/CLEP.S239511. eCollection 2020.

PMID: 32104099

 

Synthesis of Cyclobutane-Fused Tetracyclic Scaffolds via Visible-Light Photocatalysis for Building Molecular Complexity.

Oderinde MS, Mao E, Ramirez A, Pawluczyk J, Jorge C, Cornelius LAM, Kempson J, Vetrichelvan M, Pitchai M, Gupta A, Gupta AK, Meanwell NA, Mathur A, Dhar TGM.

J Am Chem Soc. 2020 Feb 12;142(6):3094-3103. doi: 10.1021/jacs.9b12129. Epub 2020 Jan 22.

PMID: 31927959

 

Glutathione and Reactive Oxygen Species Dual-Responsive Block Copolymer Prodrugs for Boosting Tumor Site-Specific Drug Release and Enhanced Antitumor Efficacy.

Yin W, Ke W, Lu N, Wang Y, Japir AAMM, Mohammed F, Wang Y, Pan Y, Ge Z.

Biomacromolecules. 2020 Feb 10;21(2):921-929. doi: 10.1021/acs.biomac.9b01578. Epub 2020 Jan 30.

PMID: 31961134

 

Gastrointestinal bleeding and the risk of colorectal cancer in anticoagulated patients with atrial fibrillation.

Rasmussen PV, Dalgaard F, Gislason GH, Brandes A, Johnsen SP, Grove EL, Torp-Pedersen C, Dybro L, Harboe L, Münster AB, Pedersen L, Blanche P, Pallisgaard JL, Hansen ML.

Eur Heart J. 2020 Feb 7. pii: ehz964. doi: 10.1093/eurheartj/ehz964. [Epub ahead of print]

PMID: 32030399

 

A pharmaceutical industry perspective on microphysiological kidney systems for evaluation of safety for new therapies.

Phillips JA, Grandhi TSP, Davis M, Gautier JC, Hariparsad N, Keller D, Sura R, Van Vleet TR.

Lab Chip. 2020 Feb 7;20(3):468-476. doi: 10.1039/c9lc00925f. Epub 2020 Jan 28.

PMID: 31989145

 

Microphysiological systems for ADME-related applications: current status and recommendations for system development and characterization.

Fowler S, Chen WLK, Duignan DB, Gupta A, Hariparsad N, Kenny JR, Lai WG, Liras J, Phillips JA, Gan J.

Lab Chip. 2020 Feb 7;20(3):446-467. doi: 10.1039/c9lc00857h. Epub 2020 Jan 14.

PMID: 31932816

 

Integrative network modeling reveals mechanisms underlying T cell exhaustion.

Bolouri H, Young M, Beilke J, Johnson R, Fox B, Huang L, Santini CC, Hill CM, Vries AVV, Shannon PT, Dervan A, Sivakumar P, Trotter M, Bassett D, Ratushny A.

Sci Rep. 2020 Feb 5;10(1):1915. doi: 10.1038/s41598-020-58600-8.

PMID: 32024856

 

Near Infrared-Triggered Liposome Cages for Rapid, Localized Small Molecule Delivery.

Shin JE, Ogunyankin MO, Zasadzinski JA.

Sci Rep. 2020 Feb 3;10(1):1706. doi: 10.1038/s41598-020-58764-3.

PMID: 32015363

 

An amide-based sulfenamide prodrug of gamma secretase inhibitor BMS-708163 delivers parent drug from an oral conventional solid dosage form in male beagle dog.

Guarino VR, Olson RE, Everlof JG, Wang N, McDonald I, Haskell R, Clarke W, Lentz KA.

Bioorg Med Chem Lett. 2020 Feb 1;30(3):126856. doi: 10.1016/j.bmcl.2019.126856. Epub 2019 Dec 16.

PMID: 31870650

 

Heterocycle amide isosteres: An approach to overcoming resistance for HIV-1 integrase strand transfer inhibitors.

Peese KM, Naidu BN, Patel M, Li C, Langley DR, Terry B, Protack T, Gali V, Lin Z, Samanta HK, Zheng M, Jenkins S, Dicker IB, Krystal MR, Meanwell NA, Walker MA.

Bioorg Med Chem Lett. 2020 Feb 1;30(3):126784. doi: 10.1016/j.bmcl.2019.126784. Epub 2019 Nov 9.

PMID: 31761656

 

Protein Biomarker Quantification by Immunoaffinity Liquid Chromatography-Tandem Mass Spectrometry: Current State and Future Vision.

Neubert H, Shuford CM, Olah TV, Garofolo F, Schultz GA, Jones BR, Amaravadi L, Laterza OF, Xu K, Ackermann BL.

Clin Chem. 2020 Feb 1;66(2):282-301. doi: 10.1093/clinchem/hvz022.

PMID: 32040572

 

Educational Impact on Apixaban Adherence in Atrial Fibrillation (the AEGEAN STUDY): A Randomized Clinical Trial.

Montalescot G, Brotons C, Cosyns B, Crijns HJ, D'Angelo A, Drouet L, Eberli F, Lane DA, Besse B, Chan A, Vicaut E, Darius H; AEGEAN Study Investigators.

Am J Cardiovasc Drugs. 2020 Feb;20(1):61-71. doi: 10.1007/s40256-019-00356-2.

PMID: 31243691

 

Model-based evaluation of the efficacy and safety of nivolumab once every 4 weeks across multiple tumor types.

Zhao X, Shen J, Ivaturi V, Gopalakrishnan M, Feng Y, Schmidt BJ, Statkevich P, Goodman V, Gobburu J, Bello A, Roy A, Agrawal S.

Ann Oncol. 2020 Feb;31(2):302-309. doi: 10.1016/j.annonc.2019.10.015. Epub 2019 Dec 9.

PMID: 31959348

 

Association of Seropositivity and Mortality in Rheumatoid Arthritis and the Impact of Treatment With Disease-Modifying Antirheumatic Drugs: Results From a Real-World Study.

Alemao E, Bao Y, Weinblatt ME, Shadick N.

Arthritis Care Res (Hoboken). 2020 Feb;72(2):176-183. doi: 10.1002/acr.24071. Epub 2020 Jan 13.

PMID: 31529682

 

Pomalidomide plus low-dose dexamethasone in relapsed refractory multiple myeloma after lenalidomide treatment failure.

Siegel DS, Schiller GJ, Song KW, Agajanian R, Stockerl-Goldstein K, Kaya H, Sebag M, Samaras C, Malek E, Talamo G, Seet CS, Mouro J, Pierceall WE, Zafar F, Chung W, Srinivasan S, Agarwal A, Bahlis NJ.

Br J Haematol. 2020 Feb;188(4):501-510. doi: 10.1111/bjh.16213. Epub 2019 Oct 6.

PMID: 31588567

 

Benefit-risk assessment of nivolumab 240 mg flat dose relative to 3 mg/kg Q2W regimen in Japanese patients with advanced cancers.

Bei D, Osawa M, Uemura S, Ohno T, Gobburu J, Roy A, Hasegawa M.

Cancer Sci. 2020 Feb;111(2):528-535. doi: 10.1111/cas.14252. Epub 2020 Jan 21.

PMID: 31773815

 

Phase 1 Study of Erlotinib and Metformin in Metastatic Triple-Negative Breast Cancer.

Fenn K, Maurer M, Lee SM, Crew KD, Trivedi MS, Accordino MK, Hershman DL, Kalinsky K.

Clin Breast Cancer. 2020 Feb;20(1):80-86. doi: 10.1016/j.clbc.2019.08.004. Epub 2019 Aug 29.

PMID: 31570268

 

Outcomes of Long-term Treatment of Chronic HBV Infection With Entecavir or Other Agents From a Randomized Trial in 24 Countries.

Hou JL, Zhao W, Lee C, Hann HW, Peng CY, Tanwandee T, Morozov V, Klinker H, Sollano JD, Streinu-Cercel A, Cheinquer H, Xie Q, Wang YM, Wei L, Jia JD, Gong G, Han KH, Cao W, Cheng M, Tang X, Tan D, Ren H, Duan Z, Tang H, Gao Z, Chen S, Lin S, Sheng J, Chen C, Shang J, Han T, Ji Y, Niu J, Sun J, Chen Y, Cooney EL, Lim SG.

Clin Gastroenterol Hepatol. 2020 Feb;18(2):457-467.e21. doi: 10.1016/j.cgh.2019.07.010. Epub 2019 Jul 12.

PMID: 31306800

 

Population Pharmacokinetics of an Anti-PD-L1 Antibody, Durvalumab in Patients with Hematologic Malignancies.

Ogasawara K, Newhall K, Maxwell SE, Dell'Aringa J, Komashko V, Kilavuz N, Delarue R, Czuczman M, Sternas L, Rose S, Beach CL, Novick S, Zhou S, Palmisano M, Li Y.

Clin Pharmacokinet. 2020 Feb;59(2):217-227. doi: 10.1007/s40262-019-00804-x.

PMID: 31332669

 

Next-Generation DILI Biomarkers: Prioritization of Biomarkers for Qualification and Best Practices for Biospecimen Collection in Drug Development.

Roth SE, Avigan MI, Bourdet D, Brott D, Church R, Dash A, Keller D, Sherratt P, Watkins PB, Westcott-Baker L, Lentini S, Merz M, Ramaiah L, Ramaiah SK, Stanley AM, Marcinak J.

Clin Pharmacol Ther. 2020 Feb;107(2):333-346. doi: 10.1002/cpt.1571. Epub 2019 Sep 14. Review.

PMID: 31314926

 

Adverse events associated with weight-based, high-dose montelukast exposures in children.

Arnold DH, Bowman N, Reiss TF, Hartert TV, Akers WS, Seger DL.

Clin Toxicol (Phila). 2020 Feb;58(2):145-146. doi: 10.1080/15563650.2019.1609686. Epub 2019 May 6. No abstract available. Erratum in: Clin Toxicol (Phila). 2020 Feb;58(2):e1.

PMID: 31056949

 

Association among anti-citrullinated protein antibody status, erosive disease and healthcare resource utilization in patients with rheumatoid arthritis.

Harrold LR, Shan Y, Connolly SE, Alemao E, Rebello S, Guo L, Kremer JM.

Curr Med Res Opin. 2020 Feb;36(2):337-342. doi: 10.1080/03007995.2019.1680354. Epub 2019 Oct 24.

PMID: 31612736

 

Validation of obesity coding among newly treated nonvalvular atrial fibrillation patients using an integrated electronic medical record and claims database.

Jain R, Watzker A, Luo X, Kang AL, Baker CL, Rosenblatt L, Mardekian J, Menzin J.

Curr Med Res Opin. 2020 Feb;36(2):189-197. doi: 10.1080/03007995.2019.1666448. Epub 2019 Sep 28.

PMID: 31564172

 

Economic and Clinical Burden of Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes in the U.S.

Younossi ZM, Tampi RP, Racila A, Qiu Y, Burns L, Younossi I, Nader F.

Diabetes Care. 2020 Feb;43(2):283-289. doi: 10.2337/dc19-1113. Epub 2019 Oct 28.

PMID: 31658974

 

Implementing robotic surgery for uterine cancer in the United States: Better outcomes without increased costs.

Casarin J, Song C, Multinu F, Cappuccio S, Liu E, Butler KA, Glaser GE, Cliby WA, Langstraat CL, Ghezzi F, Fu AZ, Mariani A.

Gynecol Oncol. 2020 Feb;156(2):451-458. doi: 10.1016/j.ygyno.2019.11.016. Epub 2019 Nov 25.

PMID: 31780236

 

Comparison of inpatient admission rates of patients treated with apixaban vs. warfarin for venous thromboembolism in the emergency department.

Deitelzweig S, Hlavacek P, Mardekian J, Rosenblatt L, Russ C, Tuell K, Lingohr-Smith M, Lin J, Guo JD.

Hosp Pract (1995). 2020 Feb;48(1):41-48. doi: 10.1080/21548331.2020.1718925. Epub 2020 Feb 6.

PMID: 31976776

 

Pharmacokinetics and safety of apremilast in pediatric patients with moderate to severe plaque psoriasis: Results from a phase 2 open-label study.

Paller AS, Hong Y, Becker EM, de Lucas R, Paris M, Zhang W, Zhang Z, Barcellona C, Maes P, Fiorillo L.

J Am Acad Dermatol. 2020 Feb;82(2):389-397. doi: 10.1016/j.jaad.2019.08.019. Epub 2019 Aug 10.

PMID: 31408686

 

Key factors associated with uncontrolled asthma - the Asthma Control in Latin America Study.

Neffen H, Chahuàn M, Hernández DD, Vallejo-Perez E, Bolivar F, Sánchez MH, Galleguillos F, Castaños C, S Silva R, Giugno E, Pavie J, Contreras R, Lamarao F, Moraes Dos Santos F, Rodriguez C, Tobler J, Viana K, Vieira C, Soares C.

J Asthma. 2020 Feb;57(2):113-122. doi: 10.1080/02770903.2018.1553050. Epub 2019 Mar 27.

PMID: 30915868

 

Safety and effectiveness of reduced-dose apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A sub-analysis of the STANDARD study.

Inoue H, Umeyama M, Yamada T, Hashimoto H, Komoto A, Yasaka M.

J Cardiol. 2020 Feb;75(2):208-215. doi: 10.1016/j.jjcc.2019.07.007. Epub 2019 Aug 15.

PMID: 31421933

 

Current treatment patterns and medical costs for multiple myeloma in Japan: a cross-sectional analysis of a health insurance claims database.

Uno S, Goto R, Suzuki K, Iwasaki K, Takeshima T, Ohtsu T.

J Med Econ. 2020 Feb;23(2):166-173. doi: 10.1080/13696998.2019.1686870. Epub 2019 Nov 18.

PMID: 31682533

 

Real-world treatment patterns, cost of care and effectiveness of therapies for patients with squamous cell carcinoma of head and neck pre and post approval of immuno-oncology agents.

Abraham P, Kish JK, Korytowsky B, Radtchenko J, Singh P, Shaw J, Feinberg B.

J Med Econ. 2020 Feb;23(2):125-131. doi: 10.1080/13696998.2019.1676760. Epub 2019 Oct 18.

PMID: 31581922

 

Tunable Two-Compartment On-Demand Sustained Drug Release Based on Lipid Gels.

Wang X, Huang L, Zhang Y, Meng F, Donoso M, Haskell R, Luo L.

J Pharm Sci. 2020 Feb;109(2):1059-1067. doi: 10.1016/j.xphs.2019.10.021. Epub 2019 Oct 17.

PMID:31629734

 

Effect of Moisture Sorption on Free Volume and Relaxation of Spray Dried Dispersions: Relation to Drug Recrystallization.

Li J, Hubert M, Pinnamaneni S, Tao L, Zhao J, Sharif S, Ramakrishnan RK, Nazarenko S.

J Pharm Sci. 2020 Feb;109(2):1050-1058. doi: 10.1016/j.xphs.2019.10.018. Epub 2019 Oct 14.

PMID: 31622601

 

Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: a double-blind, randomised, placebo-controlled, phase 2 trial.

Maher TM, Corte TJ, Fischer A, Kreuter M, Lederer DJ, Molina-Molina M, Axmann J, Kirchgaessler KU, Samara K, Gilberg F, Cottin V.

Lancet Respir Med. 2020 Feb;8(2):147-157. doi: 10.1016/S2213-2600(19)30341-8. Epub 2019 Sep 29.

PMID: 31578169

 

Immunotherapy rechallenge after nivolumab treatment in advanced non-small cell lung cancer in the real-world setting: A national data base analysis.

Giaj Levra M, Cotté FE, Corre R, Calvet C, Gaudin AF, Penrod JR, Grumberg V, Jouaneton B, Jolivel R, Assié JB, Chouaïd C.

Lung Cancer. 2020 Feb;140:99-106. doi: 10.1016/j.lungcan.2019.12.017. Epub 2019 Dec 31.

PMID: 31911324

 

Real-world effectiveness and safety of nivolumab in patients with non-small cell lung cancer: A multicenter retrospective observational study in Japan.

Morita R, Okishio K, Shimizu J, Saito H, Sakai H, Kim YH, Hataji O, Yomota M, Nishio M, Aoe K, Kanai O, Kumagai T, Kibata K, Tsukamoto H, Oizumi S, Fujimoto D, Tanaka H, Mizuno K, Masuda T, Kozuki T, Haku T, Suzuki H, Okamoto I, Hoshiyama H, Ueda J, Ohe Y.

Lung Cancer. 2020 Feb;140:8-18. doi: 10.1016/j.lungcan.2019.11.014. Epub 2019 Nov 20.

PMID: 31838169

 

Absolute lymphocyte count as a prognostic biomarker for overall survival in patients with advanced melanoma treated with ipilimumab.

Postow MA, Chasalow SD, Kuk D, Panageas KS, Cheng ML, Yuan J, Wolchok JD.

Melanoma Res. 2020 Feb;30(1):71-75. doi: 10.1097/CMR.0000000000000633.

PMID: 31425479

 

A High-Throughput BRET Cellular Target Engagement Assay Links Biochemical to Cellular Activity for Bruton's Tyrosine Kinase.

Ong LL, Vasta JD, Monereau L, Locke G, Ribeiro H, Pattoli MA, Skala S, Burke JR, Watterson SH, Tino JA, Meisenheimer PL, Arey B, Lippy J, Zhang L, Robers MB, Tebben A, Chaudhry C.

SLAS Discov. 2020 Feb;25(2):176-185. doi: 10.1177/2472555219884881. Epub 2019 Nov 9.

PMID: 31709883

 

Role of Indoleamine-2,3-Dioxygenase Inhibitors in Salvage Therapy for Non-Muscle Invasive Bladder Cancer.

Chu CE, Porten SP, Grossfeld GD, Meng MV.

Urol Clin North Am. 2020 Feb;47(1):111-118. doi: 10.1016/j.ucl.2019.09.013. Review.

PMID: 31757294

 

Treatment Pathways Leading to Biologic Therapies for Ulcerative Colitis and Crohn's Disease in the United States.

Siegel CA, Yang F, Eslava S, Cai Z.

Clin Transl Gastroenterol. 2020 Feb;11(2):e00128. doi: 10.14309/ctg.0000000000000128.

PMID: 32463619 

 

An Evaluation of T-Cell Functionality After Flow Cytometry Sorting Revealed p38 MAPK Activation.

Andrä I, Ulrich H, Dürr S, Soll D, Henkel L, Angerpointner C, Ritter J, Przibilla S, Stadler H, Effenberger M, Busch DH, Schiemann M.

Cytometry A. 2020 Feb;97(2):171-183. doi: 10.1002/cyto.a.23964. Epub 2020 Jan 16.

PMID: 31944553

 

From single-arm studies to externally controlled studies. Methodological considerations and guidelines.

Cucherat M, Laporte S, Delaitre O, Behier JM; participants of Giens XXXV Round Table Clinical Research, d'Andon A, Binlich F, Bureau S, Cornu C, Fouret C, Hoog Labouret N, Laviolle B, Miadi-Fargier H, Paoletti X, Roustit M, Simon T, Varoqueaux N, Vicaut E, Westerloppe J.

Therapie. 2020 Jan - Feb;75(1):21-27. doi: 10.1016/j.therap.2019.11.007. Epub 2019 Dec 16.

PMID: 32063399

 

Des études mono-bras aux études de comparaison externe. Considérations méthodologiques et recommandations.

Cucherat M, Laporte S, Delaitre O, Behier JM; participants à la table ronde 'Recherche clinique' des Ateliers de Giens XXXV, d'Andon A, Binlich F, Bureau S, Cornu C, Fouret C, Hoog Labouret N, Laviolle B, Miadi-Fargier H, Paoletti X, Roustit M, Simon T, Varoqueaux N, Vicaut E, Westerloppe J.

Therapie. 2020 Jan-Feb;75(1):13-19. doi: 10.1016/j.therap.2019.12.002. Epub 2019 Dec 13.

PMID: 32063401 

 

Acceptability and content validity of patient-reported measures considered from the rheumatoid arthritis patient's perspective.

Shaw Y, Zhang C, Bradley M, Simon TA, Schumacher R, McDonald D, Michaud K.

Arthritis Care Res (Hoboken). 2020 Jan 31. doi: 10.1002/acr.24156. [Epub ahead of print]

PMID: 32004411

 

Variable global distribution of cell-of-origin from the ROBUST phase III study in diffuse large B-cell lymphoma.

Nowakowski GS, Chiappella A, Witzig TE, Scott DW, Spina M, Gascoyne RD, Zhang L, Russo J, Kang J, Zhang J, Xu Y, Vitolo U.

Haematologica. 2020 Jan 31;105(2):e72-e75. doi: 10.3324/haematol.2019.220475. Print 2020. No abstract available.

PMID: 31221781

 

Stability behaviour of antiretroviral drugs and their combinations. 11: Characterization of interaction products of zidovudine and efavirenz, and evaluation of their anti HIV-1 activity, and physiochemical and ADMET properties.

Kurmi M, Sahu A, Balhara A, Singh IP, Kulkarni S, Singh NK, Garg P, Singh S.

J Pharm Biomed Anal. 2020 Jan 30;178:112911. doi: 10.1016/j.jpba.2019.112911. Epub 2019 Oct 6.

PMID: 31627078

 

Safety, tolerability and immunogenicity of V934/V935 hTERT vaccination in cancer patients with selected solid tumors: a phase I study.

Aurisicchio L, Fridman A, Mauro D, Sheloditna R, Chiappori A, Bagchi A, Ciliberto G.

J Transl Med. 2020 Jan 30;18(1):39. doi: 10.1186/s12967-020-02228-9.

PMID: 32000810

 

Author Correction: Blood-brain barrier permeable nano immunoconjugates induce local immune responses for glioma therapy.

Galstyan A, Markman JL, Shatalova ES, Chiechi A, Korman AJ, Patil R, Klymyshyn D, Tourtellotte WG, Israel LL, Braubach O, Ljubimov VA, Mashouf LA, Ramesh A, Grodzinski ZB, Penichet ML, Black KL, Holler E, Sun T, Ding H, Ljubimov AV, Ljubimova JY.

Nat Commun. 2020 Jan 30;11(1):701. doi: 10.1038/s41467-020-14427-5.

PMID: 32001685

 

Considerations for Soluble Protein Biomarker Blood Sample Matrix Selection.

Mathews JA, Ni YG, Wang C, Peterson JE, Ray C, Zhao X, Duan D, Hamon S, Allinson J, Hokom M, Wegner G.

AAPS J. 2020 Jan 29;22(2):38. doi: 10.1208/s12248-020-0412-0.

PMID: 31997095

 

Immunogenicity Risk Assessment for PEGylated Therapeutics.

Mora JR, White JT, DeWall SL.

AAPS J. 2020 Jan 28;22(2):35. doi: 10.1208/s12248-020-0420-0.

PMID: 31993858

 

Discovery of BMS-986260, a Potent, Selective, and Orally Bioavailable TGFβR1 Inhibitor as an Immuno-oncology Agent.

Velaparthi U, Darne CP, Warrier J, Liu P, Rahaman H, Augustine-Rauch K, Parrish K, Yang Z, Swanson J, Brown J, Dhar G, Anandam A, Holenarsipur VK, Palanisamy K, Wautlet BS, Fereshteh MP, Lippy J, Tebben AJ, Sheriff S, Ruzanov M, Yan C, Gupta A, Gupta AK, Vetrichelvan M, Mathur A, Gelman M, Singh R, Kinsella T, Murtaza A, Fargnoli J, Vite G, Borzilleri RM.

ACS Med Chem Lett. 2020 Jan 28;11(2):172-178. doi: 10.1021/acsmedchemlett.9b00552. eCollection 2020 Feb 13.

PMID: 32071685

 

Bleeding and recurrent VTE with apixaban vs warfarin as outpatient treatment: time-course and subgroup analyses.

Weycker D, Wygant GD, Guo JD, Lee T, Luo X, Rosenblatt L, Mardekian J, Atwood M, Hanau A, Cohen AT.

Blood Adv. 2020 Jan 28;4(2):432-439. doi: 10.1182/bloodadvances.2019001081.

PMID: 31990332

 

Decoding the small size challenges of mini-tablets for enhanced dose flexibility and micro-dosing.

Mitra B, Thool P, Meruva S, Aycinena JA, Li J, Patel J, Patel K, Agarwal A, Karki S, Bowen W.

Int J Pharm. 2020 Jan 25;574:118905. doi: 10.1016/j.ijpharm.2019.118905. Epub 2019 Dec 3.

PMID: 31809860

 

Prognosis, Biology, and Targeting of TP53 Dysregulation in Multiple Myeloma.

Flynt E, Bisht K, Sridharan V, Ortiz M, Towfic F, Thakurta A.

Cells. 2020 Jan 24;9(2). pii: E287. doi: 10.3390/cells9020287. Review.

PMID: 31991614

 

Potent, Orally Bioavailable, and Efficacious Macrocyclic Inhibitors of Factor XIa. Discovery of Pyridine-Based Macrocycles Possessing Phenylazole Carboxamide P1 Groups.

Corte JR, Pinto DJP, Fang T, Osuna H, Yang W, Wang Y, Lai A, Clark CG, Sun JH, Rampulla R, Mathur A, Kaspady M, Neithnadka PR, Li YC, Rossi KA, Myers JE Jr, Sheriff S, Lou Z, Harper TW, Huang C, Zheng JJ, Bozarth JM, Wu Y, Wong PC, Crain EJ, Seiffert DA, Luettgen JM, Lam PYS, Wexler RR, Ewing WR.

J Med Chem. 2020 Jan 23;63(2):784-803. doi: 10.1021/acs.jmedchem.9b01768. Epub 2020 Jan 2.

PMID: 31833761

 

Treatment Considerations for Patients with Unresectable Metastatic Melanoma Who Develop Pembrolizumab-Induced Guillain-Barré Toxicity: A Case Report.

Muralikrishnan S, Ronan LK, Coker S, Rauschkolb PK, Shirai K.

Case Rep Oncol. 2020 Jan 21;13(1):43-48. doi: 10.1159/000504930. eCollection 2020 Jan-Apr.

PMID: 32110218

 

Cardiovascular Toxicity Induced by Kinase Inhibitors: Mechanisms and Preclinical Approaches.

Lamore SD, Kohnken RA, Peters MF, Kolaja KL.

Chem Res Toxicol. 2020 Jan 21;33(1):125-136. doi: 10.1021/acs.chemrestox.9b00387. Epub 2020 Jan 10.

PMID: 31840498

 

Use of Zebrafish in Drug Discovery Toxicology.

Cassar S, Adatto I, Freeman JL, Gamse JT, Iturria I, Lawrence C, Muriana A, Peterson RT, Van Cruchten S, Zon LI.

Chem Res Toxicol. 2020 Jan 21;33(1):95-118. doi: 10.1021/acs.chemrestox.9b00335. Epub 2019 Nov 16.

PMID: 31625720

 

Liver microphysiological systems development guidelines for safety risk assessment in the pharmaceutical industry.

Baudy AR, Otieno MA, Hewitt P, Gan J, Roth A, Keller D, Sura R, Van Vleet TR, Proctor WR.

Lab Chip. 2020 Jan 21;20(2):215-225. doi: 10.1039/c9lc00768g. Epub 2019 Dec 4.

PMID: 31799979

 

Large-scale Analyses of Disease Biomarkers and Apremilast Pharmacodynamic Effects.

Medvedeva IV, Stokes ME, Eisinger D, LaBrie ST, Ai J, Trotter MWB, Schafer P, Yang R.

Sci Rep. 2020 Jan 17;10(1):605. doi: 10.1038/s41598-020-57542-5.

PMID: 31953524

 

Can real-world data really replace randomised clinical trials?

Ramagopalan SV, Simpson A, Sammon C.

BMC Med. 2020 Jan 15;18(1):13. doi: 10.1186/s12916-019-1481-8. No abstract available.

PMID: 31937304

 

A Phase Ib/II Trial of the First-in-Class Anti-CXCR4 Antibody Ulocuplumab in Combination with Lenalidomide or Bortezomib Plus Dexamethasone in Relapsed Multiple Myeloma.

Ghobrial IM, Liu CJ, Redd RA, Perez RP, Baz R, Zavidij O, Sklavenitis-Pistofidis R, Richardson PG, Anderson KC, Laubach J, Henrick P, Savell A, Reyes K, Hornburg K, Chuma S, Sabbatini P, Robbins MD, Becker PS.

Clin Cancer Res. 2020 Jan 15;26(2):344-353. doi: 10.1158/1078-0432.CCR-19-0647. Epub 2019 Oct 31.

PMID: 31672767

 

Costs and Cost Drivers Associated with Non-Small-Cell Lung Cancer Patients Who Received Two or More Lines of Therapy in Europe.

Verleger K, Penrod JR, Manley Daumont M, Solem C, Luo L, Macahilig C, Hertel N.

Clinicoecon Outcomes Res. 2020 Jan 15;12:23-33. doi: 10.2147/CEOR.S223760. eCollection 2020.

PMID: 32021337

 

Applications of fluorine-containing amino acids for drug design.

Mei H, Han J, Klika KD, Izawa K, Sato T, Meanwell NA, Soloshonok VA.

Eur J Med Chem. 2020 Jan 15;186:111826. doi: 10.1016/j.ejmech.2019.111826. Epub 2019 Nov 4. Review.

PMID: 31740056

 

Irp2 regulates insulin production through iron-mediated Cdkal1-catalyzed tRNA modification.

Santos MCFD, Anderson CP, Neschen S, Zumbrennen-Bullough KB, Romney SJ, Kahle-Stephan M, Rathkolb B, Gailus-Durner V, Fuchs H, Wolf E, Rozman J, de Angelis MH, Cai WM, Rajan M, Hu J, Dedon PC, Leibold EA.

Nat Commun. 2020 Jan 15;11(1):296. doi: 10.1038/s41467-019-14004-5.

PMID: 31941883 

 

Nickel-Catalyzed 1,2-Diarylation of Alkenyl Carboxylates: A Gateway to 1,2,3-Trifunctionalized Building Blocks.

Derosa J, Kang T, Tran VT, Wisniewski SR, Karunananda MK, Jankins TC, Xu KL, Engle KM.

Angew Chem Int Ed Engl. 2020 Jan 13;59(3):1201-1205. doi: 10.1002/anie.201913062. Epub 2019 Dec 12.

PMID: 31693286

 

A window-of-opportunity trial of the CXCR1/2 inhibitor reparixin in operable HER-2-negative breast cancer.

Goldstein LJ, Perez RP, Yardley D, Han LK, Reuben JM, Gao H, McCanna S, Butler B, Ruffini PA, Liu Y, Rosato RR, Chang JC.

Breast Cancer Res. 2020 Jan 10;22(1):4. doi: 10.1186/s13058-019-1243-8.

PMID: 31924241

 

High-Dose Ipilimumab and High-Dose Interleukin-2 for Patients With Advanced Melanoma.

Silk AW, Kaufman HL, Curti B, Mehnert JM, Margolin K, McDermott D, Clark J, Newman J, Bommareddy PK, Denzin L, Najmi S, Haider A, Shih W, Kane MP, Zloza A.

Front Oncol. 2020 Jan 10;9:1483. doi: 10.3389/fonc.2019.01483. eCollection 2019.

PMID: 31998643

 

Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes.

Fenaux P, Platzbecker U, Mufti GJ, Garcia-Manero G, Buckstein R, Santini V, Díez-Campelo M, Finelli C, Cazzola M, Ilhan O, Sekeres MA, Falantes JF, Arrizabalaga B, Salvi F, Giai V, Vyas P, Bowen D, Selleslag D, DeZern AE, Jurcic JG, Germing U, Götze KS, Quesnel B, Beyne-Rauzy O, Cluzeau T, Voso MT, Mazure D, Vellenga E, Greenberg PL, Hellström-Lindberg E, Zeidan AM, Adès L, Verma A, Savona MR, Laadem A, Benzohra A, Zhang J, Rampersad A, Dunshee DR, Linde PG, Sherman ML, Komrokji RS, List AF.

N Engl J Med. 2020 Jan 9;382(2):140-151. doi: 10.1056/NEJMoa1908892.

PMID: 31914241

 

Increased MSX level improves biological productivity and production stability in multiple recombinant GS CHO cell lines.

Tian J, He Q, Oliveira C, Qian Y, Egan S, Xu J, Qian NX, Langsdorf E, Warrack B, Aranibar N, Reily M, Borys M, Li ZJ.

Eng Life Sci. 2020 Jan 9;20(3-4):112-125. doi: 10.1002/elsc.201900124. eCollection 2020 Mar.

PMID: 32874175 

 

Effects of Apremilast, an Oral Inhibitor of Phosphodiesterase 4, in a Randomized Trial of Patients With Active Ulcerative Colitis.

Danese S, Neurath MF, Kopoń A, Zakko SF, Simmons TC, Fogel R, Siegel CA, Panaccione R, Zhan X, Usiskin K, Chitkara D.

Clin Gastroenterol Hepatol. 2020 Jan 8. pii: S1542-3565(20)30005-7. doi: 10.1016/j.cgh.2019.12.032. [Epub ahead of print]

PMID: 31926340

 

Application of in-sample calibration curve methodology for regulated bioanalysis: Critical considerations in method development, validation and sample analysis.

Yuan L, Gu H, Zeng J, Pillutla RC, Ji QC.

J Pharm Biomed Anal. 2020 Jan 5;177:112844. doi: 10.1016/j.jpba.2019.112844. Epub 2019 Aug 29.

PMID: 31491659

 

The Evolving Druggability and Developability Space: Chemically Modified New Modalities and Emerging Small Molecules.

Yang W, Gadgil P, Krishnamurthy VR, Landis M, Mallick P, Patel D, Patel PJ, Reid DL, Sanchez-Felix M.

AAPS J. 2020 Jan 3;22(2):21. doi: 10.1208/s12248-019-0402-2.

PMID: 31900602

 

Application and Impact of Human Dose Projection from Discovery to Early Drug Development.

Patel D, Yang W, Lipert M, Wu T.

AAPS PharmSciTech. 2020 Jan 2;21(2):44. doi: 10.1208/s12249-019-1598-2. Review.

PMID: 31897807

 

Design, synthesis and biological evaluation of phenol-linked uncialamycin antibody-drug conjugates.

Poudel YB, Rao C, Kotapati S, Deshpande M, Thevanayagam L, Pan C, Cardarelli J, Chowdari N, Kaspady M, Samikannu R, Kuppusamy P, Saravanakumar P, Arunachalam PN, Deshpande S, Rangan V, Rampulla R, Mathur A, Vite GD, Gangwar S.

Bioorg Med Chem Lett. 2020 Jan 1;30(1):126782. doi: 10.1016/j.bmcl.2019.126782. Epub 2019 Nov 9.

PMID: 31767265

 

Biomanufacturing evolution from conventional to intensified processes for productivity improvement: a case study.

Xu J, Xu X, Huang C, Angelo J, Oliveira CL, Xu M, Xu X, Temel D, Ding J, Ghose S, Borys MC, Li ZJ.

MAbs. 2020 Jan 1;12(1):1770669. doi: 10.1080/19420862.2020.1770669.

PMID: 32425110 

 

Control of Antibody Impurities Induced by Riboflavin in Culture Media During Production.

Wallace A, Trimble S, Valliere-Douglass JF, Allen M, Eakin C, Balland A, Reddy P, Treuheit MJ.

J Pharm Sci. 2020 Jan;109(1):566-575. doi: 10.1016/j.xphs.2019.10.039. Epub 2019 Oct 26.

PMID: 31669653

 

Estimates of Responsiveness, Minimally Important Differences, and Patient Acceptable Symptom State in Five Patient-Reported Outcomes Measurement Information System Short Forms in Systemic Lupus Erythematosus.

Katz P, Pedro S, Alemao E, Yazdany J, Dall'Era M, Trupin L, Rush S, Michaud K.

ACR Open Rheumatol. 2020 Jan;2(1):53-60. doi: 10.1002/acr2.11100. Epub 2019 Dec 4.

PMID: 31943975

 

Consensus guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury occurring during clinical trials in adults with chronic cholestatic liver disease.

Palmer M, Regev A, Lindor K, Avigan MI, Dimick-Santos L, Treem W, Marcinak JF, Lewis JH, Anania FA, Seekins D, Shneider BL, Chalasani N.

Aliment Pharmacol Ther. 2020 Jan;51(1):90-109. doi: 10.1111/apt.15579. Epub 2019 Nov 25. Review.

PMID: 31762074

 

Myeloid Cells Orchestrate Systemic Immunosuppression, Impairing the Efficacy of Immunotherapy against HPV+ Cancers.

Galliverti G, Wullschleger S, Tichet M, Murugan D, Zangger N, Horton W, Korman AJ, Coussens LM, Swartz MA, Hanahan D.

Cancer Immunol Res. 2020 Jan;8(1):131-145. doi: 10.1158/2326-6066.CIR-19-0315. Epub 2019 Nov 26.

PMID: 31771984

 

Connect MM Registry as a national reference for United States multiple myeloma patients.

Ailawadhi S, Jagannath S, Narang M, Rifkin RM, Terebelo HR, Toomey K, Durie BGM, Hardin JW, Gasparetto CJ, Wagner L, Omel JL, Kumar V, Yue L, Kitali A, Agarwal A, Abonour R; Connect MM Registry Investigators.

Cancer Med. 2020 Jan;9(1):35-42. doi: 10.1002/cam4.2656. Epub 2019 Nov 7.

PMID: 31701679

 

Population Pharmacokinetics of Ipilimumab in Combination With Nivolumab in Patients With Advanced Solid Tumors.

Sanghavi K, Zhang J, Zhao X, Feng Y, Statkevich P, Sheng J, Roy A, Vezina HE.

CPT Pharmacometrics Syst Pharmacol. 2020 Jan;9(1):29-39. doi: 10.1002/psp4.12477. Epub 2019 Dec 1.

PMID: 31709718

 

Treatment patterns and healthcare costs among biologic-naive patients initiating apremilast or biologics for the treatment of psoriatic arthritis: results from a US claims analysis.

Wu JJ, Pelletier C, Ung B, Tian M.

Curr Med Res Opin. 2020 Jan;36(1):169-176. doi: 10.1080/03007995.2019.1668204. Epub 2019 Sep 28.

PMID: 31517542

 

Application of Augmented Intelligence for Pharmacovigilance Case Seriousness Determination.

Routray R, Tetarenko N, Abu-Assal C, Mockute R, Assuncao B, Chen H, Bao S, Danysz K, Desai S, Cicirello S, Willis V, Alford SH, Krishnamurthy V, Mingle E.

Drug Saf. 2020 Jan;43(1):57-66. doi: 10.1007/s40264-019-00869-4.

PMID: 31605285

 

Application of the adverse outcome pathway framework to genotoxic modes of action.

Sasaki JC, Allemang A, Bryce SM, Custer L, Dearfield KL, Dietz Y, Elhajouji A, Escobar PA, Fornace AJ Jr, Froetschl R, Galloway S, Hemmann U, Hendriks G, Li HH, Luijten M, Ouedraogo G, Peel L, Pfuhler S, Roberts DJ, Thybaud V, van Benthem J, Yauk CL, Schuler M.

Environ Mol Mutagen. 2020 Jan;61(1):114-134. doi: 10.1002/em.22339. Epub 2019 Oct 31.

PMID: 31603995

 

 Potential of machine learning methods to identify patients with nonvalvular atrial fibrillation.

Suzuki R, Katada J, Ramagopalan S, McDonald L.

Future Cardiol. 2020 Jan;16(1):43-52. doi: 10.2217/fca-2019-0056. Epub 2019 Dec 3.

PMID: 31793345

 

ENERGIZE: a Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer.

Sonpavde G, Necchi A, Gupta S, Steinberg GD, Gschwend JE, Van Der Heijden MS, Garzon N, Ibrahim M, Raybold B, Liaw D, Rutstein M, Galsky MD.

Future Oncol. 2020 Jan;16(2):4359-4368. doi: 10.2217/fon-2019-0611. Epub 2019 Dec 11.

PMID: 31823654

 

Consistency of recording of chemotherapy cycles in the National Cancer Registration and Analysis Service Systemic Anti-Cancer Therapy database and the Hospital Episode Statistics Admitted Patient Care database.

McDonald L, Sammon C, Carroll R, Harish A, C AS, Tyas D, Ramagopalan SV.

Future Oncol. 2020 Jan;16(3):4455-4460. doi: 10.2217/fon-2019-0669. Epub 2019 Dec 10.

PMID: 31820657

 

Correction to: Developing real-world comparators for clinical trials in chemotherapy-refractory patients with gastric cancer or gastroesophageal junction cancer.

Chau I, Le DT, Ott PA, Korytowsky B, Le H, Le TK, Zhang Y, Sanchez T, Maglinte GA, Laurie M, Abraham P, Patel D, Shangguan T.

Gastric Cancer. 2020 Jan;23(1):142. doi: 10.1007/s10120-019-01021-y.

PMID: 31679092

 

Developing real-world comparators for clinical trials in chemotherapy-refractory patients with gastric cancer or gastroesophageal junction cancer.

Chau I, Le DT, Ott PA, Korytowsky B, Le H, Le TK, Zhang Y, Sanchez T, Maglinte GA, Laurie M, Abraham P, Patel D, Shangguan T.

Gastric Cancer. 2020 Jan;23(1):133-141. doi: 10.1007/s10120-019-01008-9. Epub 2019 Sep 23. Erratum in: Gastric Cancer. 2019 Nov 3;:.

PMID: 31549264

 

Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma.

Ambavane A, Yang S, Atkins MB, Rao S, Shah A, Regan MM, McDermott DF, Michaelson MD.

Immunotherapy. 2020 Jan;12(1):37-51. doi: 10.2217/imt-2019-0199. Epub 2020 Jan 29.

PMID: 31992108

 

Left atrial ejection fraction and outcomes in heart failure with preserved ejection fraction.

Kanagala P, Arnold JR, Cheng ASH, Singh A, Khan JN, Gulsin GS, Yang J, Zhao L, Gupta P, Squire IB, Ng LL, McCann GP.

Int J Cardiovasc Imaging. 2020 Jan;36(1):101-110. doi: 10.1007/s10554-019-01684-9. Epub 2019 Aug 10.

PMID: 31401742

 

Elotuzumab plus lenalidomide and dexamethasone for newly diagnosed multiple myeloma: a randomized, open-label, phase 2 study in Japan.

Kubo K, Hori M, Ohta K, Handa H, Hatake K, Matsumoto M, Hagiwara S, Ohashi K, Nakaseko C, Suzuki K, Ito S, Kinoshita G, Shelat SG, Miyoshi M, Takezako N.

Int J Hematol. 2020 Jan;111(1):65-74. doi: 10.1007/s12185-019-02757-0. Epub 2019 Nov 7.

PMID: 31701481

 

Incidence of seroconversion and sero-reversion in patients with multiple sclerosis (MS) who had been treated with natalizumab: A systematic review and meta-analysis.

Azimi A, Hanaei S, Sahraian MA, Mohammadifar M, Ramagopalan SV, Ghajarzadeh M.

J Clin Neurosci. 2020 Jan;71:129-134. doi: 10.1016/j.jocn.2019.08.103. Epub 2019 Sep 23.

PMID: 31558363

 

Population Pharmacokinetic Model to Assess the Impact of Disease State on Thalidomide Pharmacokinetics.

Gaudy A, Hwang R, Palmisano M, Chen N.

J Clin Pharmacol. 2020 Jan;60(1):67-74. doi: 10.1002/jcph.1506. Epub 2019 Aug 7.

PMID: 31392755

 

Comparative effectiveness of nivolumab versus clinical practice for advanced gastric or gastroesophageal junction cancer.

Chau I, Ayers D, Goring S, Cope S, Korytowsky B, Abraham P.

J Comp Eff Res. 2020 Jan;9(2):103-114. doi: 10.2217/cer-2019-0145. Epub 2019 Dec 24.

PMID: 31872771

 

Therapeutic inertia in the management of moderate-to-severe plaque psoriasis.

Halioua B, Corgibet F, Maghia R, Hello S, Caillet G, Nicolas C, Riboulet JL, Mahé E.

J Eur Acad Dermatol Venereol. 2020 Jan;34(1):e30-e32. doi: 10.1111/jdv.15882. Epub 2019 Sep 2. No abstract available.

PMID: 31419345

 

Unique Impacts of Methionine Oxidation, Tryptophan Oxidation, and Asparagine Deamidation on Antibody Stability and Aggregation.

Alam ME, Slaney TR, Wu L, Das TK, Kar S, Barnett GV, Leone A, Tessier PM.

J Pharm Sci. 2020 Jan;109(1):656-669. doi: 10.1016/j.xphs.2019.10.051. Epub 2019 Oct 31.

PMID: 31678251

 

A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products.

Hubert M, Yang DT, Kwok SC, Rios A, Das TK, Patel A, Wuchner K, Antochshuk V, Junge F, Bou-Assaf GM, Cao S, Saggu M, Montrond L, Afonina N, Kolhe P, Loladze V, Narhi L.

J Pharm Sci. 2020 Jan;109(1):830-844. doi: 10.1016/j.xphs.2019.10.025. Epub 2019 Oct 21.

PMID: 31647951

 

Stress Factors in mAb Drug Substance Production Processes: Critical Assessment of Impact on Product Quality and Control Strategy.

Das TK, Narhi LO, Sreedhara A, Menzen T, Grapentin C, Chou DK, Antochshuk V, Filipe V.

J Pharm Sci. 2020 Jan;109(1):116-133. doi: 10.1016/j.xphs.2019.09.023. Epub 2019 Oct 5. Review.

PMID: 31593689

 

An Industry Perspective on Forced Degradation Studies of Biopharmaceuticals: Survey Outcome and Recommendations.

Halley J, Chou YR, Cicchino C, Huang M, Sharma V, Tan NC, Thakkar S, Zhou LL, Al-Azzam W, Cornen S, Gauden M, Gu Z, Kar S, Lazar AC, Mehndiratta P, Smith J, Sosic Z, Weisbach P, Stokes ESE.

J Pharm Sci. 2020 Jan;109(1):6-21. doi: 10.1016/j.xphs.2019.09.018. Epub 2019 Sep 26.

PMID: 31563512

 

Structure-Function Assessment and High-Throughput Quantification of Site-Specific Aspartate Isomerization in Monoclonal Antibody Using a Novel Analytical Tool Kit.

Zhou K, Cao X, Bautista J, Chen Z, Hershey N, Ludwig R, Tao L, Zeng M, Das TK.

J Pharm Sci. 2020 Jan;109(1):422-428. doi: 10.1016/j.xphs.2019.08.018. Epub 2019 Aug 27.

PMID: 31469998

 

A simplified frailty scale predicts outcomes in transplant-ineligible patients with newly diagnosed multiple myeloma treated in the FIRST (MM-020) trial.

Facon T, Dimopoulos MA, Meuleman N, Belch A, Mohty M, Chen WM, Kim K, Zamagni E, Rodriguez-Otero P, Renwick W, Rose C, Tempescul A, Boyle E, Manier S, Attal M, Moreau P, Macro M, Leleu X, Lorraine Chretien M, Ludwig H, Guo S, Sturniolo M, Tinel A, Silvia Monzini M, Costa B, Houck V, Hulin C, Yves Mary J.

Leukemia. 2020 Jan;34(1):224-233. doi: 10.1038/s41375-019-0539-0. Epub 2019 Aug 19.

PMID: 31427722

 

Soluble SLAMF7 promotes the growth of myeloma cells via homophilic interaction with surface SLAMF7.

Kikuchi J, Hori M, Iha H, Toyama-Sorimachi N, Hagiwara S, Kuroda Y, Koyama D, Izumi T, Yasui H, Suzuki A, Furukawa Y.

Leukemia. 2020 Jan;34(1):180-195. doi: 10.1038/s41375-019-0525-6. Epub 2019 Jul 29.

PMID: 31358854

 

Incident cardiovascular disease in patients diagnosed with multiple sclerosis: A multi-database study.

Persson R, Lee S, Yood MU, Wagner M, Minton N, Niemcryk S, Lindholm A, Evans A, Jick S.

Mult Scler Relat Disord. 2020 Jan;37:101423. doi: 10.1016/j.msard.2019.101423. Epub 2019 Oct 1.

PMID: 32172996

 

Analysis of historical negative control group data from the rat in vivo micronucleus assay.

Lovell DP, Fellows M, Saul J, Whitwell J, Custer L, Dertinger S, Escobar P, Fiedler R, Hemmann U, Kenny J, Smith R, van der Leede BM, Zeller A.

Mutat Res. 2020 Jan;849:503086. doi: 10.1016/j.mrgentox.2019.503086. Epub 2019 Oct 12.

PMID: 32087845

 

Evaluating Partitioned Survival and Markov Decision-Analytic Modeling Approaches for Use in Cost-Effectiveness Analysis: Estimating and Comparing Survival Outcomes.

Smare C, Lakhdari K, Doan J, Posnett J, Johal S.

Pharmacoeconomics. 2020 Jan;38(1):97-108. doi: 10.1007/s40273-019-00845-x.

PMID: 31741315

 

A Systematic Review of Network Meta-Analyses and Real-World Evidence Comparing Apixaban and Rivaroxaban in Nonvalvular Atrial Fibrillation.

Hill NR, Sandler B, Bergrath E, Milenković D, Ashaye AO, Farooqui U, Cohen AT.

Clin Appl Thromb Hemost. 2020 Jan-Dec;26:1076029619898764. doi: 10.1177/1076029619898764.

PMID: 31918558

 

Design and characterization of mouse IgG1 and IgG2a bispecific antibodies for use in syngeneic models.

Wang F, Tsai JC, Davis JH, Chau B, Dong J, West SM, Hogan JM, Wheeler ML, Bee C, Morishige W, Cayton T, David-Brown D, Zhang C, Kozhich A, Sproul T, Dollinger G, Rajpal A, Strop P.

MAbs. 2020 Jan-Dec;12(1):1685350. doi: 10.1080/19420862.2019.1685350.

PMID: 31856660

 

Design of next-generation therapeutic IgG4 with improved manufacturability and bioanalytical characteristics.

Chen Z, Qian Y, Song Y, Xu X, Tao L, Mussa N, Ghose S, Li ZJ.

MAbs. 2020 Jan-Dec;12(1):1829338. doi: 10.1080/19420862.2020.1829338.

PMID: 33044887 

 

Optimization and kinetic modeling of interchain disulfide bond reoxidation of monoclonal antibodies in bioprocesses.

Tang P, Tan Z, Ehamparanathan V, Ren T, Hoffman L, Du C, Song Y, Tao L, Lewandowski A, Ghose S, Li ZJ, Liu S.

MAbs. 2020 Jan-Dec;12(1):1829336. doi: 10.1080/19420862.2020.1829336.

PMID: 33031716 

 

On-column disulfide bond formation of monoclonal antibodies during Protein A chromatography eliminates low molecular weight species and rescues reduced antibodies.

Tan Z, Ehamparanathan V, Ren T, Tang P, Hoffman L, Kuang J, Liu P, Huang C, Du C, Tao L, Chemmalil L, Lewandowski A, Ghose S, Li ZJ, Liu S.

MAbs. 2020 Jan-Dec;12(1):1829333. doi: 10.1080/19420862.2020.1829333.

PMID: 33016217 

 

Enabling speed to clinic for monoclonal antibody programs using a pool of clones for IND-enabling toxicity studies.

Bolisetty P, Tremml G, Xu S, Khetan A.

MAbs. 2020 Jan-Dec;12(1):1763727. doi: 10.1080/19420862.2020.1763727.

PMID: 32449878 

 

Investigation of anomalous charge variant profile reveals discrete pH-dependent conformations and conformation-dependent charge states within the CDR3 loop of a therapeutic mAb.

Lan W, Valente JJ, Ilott A, Chennamsetty N, Liu Z, Rizzo JM, Yamniuk AP, Qiu D, Shackman HM, Bolgar MS.

MAbs. 2020 Jan-Dec;12(1):1763138. doi: 10.1080/19420862.2020.1763138.

PMID: 32432964 

Single-Dose Pharmacokinetics, Safety, and Tolerability of Avadomide (CC-122) in Subjects With Mild, Moderate, or Severe Renal Impairment.

Li Y, MacGorman K, Liu L, Chen J, Hoffmann M, Palmisano M, Zhou S.

Clin Pharmacol Drug Dev. 2019 Dec 31. doi: 10.1002/cpdd.760. [Epub ahead of print]

PMID: 31891240

 

Recent advances and optimal management of human epidermal growth factor receptor-2-positive early-stage breast cancer.

Batoo S, Bayraktar S, Al-Hattab E, Basu S, Okuno S, Glück S.

J Carcinog. 2019 Dec 31;18:5. doi: 10.4103/jcar.JCar_14_19. eCollection 2019. Review.

PMID: 31949426

 

Solid state nuclear magnetic resonance studies of hydroxypropylmethylcellulose acetyl succinate polymer, a useful carrier in pharmaceutical solid dispersions.

Pugliese A, Hawarden LE, Abraham A, Tobyn M, Blanc F.

Magn Reson Chem. 2019 Dec 27. doi: 10.1002/mrc.4984. [Epub ahead of print]

PMID: 31880823

 

Trajectories of health-related quality of life among renal transplant patients associated with graft failure and symptom distress: Analysis of the BENEFIT and BENEFIT-EXT trials.

Purnajo I, Beaumont JL, Polinsky M, Alemao E, Everly MJ.

Am J Transplant. 2019 Dec 24. doi: 10.1111/ajt.15757. [Epub ahead of print]

PMID: 31874117

 

Pegbelfermin (BMS-986036), a PEGylated fibroblast growth factor 21 analogue, in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 2a trial.

Sanyal A, Charles ED, Neuschwander-Tetri BA, Loomba R, Harrison SA, Abdelmalek MF, Lawitz EJ, Halegoua-DeMarzio D, Kundu S, Noviello S, Luo Y, Christian R.

Lancet. 2019 Dec 22;392(10165):2705-2717. doi: 10.1016/S0140-6736(18)31785-9. Epub 2018 Dec 13.

PMID: 30554783

 

Covariate adjustment for randomized controlled trials revisited.

Wang J.

Pharm Stat. 2019 Dec 21. doi: 10.1002/pst.1988. [Epub ahead of print]

PMID: 31863636

 

Inflammatory bowel disease - one entity with many molecular faces.

Szymańska S, Matuszczyk M, Osuch M, Meglicka M, Szymanska E, Bierła J, Kierkuś J.

Prz Gastroenterol. 2019 Dec 20;14(4):228-232. doi: 10.5114/pg.2019.90249. Epub 2019 Dec 20. Review.

PMID: 31988668

 

Cancer diagnosis and care among rural-to-urban migrants in China.

Myerson R, Lu T, Yuan Y, Liu GG.

BMJ Glob Health. 2019 Dec 18;4(6):e001923. doi: 10.1136/bmjgh-2019-001923. eCollection 2019.

PMID: 31908866

An Integrated Approach for Determining a Protein-Protein Binding Interface in Solution and an Evaluation of Hydrogen-Deuterium Exchange Kinetics for Adjudicating Candidate Docking Models.

Zhang MM, Beno BR, Huang RY, Adhikari J, Deyanova EG, Li J, Chen G, Gross ML.

Anal Chem. 2019 Dec 17;91(24):15709-15717. doi: 10.1021/acs.analchem.9b03879. Epub 2019 Nov 22.

PMID: 31710208

 

Cost-Effectiveness of Extended and One-Time Screening Versus No Screening for Non-Valvular Atrial Fibrillation in the USA.

Oguz M, Lanitis T, Li X, Wygant G, Singer DE, Friend K, Hlavacek P, Nikolaou A, Mattke S.

Appl Health Econ Health Policy. 2019 Dec 17. doi: 10.1007/s40258-019-00542-y. [Epub ahead of print]

PMID: 31849021

 

Nonhomologous end-joining repair is likely involved in the repair of double-stranded DNA breaks induced by riluzole in melanoma cells.

Cerchio R Jr, Marinaro C, Foo TK, Xia B, Chen S.

Melanoma Res. 2019 Dec 17. doi: 10.1097/CMR.0000000000000652. [Epub ahead of print]

PMID:31855905

 

Mongersen (GED-0301) for Active Crohn's Disease: Results of a Phase 3 Study.

Sands BE, Feagan BG, Sandborn WJ, Schreiber S, Peyrin-Biroulet L, Colombel JF, Rossiter G, Usiskin K, Ather S, Zhan X, DʼHaens G.

Am J Gastroenterol. 2019 Dec 16. doi: 10.14309/ajg.0000000000000493. [Epub ahead of print]

PMID: 31850931

 

Practical applications of bio-fluorescent particle counting in Environmental Monitoring investigations.

Prasad A, Villari P, Henry R', Weber J, Hauschild J, Yan L, Horsch J, Shereefa S, Rau JE, Milling A, Bolden JS, Plourde L, Claassen M, IJzerman-Boon P, Forng RY, Portmann R, Urwyler S, Dassu D.

PDA J Pharm Sci Technol. 2019 Dec 16. pii: pdajpst.2019.009969. doi: 10.5731/pdajpst.2019.009969. [Epub ahead of print]

PMID: 31843986

 

Triple Therapy with MerTK and PD1 Inhibition Plus Radiotherapy Promotes Abscopal Antitumor Immune Responses.

Caetano MS, Younes AI, Barsoumian HB, Quigley M, Menon H, Gao C, Spires T, Reilly TP, Cadena AP, Cushman TR, Schoenhals JE, Li A, Nguyen QN, Cortez MA, Welsh JW.

Clin Cancer Res. 2019 Dec 15;25(24):7576-7584. doi: 10.1158/1078-0432.CCR-19-0795. Epub 2019 Sep 20.

PMID: 31540976

 

Colocalization of GWAS and eQTL signals at loci with multiple signals identifies additional candidate genes for body fat distribution.

Wu Y, Broadaway KA, Raulerson CK, Scott LJ, Pan C, Ko A, He A, Tilford C, Fuchsberger C, Locke AE, Stringham HM, Jackson AU, Narisu N, Kuusisto J, Pajukanta P, Collins FS, Boehnke M, Laakso M, Lusis AJ, Civelek M, Mohlke KL.

Hum Mol Genet. 2019 Dec 15;28(24):4161-4172. doi: 10.1093/hmg/ddz263.

PMID: 31691812

 

Adverse vacuolation in multiple tissues in cynomolgus monkeys following repeat-dose administration of a PEGylated protein.

Fletcher AM, Tellier P, Douville J, Mansell P, Graziano MJ, Mangipudy RS, Brodie TA, Achanzar WE.

Toxicol Lett. 2019 Dec 15;317:120-129. doi: 10.1016/j.toxlet.2019.09.023. Epub 2019 Sep 30.

PMID: 31580884

 

First-In-Human Phase I Study Of A Dual mTOR Kinase And DNA-PK Inhibitor (CC-115) In Advanced Malignancy.

Munster P, Mita M, Mahipal A, Nemunaitis J, Massard C, Mikkelsen T, Cruz C, Paz-Ares L, Hidalgo M, Rathkopf D, Blumenschein G Jr, Smith DC, Eichhorst B, Cloughesy T, Filvaroff EH, Li S, Raymon H, de Haan H, Hege K, Bendell JC.

Cancer Manag Res. 2019 Dec 13;11:10463-10476. doi: 10.2147/CMAR.S208720. eCollection 2019.

PMID: 31853198

 

First-Line Doublet Chemotherapy for Metastatic Triple-Negative Breast Cancer: Circulating Tumor Cell Analysis of the tnAcity Trial.

Liu MC, Janni W, Georgoulias V, Yardley DA, Harbeck N, Wei X, McGovern D, Beck R.

Cancer Manag Res. 2019 Dec 12;11:10427-10433. doi: 10.2147/CMAR.S208712. eCollection 2019.

PMID: 31849532

Development of a prognostic composite cytokine signature based on the correlation with nivolumab clearance: translational PK/PD analysis in patients with renal cell carcinoma.

Wang R, Zheng J, Shao X, Ishii Y, Roy A, Bello A, Lee R, Zhang J, Wind-Rotolo M, Feng Y.

J Immunother Cancer. 2019 Dec 11;7(1):348. doi: 10.1186/s40425-019-0819-2.

PMID: 31829287

 

An analysis of orphan medicine expenditure in Europe: is it sustainable?

Mestre-Ferrandiz J, Palaska C, Kelly T, Hutchings A, Parnaby A.

Orphanet J Rare Dis. 2019 Dec 11;14(1):287. doi: 10.1186/s13023-019-1246-7.

PMID: 31829218

 

Visualizing the Selectivity and Dynamics of Interferon Signaling In Vivo.

Stifter SA, Bhattacharyya N, Sawyer AJ, Cootes TA, Stambas J, Doyle SE, Feigenbaum L, Paul WE, Britton WJ, Sher A, Feng CG.

Cell Rep. 2019 Dec 10;29(11):3539-3550.e4. doi: 10.1016/j.celrep.2019.11.021.

PMID: 31825834

 

Treatment-Free Survival: A Novel Outcome Measure of the Effects of Immune Checkpoint Inhibition-A Pooled Analysis of Patients With Advanced Melanoma.

Regan MM, Werner L, Rao S, Gupte-Singh K, Hodi FS, Kirkwood JM, Kluger HM, Larkin J, Postow MA, Ritchings C, Sznol M, Tarhini AA, Wolchok JD, Atkins MB, McDermott DF.

J Clin Oncol. 2019 Dec 10;37(35):3350-3358. doi: 10.1200/JCO.19.00345. Epub 2019 Sep 9.

PMID: 31498030

 

Disease activity measures at baseline predict structural damage progression: data from the randomized, controlled AMPLE and AVERT trials.

Keystone EC, Ahmad HA, Yazici Y, Bergman MJ.

Rheumatology (Oxford). 2019 Dec 9. pii: kez455. doi: 10.1093/rheumatology/kez455. [Epub ahead of print]

PMID: 31819995

 

Prospective Study Evaluating Changes in Bone Quality in Premenopausal Women With Breast Cancer Undergoing Adjuvant Chemotherapy.

Hopson MB, Onishi M, Awad D, Buono D, Maurer M, Crew KD, Shane E, Hershman DL, Kalinsky K.

Clin Breast Cancer. 2019 Dec 5. pii: S1526-8209(19)30759-1. doi: 10.1016/j.clbc.2019.12.001. [Epub ahead of print]

PMID: 31926840

Prospective Study Evaluating Changes in Bone Quality in Premenopausal Women With Breast Cancer Undergoing Adjuvant Chemotherapy.

Hopson MB, Onishi M, Awad D, Buono D, Maurer M, Crew KD, Shane E, Hershman DL, Kalinsky K.

Clin Breast Cancer. 2019 Dec 5. pii: S1526-8209(19)30759-1. doi: 10.1016/j.clbc.2019.12.001. [Epub ahead of print]

PMID: 31926840

 

Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.

Windecker S, Lopes RD, Massaro T, Jones-Burton C, Granger CB, Aronson R, Heizer G, Goodman SG, Darius H, Jones WS, Aschermann M, Brieger D, Cura F, Engstrøm T, Fridrich V, Halvorsen S, Huber K, Kang HJ, Leiva-Pons JL, Lewis BS, Malaga G, Meneveau N, Merkely B, Milicic D, Morais J, Potpara TS, Raev D, Sabaté M, de Waha-Thiele S, Welsh RC, Xavier D, Mehran R, Alexander JH; AUGUSTUS Investigators.

Circulation. 2019 Dec 3;140(23):1921-1932. doi: 10.1161/CIRCULATIONAHA.119.043308. Epub 2019 Sep 26.

PMID: 31557056

 

Hospitalization Among Patients With Atrial Fibrillation and a Recent Acute Coronary Syndrome or Percutaneous Coronary Intervention Treated With Apixaban or Aspirin: Insights From the AUGUSTUS Trial.

Vora AN, Alexander JH, Wojdyla DM, Aronson R, Granger CB, Darius H, Windecker S, Mehran R, Averkov O, Budaj A, Kong DF, Kobalava Z, Mehta RH, Mirza Z, Guimaraes PO, Parkhomenko A, Quadros A, Thiele H, Goodman SG, Lopes RD.

Circulation. 2019 Dec 3;140(23):1960-1963. doi: 10.1161/CIRCULATIONAHA.119.043754. Epub 2019 Sep 25. No abstract available.

PMID: 31553201

 

Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.

Windecker S, Lopes RD, Massaro T, Jones-Burton C, Granger CB, Aronson R, Heizer G, Goodman SG, Darius H, Jones WS, Aschermann M, Brieger D, Cura F, Engstrøm T, Fridrich V, Halvorsen S, Huber K, Kang HJ, Leiva-Pons JL, Lewis BS, Malaga G, Meneveau N, Merkely B, Milicic D, Morais J, Potpara TS, Raev D, Sabaté M, de Waha-Thiele S, Welsh RC, Xavier D, Mehran R, Alexander JH; AUGUSTUS Investigators.

Circulation. 2019 Dec 3;140(23):1921-1932. doi: 10.1161/CIRCULATIONAHA.119.043308. Epub 2019 Sep 26.

PMID: 31557056

 

Hospitalization Among Patients With Atrial Fibrillation and a Recent Acute Coronary Syndrome or Percutaneous Coronary Intervention Treated With Apixaban or Aspirin: Insights From the AUGUSTUS Trial.

Vora AN, Alexander JH, Wojdyla DM, Aronson R, Granger CB, Darius H, Windecker S, Mehran R, Averkov O, Budaj A, Kong DF, Kobalava Z, Mehta RH, Mirza Z, Guimaraes PO, Parkhomenko A, Quadros A, Thiele H, Goodman SG, Lopes RD.

Circulation. 2019 Dec 3;140(23):1960-1963. doi: 10.1161/CIRCULATIONAHA.119.043754. Epub 2019 Sep 25. No abstract available.

PMID: 31553201

 

Galectin-1-driven T cell exclusion in the tumor endothelium promotes immunotherapy resistance.

Nambiar DK, Aguilera T, Cao H, Kwok S, Kong C, Bloomstein J, Wang Z, Rangan VS, Jiang D, von Eyben R, Liang R, Agarwal S, Colevas AD, Korman A, Allen CT, Uppaluri R, Koong AC, Giaccia A, Le QT.

J Clin Invest. 2019 Dec 2;129(12):5553-5567. doi: 10.1172/JCI129025.

PMID: 31710313

Galectin-1-driven T cell exclusion in the tumor endothelium promotes immunotherapy resistance.

Nambiar DK, Aguilera T, Cao H, Kwok S, Kong C, Bloomstein J, Wang Z, Rangan VS, Jiang D, von Eyben R, Liang R, Agarwal S, Colevas AD, Korman A, Allen CT, Uppaluri R, Koong AC, Giaccia A, Le QT.

J Clin Invest. 2019 Dec 2;129(12):5553-5567. doi: 10.1172/JCI129025.

PMID: 31710313

 

The potential role of YAP in Axl-mediated resistance to EGFR tyrosine kinase inhibitors.

Saab S, Chang OS, Nagaoka K, Hung MC, Yamaguchi H.

Am J Cancer Res. 2019 Dec 1;9(12):2719-2729. eCollection 2019.

PMID: 31911857

The potential role of YAP in Axl-mediated resistance to EGFR tyrosine kinase inhibitors.

Saab S, Chang OS, Nagaoka K, Hung MC, Yamaguchi H.

Am J Cancer Res. 2019 Dec 1;9(12):2719-2729. eCollection 2019.

PMID: 31911857

A generic method for intact and subunit level characterization of mAb charge variants by native mass spectrometry.

Leblanc Y, Faid V, Lauber MA, Wang Q, Bihoreau N, Chevreux G.

J Chromatogr B Analyt Technol Biomed Life Sci. 2019 Dec 1;1133:121814. doi: 10.1016/j.jchromb.2019.121814. Epub 2019 Oct 16.

PMID: 31731217

 

The Effects of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Volunteers: A Single-Sequence Crossover Study.

Garonzik S, Byon W, Myers E, Li X, Marchisin D, Murthy B.

Am J Cardiovasc Drugs. 2019 Dec;19(6):561-567. doi: 10.1007/s40256-019-00348-2.

PMID: 31030414

 

Toward Accelerated Authorization and Access to New Medicines for Juvenile Idiopathic Arthritis.

Schanberg LE, Ramanan AV, De Benedetti F, Beukelman T, Eakin GS, Del Gaizo V, Ringold S, Vesely R, Schrandt S, Jaki T, Bili A, Chung JB, De Bono S, Douglass W, Enejosa JV, Kanik KS, Knobe K, Kunder R, Leite-Schnell JC, Suehiro RM, Wong RL, Mieszkalski KL, Marrow LC, Siebenaler K, Fraulo E, Kimura Y.

Arthritis Rheumatol. 2019 Dec;71(12):1976-1984. doi: 10.1002/art.41043. Epub 2019 Nov 1.

PMID: 31313532

 

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).

Booth B, Stevenson L, Pillutla R, Buonarati M, Beaver C, Fraier D, Garofolo F, Haidar S, Islam R, James C, Kadavil J, Kavetska O, Li F, Satterwhite C, Savoie N, Subramaniam S, Tampal N, Thway T, Woolf E, Blaye OL, Andisik M, Briscoe C, Cape S, Dasgupta A, Fischer S, Haidar S, Hayes R, Kamerud J, Lima Santos GM, Nehls C, Soo C, Vinter S, Whale E, Xu K, Cho SJ, Edmison A, Kassim S, Rocha TC, Welink J, Amur S, Bandukwala A, Cherry E, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Pedras-Vasconcelos J, Saito Y, Saunders TS, Skibeli V, Verthelyi D, Wang YM, Yan H.

Bioanalysis. 2019 Dec;11(23):2099-2132. doi: 10.4155/bio-2019-0270. Epub 2019 Dec 9.

PMID: 31833782

 

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).

Piccoli S, Mehta D, Vitaliti A, Allinson J, Amur S, Eck S, Green C, Hedrick M, Hopper S, Ji A, Joyce A, Litwin V, Maher K, Mathews J, Peng K, Safavi A, Wang YM, Zhang Y, Amaravadi L, Palackal N, Thankamony S, Beaver C, Bame E, Emrich T, Grimaldi C, Haulenbeek J, Joyce A, Kakkanaiah V, Lanham D, Maher K, Mayer A, Trampont PC, Vermet L, Dakappagari N, Fleener C, Garofolo F, Rogers C, Tangri S, Xu Y, Liang M, Rajadhyaksha M, Richards S, Schweighardt B, Purushothama S, Baltrukonis D, Brumm J, Cherry E, Delcarpini J, Gleason C, Kirshner S, Kubiak R, Pan L, Partridge M, Pedras-Vasconcelos J, Qu Q, Skibeli V, Saunders TS, Staack RF, Stubenrauch K, Torri A, Verthelyi D, Yan H, Gorovits B, Palmer R, Milton M, Long B, Corsaro B, Farrokhi V, Fiscella M, Henderson N, Jawa V, McNally J, Murphy R, Waldner H, Yang TY.

Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10.

PMID: 31820675

 

Exploratory biomarker assays: key assay parameters to evaluate in the face of evolving biomarker context-of-use.

Thankamony SP, Zhang Y.

Bioanalysis. 2019 Dec;11(23):2095-2097. doi: 10.4155/bio-2019-0223. Epub 2019 Nov 28. No abstract available.

PMID: 31777269

 

Development of a prognostic model for overall survival in multiple myeloma using the Connect_® MM Patient Registry.

Terebelo HR, Abonour R, Gasparetto CJ, Toomey K, Durie BGM, Hardin JW, Jagannath S, Wagner L, Narang M, Flick ED, Srinivasan S, Yue L, Kitali A, Agarwal A, Rifkin RM; CONNECT MM Registry Investigators.

Br J Haematol. 2019 Dec;187(5):602-614. doi: 10.1111/bjh.16139. Epub 2019 Aug 5.

PMID: 31382320

 

Myocardial Microvascular Dysfunction in Rheumatoid Arthritis_{Quantitation by 13N-Ammonia Positron Emission Tomography/Computed Tomography}.

Amigues I, Russo C, Giles JT, Tugcu A, Weinberg R, Bokhari S, Bathon JM.

Circ Cardiovasc Imaging. 2019 Dec;12(1):e007495. doi: 10.1161/CIRCIMAGING.117.007495.

PMID: 30636512

 

Population Pharmacokinetics of Nivolumab in Combination With Ipilimumab in Patients With Advanced Malignancies.

Zhang J, Sanghavi K, Shen J, Zhao X, Feng Y, Statkevich P, Sheng J, Roy A, Zhu L.

CPT Pharmacometrics Syst Pharmacol. 2019 Dec;8(12):962-970. doi: 10.1002/psp4.12476. Epub 2019 Dec 1.

PMID: 31710163

 

Antibodies to Modulate Surface Receptor Systems Are Often Bivalent and Must Compete in a Two-Dimensional Cell Contact Region.

Schmidt BJ, Bee C, Han M, Jing Y, Cheng Y, Tenney DJ, Leil TA.

CPT Pharmacometrics Syst Pharmacol. 2019 Dec;8(12):873-877. doi: 10.1002/psp4.12468. Epub 2019 Oct 23. No abstract available.

PMID: 31529681

 

The Effects of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Volunteers: A Single-Sequence Crossover Study.

Garonzik S, Byon W, Myers E, Li X, Marchisin D, Murthy B.

Am J Cardiovasc Drugs. 2019 Dec;19(6):561-567. doi: 10.1007/s40256-019-00348-2.

PMID: 31030414

 

Toward Accelerated Authorization and Access to New Medicines for Juvenile Idiopathic Arthritis.

Schanberg LE, Ramanan AV, De Benedetti F, Beukelman T, Eakin GS, Del Gaizo V, Ringold S, Vesely R, Schrandt S, Jaki T, Bili A, Chung JB, De Bono S, Douglass W, Enejosa JV, Kanik KS, Knobe K, Kunder R, Leite-Schnell JC, Suehiro RM, Wong RL, Mieszkalski KL, Marrow LC, Siebenaler K, Fraulo E, Kimura Y.

Arthritis Rheumatol. 2019 Dec;71(12):1976-1984. doi: 10.1002/art.41043. Epub 2019 Nov 1.

PMID: 31313532

 

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).

Booth B, Stevenson L, Pillutla R, Buonarati M, Beaver C, Fraier D, Garofolo F, Haidar S, Islam R, James C, Kadavil J, Kavetska O, Li F, Satterwhite C, Savoie N, Subramaniam S, Tampal N, Thway T, Woolf E, Blaye OL, Andisik M, Briscoe C, Cape S, Dasgupta A, Fischer S, Haidar S, Hayes R, Kamerud J, Lima Santos GM, Nehls C, Soo C, Vinter S, Whale E, Xu K, Cho SJ, Edmison A, Kassim S, Rocha TC, Welink J, Amur S, Bandukwala A, Cherry E, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Pedras-Vasconcelos J, Saito Y, Saunders TS, Skibeli V, Verthelyi D, Wang YM, Yan H.

Bioanalysis. 2019 Dec;11(23):2099-2132. doi: 10.4155/bio-2019-0270. Epub 2019 Dec 9.

PMID: 31833782

 

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).

Piccoli S, Mehta D, Vitaliti A, Allinson J, Amur S, Eck S, Green C, Hedrick M, Hopper S, Ji A, Joyce A, Litwin V, Maher K, Mathews J, Peng K, Safavi A, Wang YM, Zhang Y, Amaravadi L, Palackal N, Thankamony S, Beaver C, Bame E, Emrich T, Grimaldi C, Haulenbeek J, Joyce A, Kakkanaiah V, Lanham D, Maher K, Mayer A, Trampont PC, Vermet L, Dakappagari N, Fleener C, Garofolo F, Rogers C, Tangri S, Xu Y, Liang M, Rajadhyaksha M, Richards S, Schweighardt B, Purushothama S, Baltrukonis D, Brumm J, Cherry E, Delcarpini J, Gleason C, Kirshner S, Kubiak R, Pan L, Partridge M, Pedras-Vasconcelos J, Qu Q, Skibeli V, Saunders TS, Staack RF, Stubenrauch K, Torri A, Verthelyi D, Yan H, Gorovits B, Palmer R, Milton M, Long B, Corsaro B, Farrokhi V, Fiscella M, Henderson N, Jawa V, McNally J, Murphy R, Waldner H, Yang TY.

Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10.

PMID: 31820675

 

Exploratory biomarker assays: key assay parameters to evaluate in the face of evolving biomarker context-of-use.

Thankamony SP, Zhang Y.

Bioanalysis. 2019 Dec;11(23):2095-2097. doi: 10.4155/bio-2019-0223. Epub 2019 Nov 28. No abstract available.

PMID: 31777269

 

Development of a prognostic model for overall survival in multiple myeloma using the Connect_® MM Patient Registry.

Terebelo HR, Abonour R, Gasparetto CJ, Toomey K, Durie BGM, Hardin JW, Jagannath S, Wagner L, Narang M, Flick ED, Srinivasan S, Yue L, Kitali A, Agarwal A, Rifkin RM; CONNECT MM Registry Investigators.

Br J Haematol. 2019 Dec;187(5):602-614. doi: 10.1111/bjh.16139. Epub 2019 Aug 5.

PMID: 31382320

 

Safety, effectiveness, and health care cost comparisons among elderly patients with venous thromboembolism prescribed warfarin or apixaban in the United States Medicare population.

Hlavacek P, Guo JD, Rosenblatt L, Keshishian A, Russ C, Mardekian J, Ferri M, Poretta T, Yuce H, McBane R.

Curr Med Res Opin. 2019 Dec;35(12):2043-2051. doi: 10.1080/03007995.2019.1653067. Epub 2019 Sep 3.

PMID: 31387467

 

Chemical and physical instabilities in manufacturing and storage of therapeutic proteins.

Krause ME, Sahin E.

Curr Opin Biotechnol. 2019 Dec;60:159-167. doi: 10.1016/j.copbio.2019.01.014. Epub 2019 Mar 9. Review.

PMID: 30861476

 

Early Access to Medicines Scheme: real-world data collection.

Pang H, Wang M, Kiff C, Soni M, Stein D, Tyas D.

Drug Discov Today. 2019 Dec;24(12):2231-2233. doi: 10.1016/j.drudis.2019.06.009. Epub 2019 Jun 19.

PMID: 31228615

 

Apremilast Normalizes Gene Expression of Inflammatory Mediators in Human Keratinocytes and Reduces Antigen-Induced Atopic Dermatitis in Mice.

Schafer PH, Adams M, Horan G, Truzzi F, Marconi A, Pincelli C.

Drugs R D. 2019 Dec;19(4):329-338. doi: 10.1007/s40268-019-00284-1.

PMID: 31598889

 

Report of the European Society of Cardiology Cardiovascular Round Table regulatory workshop update of the evaluation of new agents for the treatment of acute coronary syndrome: Executive summary.

Bueno H, de Graeff P, Richard-Lordereau I, Emmerich J, Fox KA, Friedman CP, Gaudin C, El-Gazayerly A, Goldman S, Hemmrich M, Henderson RA, Himmelmann A, Irs A, Jackson N, James SK, Katus HA, Laslop A, Laws I, Mehran R, Ong S, Prasad K, Roffi M, Rosano GM, Rose M, Sinnaeve PR, Stough WG, Thygesen K, Van de Werf F, Varin C, Verheugt FW, de Los Angeles Alonso García M.

Eur Heart J Acute Cardiovasc Care. 2019 Dec;8(8):745-754. doi: 10.1177/2048872616649859. Epub 2016 Jun 29.

PMID: 27357206

 

Phase II study of CC-486 (oral azacitidine) in previously treated patients with locally advanced or metastatic nasopharyngeal carcinoma.

Mesia R, Bossi P, Hansen AR, Hsieh CY, Licitra LF, Tan EH, Chen P, Miller J, Siu LL, Haddad RI.

Eur J Cancer. 2019 Dec;123:138-145. doi: 10.1016/j.ejca.2019.10.002. Epub 2019 Nov 4.

PMID: 31698327

 

Considering B7-CD28 as a family through sequence and structure.

West SM, Deng XA.

Exp Biol Med (Maywood). 2019 Dec;244(17):1577-1583. doi: 10.1177/1535370219855970. Epub 2019 Jun 17. No abstract available.

PMID: 31208204

 

Lenalidomide maintenance post-transplantation in newly diagnosed multiple myeloma: real-world outcomes and costs.

Hari P, Ung B, Abouzaid S, Agarwal A, Parikh K.

Future Oncol. 2019 Dec;15(35):4045-4056. doi: 10.2217/fon-2019-0422. Epub 2019 Oct 18.

PMID: 31625415

 

Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease.

Vos MB, Dimick-Santos L, Mehta R, Omokaro SO, Taminiau J, Schabel E, Kleiner DE, Szitanyi P, Socha P, Schwimmer JB, Noviello S, Silberg DG, Torstenson R, Miller V, Lavine JE; Liver Forum Pediatric Working Group.

Gastroenterology. 2019 Dec;157(6):1448-1456.e1. doi: 10.1053/j.gastro.2019.08.048. Epub 2019 Sep 12. No abstract available.

PMID: 31520612

 

Improving health determinants outside of the clinic does not mean outside of clinical science.

Smith T, Mattingly TJ, Slabaugh L.

Healthc (Amst). 2019 Dec;7(4). pii: S2213-0764(19)30148-4. doi: 10.1016/j.hjdsi.2019.06.001. Epub 2019 Jun 27.

PMID: 31257162

 

Hydrogen-Deuterium Exchange and Hydroxyl Radical Footprinting for Mapping Hydrophobic Interactions of Human Bromodomain with a Small Molecule Inhibitor.

Li KS, Schaper Bergman ET, Beno BR, Huang RY, Deyanova E, Chen G, Gross ML.

J Am Soc Mass Spectrom. 2019 Dec;30(12):2795-2804. doi: 10.1007/s13361-019-02316-1. Epub 2019 Nov 12.

PMID: 31720974

Drug-Drug Interaction Study to Assess the Effect of Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of the Novel Cereblon Modulator Avadomide (CC-122) in Healthy Adult Subjects.

Ogasawara K, MacGorman K, Liu L, Chen J, Carayannopoulos LN, Zhou S, Palmisano M, Li Y.

J Clin Pharmacol. 2019 Dec;59(12):1620-1631. doi: 10.1002/jcph.1453. Epub 2019 Jun 6.

PMID: 31172535

 

Adjuvant therapy with nivolumab versus ipilimumab after complete resection of stage III/IV melanoma: Japanese subgroup analysis from the phase 3 CheckMate 238 study.

Yokota K, Uchi H, Uhara H, Yoshikawa S, Takenouchi T, Inozume T, Ozawa K, Ihn H, Fujisawa Y, Qureshi A, de Pril V, Otsuka Y, Weber J, Yamazaki N.

J Dermatol. 2019 Dec;46(12):1197-1201. doi: 10.1111/1346-8138.15103. Epub 2019 Oct 22.

PMID: 31638282

 

Apremilast mechanism of efficacy in systemic-naive patients with moderate plaque psoriasis: Pharmacodynamic results from the UNVEIL study.

Strober B, Alikhan A, Lockshin B, Shi R, Cirulli J, Schafer P.

J Dermatol Sci. 2019 Dec;96(3):126-133. doi: 10.1016/j.jdermsci.2019.09.003. Epub 2019 Sep 10.

PMID: 31787506

 

Qualitative analysis and reproducibility assessment of the Scalp Itch Numeric Rating Scale among patients with moderate to severe plaque psoriasis of the scalp.

Wang Y, Coyne K, Sofen H, Santanello N, Currie B, Zhang Z, Nograles K.

J Dermatolog Treat. 2019 Dec;30(8):775-783. doi: 10.1080/09546634.2019.1577546. Epub 2019 Mar 5.

PMID: 30747550

 

Corrigendum to "Nivolumab in advanced hepatocellular carcinoma: Sorafenib-experienced Asian cohort analysis" [J Hepatol 71 (2019) 543-552].

Yau T, Hsu C, Kim TY, Choo SP, Kang YK, Hou MM, Numata K, Yeo W, Chopra A, Ikeda M, Kuromatsu R, Moriguchi M, Chao Y, Zhao H, Anderson J, Dela Cruz C, Kudo M.

J Hepatol. 2019 Dec;71(6):1278. doi: 10.1016/j.jhep.2019.09.013. Epub 2019 Oct 25. No abstract available.

PMID: 31668671

 

Meeting Report of the 34th Annual Meeting of the Academy of Surgical Research: Summary of Presentations, Labs, and Workshops, Focusing on Experimental Surgery, Charleston, SC, September 26-28, 2018.

Graham ML, Stoll LJ, Ehrmann J.

J Invest Surg. 2019 Dec;32(8):773-784. doi: 10.1080/08941939.2019.1649767. Epub 2019 Aug 28.

PMID: 31455106

 

Total costs of treating venous thromboembolism: implication of different cost perspectives in a Danish setting.

Nielsen A, Poulsen PB, Dybro L, Kloster B, Lorentzen A, Olsen J, Kümler T.

J Med Econ. 2019 Dec;22(12):1321-1327. doi: 10.1080/13696998.2019.1668193. Epub 2019 Sep 27.

PMID: 31516054

 

Assessing an ASCO Decision Aid for Improving the Accuracy and Attribution of Serious Adverse Event Reporting From Investigators to Sponsors.

Mileham KF, Schenkel C, Chuk MK, Buchmeier A, Perez RP, Hurley P, Levit LA, Garrett-Mayer E, Davis C, Bruinooge SS, Vose J.

J Oncol Pract. 2019 Dec;15(12):e1050-e1065. doi: 10.1200/JOP.19.00366. Epub 2019 Oct 24.

PMID: 31647695

 

Emerging Immunotherapy Options for bacillus Calmette-Guérin Unresponsive Nonmuscle Invasive Bladder Cancer.

Meng MV, Gschwend JE, Shore N, Grossfeld GD, Mostafid H, Black PC.

J Urol. 2019 Dec;202(6):1111-1119. doi: 10.1097/JU.0000000000000297. Epub 2019 May 1. Review.

PMID: 31042108

 

Clinical Characteristics and Natural History of Autoimmune Forms of Interstitial Lung Disease: A Single-Center Experience.

Chartrand S, Lee JS, Swigris JJ, Stanchev L, Fischer A.

Lung. 2019 Dec;197(6):709-713. doi: 10.1007/s00408-019-00276-7. Epub 2019 Oct 3.

PMID: 31583453

 

Prevalence of Sexual Dysfunction in Women with Multiple Sclerosis: a Systematic Review and Meta-Analysis.

Azimi A, Hanaei S, Sahraian MA, Mohammadifar M, Ramagopalan SV, Ghajarzadeh M.

Maedica (Buchar). 2019 Dec;14(4):408-412. doi: 10.26574/maedica.2019.14.4.408.

PMID: 32153674

 

Immunotargeted therapy in melanoma: patient, provider preferences, and willingness to pay at an academic cancer center.

Stenehjem DD, Au TH, Ngorsuraches S, Ma J, Bauer H, Wanishayakorn T, Nelson RS, Pfeiffer CM, Schwartz J, Korytowsky B, Oderda G, Brixner DI.

Melanoma Res. 2019 Dec;29(6):626-634. doi: 10.1097/CMR.0000000000000572.

PMID: 30688762

 

Anti-B-cell Maturation Antigen Chimeric Antigen Receptor T cell Function against Multiple Myeloma Is Enhanced in the Presence of Lenalidomide.

Works M, Soni N, Hauskins C, Sierra C, Baturevych A, Jones JC, Curtis W, Carlson P, Johnstone TG, Kugler D, Hause RJ, Jiang Y, Wimberly L, Clouser CR, Jessup HK, Sather B, Salmon RA, Ports MO.

Mol Cancer Ther. 2019 Dec;18(12):2246-2257. doi: 10.1158/1535-7163.MCT-18-1146. Epub 2019 Aug 8.

PMID: 31395689

 

Expedited mapping of the ligandable proteome using fully functionalized enantiomeric probe pairs.

Wang Y, Dix MM, Bianco G, Remsberg JR, Lee HY, Kalocsay M, Gygi SP, Forli S, Vite G, Lawrence RM, Parker CG, Cravatt BF.

Nat Chem. 2019 Dec;11(12):1113-1123. doi: 10.1038/s41557-019-0351-5. Epub 2019 Oct 28.

PMID: 31659311

 

Parameter estimation for roller compaction process using an instrumented vector TF mini roller compactor.

Reddy JP, Phanse R, Nesarikar V.

Pharm Dev Technol. 2019 Dec;24(10):1250-1257. doi: 10.1080/10837450.2019.1658775. Epub 2019 Sep 9.

PMID: 31437082

 

Efficacy of Abatacept and Adalimumab in Patients with Early Rheumatoid Arthritis With Multiple Poor Prognostic Factors: Post Hoc Analysis of a Randomized Controlled Clinical Trial (AMPLE).

Fleischmann R, Weinblatt M, Ahmad H, Maldonado MA, Alemao E, Ye J, Schiff M.

Rheumatol Ther. 2019 Dec;6(4):559-571. doi: 10.1007/s40744-019-00174-7. Epub 2019 Oct 22.

PMID: 31642045

 

Comparative safety of abatacept in rheumatoid arthritis with COPD: A real-world population-based observational study.

Suissa S, Hudson M, Dell'Aniello S, Shen S, Simon TA, Ernst P.

Semin Arthritis Rheum. 2019 Dec;49(3):366-372. doi: 10.1016/j.semarthrit.2019.03.007. Epub 2019 Mar 16.

PMID: 30979397

 

Identification of novel glutathione conjugates of terbinafine in liver microsomes and hepatocytes across species.

Patil A, Ladumor MK, Kamble SH, Johnson BM, Subramanian M, Sinz MW, Singh DK, Putlur S, Bhutani P, Ahire DS, Singh S.

Xenobiotica. 2019 Dec;49(12):1403-1413. doi: 10.1080/00498254.2019.1581959. Epub 2019 Mar 7.

PMID: 30747549

Protein aggregation and mitigation strategy in low pH viral inactivation for monoclonal antibody purification.

Jin W, Xing Z, Song Y, Huang C, Xu X, Ghose S, Li ZJ.

MAbs. 2019 Nov-Dec;11(8):1479-1491. doi: 10.1080/19420862.2019.1658493. Epub 2019 Sep 2.

PMID: 31441367

 

Process intensification in fed-batch production bioreactors using non-perfusion seed cultures.

Yongky A, Xu J, Tian J, Oliveira C, Zhao J, McFarland K, Borys MC, Li ZJ.

MAbs. 2019 Nov-Dec;11(8):1502-1514. doi: 10.1080/19420862.2019.1652075. Epub 2019 Aug 19.

PMID: 31379298

Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System.

Oni Y, Song X, Schrader M, Kulshrestha A, Franck J, Asselta R, Flores-Crespo C, Mantri RV.

PDA J Pharm Sci Technol. 2019 Nov-Dec;73(6):572-587. doi: 10.5731/pdajpst.2018.009670. Epub 2019 May 17.

PMID: 31101708

 

Determinants of treatment in patients with stage IV renal cell carcinoma.

Hollenbeak CS, Schaefer EW, Doan J, Raman JD.

BMC Urol. 2019 Nov 29;19(1):123. doi: 10.1186/s12894-019-0559-0.

PMID: 31783828

 

An observational study of INR control according to NICE criteria in patients with non-valvular atrial fibrillation-The SAIL Warfarin Out of Range Descriptors Study (SWORDS).

Harris DE, Thayer D, Wang T, Brooks C, Murley G, Gravenor M, Hill NR, Lister S, Halcox J.

Eur Heart J Cardiovasc Pharmacother. 2019 Nov 27. pii: pvz071. doi: 10.1093/ehjcvp/pvz071. [Epub ahead of print]

PMID: 31774502

 

Biphenyl Acid Derivatives as APJ Receptor Agonists.

Su S, Clarke A, Han Y, Chao HJ, Bostwick J, Schumacher W, Wang T, Yan M, Hsu MY, Simmons E, Luk C, Xu C, Dabros M, Galella M, Onorato J, Gordon D, Wexler R, Gargalovic PS, Lawrence RM.

J Med Chem. 2019 Nov 27;62(22):10456-10465. doi: 10.1021/acs.jmedchem.9b01513. Epub 2019 Nov 14.

PMID: 31724863

 

Lipid order and charge protect killer T cells from accidental death.

Rudd-Schmidt JA, Hodel AW, Noori T, Lopez JA, Cho HJ, Verschoor S, Ciccone A, Trapani JA, Hoogenboom BW, Voskoboinik I.

Nat Commun. 2019 Nov 27;10(1):5396. doi: 10.1038/s41467-019-13385-x.

PMID: 31776337

 

Safety and Efficacy Results of a Phase I, Open-Label Study of Concurrent and Delayed Nivolumab in Combination With nab-Paclitaxel and Carboplatin in Advanced Non-small Cell Lung Cancer.

Goldman JW, Waterhouse DM, George B, O'Dwyer PJ, Bhore R, Banerjee S, Lyons L, Louis CU, Ong TJ, Kelly K.

Front Oncol. 2019 Nov 26;9:1256. doi: 10.3389/fonc.2019.01256. eCollection 2019.

PMID: 31850192

 

Response to: Olry de Labry Lima A et al., Cost-effectiveness of lenalidomide maintenance in patients with multiple myeloma who have undergone autologous transplant hematopoietic progenitor cells.

Dhanasiri S.

Bone Marrow Transplant. 2019 Nov 21. doi: 10.1038/s41409-019-0749-0. [Epub ahead of print] No abstract available.

PMID: 31754250

 

Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer.

Hellmann MD, Paz-Ares L, Bernabe Caro R, Zurawski B, Kim SW, Carcereny Costa E, Park K, Alexandru A, Lupinacci L, de la Mora Jimenez E, Sakai H, Albert I, Vergnenegre A, Peters S, Syrigos K, Barlesi F, Reck M, Borghaei H, Brahmer JR, O'Byrne KJ, Geese WJ, Bhagavatheeswaran P, Rabindran SK, Kasinathan RS, Nathan FE, Ramalingam SS.

N Engl J Med. 2019 Nov 21;381(21):2020-2031. doi: 10.1056/NEJMoa1910231. Epub 2019 Sep 28.

PMID: 31562796

 

Nivolumab Combined With Brentuximab Vedotin for Relapsed/Refractory Primary Mediastinal Large B-Cell Lymphoma: Efficacy and Safety From the Phase II CheckMate 436 Study.

Zinzani PL, Santoro A, Gritti G, Brice P, Barr PM, Kuruvilla J, Cunningham D, Kline J, Johnson NA, Mehta-Shah N, Manley T, Francis S, Sharma M, Moskowitz AJ.

J Clin Oncol. 2019 Nov 20;37(33):3081-3089. doi: 10.1200/JCO.19.01492. Epub 2019 Aug 9.

PMID: 31398081

 

Palladium(0)-Catalyzed Directed syn-1,2-Carboboration and -Silylation: Alkene Scope, Applications in Dearomatization, and Stereocontrol by a Chiral Auxiliary.

Liu Z, Chen J, Lu HX, Li X, Gao Y, Coombs JR, Goldfogel MJ, Engle KM.

Angew Chem Int Ed Engl. 2019 Nov 18;58(47):17068-17073. doi: 10.1002/anie.201910304. Epub 2019 Oct 8. Review.

PMID: 31538388

 

Presence of anti-cyclic citrullinated peptide antibodies is associated with better treatment response to abatacept but not to TNF inhibitors in patients with rheumatoid arthritis: a meta-analysis.

Alemao E, Postema R, Elbez Y, Mamane C, Finckh A.

Clin Exp Rheumatol. 2019 Nov 16. [Epub ahead of print]

PMID: 31770089

 

An Integrative Approach to Inform Optimal Administration of OX40 Agonist Antibodies in Patients with Advanced Solid Tumors.

Wang R, Gao C, Raymond M, Dito G, Kabbabe D, Shao X, Hilt E, Sun Y, Pak I, Gutierrez M, Melero I, Spreafico A, Carvajal RD, Ong M, Olszanski AJ, Milburn C, Thudium K, Yang Z, Feng Y, Fracasso PM, Korman AJ, Aanur P, Huang SA, Quigley M.

Clin Cancer Res. 2019 Nov 15;25(22):6709-6720. doi: 10.1158/1078-0432.CCR-19-0526. Epub 2019 Oct 1.

PMID: 31573956

 

One-Step Diastereoselective Pyrrolidine Synthesis Using a Sulfinamide Annulating Reagent.

Shi Q, Greenwood NS, Meehan MC, Park H, Galella M, Sandhu B, Khandelwal P, Coombs JR, Gallagher WP, Guerrero CA, Hynes J Jr, Dhar TGM, Gonzalez Bobes F, Marcoux D.

Org Lett. 2019 Nov 15;21(22):9198-9202. doi: 10.1021/acs.orglett.9b03560. Epub 2019 Oct 24.

PMID: 31647672

 

Age at menarche and risk of multiple sclerosis (MS): a systematic review and meta-analysis.

Azimi A, Hanaei S, Sahraian MA, Mohammadifar M, Ramagopalan SV, Ghajarzadeh M.

BMC Neurol. 2019 Nov 14;19(1):286. doi: 10.1186/s12883-019-1473-5.

PMID: 31727014

 

Rationally Designed, Conformationally Constrained Inverse Agonists of RORγt-Identification of a Potent, Selective Series with Biologic-Like in Vivo Efficacy.

Marcoux D, Duan JJ, Shi Q, Cherney RJ, Srivastava AS, Cornelius L, Batt DG, Liu Q, Beaudoin-Bertrand M, Weigelt CA, Khandelwal P, Vishwakrishnan S, Selvakumar K, Karmakar A, Gupta AK, Basha M, Ramlingam S, Manjunath N, Vanteru S, Karmakar S, Maddala N, Vetrichelvan M, Gupta A, Rampulla RA, Mathur A, Yip S, Li P, Wu DR, Khan J, Ruzanov M, Sack JS, Wang J, Yarde M, Cvijic ME, Li S, Shuster DJ, Borowski V, Xie JH, McIntyre KW, Obermeier MT, Fura A, Stefanski K, Cornelius G, Hynes J Jr, Tino JA, Macor JE, Salter-Cid L, Denton R, Zhao Q, Carter PH, Dhar TGM.

J Med Chem. 2019 Nov 14;62(21):9931-9946. doi: 10.1021/acs.jmedchem.9b01369. Epub 2019 Oct 31.

PMID: 31638797

 

Clinical outcomes and treatment patterns among Medicare patients with nonvalvular atrial fibrillation (NVAF) and chronic kidney disease.

Wilson LE, Luo X, Li X, Mardekian J, Garcia Reeves AB, Skinner A.

PLoS One. 2019 Nov 14;14(11):e0225052. doi: 10.1371/journal.pone.0225052. eCollection 2019.

PMID: 31725743

 

Preservation of Post-Infarction Cardiac Structure and Function via Long-Term Oral Formyl Peptide Receptor Agonist Treatment.

García RA, Ito BR, Lupisella JA, Carson NA, Hsu MY, Fernando G, Heroux M, Bouvier M, Dierks E, Kick EK, Gordon DA, Chen J, Mintier G, Carrier M, St-Onge S, Shah H, Towne J, Bucardo MS, Ma X, Ryan CS, Wurtz NR, Ostrowski J, Villarreal FJ.

JACC Basic Transl Sci. 2019 Nov 13;4(8):905-920. doi: 10.1016/j.jacbts.2019.07.005. eCollection 2019 Dec.

PMID: 31909300

 

Tumor mutational burden in lung cancer: a systematic literature review.

Willis C, Fiander M, Tran D, Korytowsky B, Thomas JM, Calderon F, Zyczynski TM, Brixner D, Stenehjem DD.

Oncotarget. 2019 Nov 12;10(61):6604-6622. doi: 10.18632/oncotarget.27287. eCollection 2019 Nov 12. Review.

PMID: 31762941

 

Comparative risk of malignancies and infections in patients with rheumatoid arthritis initiating abatacept versus other biologics: a multi-database real-world study.

Simon TA, Boers M, Hochberg M, Baker N, Skovron ML, Ray N, Singhal S, Suissa S, Gomez-Caminero A.

Arthritis Res Ther. 2019 Nov 8;21(1):228. doi: 10.1186/s13075-019-1992-x.

PMID: 31703717

 

Author Correction: Targeting CLDN18.2 by CD3 Bispecific and ADC Modalities for the Treatments of Gastric and Pancreatic Cancer.

Zhu G, Foletti D, Liu X, Ding S, Melton Witt J, Hasa-Moreno A, Rickert M, Holz C, Aschenbrenner L, Yang AH, Kraynov E, Evering W, Obert L, Lee C, Sai T, Mistry T, Lindquist KC, Van Blarcom T, Strop P, Chaparro-Riggers J, Liu SH.

Sci Rep. 2019 Nov 8;9(1):16735. doi: 10.1038/s41598-019-53130-4.

PMID: 31700121

 

Safety, Tolerability, and Potential Clinical Activity of a Glucocorticoid-Induced TNF Receptor-Related Protein Agonist Alone or in Combination With Nivolumab for Patients With Advanced Solid Tumors: A Phase 1/2a Dose-Escalation and Cohort-Expansion Clinical Trial.

Heinhuis KM, Carlino M, Joerger M, Di Nicola M, Meniawy T, Rottey S, Moreno V, Gazzah A, Delord JP, Paz-Ares L, Britschgi C, Schilder RJ, O'Byrne K, Curigliano G, Romano E, Patah P, Wang R, Liu Y, Bajaj G, Siu LL.

JAMA Oncol. 2019 Nov 7:1-8. doi: 10.1001/jamaoncol.2019.3848. [Epub ahead of print]

PMID: 31697308

Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial.

Naumann RW, Hollebecque A, Meyer T, Devlin MJ, Oaknin A, Kerger J, López-Picazo JM, Machiels JP, Delord JP, Evans TRJ, Boni V, Calvo E, Topalian SL, Chen T, Soumaoro I, Li B, Gu J, Zwirtes R, Moore KN.

J Clin Oncol. 2019 Nov 1;37(31):2825-2834. doi: 10.1200/JCO.19.00739. Epub 2019 Sep 5.

PMID: 31487218

 

Pharmacological Characterization of GPCR Agonists, Antagonists, Allosteric Modulators and Biased Ligands from HTS Hits to Lead Optimization.

Sum CS, Murphy BJ, Li Z, Wang T, Zhang L, Cvijic ME.

In: Sittampalam GS, Grossman A, Brimacombe K, Arkin M, Auld D, Austin CP, Baell J, Bejcek B, Caaveiro JMM, Chung TDY, Coussens NP, Dahlin JL, Devanaryan V, Foley TL, Glicksman M, Hall MD, Haas JV, Hoare SRJ, Inglese J, Iversen PW, Kahl SD, Kales SC, Kirshner S, Lal-Nag M, Li Z, McGee J, McManus O, Riss T, Saradjian P, Trask OJ Jr., Weidner JR, Wildey MJ, Xia M, Xu X, editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004-2019 Nov 1.

PMID: 31693331

Predicting atrial fibrillation in primary care using machine learning.

Hill NR, Ayoubkhani D, McEwan P, Sugrue DM, Farooqui U, Lister S, Lumley M, Bakhai A, Cohen AT, O'Neill M, Clifton D, Gordon J.

PLoS One. 2019 Nov 1;14(11):e0224582. doi: 10.1371/journal.pone.0224582. eCollection 2019.

PMID: 31675367

 

Realized and Projected Cost-Savings from the Introduction of Generic Imatinib Through Formulary Management in Patients with Chronic Myelogenous Leukemia.

Campbell D, Blazer M, Bloudek L, Brokars J, Makenbaeva D.

Am Health Drug Benefits. 2019 Nov;12(7):333-342.

PMID: 32055281

 

A multi-national trial of a direct oral anticoagulant in children with cardiac disease: Design and rationale of the Safety of ApiXaban On Pediatric Heart disease On the preventioN of Embolism (SAXOPHONE) study.

Payne RM, Burns KM, Glatz AC, Li D, Li X, Monagle P, Newburger JW, Swan EA, Wheaton O, Male C; Pediatric Heart Network Investigators.

Am Heart J. 2019 Nov;217:52-63. doi: 10.1016/j.ahj.2019.08.002. Epub 2019 Aug 9.

PMID: 31493728

 

2019 White Paper on Recent Issues in Bioanalysis: Chromatographic Assays (Part 1 - Innovation in Small Molecules and Oligonucleotides & Mass Spectrometric Method Development Strategies for Large Molecule Bioanalysis).

Fandozzi C, Evans C, Wilson A, Su D, Anderson M, Clausen V, Dillen L, Garofolo F, Holliman C, Nickbarg E, Olah T, Ramanathan R, Zhang H, Kaur S, Pillutla R, Yu H, Bateman K, Donato LD, Hengel S, Jian W, Jones B, Kellie J, Lee A, Palandra J, Savoie N, Shipkova P, Spitz S, Su D, Szapacs M, Wang J, Wright K, Zeng J.

Bioanalysis. 2019 Nov;11(22):2029-2048. doi: 10.4155/bio-2019-0260. Epub 2019 Dec 6.

PMID: 31808716

 

Nivolumab Clearance Is Stationary in Patients With Resected Melanoma on Adjuvant Therapy: Implications of Disease Status on Time-Varying Clearance.

Hamuro L, Statkevich P, Bello A, Roy A, Bajaj G.

Clin Pharmacol Ther. 2019 Nov;106(5):1018-1027. doi: 10.1002/cpt.1502. Epub 2019 Jul 10.

PMID: 31090921

 

Abatacept retention and clinical outcomes in rheumatoid arthritis: real-world data from the German cohort of the ACTION study and a comparison with other participating countries.

Alten R, Feist E, Lorenz HM, Nüßlein H, Voll RE, Chartier M, Elbez Y, Rauch C.

Clin Rheumatol. 2019 Nov;38(11):3049-3059. doi: 10.1007/s10067-019-04648-5. Epub 2019 Jul 12.

PMID: 31300979

 

A Quantitative Systems Pharmacology Consortium Approach to Managing Immunogenicity of Therapeutic Proteins.

Kierzek AM, Hickling TP, Figueroa I, Kalvass JC, Nijsen M, Mohan K, Veldman GM, Yamada A, Sayama H, Yokoo S, Gulati A, Dhanikula RS, Gokemeijer J, Leil TA, Thalhauser CJ, Giorgi M, Swat MJ, Chelliah V, Small BG, Benson N, Walker M, Gadkar K, Quarmby V, Deng R, Ferrante A, Dickinson GL, Van Der Walt JS, Zhou L, Chen X, Jones HM, Narula J, Tourdot S, Lavé T, Ribba B, van der Graaf PH.

CPT Pharmacometrics Syst Pharmacol. 2019 Nov;8(11):773-776. doi: 10.1002/psp4.12465. Epub 2019 Oct 8. No abstract available.

PMID: 31529677

 

Linking Tumor Growth Dynamics to Survival in Ipilimumab-Treated Patients With Advanced Melanoma Using Mixture Tumor Growth Dynamic Modeling.

Feng Y, Wang X, Suryawanshi S, Bello A, Roy A.

CPT Pharmacometrics Syst Pharmacol. 2019 Nov;8(11):825-834. doi: 10.1002/psp4.12454. Epub 2019 Aug 13.

PMID: 31334596

 

Influence of Diabetes Complications on HbA_1c Treatment Goals Among Older U.S. Adults: A Cost-effectiveness Analysis.

Shao H, Lin J, Zhuo X, Rolka DB, Gregg EW, Zhang P.

Diabetes Care. 2019 Nov;42(11):2136-2142. doi: 10.2337/dc19-0381. Epub 2019 Sep 17.

PMID: 31530661

 

Enhanced and Persistent Inhibition of Organic Cation Transporter 1 Activity by Preincubation of Cyclosporine A.

Panfen E, Chen W, Zhang Y, Sinz M, Marathe P, Gan J, Shen H.

Drug Metab Dispos. 2019 Nov;47(11):1352-1360. doi: 10.1124/dmd.119.087197. Epub 2019 Aug 19.

PMID: 31427432

 

Characterization of therapeutic antibody fragmentation using automated capillary western blotting as an orthogonal analytical technique.

Zhu Y, Ahluwalia D, Chen Y, Belakavadi M, Katiyar A, Das TK.

Electrophoresis. 2019 Nov;40(21):2888-2898. doi: 10.1002/elps.201900119. Epub 2019 Jul 16.

PMID: 31271455

Safety and efficacy of nivolumab in challenging subgroups with advanced melanoma who progressed on or after ipilimumab treatment: A single-arm, open-label, phase II study (CheckMate 172).

Schadendorf D, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Muñoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Nathan P.

Eur J Cancer. 2019 Nov;121:144-153. doi: 10.1016/j.ejca.2019.08.014. Epub 2019 Sep 30.

PMID: 31581055

 

Fibroblast Growth Factor Receptor 3 Alterations and Response to PD-1/PD-L1 Blockade in Patients with Metastatic Urothelial Cancer.

Wang L, Gong Y, Saci A, Szabo PM, Martini A, Necchi A, Siefker-Radtke A, Pal S, Plimack ER, Sfakianos JP, Bhardwaj N, Horowitz A, Farkas AM, Mulholland D, Fischer BS, Oh WK, Sharma P, Zhu J, Galsky MD.

Eur Urol. 2019 Nov;76(5):599-603. doi: 10.1016/j.eururo.2019.06.025. Epub 2019 Jul 1.

PMID: 31272788

 

Suspected cancer symptoms and blood test results in primary care before a diagnosis of lung cancer: a case-control study.

McDonald L, Carroll R, Harish A, Tanna N, Mehmud F, Alikhan R, Ramagopalan SV.

Future Oncol. 2019 Nov;15(33):3755-3762. doi: 10.2217/fon-2019-0442. Epub 2019 Oct 31.

PMID: 31668096

 

Comparison of accelerometer-derived physical activity levels between individuals with and without cancer: a UK Biobank study.

McDonald L, Oguz M, Carroll R, Thakkar P, Yang F, Dhalwani N, Cox A, Merinopoulou E, Malcolm B, Mehmud F, Ramagopalan S.

Future Oncol. 2019 Nov;15(33):3763-3774. doi: 10.2217/fon-2019-0443. Epub 2019 Oct 22.

PMID: 31637942

 

Automated extraction of treatment patterns from social media posts: an exploratory analysis in renal cell carcinoma.

Ramagopalan SV, Malcolm B, Merinopoulou E, McDonald L, Cox A.

Future Oncol. 2019 Nov;15(31):3587-3596. doi: 10.2217/fon-2019-0406. Epub 2019 Sep 4.

PMID: 31483164

Japanese real-world study of sequential nivolumab and ipilimumab treament in melanoma.

Tsutsumida A, Fukushima S, Yokota K, Yoshikawa S, Yamasaki O, Tanemura A, Okuyama R, Uhara H, Muto Y, Miyashita A, Akiyama M, Kaji T, Koga H, Kato J, Katayama T, Itakura E, Yamazaki N, Kiyohara Y.

J Dermatol. 2019 Nov;46(11):947-955. doi: 10.1111/1346-8138.15073. Epub 2019 Sep 17.

PMID: 31531895

 

Economic modeling to evaluate the impact of chronic myeloid leukemia therapy management on the oncology care model in the US.

Jabbour EJ, Mendiola MF, Lingohr-Smith M, Lin J, Makenbaeva D.

J Med Econ. 2019 Nov;22(11):1113-1118. doi: 10.1080/13696998.2019.1618316. Epub 2019 May 31.

PMID: 31074658

  

Increasing value of autopsies in patients with brain tumors in the molecular era.

Ahrendsen JT, Filbin MG, Chi SN, Manley PE, Wright KD, Bandopadhayay P, Clymer JR, Yeo KK, Kieran MW, Jones R, Lidov HG, Ligon KL, Alexandrescu S.

J Neurooncol. 2019 Nov;145(2):349-355. doi: 10.1007/s11060-019-03302-z. Epub 2019 Sep 30.

PMID: 31571114

 

A Proposal for an Alternative Approach to Particle Size Method Development During Early-Stage Small Molecule Pharmaceutical Development.

Gamble JF, Dawson N, Murphy D, Theophilus A, Kippax P.

J Pharm Sci. 2019 Nov;108(11):3515-3520. doi: 10.1016/j.xphs.2019.08.007. Epub 2019 Aug 21.

PMID: 31445006

 

Two-year abatacept retention rate in clinical practice in the French ACTION cohort.

Mariette X, Schaeverbeke T, Gaudin P, Chartier M, Heitzmann J, Vannier-Moreau V, Hilliquin P, Cantagrel A.

Joint Bone Spine. 2019 Nov;86(6):753-759. doi: 10.1016/j.jbspin.2019.07.006. Epub 2019 Jul 25.

PMID: 31352138

 

Human or mouse? Practice makes perfect.

Stanislawczyk L.

Lab Anim (NY). 2019 Nov;48(11):319. doi: 10.1038/s41684-019-0419-2. No abstract available.

PMID: 31645691

 

Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial.

Kato K, Cho BC, Takahashi M, Okada M, Lin CY, Chin K, Kadowaki S, Ahn MJ, Hamamoto Y, Doki Y, Yen CC, Kubota Y, Kim SB, Hsu CH, Holtved E, Xynos I, Kodani M, Kitagawa Y.

Lancet Oncol. 2019 Nov;20(11):1506-1517. doi: 10.1016/S1470-2045(19)30626-6. Epub 2019 Sep 30. Erratum in: Lancet Oncol. 2019 Nov;20(11):e613.

PMID: 31582355

 

A Review of Survival Analysis Methods Used in NICE Technology Appraisals of Cancer Treatments: Consistency, Limitations, and Areas for Improvement.

Bell Gorrod H, Kearns B, Stevens J, Thokala P, Labeit A, Latimer N, Tyas D, Sowdani A.

Med Decis Making. 2019 Nov;39(8):899-909. doi: 10.1177/0272989X19881967. Epub 2019 Nov 9.

PMID: 31707911

 

Preclinical Efficacy and Safety Comparison of CD3 Bispecific and ADC Modalities Targeting BCMA for the Treatment of Multiple Myeloma.

Panowski SH, Kuo TC, Zhang Y, Chen A, Geng T, Aschenbrenner L, Kamperschroer C, Pascua E, Chen W, Delaria K, Farias S, Bateman M, Dushin RG, Chin SM, Van Blarcom TJ, Yeung YA, Lindquist KC, Chunyk AG, Kuang B, Han B, Mirsky M, Pardo I, Buetow B, Martin TG, Wolf JL, Shelton D, Rajpal A, Strop P, Chaparro-Riggers J, Sasu BJ.

Mol Cancer Ther. 2019 Nov;18(11):2008-2020. doi: 10.1158/1535-7163.MCT-19-0007. Epub 2019 Aug 21.

PMID: 31434693

 

Safety of Nivolumab plus Low-Dose Ipilimumab in Previously Treated Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer.

Morse MA, Overman MJ, Hartman L, Khoukaz T, Brutcher E, Lenz HJ, Atasoy A, Shangguan T, Zhao H, El-Rayes B.

Oncologist. 2019 Nov;24(11):1453-1461. doi: 10.1634/theoncologist.2019-0129. Epub 2019 May 30.

PMID: 31147488

 

Elucidating spray-dried dispersion dissolution mechanisms with focused beam reflectance measurement: contribution of polymer chemistry and particle properties to performance.

Rawlinson-Malone CF, Ferreira AP, Nicholls D, Nicholson S.

Pharm Dev Technol. 2019 Nov;24(9):1055-1062. doi: 10.1080/10837450.2018.1559189. Epub 2019 Jun 26.

PMID: 30640552

 

A comparison of self-rated health using EQ-5D VAS in the United States in 2002 and 2017.

Cha AS, Law EH, Shaw JW, Pickard AS.

Qual Life Res. 2019 Nov;28(11):3065-3069. doi: 10.1007/s11136-019-02249-y. Epub 2019 Jul 18.

PMID: 31321671

 

Daclatasvir and sofosbuvir with ribavirin for 24 weeks in chronic hepatitis C genotype-3-infected patients with cirrhosis: a Phase III study (ALLY-3C).

Poordad F, Shiffman ML, Ghesquiere W, Wong A, Huhn GD, Wong F, Ramji A, Shafran SD, McPhee F, Yang R, Noviello S, Linaberry M; ALLY-3C study team.

Antivir Ther. 2019 Nov;24(1):35-44. doi: 10.3851/IMP3278.

PMID: 30382942

 

Cost-Effectiveness Analysis of Apixaban Versus Edoxaban in Patients with Atrial Fibrillation for Stroke Prevention.

Oyagüez I, Suárez C, López-Sendón JL, González-Juanatey JR, de Andrés-Nogales F, Suárez J, Polanco C, Soto J.

Pharmacoecon Open. 2019 Oct 31. doi: 10.1007/s41669-019-00186-7. [Epub ahead of print]

PMID: 31673882

 

Phase-Appropriate Application of Analytical Methods to Monitor Subvisible Particles Across the Biotherapeutic Drug Product Life Cycle.

Mathaes R, Narhi L, Hawe A, Matter A, Bechtold-Peters K, Kenrick S, Kar S, Laskina O, Carpenter J, Cavicchi R, Koepf E, Lewis EN, De Silva R, Ripple D.

AAPS J. 2019 Oct 30;22(1):1. doi: 10.1208/s12248-019-0384-0.

PMID: 31677011

 

Randomized phase-II evaluation of letrozole plus dasatinib in hormone receptor positive metastatic breast cancer patients.

Paul D, Vukelja SJ, Ann Holmes F, Blum JL, McIntyre KJ, Lindquist DL, Osborne CR, Sanchez IJ, Goldschmidt JH, Wang Y, Asmar L, Strauss L, O'Shaughnessy J.

NPJ Breast Cancer. 2019 Oct 28;5:36. doi: 10.1038/s41523-019-0132-8. eCollection 2019.

PMID: 31667338

 

Anti-Markovnikov Hydroamination of Unactivated Alkenes with Primary Alkyl Amines.

Miller DC, Ganley JM, Musacchio AJ, Sherwood TC, Ewing WR, Knowles RR.

J Am Chem Soc. 2019 Oct 23;141(42):16590-16594. doi: 10.1021/jacs.9b08746. Epub 2019 Oct 14.

PMID: 31603324

 

Utilization of In Vitro, In Vivo and In Silico Tools to Evaluate the pH-Dependent Absorption of a BCS Class II Compound and Identify a pH-Effect Mitigating Strategy.

Gesenberg C, Mathias NR, Xu Y, Crison J, Savant I, Saari A, Good DJ, Hemenway JN, Narang AS, Schartman RR, Zheng N, Buzescu A, Patel J.

Pharm Res. 2019 Oct 21;36(12):164. doi: 10.1007/s11095-019-2698-0.

PMID: 31637544

 

The hepatoprotective activities of Kalimeris indica ethanol extract against liver injury in vivo.

Wang GK, Zhang N, Wang Y, Liu JS, Wang G, Zhou ZY, Lu CC, Yang JS.

Food Sci Nutr. 2019 Oct 18;7(11):3797-3807. doi: 10.1002/fsn3.1241. eCollection 2019 Nov.

PMID: 31763029

 

Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.

Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hogg D, Hill A, Márquez-Rodas I, Haanen J, Guidoboni M, Maio M, Schöffski P, Carlino MS, Lebbé C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bastholt L, Rizzo JI, Balogh A, Moshyk A, Hodi FS, Wolchok JD.

N Engl J Med. 2019 Oct 17;381(16):1535-1546. doi: 10.1056/NEJMoa1910836. Epub 2019 Sep 28.

PMID: 31562797

 

Resistance profile of the HIV-1 maturation inhibitor GSK3532795 in vitro and in a clinical study.

Dicker I, Zhang S, Ray N, Beno BR, Regueiro-Ren A, Joshi S, Cockett M, Krystal M, Lataillade M.

PLoS One. 2019 Oct 17;14(10):e0224076. doi: 10.1371/journal.pone.0224076. eCollection 2019. Erratum in: PLoS One. 2019 Nov 5;14(11):e0224976.

PMID: 31622432

 

Benzothiazole-based compounds as potent endothelial lipase inhibitors.

Meng W, Adam LP, Behnia K, Zhao L, Yang R, Kopcho LM, Locke GA, Taylor DS, Yin X, Wexler RR, Finlay H.

Bioorg Med Chem Lett. 2019 Oct 15;29(20):126673. doi: 10.1016/j.bmcl.2019.126673. Epub 2019 Sep 6.

PMID: 31519373

 

Germline-Encoded Affinity for Cognate Antigen Enables Vaccine Amplification of a Human Broadly Neutralizing Response against Influenza Virus.

Sangesland M, Ronsard L, Kazer SW, Bals J, Boyoglu-Barnum S, Yousif AS, Barnes R, Feldman J, Quirindongo-Crespo M, McTamney PM, Rohrer D, Lonberg N, Chackerian B, Graham BS, Kanekiyo M, Shalek AK, Lingwood D.

Immunity. 2019 Oct 15;51(4):735-749.e8. doi: 10.1016/j.immuni.2019.09.001. Epub 2019 Sep 25.

PMID: 31563464

 

Workshop Report: FDA Workshop on Improving Cardiotoxicity Assessment With Human-Relevant Platforms.

Pang L, Sager P, Yang X, Shi H, Sannajust F, Brock M, Wu JC, Abi-Gerges N, Lyn-Cook B, Berridge BR, Stockbridge N.

Circ Res. 2019 Oct 11;125(9):855-867. doi: 10.1161/CIRCRESAHA.119.315378. Epub 2019 Oct 10.

PMID: 31600125

 

Modelling Survival of Patients Treated with Adjuvant Nivolumab Who Have Melanoma with Lymph Node Involvement or Metastatic Disease After Complete Resection.

Batteson R, Hart R, Hemstock M, Gooden K, Kotapati S, Roze S, Lee D, Amadi A.

Pharmacoecon Open. 2019 Oct 5. doi: 10.1007/s41669-019-00181-y. [Epub ahead of print]

PMID: 31587138

 

Risk of Recurrent Bleeding Events in Nonvalvular Atrial Fibrillation Treated with Vitamin K Antagonists: A Clinical Practice Research Datalink Study.

Alikhan R, Lefevre C, Menown I, Lister S, Bird A, You M, Evans D, Sammon C.

TH Open. 2019 Oct 4;3(4):e316-e324. doi: 10.1055/s-0039-1698413. eCollection 2019 Oct.

PMID: 31592518

 

Hemilabile Benzyl Ether Enables γ-C(sp₃)-H Carbonylation and Olefination of Alcohols.

Tanaka K, Ewing WR, Yu JQ.

J Am Chem Soc. 2019 Oct 2;141(39):15494-15497. doi: 10.1021/jacs.9b08238. Epub 2019 Sep 18.

PMID: 31519108

Structure based design of macrocyclic factor XIa inhibitors: Discovery of cyclic P1 linker moieties with improved oral bioavailability.

Clark CG, Rossi KA, Corte JR, Fang T, Smallheer JM, De Lucca I, Nirschl DS, Orwat MJ, Pinto DJP, Hu Z, Wang Y, Yang W, Jeon Y, Ewing WR, Myers JE Jr, Sheriff S, Lou Z, Bozarth JM, Wu Y, Rendina A, Harper T, Zheng J, Xin B, Xiang Q, Luettgen JM, Seiffert DA, Wexler RR, Lam PYS.

Bioorg Med Chem Lett. 2019 Oct 1;29(19):126604. doi: 10.1016/j.bmcl.2019.08.008. Epub 2019 Aug 16.

PMID: 31445854

Allogeneic murine pregnancy models for assessing the developmental effects of immune-stimulating antibodies: Challenges in reproducibility.

Thompson KE, Danberry TL, Bunch RT, Graziano MJ, McNerney ME.

Birth Defects Res. 2019 Oct 1;111(16):1178-1191. doi: 10.1002/bdr2.1542. Epub 2019 Jun 22.

PMID: 31228335

Restricting Glycolysis Preserves T Cell Effector Functions and Augments Checkpoint Therapy.

Renner K, Bruss C, Schnell A, Koehl G, Becker HM, Fante M, Menevse AN, Kauer N, Blazquez R, Hacker L, Decking SM, Bohn T, Faerber S, Evert K, Aigle L, Amslinger S, Landa M, Krijgsman O, Rozeman EA, Brummer C, Siska PJ, Singer K, Pektor S, Miederer M, Peter K, Gottfried E, Herr W, Marchiq I, Pouyssegur J, Roush WR, Ong S, Warren S, Pukrop T, Beckhove P, Lang SA, Bopp T, Blank CU, Cleveland JL, Oefner PJ, Dettmer K, Selby M, Kreutz M.

Cell Rep. 2019 Oct 1;29(1):135-150.e9. doi: 10.1016/j.celrep.2019.08.068.

PMID: 31577944

Optimizing ethambutol dosing among HIV/tuberculosis co-infected patients: a population pharmacokinetic modelling and simulation study.

Mehta K, Ravimohan S, Pasipanodya JG, Srivastava S, Modongo C, Zetola NM, Weissman D, Ivaturi V, Gumbo T, Bisson GP, Vinnard C.

J Antimicrob Chemother. 2019 Oct 1;74(10):2994-3002. doi: 10.1093/jac/dkz265.

PMID: 31273386

 

Indirect Treatment Comparison of Nivolumab Versus Observation or Ipilimumab as Adjuvant Therapy in Resected Melanoma Using Pooled Clinical Trial Data.

Freeman M, Betts KA, Jiang S, Du EX, Gupte-Singh K, Lu Y, Rao S, Shoushtari AN.

Adv Ther. 2019 Oct;36(10):2783-2796. doi: 10.1007/s12325-019-01060-y. Epub 2019 Aug 22.

PMID: 31440980

 

Stereospecific interactions between histidine and monoclonal antibodies.

Baek Y, Emami P, Singh N, Ilott A, Sahin E, Zydney A.

Biotechnol Bioeng. 2019 Oct;116(10):2632-2639. doi: 10.1002/bit.27109. Epub 2019 Jul 24.

PMID: 31286487

 

Control of antibody high and low molecular weight species by depth filtration-based cell culture harvesting.

Yu D, Mayani M, Song Y, Xing Z, Ghose S, Li ZJ.

Biotechnol Bioeng. 2019 Oct;116(10):2610-2620. doi: 10.1002/bit.27081. Epub 2019 Jun 29.

PMID: 31184373

 

The effects of buffer condition on the fouling behavior of MVM virus filtration of an Fc-fusion protein.

Namila F, Zhang D, Traylor S, Nguyen T, Singh N, Wickramasinghe R, Qian X.

Biotechnol Bioeng. 2019 Oct;116(10):2621-2631. doi: 10.1002/bit.27085. Epub 2019 Jul 6.

PMID: 31184371

 

Enhanced SLAMF7 Homotypic Interactions by Elotuzumab Improves NK Cell Killing of Multiple Myeloma.

Pazina T, James AM, Colby KB, Yang Y, Gale A, Jhatakia A, Kearney AY, Graziano RF, Bezman NA, Robbins MD, Cohen AD, Campbell KS.

Cancer Immunol Res. 2019 Oct;7(10):1633-1646. doi: 10.1158/2326-6066.CIR-18-0579. Epub 2019 Aug 20.

PMID: 31431433

 

EvaluatioN of ApiXaban in strOke and systemic embolism prevention in patients with non-valvular atrial fibrillation in clinical practice Setting in France, rationale and design of the NAXOS: SNIIRAM study.

Picard F, Van Ganse E, Ducrocq G, Danchin N, Falissard B, Hanon O, Belhassen M, Ginoux M, Lefevre C, Cotte FE, Mahé I, Steg PG.

Clin Cardiol. 2019 Oct;42(10):851-859. doi: 10.1002/clc.23231. Epub 2019 Jul 17.

PMID: 31313832

 

A Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) Analysis of Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma (aRCC).

Shah R, Botteman M, Solem CT, Luo L, Doan J, Cella D, Motzer RJ.

Clin Genitourin Cancer. 2019 Oct;17(5):356-365.e1. doi: 10.1016/j.clgc.2019.05.010. Epub 2019 May 31.

PMID: 31272883

 

Treatment Patterns and Clinical and Economic Outcomes in Patients With Newly Diagnosed Multiple Myeloma Treated With Lenalidomide- and/or Bortezomib-containing Regimens Without Stem Cell Transplant in a Real-world Setting.

Chari A, Parikh K, Ni Q, Abouzaid S.

Clin Lymphoma Myeloma Leuk. 2019 Oct;19(10):645-655. doi: 10.1016/j.clml.2019.06.007. Epub 2019 Jun 18.

PMID: 31377207

 

Apixaban: A Clinical Pharmacokinetic and Pharmacodynamic Review.

Byon W, Garonzik S, Boyd RA, Frost CE.

Clin Pharmacokinet. 2019 Oct;58(10):1265-1279. doi: 10.1007/s40262-019-00775-z. Review.

PMID: 31089975

   

Exposure-Response Analysis for Efficacy of Daclatasvir, Asunaprevir, and Beclabuvir Combinations in HCV-Infected Patients.

Ueno T, Osawa M, Shiozaki T, Green M, Garimella T.

Clin Pharmacol Drug Dev. 2019 Oct;8(7):903-913. doi: 10.1002/cpdd.646. Epub 2019 Jan 22.

PMID: 30667592

 

Continuation with apixaban treatment is associated with lower risk for hospitalization and medical costs among elderly patients.

Dhamane AD, Baker CL, Rajpura J, Mardekian J, Dina O, Russ C, Rosenblatt L, Lingohr-Smith M, Lin J.

Curr Med Res Opin. 2019 Oct;35(10):1769-1776. doi: 10.1080/03007995.2019.1623187. Epub 2019 Jun 5.

PMID: 31120309

 

Developments in the treatment of HCV genotype 3 infection.

McPhee F.

Expert Rev Anti Infect Ther. 2019 Oct;17(10):775-785. doi: 10.1080/14787210.2019.1676730. Epub 2019 Oct 21. Review.

PMID: 31584833

 

Immune checkpoint inhibition in sepsis: a Phase 1b randomized study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of nivolumab.

Hotchkiss RS, Colston E, Yende S, Crouser ED, Martin GS, Albertson T, Bartz RR, Brakenridge SC, Delano MJ, Park PK, Donnino MW, Tidswell M, Mayr FB, Angus DC, Coopersmith CM, Moldawer LL, Catlett IM, Girgis IG, Ye J, Grasela DM.

Intensive Care Med. 2019 Oct;45(10):1360-1371. doi: 10.1007/s00134-019-05704-z. Epub 2019 Oct 1.

PMID: 31576433

 

Model-Based Population Pharmacokinetic Analysis of Nivolumab in Chinese Patients With Previously Treated Advanced Solid Tumors, Including Non-Small Cell Lung Cancer.

Zhang J, Cai J, Bello A, Roy A, Sheng J.

J Clin Pharmacol. 2019 Oct;59(10):1415-1424. doi: 10.1002/jcph.1432. Epub 2019 May 22.

PMID: 31115908

 

Systematic review of societal costs associated with stroke, bleeding and monitoring in atrial fibrillation.

Martin AL, Reeves AG, Berger SE, Fusco MD, Wygant GD, Savone M, Snook K, Nejati M, Lanitis T.

J Comp Eff Res. 2019 Oct;8(14):1147-1166. doi: 10.2217/cer-2019-0089. Epub 2019 Aug 22.

PMID: 31436488

 

Patient characteristics and stroke and bleeding events in nonvalvular atrial fibrillation patients treated with apixaban and vitamin K antagonists: a Spanish real-world study.

Ramagopalan SV, Sicras-Mainar A, Polanco-Sanchez C, Carroll R, de Bobadilla JF.

J Comp Eff Res. 2019 Oct;8(14):1201-1212. doi: 10.2217/cer-2019-0079. Epub 2019 Jul 23.

PMID: 31333045

 

Electrostatic-field and surface-shape similarity for virtual screening and pose prediction.

Cleves AE, Johnson SR, Jain AN.

J Comput Aided Mol Des. 2019 Oct;33(10):865-886. doi: 10.1007/s10822-019-00236-6. Epub 2019 Oct 24.

PMID: 31650386

 

The global epidemiology of NAFLD and NASH in patients with type 2 diabetes: A systematic review and meta-analysis.

Younossi ZM, Golabi P, de Avila L, Paik JM, Srishord M, Fukui N, Qiu Y, Burns L, Afendy A, Nader F.

J Hepatol. 2019 Oct;71(4):793-801. doi: 10.1016/j.jhep.2019.06.021. Epub 2019 Jul 4.

PMID: 31279902

 

Forced Oxidative Degradation Pathways of the Imidazole Moiety of Daclatasvir.

Huang Y, Su BN, Marshall J, Miller SA.

J Pharm Sci. 2019 Oct;108(10):3312-3318. doi: 10.1016/j.xphs.2019.05.022. Epub 2019 May 27.

PMID: 31145924

 

Cyclization of N-Terminal Glutamic Acid to pyro-Glutamic Acid Impacts Monoclonal Antibody Charge Heterogeneity Despite Its Appearance as a Neutral Transformation.

Liu Z, Valente J, Lin S, Chennamsetty N, Qiu D, Bolgar M.

J Pharm Sci. 2019 Oct;108(10):3194-3200. doi: 10.1016/j.xphs.2019.05.023. Epub 2019 May 27.

PMID: 31145921

 

Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial.

Motzer RJ, Rini BI, McDermott DF, Arén Frontera O, Hammers HJ, Carducci MA, Salman P, Escudier B, Beuselinck B, Amin A, Porta C, George S, Neiman V, Bracarda S, Tykodi SS, Barthélémy P, Leibowitz-Amit R, Plimack ER, Oosting SF, Redman B, Melichar B, Powles T, Nathan P, Oudard S, Pook D, Choueiri TK, Donskov F, Grimm MO, Gurney H, Heng DYC, Kollmannsberger CK, Harrison MR, Tomita Y, Duran I, Grünwald V, McHenry MB, Mekan S, Tannir NM; CheckMate 214 investigators.

Lancet Oncol. 2019 Oct;20(10):1370-1385. doi: 10.1016/S1470-2045(19)30413-9. Epub 2019 Aug 16. Erratum in: Lancet Oncol. 2019 Aug 21;:.

PMID: 31427204

 

Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis.

Antonia SJ, Borghaei H, Ramalingam SS, Horn L, De Castro Carpeño J, Pluzanski A, Burgio MA, Garassino M, Chow LQM, Gettinger S, Crinò L, Planchard D, Butts C, Drilon A, Wojcik-Tomaszewska J, Otterson GA, Agrawal S, Li A, Penrod JR, Brahmer J.

Lancet Oncol. 2019 Oct;20(10):1395-1408. doi: 10.1016/S1470-2045(19)30407-3. Epub 2019 Aug 14.

PMID: 31422028

 

VISTA is an acidic pH-selective ligand for PSGL-1.

Johnston RJ, Su LJ, Pinckney J, Critton D, Boyer E, Krishnakumar A, Corbett M, Rankin AL, Dibella R, Campbell L, Martin GH, Lemar H, Cayton T, Huang RY, Deng X, Nayeem A, Chen H, Ergel B, Rizzo JM, Yamniuk AP, Dutta S, Ngo J, Shorts AO, Ramakrishnan R, Kozhich A, Holloway J, Fang H, Wang YK, Yang Z, Thiam K, Rakestraw G, Rajpal A, Sheppard P, Quigley M, Bahjat KS, Korman AJ.

Nature. 2019 Oct;574(7779):565-570. doi: 10.1038/s41586-019-1674-5. Epub 2019 Oct 23.

PMID: 31645726

 

Evaluation of the Implementation of Additional Risk Minimization Activities in Europe, the USA, and Japan.

Yasuoka Y, Kaneko M, Narukawa M.

Pharmaceut Med. 2019 Oct;33(5):417-424. doi: 10.1007/s40290-019-00303-1.

PMID: 31933232

 

Concordance of hospitalizations between Clinical Practice Research Datalink and linked Hospital Episode Statistics among patients treated with oral antidiabetic therapies.

Saine ME, Carbonari DM, Newcomb CW, Gallagher AM, Blak BT, Roy JA, Wood J, Cardillo S, Hennessy S, Strom BL, Lo Re V 3rd.

Pharmacoepidemiol Drug Saf. 2019 Oct;28(10):1328-1335. doi: 10.1002/pds.4853. Epub 2019 Jul 22.

PMID: 31328342

 

Exposure assessments in reproductive and developmental toxicity testing: An IQ-DruSafe industry survey on current practices and experiences in support of exposure-based high dose selection.

Andrews PA, McNerney ME, DeGeorge JJ.

Regul Toxicol Pharmacol. 2019 Oct;107:104413. doi: 10.1016/j.yrtph.2019.104413. Epub 2019 Jun 20.

PMID: 31229519

 

Genetic toxicology in silico protocol.

Hasselgren C, Ahlberg E, Akahori Y, Amberg A, Anger LT, Atienzar F, Auerbach S, Beilke L, Bellion P, Benigni R, Bercu J, Booth ED, Bower D, Brigo A, Cammerer Z, Cronin MTD, Crooks I, Cross KP, Custer L, Dobo K, Doktorova T, Faulkner D, Ford KA, Fortin MC, Frericks M, Gad-McDonald SE, Gellatly N, Gerets H, Gervais V, Glowienke S, Van Gompel J, Harvey JS, Hillegass J, Honma M, Hsieh JH, Hsu CW, Barton-Maclaren TS, Johnson C, Jolly R, Jones D, Kemper R, Kenyon MO, Kruhlak NL, Kulkarni SA, Kümmerer K, Leavitt P, Masten S, Miller S, Moudgal C, Muster W, Paulino A, Lo Piparo E, Powley M, Quigley DP, Reddy MV, Richarz AN, Schilter B, Snyder RD, Stavitskaya L, Stidl R, Szabo DT, Teasdale A, Tice RR, Trejo-Martin A, Vuorinen A, Wall BA, Watts P, White AT, Wichard J, Witt KL, Woolley A, Woolley D, Zwickl C, Myatt GJ.

Regul Toxicol Pharmacol. 2019 Oct;107:104403. doi: 10.1016/j.yrtph.2019.104403. Epub 2019 Jun 11.

PMID: 31195068

 

Comparison of immune system development in nonclinical species and humans: Closing information gaps for immunotoxicity testing and human translatability.

Skaggs H, Chellman GJ, Collinge M, Enright B, Fuller CL, Krayer J, Sivaraman L, Weinbauer GF.

Reprod Toxicol. 2019 Oct;89:178-188. doi: 10.1016/j.reprotox.2019.06.005. Epub 2019 Jun 21. Review. No abstract available.

PMID: 31233776

 

Retrospective Evaluation of Cycled Resin in Viral Clearance Studies-A Multiple Company Collaboration.

Mattila J, Curtis S, Webb-Vargas Y, Wilson E, Galperina O, Roush D, Tobler S, Stanley B, Clark M, Weaver J, Pike J, Yu D, Li X, Flicker A, Kindermann J, Schuelke N, Whitcombe R, Bennett L.

PDA J Pharm Sci Technol. 2019 Sep-Oct;73(5):470-486. doi: 10.5731/pdajpst.2018.009605. Epub 2019 May 17.

PMID: 31101706

 

Comparative electrophysiology and pharmacology of hiPSC cardiomyocyte 2D mono-cultures and 2D co-cultures with human ventricular fibroblasts.

Shi H, Huang M, Kwagh J, Levesque P.

J Pharmacol Toxicol Methods. 2019 Sep - Oct;99:106595. doi: 10.1016/j.vascn.2019.05.037. Epub 2019 Oct 17. No abstract available.

PMID: 31963065

 

Evaluating the use of microelectrode array technology and cell-based neuronal culture models for proconvulsant risk assessment: progress from the HESI NeuTox consortium.

Millard DC, Nicolini AM, Arrowood CA, Hayes HB, Bradley JA, Strock CJ, Freudenrich TM, Wallace K, Shafer TJ, Cato MJ, Chaudhary KW, Saavedra L, Haag D, Feaster TK, Anson BD, Luerman G, Hess D, Shi Y, Li J, Shi H, Levesque P, Kreir M, Lu HR, Suzuki I, Odawara A, Miyamoto N, Ojima A, Kanda Y, Blinova K, Herr D, Roberts R, Pierson J.

J Pharmacol Toxicol Methods. 2019 Sep - Oct;99:106595. doi: 10.1016/j.vascn.2019.05.076. Epub 2019 Oct 17. No abstract available.

PMID: 31963054

 

Characterization of a renal hypertensive model in telemetrized cynomolgus monkeys.

Arthur SR, Love A, Bounous DI, Ehrmann J, Lehman B, Johnson W, Smith R, Adamo R, Gill M, Hennan J.

J Pharmacol Toxicol Methods. 2019 Sep - Oct;99:106595. doi: 10.1016/j.vascn.2019.05.044. Epub 2019 Oct 17. No abstract available.

PMID: 31963043

 

Characterization of contractile properties of hIPSC-CMs cultured with or without fibroblast and chronic electrical stimulation.

Huang M, Shi H, Levesque P.

J Pharmacol Toxicol Methods. 2019 Sep - Oct;99:106595. doi: 10.1016/j.vascn.2019.05.164. Epub 2019 Oct 17. No abstract available.

PMID: 31962937

GSK3732394: a Multi-specific Inhibitor of HIV Entry.

Wensel D, Sun Y, Davis J, Li Z, Zhang S, McDonagh T, Langley D, Mitchell T, Tabruyn S, Nef P, Cockett M, Krystal M.

J Virol. 2019 Sep 30;93(20). pii: e00907-19. doi: 10.1128/JVI.00907-19. Print 2019 Oct 15.

PMID: 31375580

 

Mechanistic modeling based process development for monoclonal antibody monomer-aggregate separations in multimodal cation exchange chromatography.

Zhang L, Parasnavis S, Li Z, Chen J, Cramer S.

J Chromatogr A. 2019 Sep 27;1602:317-325. doi: 10.1016/j.chroma.2019.05.056. Epub 2019 Jun 6.

PMID: 31248584

 

Discovery of Pyridazinone and Pyrazolo[1,5-a]pyridine Inhibitors of C-Terminal Src Kinase.

O'Malley DP, Ahuja V, Fink B, Cao C, Wang C, Swanson J, Wee S, Gavai AV, Tokarski J, Critton D, Paiva AA, Johnson BM, Szapiel N, Xie D.

ACS Med Chem Lett. 2019 Sep 25;10(10):1486-1491. doi: 10.1021/acsmedchemlett.9b00354. eCollection 2019 Oct 10.

PMID: 31620238

 

Metabolomic adaptations and correlates of survival to immune checkpoint blockade.

Li H, Bullock K, Gurjao C, Braun D, Shukla SA, Bossé D, Lalani AA, Gopal S, Jin C, Horak C, Wind-Rotolo M, Signoretti S, McDermott DF, Freeman GJ, Van Allen EM, Schreiber SL, Stephen Hodi F, Sellers WR, Garraway LA, Clish CB, Choueiri TK, Giannakis M.

Nat Commun. 2019 Sep 25;10(1):4346. doi: 10.1038/s41467-019-12361-9.

PMID: 31554815

 

Baseline Objective Inflammation by Magnetic Resonance Imaging as a Predictor of Therapeutic Benefit in Early, Poor Prognosis Rheumatoid Arthritis.

Ahmad HA, Baker JF, Østergaard M, Emery P, Durez P, Ye J, Banerjee S, Conaghan PG.

Arthritis Care Res (Hoboken). 2019 Sep 24. doi: 10.1002/acr.24072. [Epub ahead of print]

PMID: 31549793

 

Comparing record linkage software programs and algorithms using real-world data.

Karr AF, Taylor MT, West SL, Setoguchi S, Kou TD, Gerhard T, Horton DB.

PLoS One. 2019 Sep 24;14(9):e0221459. doi: 10.1371/journal.pone.0221459. eCollection 2019.

PMID: 31550255

 

Reduced Compensatory β-Cell Proliferation in Nfatc3-Deficient Mice Fed on High-Fat Diet.

Hu L, He F, Luo Y, Luo H, Hai L, Li Y, Zhou Z, Liu F, Dai YS.

Exp Clin Endocrinol Diabetes. 2019 Sep 23. doi: 10.1055/a-1008-9110. [Epub ahead of print]

PMID: 31546271

 

Viral Infections and Autoimmune Disease: Roles of LCMV in Delineating Mechanisms of Immune Tolerance.

Fousteri G, Dave Jhatakia A.

Viruses. 2019 Sep 21;11(10). pii: E885. doi: 10.3390/v11100885. Review.

PMID: 31546586

 

meta C-H Arylation of Electron-Rich Arenes: Reversing the Conventional Site Selectivity.

Liu LY, Qiao JX, Yeung KS, Ewing WR, Yu JQ.

J Am Chem Soc. 2019 Sep 18;141(37):14870-14877. doi: 10.1021/jacs.9b07887. Epub 2019 Sep 6.

PMID: 31449745

 

Rapid, direct, and sensitive determination of aziridine and 2-chloroethylamine by hydrophilic interaction liquid chromatography-mass spectrometry.

Shackman JG.

MethodsX. 2019 Sep 18;6:2176-2180. doi: 10.1016/j.mex.2019.09.017. eCollection 2019.

PMID: 31667117

 

Cost-effectiveness of apixaban compared to other anticoagulants in patients with atrial fibrillation in the real-world and trial settings.

de Jong LA, Groeneveld J, Stevanovic J, Rila H, Tieleman RG, Huisman MV, Postma MJ, van Hulst M.

PLoS One. 2019 Sep 17;14(9):e0222658. doi: 10.1371/journal.pone.0222658. eCollection 2019.

PMID: 31527894

 

Nivolumab treatment beyond RECIST-defined progression in recurrent or metastatic squamous cell carcinoma of the head and neck in CheckMate 141: A subgroup analysis of a randomized phase 3 clinical trial.

Haddad R, Concha-Benavente F, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Kasper S, Vokes EE, Worden F, Saba NF, Tahara M, Jayaprakash V, Lynch M, Li L, Gillison ML, Harrington KJ, Ferris RL.

Cancer. 2019 Sep 15;125(18):3208-3218. doi: 10.1002/cncr.32190. Epub 2019 Jun 27.

PMID: 31246283

 

To Go or Stay: The Development, Benefit, and Detriment of Tissue-Resident Memory CD8 T Cells during Central Nervous System Viral Infections.

Mockus TE, Ren HM; Shwetank, Lukacher AE.

Viruses. 2019 Sep 11;11(9). pii: E842. doi: 10.3390/v11090842. Review.

PMID: 31514273

 

A note on the empirical Bayes heterogeneity variance estimator in meta-analysis.

Sidik K, Jonkman JN.

Stat Med. 2019 Sep 10;38(20):3804-3816. doi: 10.1002/sim.8197. Epub 2019 Jun 18.

PMID: 31209917

 

Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.

Bines J, Procter M, Restuccia E, Viale G, Zardavas D, Suter T, Arahmani A, Van Dooren V, Baselga J, Clark E, Eng-Wong J, Gelber RD, Piccart M, Mobus V, de Azambuja E; APHINITY Steering Committee and Investigators.

Clin Breast Cancer. 2019 Sep 5. pii: S1526-8209(19)30656-1. doi: 10.1016/j.clbc.2019.06.016. [Epub ahead of print]

PMID: 31924513

 

Clinical Validation of PBRM1 Alterations as a Marker of Immune Checkpoint Inhibitor Response in Renal Cell Carcinoma.

Braun DA, Ishii Y, Walsh AM, Van Allen EM, Wu CJ, Shukla SA, Choueiri TK.

JAMA Oncol. 2019 Sep 5. doi: 10.1001/jamaoncol.2019.3158. [Epub ahead of print] No abstract available.

PMID: 31486842

 

Supplementing Claims Data with Electronic Medical Records to Improve Estimation and Classification of Rheumatoid Arthritis Disease Activity: A Machine Learning Approach.

Feldman CH, Yoshida K, Xu C, Frits ML, Shadick NA, Weinblatt ME, Connolly SE, Alemao E, Solomon DH.

ACR Open Rheumatol. 2019 Sep 4;1(9):552-559. doi: 10.1002/acr2.11068. eCollection 2019 Nov.

PMID: 31777839

 

Validity of social media for assessing treatment patterns in oncology patients: a case study in melanoma.

McDonald L, Behl V, Sundar V, Mehmud F, Malcolm B, Ramagopalan S.

JAMIA Open. 2019 Sep 3;2(4):416-422. doi: 10.1093/jamiaopen/ooz013. eCollection 2019 Dec.

PMID: 32025637

 

Renal Excretion of Dabigatran: The Potential Role of Multidrug and Toxin Extrusion (MATE) Proteins.

Shen H, Yao M, Sinz M, Marathe P, Rodrigues AD, Zhu M.

Mol Pharm. 2019 Sep 3;16(9):4065-4076. doi: 10.1021/acs.molpharmaceut.9b00472. Epub 2019 Aug 7.

PMID: 31335150

Emerging biomaterials for downstream manufacturing of therapeutic proteins.

Li Y, Stern D, Lock LL, Mills J, Ou SH, Morrow M, Xu X, Ghose S, Li ZJ, Cui H.

Acta Biomater. 2019 Sep 1;95:73-90. doi: 10.1016/j.actbio.2019.03.015. Epub 2019 Mar 9. Review.

PMID: 30862553

Nivolumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: Efficacy and Safety in CheckMate 141 by Prior Cetuximab Use.

Ferris RL, Licitra L, Fayette J, Even C, Blumenschein G Jr, Harrington KJ, Guigay J, Vokes EE, Saba NF, Haddad R, Ramkumar S, Russell J, Brossart P, Tahara M, Colevas AD, Concha-Benavente F, Lynch M, Li L, Gillison ML.

Clin Cancer Res. 2019 Sep 1;25(17):5221-5230. doi: 10.1158/1078-0432.CCR-18-3944. Epub 2019 Jun 25.

PMID: 31239321

 

Determining MRI Inflammation Targets When Considering a Rheumatoid Arthritis Treat-to-Target Strategy: Results of a Randomized, Placebo-Controlled Trial.

Ahmad HA, Baker JF, Østergaard M, Ye J, Emery P, Conaghan PG.

Adv Ther. 2019 Sep;36(9):2384-2393. doi: 10.1007/s12325-019-01020-6. Epub 2019 Jul 5.

PMID: 31278695

 

Timing of Abatacept Before Elective Arthroplasty and Risk of Postoperative Outcomes.

George MD, Baker JF, Winthrop K, Alemao E, Chen L, Connolly S, Hsu JY, Simon TA, Wu Q, Xie F, Yang S, Curtis JR.

Arthritis Care Res (Hoboken). 2019 Sep;71(9):1224-1233. doi: 10.1002/acr.23843. Epub 2019 Jul 11.

PMID: 30740938

 

Perspectives on exploring hybrid LBA/LC-MS approach for clinical immunogenicity testing.

Jiang H, Myler H, Zeng J, Mora J, Kolaitis G, Pillutla R.

Bioanalysis. 2019 Sep;11(17):1605-1617. doi: 10.4155/bio-2018-0107. Epub 2019 Jun 18. Review.

PMID: 31208198

 

Best practices in bioassay development to support registration of biopharmaceuticals.

White JR, Abodeely M, Ahmed S, Debauve G, Johnson E, Meyer DM, Mozier NM, Naumer M, Pepe A, Qahwash I, Rocnik E, Smith JG, Stokes ES, Talbot JJ, Wong PY.

Biotechniques. 2019 Sep;67(3):126-137. doi: 10.2144/btn-2019-0031. Epub 2019 Aug 5.

PMID: 31379198

 

Virus clearance validation across continuous capture chromatography.

Angelo J, Chollangi S, Müller-Späth T, Jusyte S, Xu X, Ghose S, Li Z.

Biotechnol Bioeng. 2019 Sep;116(9):2275-2284. doi: 10.1002/bit.27012. Epub 2019 May 27.

PMID: 31062872

 

Suitability of a generic virus safety evaluation for monoclonal antibody investigational new drug applications.

Sipple P, Nguyen T, Patel K, Jaffe N, Chen Y, Khetan A.

Biotechnol Prog. 2019 Sep;35(5):e2850. doi: 10.1002/btpr.2850. Epub 2019 Jun 9.

PMID: 31125511

 

Evaluation of covariate effects on pharmacokinetics of monoclonal antibodies in oncology.

Bajaj G, Suryawanshi S, Roy A, Gupta M.

Br J Clin Pharmacol. 2019 Sep;85(9):2045-2058. doi: 10.1111/bcp.13996. Epub 2019 Jul 17.

PMID: 31140642

 

Recommendations for the Design of Clinical Drug-Drug Interaction Studies With Itraconazole Using a Mechanistic Physiologically-Based Pharmacokinetic Model.

Chen Y, Cabalu TD, Callegari E, Einolf H, Liu L, Parrott N, Peters SA, Schuck E, Sharma P, Tracey H, Upreti VV, Zheng M, Zhu AZX, Hall SD.

CPT Pharmacometrics Syst Pharmacol. 2019 Sep;8(9):685-695. doi: 10.1002/psp4.12449. Epub 2019 Aug 7.

PMID: 31215774

 

Safety and efficacy of nivolumab in patients with rare melanoma subtypes who progressed on or after ipilimumab treatment: a single-arm, open-label, phase II study (CheckMate 172).

Nathan P, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Muñoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Schadendorf D.

Eur J Cancer. 2019 Sep;119:168-178. doi: 10.1016/j.ejca.2019.07.010. Epub 2019 Aug 21.

PMID: 31445199

 

Adjuvant ipilimumab versus placebo after complete resection of stage III melanoma: long-term follow-up results of the European Organisation for Research and Treatment of Cancer 18071 double-blind phase 3 randomised trial.

Eggermont AMM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbe C, Ferraresi V, Smylie M, Weber JS, Maio M, Hosein F, de Pril V, Kicinski M, Suciu S, Testori A.

Eur J Cancer. 2019 Sep;119:1-10. doi: 10.1016/j.ejca.2019.07.001. Epub 2019 Aug 7.

PMID: 31400634

 

In vivo models and decision trees for formulation development in early drug development: A review of current practices and recommendations for biopharmaceutical development.

Zane P, Gieschen H, Kersten E, Mathias N, Ollier C, Johansson P, Van den Bergh A, Van Hemelryck S, Reichel A, Rotgeri A, Schäfer K, Müllertz A, Langguth P.

Eur J Pharm Biopharm. 2019 Sep;142:222-231. doi: 10.1016/j.ejpb.2019.06.010. Epub 2019 Jun 21. Review.

PMID: 31233862

 

Nivolumab in patients with unresectable locally advanced or metastatic urothelial carcinoma: CheckMate 275 2-year global and Japanese patient population analyses.

Ohyama C, Kojima T, Kondo T, Naya Y, Inoue T, Tomita Y, Eto M, Hisasue S, Uemura H, Obara W, Kikuchi E, Sharma P, Galsky MD, Siefker-Radtke A, Grossfeld G, Collette S, Gooden K, Kimura G.

Int J Clin Oncol. 2019 Sep;24(9):1089-1098. doi: 10.1007/s10147-019-01450-w. Epub 2019 Jun 19.

PMID: 31218529

 

Commonly used definitions in real-world studies may underestimate the prevalence of renal disease among nonvalvular atrial fibrillation patients.

Schultze A, Graham S, Nordstrom BL, Mehmud F, Ramagopalan SV.

J Comp Eff Res. 2019 Sep;8(12):961-968. doi: 10.2217/cer-2019-0070. Epub 2019 Jul 18.

PMID: 31317772

 

Nivolumab in advanced hepatocellular carcinoma: Sorafenib-experienced Asian cohort analysis.

Yau T, Hsu C, Kim TY, Choo SP, Kang YK, Hou MM, Numata K, Yeo W, Chopra A, Ikeda M, Kuromatsu R, Moriguchi M, Chao Y, Zhao H, Anderson J, Cruz CD, Kudo M.

J Hepatol. 2019 Sep;71(3):543-552. doi: 10.1016/j.jhep.2019.05.014. Epub 2019 Jun 7. Erratum in: J Hepatol. 2019 Dec;71(6):1278.

PMID: 31176752

 

Deuterated active pharmaceutical ingredients: A science-based proposal for synthesis, analysis, and control. Part 1: Framing the problem.

Czeskis B, Elmore CS, Haight A, Hesk D, Maxwell BD, Miller SA, Raglione T, Schildknegt K, Traverse JF, Wang P.

J Labelled Comp Radiopharm. 2019 Sep;62(11):690-694. doi: 10.1002/jlcr.3743. Epub 2019 Jun 18.

PMID: 31034626

 

Reliable Gene Expression Profiling from Small and Hematoxylin and Eosin-Stained Clinical Formalin-Fixed, Paraffin-Embedded Specimens Using the HTG EdgeSeq Platform.

Qi Z, Wang L, Desai K, Cogswell J, Stern M, Lawson B, Kerkar SP, Vitazka P.

J Mol Diagn. 2019 Sep;21(5):796-807. doi: 10.1016/j.jmoldx.2019.04.011. Epub 2019 Jun 27.

PMID: 31255795

 

Safety, Efficacy, and Patient-Reported Health-Related Quality of Life and Symptom Burden with Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer, Including Patients Aged 70 Years or Older or with Poor Performance Status (CheckMate 153).

Spigel DR, McCleod M, Jotte RM, Einhorn L, Horn L, Waterhouse DM, Creelan B, Babu S, Leighl NB, Chandler JC, Couture F, Keogh G, Goss G, Daniel DB, Garon EB, Schwartzberg LS, Sen R, Korytowsky B, Li A, Aanur N, Hussein MA.

J Thorac Oncol. 2019 Sep;14(9):1628-1639. doi: 10.1016/j.jtho.2019.05.010. Epub 2019 May 20.

PMID: 31121324

 

Neoadjuvant letrozole plus taselisib versus letrozole plus placebo in postmenopausal women with oestrogen receptor-positive, HER2-negative, early-stage breast cancer (LORELEI): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.

Saura C, Hlauschek D, Oliveira M, Zardavas D, Jallitsch-Halper A, de la Peña L, Nuciforo P, Ballestrero A, Dubsky P, Lombard JM, Vuylsteke P, Castaneda CA, Colleoni M, Santos Borges G, Ciruelos E, Fornier M, Boer K, Bardia A, Wilson TR, Stout TJ, Hsu JY, Shi Y, Piccart M, Gnant M, Baselga J, de Azambuja E.

Lancet Oncol. 2019 Sep;20(9):1226-1238. doi: 10.1016/S1470-2045(19)30334-1. Epub 2019 Aug 8.

PMID: 31402321

 

Efficacy and safety of first-line carboplatin-versus cisplatin-based chemotherapy for non-small cell lung cancer: A meta-analysis.

Griesinger F, Korol EE, Kayaniyil S, Varol N, Ebner T, Goring SM.

Lung Cancer. 2019 Sep;135:196-204. doi: 10.1016/j.lungcan.2019.07.010. Epub 2019 Jul 13.

PMID: 31446995

 

Safety and effectiveness of abatacept in Japanese non-elderly and elderly patients with rheumatoid arthritis in an all-cases post-marketing surveillance.

Harigai M, Ishiguro N, Inokuma S, Mimori T, Ryu J, Takei S, Takeuchi T, Tanaka Y, Takasaki Y, Yamanaka H, Yoshizawa Y, Chinen I, Nakao T, Koike T.

Mod Rheumatol. 2019 Sep;29(5):747-755. doi: 10.1080/14397595.2018.1524998. Epub 2018 Oct 25.

PMID: 30217117

 

Hindered dialkyl ether synthesis with electrogenerated carbocations.

Xiang J, Shang M, Kawamata Y, Lundberg H, Reisberg SH, Chen M, Mykhailiuk P, Beutner G, Collins MR, Davies A, Del Bel M, Gallego GM, Spangler JE, Starr J, Yang S, Blackmond DG, Baran PS.

Nature. 2019 Sep;573(7774):398-402. doi: 10.1038/s41586-019-1539-y. Epub 2019 Sep 9.

PMID: 31501569

 

Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age.

Saba NF, Blumenschein G Jr, Guigay J, Licitra L, Fayette J, Harrington KJ, Kiyota N, Gillison ML, Ferris RL, Jayaprakash V, Li L, Brossart P.

Oral Oncol. 2019 Sep;96:7-14. doi: 10.1016/j.oraloncology.2019.06.017. Epub 2019 Jul 3.

PMID: 31422216

 

Economic Evaluation of Nivolumab Plus Ipilimumab Combination as First-Line Treatment for Patients with Advanced Melanoma in Canada.

Quon PL, Xiao Y, Sorensen S, Monfared AAT.

Pharmacoecon Open. 2019 Sep;3(3):321-331. doi: 10.1007/s41669-018-0112-1.

PMID: 30617952

 

Cost per response for abatacept versus adalimumab in patients with seropositive, erosive early rheumatoid arthritis in the US, Germany, Spain, and Canada.

Foo J, Morel C, Bergman M, Baerwald C, Rodriguez-Heredia JM, Marshall A, Polanco-Sánchez C, Postema R.

Rheumatol Int. 2019 Sep;39(9):1621-1630. doi: 10.1007/s00296-019-04352-2. Epub 2019 Jun 25.

PMID: 31240388

 

Overview and considerations for the reporting of clinical pathology interpretations in nonclinical toxicology studies.

Aulbach A, Vitsky A, Arndt T, Ramaiah L, Logan M, Siska W, Cregar L, Tripathi N, Adedeji A, Provencher A, Gupta A, Jordan H, Bounous D, Boone L.

Vet Clin Pathol. 2019 Sep;48(3):389-399. doi: 10.1111/vcp.12772. Review.

PMID: 31556157

 

Interpretative considerations for clinical pathology findings in nonclinical toxicology studies.

Aulbach A, Vitsky A, Arndt T, Ramaiah L, Logan M, Siska W, Cregar L, Tripathi N, Adedeji A, Provencher A, Gupta A, Jordan H, Bounous D, Boone L.

Vet Clin Pathol. 2019 Sep;48(3):383-388. doi: 10.1111/vcp.12773. Epub 2019 Sep 24. Review.

PMID: 31549731

 

Real-world clinical outcomes among individuals with chronic HCV infection in China: CCgenos study.

Rao H, Xie Q, Shang J, Gao Z, Chen H, Sun Y, Jiang J, Niu J, Zhang L, Wang L, Zhao L, Li J, Yang R, Zhu S, Li R, Wei L.

Antivir Ther. 2019 Sept;24(7):473-483. doi: 10.3851/IMP3334.

PMID: 31566575

 

Treatment sequences for advanced renal cell carcinoma: A health economic assessment.

Deniz B, Ambavane A, Yang S, Altincatal A, Doan J, Rao S, Michaelson MD.

PLoS One. 2019 Aug 29;14(8):e0215761. doi: 10.1371/journal.pone.0215761. eCollection 2019.

PMID: 31465470

 

Blood-brain barrier permeable nano immunoconjugates induce local immune responses for glioma therapy.

Galstyan A, Markman JL, Shatalova ES, Chiechi A, Korman AJ, Patil R, Klymyshyn D, Tourtellotte WG, Israel LL, Braubach O, Ljubimov VA, Mashouf LA, Ramesh A, Grodzinski ZB, Penichet ML, Black KL, Holler E, Sun T, Ding H, Ljubimov AV, Ljubimova JY.

Nat Commun. 2019 Aug 28;10(1):3850. doi: 10.1038/s41467-019-11719-3. Erratum in: Nat Commun. 2020 Jan 30;11(1):701.

PMID: 31462642

 

Discovery of Potent Protease-Activated Receptor 4 Antagonists with in Vivo Antithrombotic Efficacy.

Miller MM, Banville J, Friends TJ, Gagnon M, Hangeland JJ, Lavallée JF, Martel A, O'Grady H, Rémillard R, Ruediger E, Tremblay F, Posy SL, Allegretto NJ, Guarino VR, Harden DG, Harper TW, Hartl K, Josephs J, Malmstrom S, Watson C, Yang Y, Zhang G, Wong P, Yang J, Bouvier M, Seiffert DA, Wexler RR, Lawrence RM, Priestley ES, Marinier A.

J Med Chem. 2019 Aug 22;62(16):7400-7416. doi: 10.1021/acs.jmedchem.9b00186. Epub 2019 Aug 5.

PMID: 31246024

 

Mitogenic and progenitor gene programmes in single pilocytic astrocytoma cells.

Reitman ZJ, Paolella BR, Bergthold G, Pelton K, Becker S, Jones R, Sinai CE, Malkin H, Huang Y, Grimmet L, Herbert ZT, Sun Y, Weatherbee JL, Alberta JA, Daley JF, Rozenblatt-Rosen O, Condurat AL, Qian K, Khadka P, Segal RA, Haas-Kogan D, Filbin MG, Suva ML, Regev A, Stiles CD, Kieran MW, Goumnerova L, Ligon KL, Shalek AK, Bandopadhayay P, Beroukhim R.

Nat Commun. 2019 Aug 19;10(1):3731. doi: 10.1038/s41467-019-11493-2.

PMID: 31427603

 

Identification of potent, selective and orally bioavailable phenyl ((R)-3-phenylpyrrolidin-3-yl)sulfone analogues as RORγt inverse agonists.

Lu Z, Duan JJ, Xiao H, Neels J, Wu DR, Weigelt CA, Sack JS, Khan J, Ruzanov M, An Y, Yarde M, Karmakar A, Vishwakrishnan S, Baratam V, Shankarappa H, Vanteru S, Babu V, Basha M, Kumar Gupta A, Kumaravel S, Mathur A, Zhao Q, Salter-Cid LM, Carter PH, Murali Dhar TG.

Bioorg Med Chem Lett. 2019 Aug 15;29(16):2265-2269. doi: 10.1016/j.bmcl.2019.06.036. Epub 2019 Jun 20.

PMID: 31257087

 

Association Between Bilirubin, Atazanavir, and Cardiovascular Disease Events Among People Living With HIV Across the United States.

Crane HM, Nance RM, Heckbert SR, Ritchings C, Rosenblatt L, Budoff M, Wood BR, Tirschwell DL, Kim HN, Mathews WC, Geng E, Moore RD, Hunt PW, Eron JJ, Burkholder GA, Drozd DR, Chow FC, Becker KJ, Zunt JR, Ho EL, Kalani R, Huffer A, Whitney BM, Saag MS, Kitahata MM, Delaney JAC.

J Acquir Immune Defic Syndr. 2019 Aug 15;81(5):e141-e147. doi: 10.1097/QAI.0000000000002071.

PMID: 31135582

 

RNA sequencing of transplant-stage idiopathic pulmonary fibrosis lung reveals unique pathway regulation.

Sivakumar P, Thompson JR, Ammar R, Porteous M, McCoubrey C, Cantu E 3rd, Ravi K, Zhang Y, Luo Y, Streltsov D, Beers MF, Jarai G, Christie JD.

ERJ Open Res. 2019 Aug 12;5(3). pii: 00117-2019. doi: 10.1183/23120541.00117-2019. eCollection 2019 Jul.

PMID: 31423451

 

Nivolumab for Newly Diagnosed Advanced-Stage Classic Hodgkin Lymphoma: Safety and Efficacy in the Phase II CheckMate 205 Study.

Ramchandren R, Domingo-Domènech E, Rueda A, Trněný M, Feldman TA, Lee HJ, Provencio M, Sillaber C, Cohen JB, Savage KJ, Willenbacher W, Ligon AH, Ouyang J, Redd R, Rodig SJ, Shipp MA, Sacchi M, Sumbul A, Armand P, Ansell SM.

J Clin Oncol. 2019 Aug 10;37(23):1997-2007. doi: 10.1200/JCO.19.00315. Epub 2019 May 21.

PMID: 31112476

 

Evolution of the burden of active hepatitis C virus infection in England from September 2015 to September 2016: a repeated cross-sectional analysis.

Lacoin L, Hurst M, Hill NR, Gordon J, Geretti AM, Aspinall R, Corless L, Gao-Du Y, Mistry L, Mutimer D.

BMJ Open. 2019 Aug 5;9(8):e029066. doi: 10.1136/bmjopen-2019-029066.

PMID: 31383704

 

Oxidative degradation pathways of beclabuvir hydrochloride mediated by hydrogen peroxide and UV/Vis light.

Ye Q, Huang Y, Grier S, Miller SA.

J Pharm Biomed Anal. 2019 Aug 5;172:388-394. doi: 10.1016/j.jpba.2019.05.017. Epub 2019 May 8.

PMID: 31100536

 

Development of simple isocratic HPLC methods for siRNA quantitation in lipid-based nanoparticles.

Huang Z, Fish WP.

J Pharm Biomed Anal. 2019 Aug 5;172:253-258. doi: 10.1016/j.jpba.2019.04.026. Epub 2019 Apr 27.

PMID: 31071650

 

Streamlining the polishing step development process via physicochemical characterization of monoclonal antibody aggregates.

Doss HR, Raman M, Knihtila R, Chennamsetty N, Wang D, Shupe A, Mussa N.

J Chromatogr A. 2019 Aug 2;1598:101-112. doi: 10.1016/j.chroma.2019.03.044. Epub 2019 Mar 22.

PMID: 30954243

 

Identification of substituted benzothiazole sulfones as potent and selective inhibitors of endothelial lipase.

Kim SH, Johnson JA, Jiang J, Parkhurst B, Phillips M, Pi Z, Qiao JX, Tora G, Ye Chen A, Liu E, Yin X, Yang R, Zhao L, Taylor DS, Basso M, Behnia K, Onorato J, Chen XQ, Abell LM, Lu H, Locke G, Caporuscio C, Adam LP, Gordon D, Wexler RR, Finlay HJ.

Bioorg Med Chem Lett. 2019 Aug 1;29(15):1918-1921. doi: 10.1016/j.bmcl.2019.05.048. Epub 2019 May 25. Erratum in: Bioorg Med Chem Lett. 2019 Sep 1;29(17):2525.

PMID: 31176700

 

Therapeutic protein purity and fragmented species characterization by capillary electrophoresis sodium dodecyl sulfate using systematic hybrid cleavage and forced degradation.

Duhamel L, Gu Y, Barnett G, Tao Y, Voronov S, Ding J, Mussa N, Li ZJ.

Anal Bioanal Chem. 2019 Aug;411(21):5617-5629. doi: 10.1007/s00216-019-01942-8. Epub 2019 Jun 18.

PMID: 31214752

 

Methadone and buprenorphine pharmacokinetics and pharmacodynamics when coadministered with fostemsavir to opioid-dependent, human immunodeficiency virus seronegative participants.

Moore K, Magee M, Sevinsky H, Chang M, Lubin S, Myers E, Ackerman P, Llamoso C.

Br J Clin Pharmacol. 2019 Aug;85(8):1771-1780. doi: 10.1111/bcp.13964. Epub 2019 Jun 5.

PMID: 30980734

 

The effects of lapatinib on cardiac repolarization: results from a placebo controlled, single sequence, crossover study in patients with advanced solid tumors.

Coker SA, Hurwitz HI, Sharma S, Wang D, Jordaan P, Zarate JP, Lewis LD.

Cancer Chemother Pharmacol. 2019 Aug;84(2):383-392. doi: 10.1007/s00280-019-03880-9. Epub 2019 Jun 11.

PMID: 31187169

 

Cross-Species Single-Cell Analysis of Pancreatic Ductal Adenocarcinoma Reveals Antigen-Presenting Cancer-Associated Fibroblasts.

Elyada E, Bolisetty M, Laise P, Flynn WF, Courtois ET, Burkhart RA, Teinor JA, Belleau P, Biffi G, Lucito MS, Sivajothi S, Armstrong TD, Engle DD, Yu KH, Hao Y, Wolfgang CL, Park Y, Preall J, Jaffee EM, Califano A, Robson P, Tuveson DA.

Cancer Discov. 2019 Aug;9(8):1102-1123. doi: 10.1158/2159-8290.CD-19-0094. Epub 2019 Jun 13.

PMID: 31197017

 

Population Pharmacokinetic Analysis of Daclatasvir, Asunaprevir, and Beclabuvir Combination in HCV-Infected Subjects.

Osawa M, Ueno T, Shiozaki T, Ishikawa H, Li H, Garimella T.

Clin Pharmacol Drug Dev. 2019 Aug;8(6):802-817. doi: 10.1002/cpdd.649. Epub 2019 Jan 10.

PMID: 30629858

 

Pancreatitis Incidence in the Exenatide BID, Exenatide QW, and Exenatide QW Suspension Development Programs: Pooled Analysis of 35 Clinical Trials.

Vetter ML, Johnsson K, Hardy E, Wang H, Iqbal N.

Diabetes Ther. 2019 Aug;10(4):1249-1270. doi: 10.1007/s13300-019-0627-1. Epub 2019 May 10.

PMID: 31077072

 

Rationale and design for the development of a novel nitroxyl donor in patients with acute heart failure.

Felker GM, Borentain M, Cleland JG, DeSouza MM, Kessler PD, O'Connor CM, Seiffert D, Teerlink JR, Voors AA, McMurray JJV.

Eur J Heart Fail. 2019 Aug;21(8):1022-1031. doi: 10.1002/ejhf.1504. Epub 2019 Jun 6.

PMID: 31168885

 

Health and functional status, health events, use of healthcare services and costs associated with overactive bladder among the medically complex vulnerable elderly in the US.

Chuang CC, Yang E, Zou KH, Araiza A, Wang A, Luo X.

Int J Clin Pract. 2019 Aug;73(8):e13207. doi: 10.1111/ijcp.13207. Epub 2018 Jul 16.

PMID: 30011108

 

Comparisons between Oral Anticoagulants among Older Nonvalvular Atrial Fibrillation Patients.

Deitelzweig S, Keshishian A, Li X, Kang A, Dhamane AD, Luo X, Balachander N, Rosenblatt L, Mardekian J, Pan X, Nadkarni A, Di Fusco M, Garcia Reeves AB, Yuce H, Lip GYH.

J Am Geriatr Soc. 2019 Aug;67(8):1662-1671. doi: 10.1111/jgs.15956. Epub 2019 May 21.

PMID: 31112292

 

Comparative clinical outcomes between direct oral anticoagulants and warfarin among elderly patients with non-valvular atrial fibrillation in the CMS medicare population.

Amin A, Keshishian A, Dina O, Dhamane A, Nadkarni A, Carda E, Russ C, Rosenblatt L, Mardekian J, Yuce H, Baker CL.

J Thromb Thrombolysis. 2019 Aug;48(2):240-249. doi: 10.1007/s11239-019-01838-5.

PMID: 30924051

 

Cellular proliferation by multiplex immunohistochemistry identifies aggressive disease behavior in relapsed multiple myeloma.

Forsberg PA, Hammes A, Abbott D, Sherbenou DW, Rossi A, Jayabalan D, Niesvizky R, Mark TM, Ely S.

Leuk Lymphoma. 2019 Aug;60(8):2085-2087. doi: 10.1080/10428194.2018.1551537. Epub 2019 Jan 11. No abstract available.

PMID: 30632821

 

A nondestructive and noninvasive method to determine water content in lyophilized proteins using low-field time-domain NMR.

Abraham A, Elkassabany O, Krause ME, Ott A.

Magn Reson Chem. 2019 Aug;57(10):873-877. doi: 10.1002/mrc.4864. Epub 2019 Apr 29.

PMID: 30861192

 

Bioinformatic Methods and Bridging of Assay Results for Reliable Tumor Mutational Burden Assessment in Non-Small-Cell Lung Cancer.

Chang H, Sasson A, Srinivasan S, Golhar R, Greenawalt DM, Geese WJ, Green G, Zerba K, Kirov S, Szustakowski J.

Mol Diagn Ther. 2019 Aug;23(4):507-520. doi: 10.1007/s40291-019-00408-y.

PMID: 31250328

 

The trials and tribulations of CAR-T cell development for cancer and AIDS.

Hege K.

Nat Med. 2019 Aug;25(8):1183. doi: 10.1038/s41591-019-0538-8. No abstract available.

PMID: 31388173

 

A Q-TWiST Analysis Comparing Nivolumab and Therapy of Investigator's Choice in Patients with Recurrent/Metastatic Platinum-Refractory Squamous Cell Carcinoma of the Head and Neck.

Cocks K, Contente M, Simpson S, DeRosa M, Taylor FC, Shaw JW.

Pharmacoeconomics. 2019 Aug;37(8):1041-1047. doi: 10.1007/s40273-019-00798-1.

PMID: 30972702

 

Addition of Optimized Bovine Serum Albumin Level in a High-Throughput Caco-2 Assay Enabled Accurate Permeability Assessment for Lipophilic Compounds.

Cai X, Madari S, Walker A, Paiva A, Li Y, Herbst J, Shou W, Weller H.

SLAS Discov. 2019 Aug;24(7):738-744. doi: 10.1177/2472555219848483. Epub 2019 May 10.

PMID: 31076010

 

United States Valuation of EQ-5D-5L Health States Using an International Protocol.

Pickard AS, Law EH, Jiang R, Pullenayegum E, Shaw JW, Xie F, Oppe M, Boye KS, Chapman RH, Gong CL, Balch A, Busschbach JJV.

Value Health. 2019 Aug;22(8):931-941. doi: 10.1016/j.jval.2019.02.009. Epub 2019 May 25.

PMID: 31426935

 

Five-Year Survival and Correlates Among Patients With Advanced Melanoma, Renal Cell Carcinoma, or Non-Small Cell Lung Cancer Treated With Nivolumab.

Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Drilon A, Wolchok JD, Carvajal RD, McHenry MB, Hosein F, Harbison CT, Grosso JF, Sznol M.

JAMA Oncol. 2019 Jul 25. doi: 10.1001/jamaoncol.2019.2187. [Epub ahead of print]

PMID: 31343665

 

Evaluating a Multiscale Mechanistic Model of the Immune System to Predict Human Immunogenicity for a Biotherapeutic in Phase 1.

Hamuro L, Tirucherai GS, Crawford SM, Nayeem A, Pillutla RC, DeSilva BS, Leil TA, Thalhauser CJ.

AAPS J. 2019 Jul 24;21(5):94. doi: 10.1208/s12248-019-0361-7.

PMID: 31342199

 

Autoimmune pathways in mice and humans are blocked by pharmacological stabilization of the TYK2 pseudokinase domain.

Burke JR, Cheng L, Gillooly KM, Strnad J, Zupa-Fernandez A, Catlett IM, Zhang Y, Heimrich EM, McIntyre KW, Cunningham MD, Carman JA, Zhou X, Banas D, Chaudhry C, Li S, D'Arienzo C, Chimalakonda A, Yang X, Xie JH, Pang J, Zhao Q, Rose SM, Huang J, Moslin RM, Wrobleski ST, Weinstein DS, Salter-Cid LM.

Sci Transl Med. 2019 Jul 24;11(502). pii: eaaw1736. doi: 10.1126/scitranslmed.aaw1736.

PMID: 31341059

 

A Fit-for-Purpose Method for the Detection of Human Antibodies to Surface-Exposed Components of BMS-986263, a Lipid Nanoparticle-Based Drug Product Containing a siRNA Drug Substance.

Kavita U, Miller W, Ji QC, Pillutla RC.

AAPS J. 2019 Jul 22;21(5):92. doi: 10.1208/s12248-019-0360-8.

PMID: 31332587

 

Implementation of a mathematical model for the photochemical kinetics of a solid form active pharmaceutical ingredient.

La Cruz TE, Carvalho TC, Ramírez A, Tábora JE.

Int J Pharm. 2019 Jul 20;566:500-512. doi: 10.1016/j.ijpharm.2019.05.054. Epub 2019 May 23.

PMID: 31129341

 

In Praise of Remarkably Powerful Centamolecular Therapeutic Agents.

Meanwell NA, Ewing WR.

ACS Med Chem Lett. 2019 Jul 18;10(8):1094-1097. doi: 10.1021/acsmedchemlett.9b00286. eCollection 2019 Aug 8.

PMID: 31413789

 

Real-world effectiveness and tolerability of small-cell lung cancer (SCLC) treatments: A systematic literature review (SLR).

Povsic M, Enstone A, Wyn R, Kornalska K, Penrod JR, Yuan Y.

PLoS One. 2019 Jul 18;14(7):e0219622. doi: 10.1371/journal.pone.0219622. eCollection 2019.

PMID: 31318909

 

Lysosomal P-gp-MDR1 Confers Drug Resistance of Brentuximab Vedotin and Its Cytotoxic Payload Monomethyl Auristatin E in Tumor Cells.

Liu-Kreyche P, Shen H, Marino AM, Iyer RA, Humphreys WG, Lai Y.

Front Pharmacol. 2019 Jul 17;10:749. doi: 10.3389/fphar.2019.00749. eCollection 2019.

PMID: 31379564

 

Pharmacokinetics of 40 kDa PEG in rodents using high-field NMR spectroscopy.

Khandelwal P, Zhang L, Chimalakonda A, Caceres-Cortes J, Huang C, Marathe P, Reily MD.

J Pharm Biomed Anal. 2019 Jul 15;171:30-34. doi: 10.1016/j.jpba.2019.03.066. Epub 2019 Apr 1.

PMID: 30959317

 

Predicting High-Concentration Interactions of Monoclonal Antibody Solutions: Comparison of Theoretical Approaches for Strongly Attractive Versus Repulsive Conditions.

Calero-Rubio C, Saluja A, Sahin E, Roberts CJ.

J Phys Chem B. 2019 Jul 11;123(27):5709-5720. doi: 10.1021/acs.jpcb.9b03779. Epub 2019 Jun 26.

PMID: 31241333

 

The development of resilience among rheumatoid arthritis patients: a qualitative study.

Shaw Y, Bradley M, Zhang C, Dominique A, Michaud K, McDonald D, Simon TA.

Arthritis Care Res (Hoboken). 2019 Jul 8. doi: 10.1002/acr.24024. [Epub ahead of print]

PMID: 31282121

Phase II trial of AKT inhibitor MK-2206 in patients with advanced breast cancer who have tumors with PIK3CA or AKT mutations, and/or PTEN loss/PTEN mutation.

Xing Y, Lin NU, Maurer MA, Chen H, Mahvash A, Sahin A, Akcakanat A, Li Y, Abramson V, Litton J, Chavez-MacGregor M, Valero V, Piha-Paul SA, Hong D, Do KA, Tarco E, Riall D, Eterovic AK, Wulf GM, Cantley LC, Mills GB, Doyle LA, Winer E, Hortobagyi GN, Gonzalez-Angulo AM, Meric-Bernstam F.

Breast Cancer Res. 2019 Jul 5;21(1):78. doi: 10.1186/s13058-019-1154-8.

PMID: 31277699

 

Identification and biochemical analyses of selective CB₂ agonists.

Scott CE, Tang Y, Alt A, Burford NT, Gerritz SW, Ogawa LM, Zhang L, Kendall DA.

Eur J Pharmacol. 2019 Jul 5;854:1-8. doi: 10.1016/j.ejphar.2019.03.054. Epub 2019 Apr 3.

PMID: 30951717

 

Decarboxylative Intramolecular Arene Alkylation Using N-(Acyloxy)phthalimides, an Organic Photocatalyst, and Visible Light.

Sherwood TC, Xiao HY, Bhaskar RG, Simmons EM, Zaretsky S, Rauch MP, Knowles RR, Dhar TGM.

J Org Chem. 2019 Jul 5;84(13):8360-8379. doi: 10.1021/acs.joc.9b00432. Epub 2019 Mar 27.

PMID: 30905152

 

Differential left ventricular and left atrial remodelling in heart failure with preserved ejection fraction patients with and without diabetes.

Gulsin GS, Kanagala P, Chan DCS, Cheng ASH, Athithan L, Graham-Brown MPM, Singh A, Yang J, Li Z, Khunti K, Davies MJ, Arnold JR, Squire IB, Ng LL, McCann GP.

Ther Adv Endocrinol Metab. 2019 Jul 5;10:2042018819861593. doi: 10.1177/2042018819861593. eCollection 2019.

PMID: 31308926

 

Correction to: Toward a comprehensive view of cancer immune responsiveness: a synopsis from the SITC workshop.

Bedognetti D, Ceccarelli M, Galluzzi L, Lu R, Palucka K, Samayoa J, Spranger S, Warren S, Wong KK, Ziv E, Chowell D, Coussens LM, De Carvalho DD, DeNardo DG, Galon J, Kaufman HL, Kirchhoff T, Lotze MT, Luke JJ, Minn AJ, Politi K, Shultz LD, Simon R, Thórsson V, Weidhaas JB, Ascierto ML, Ascierto PA, Barnes JM, Barsan V, Bommareddy PK, Bot A, Church SE, Ciliberto G, De Maria A, Draganov D, Ho WS, McGee HM, Monette A, Murphy JF, Nisticò P, Park W, Patel M, Quigley M, Radvanyi L, Raftopoulos H, Rudqvist NP, Snyder A, Sweis RF, Valpione S, Zappasodi R, Butterfield LH, Disis ML, Fox BA, Cesano A, Marincola FM; Society for Immunotherapy of Cancer (SITC) Cancer Immune Responsiveness Task Force and Working Groups.

J Immunother Cancer. 2019 Jul 4;7(1):167. doi: 10.1186/s40425-019-0640-y.

PMID: 31272507

 

Healthcare cost comparison analysis of nivolumab in combination with ipilimumab versus nivolumab monotherapy and ipilimumab monotherapy in advanced melanoma.

Potluri R, Ranjan S, Bhandari H, Johnson H, Moshyk A, Kotapati S.

Exp Hematol Oncol. 2019 Jul 3;8:14. doi: 10.1186/s40164-019-0138-9. eCollection 2019.

PMID: 31312536

Near-Complete Genome Sequence of a Hepatitis A Subgenotype IB Virus Isolated from Frozen Raspberries.

Chen H, Wang W, Wang S, Hu Y.

Microbiol Resour Announc. 2019 Jul 3;8(27). pii: e00522-19. doi: 10.1128/MRA.00522-19.

PMID: 31270195

 

Eliminating Preparation of Multisample External Calibration Curves and Dilution of Study Samples Using the Multiple Isotopologue Reaction Monitoring (MIRM) Technique in Quantitative LC-MS/MS Bioanalysis.

Gu H, Zhao Y, DeMichele M, Zheng N, Zhang YJ, Pillutla R, Zeng J.

Anal Chem. 2019 Jul 2;91(13):8652-8659. doi: 10.1021/acs.analchem.9b02136. Epub 2019 Jun 21.

PMID: 31180205

Nivolumab Alone and With Ipilimumab in Previously Treated Metastatic Urothelial Carcinoma: CheckMate 032 Nivolumab 1 mg/kg Plus Ipilimumab 3 mg/kg Expansion Cohort Results.

Sharma P, Siefker-Radtke A, de Braud F, Basso U, Calvo E, Bono P, Morse MA, Ascierto PA, Lopez-Martin J, Brossart P, Rohrberg K, Mellado B, Fischer BS, Meadows-Shropshire S, Abdel Saci, Callahan MK, Rosenberg J.

J Clin Oncol. 2019 Jul 1;37(19):1608-1616. doi: 10.1200/JCO.19.00538. Epub 2019 May 17. Erratum in: J Clin Oncol. 2019 Aug 10;37(23):2094.

PMID: 31100038

Microbiota Metabolite Short-Chain Fatty Acids Facilitate Mucosal Adjuvant Activity of Cholera Toxin through GPR43.

Yang W, Xiao Y, Huang X, Chen F, Sun M, Bilotta AJ, Xu L, Lu Y, Yao S, Zhao Q, Liu Z, Cong Y.

J Immunol. 2019 Jul 1;203(1):282-292. doi: 10.4049/jimmunol.1801068. Epub 2019 May 10.

PMID: 31076530

 

Impact of depth filtration on disulfide bond reduction during downstream processing of monoclonal antibodies from CHO cell cultures.

O'Mara B, Gao ZH, Kuruganti M, Mallett R, Nayar G, Smith L, Meyer JD, Therriault J, Miller C, Cisney J, Fann J.

Biotechnol Bioeng. 2019 Jul;116(7):1669-1683. doi: 10.1002/bit.26964. Epub 2019 Apr 4.

PMID: 30883673

 

Mass Balance Model with Donnan Equilibrium Accurately Describes Unusual pH and Excipient Profiles during Diafiltration of Monoclonal Antibodies.

Baek Y, Singh N, Arunkumar A, Borwankar A, Zydney AL.

Biotechnol J. 2019 Jul;14(7):e1800517. doi: 10.1002/biot.201800517. Epub 2019 May 20.

PMID: 30791230

 

Real-World Clinical Impact of Immune Checkpoint Inhibitors in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer After Platinum Chemotherapy.

Schwartzberg L, Korytowsky B, Penrod JR, Zhang Y, Le TK, Batenchuk C, Krug L.

Clin Lung Cancer. 2019 Jul;20(4):287-296.e4. doi: 10.1016/j.cllc.2019.04.004. Epub 2019 Apr 19.

PMID: 31130450

 

Low-Dose Lenalidomide After Nonmyeloablative Allogeneic Hematopoietic Cell Transplantation With Bortezomib as Graft-Versus-Host Disease Prophylaxis in High-Risk Multiple Myeloma.

Khouri J, Reu F, Majhail NS, Gerds A, Jagadeesh D, Dean R, Sobecks R, Hamilton BK, Pohlman B, Hill BT, Corrigan D, Kalaycio M, Bolwell BJ, Liu HD.

Clin Lymphoma Myeloma Leuk. 2019 Jul;19(7):e374-e376. doi: 10.1016/j.clml.2019.03.019. Epub 2019 Apr 8. No abstract available.

PMID: 31053548

 

Interindividual and Regional Variability in Drug Transporter Abundance at the Human Blood-Brain Barrier Measured by Quantitative Targeted Proteomics.

Billington S, Salphati L, Hop CECA, Chu X, Evers R, Burdette D, Rowbottom C, Lai Y, Xiao G, Humphreys WG, Nguyen TB, Prasad B, Unadkat JD.

Clin Pharmacol Ther. 2019 Jul;106(1):228-237. doi: 10.1002/cpt.1373. Epub 2019 Mar 18.

PMID: 30673124

 

Organic Anion Transporter Polypeptide 1B1 Polymorphism Modulates the Extent of Drug-Drug Interaction and Associated Biomarker Levels in Healthy Volunteers.

Yee SW, Giacomini MM, Shen H, Humphreys WG, Horng H, Brian W, Lai Y, Kroetz DL, Giacomini KM.

Clin Transl Sci. 2019 Jul;12(4):388-399. doi: 10.1111/cts.12625. Epub 2019 Apr 13.

PMID: 30982223

 

Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial.

Reck M, Schenker M, Lee KH, Provencio M, Nishio M, Lesniewski-Kmak K, Sangha R, Ahmed S, Raimbourg J, Feeney K, Corre R, Franke FA, Richardet E, Penrod JR, Yuan Y, Nathan FE, Bhagavatheeswaran P, DeRosa M, Taylor F, Lawrance R, Brahmer J.

Eur J Cancer. 2019 Jul;116:137-147. doi: 10.1016/j.ejca.2019.05.008. Epub 2019 Jun 11.

PMID: 31195357

 

Real-world treatment patterns, resource use and cost burden of multiple myeloma in Portugal.

Antunes L, Rocha-Gonçalves F, Chacim S, Lefèvre C, Pereira M, Pereira S, Zagorska A, Bento MJ.

Eur J Cancer Care (Engl). 2019 Jul;28(4):e13026. doi: 10.1111/ecc.13026. Epub 2019 Mar 3.

PMID: 30828907

 

Biorelevant dissolution testing of a weak base: Interlaboratory reproducibility and investigation of parameters controlling in vitro precipitation.

Berben P, Ashworth L, Beato S, Bevernage J, Bruel JL, Butler J, Dressman J, Schäfer K, Hutchins P, Klumpp L, Mann J, Nicolai J, Ojala K, Patel S, Powell S, Rosenblatt K, Tomaszewska I, Williams J, Augustijns P.

Eur J Pharm Biopharm. 2019 Jul;140:141-148. doi: 10.1016/j.ejpb.2019.04.017. Epub 2019 Apr 30.

PMID: 31051249

 

Impact of atrial fibrillation awareness campaigns: interrupted time series using the Clinical Practice Research Datalink.

Allan V, Sammon CJ, McDonald L, Mehmud F, Alikhan R, Ramagopalan SV.

Future Cardiol. 2019 Jul;15(4):311-318. doi: 10.2217/fca-2019-0025. Epub 2019 Jun 26.

PMID: 31241353

 

Renal function and oral anticoagulant treatment of incident non-valvular atrial fibrillation: a retrospective study.

Ramagopalan SV, Stamp E, Sammon CJ, Besford M, Carroll R, Mehmud F, Alikhan R.

Future Cardiol. 2019 Jul;15(4):301-309. doi: 10.2217/fca-2019-0012. Epub 2019 May 29.

PMID: 31140872

 

Extracting data from a chemotherapy prescription platform for real-world oncology research in the UK: a pilot study.

McDonald L, Stein D, Carroll R, Soni M, Schultze A, Ramagopalan S, Wagstaff J.

Future Oncol. 2019 Jul;15(21):2471-2477. doi: 10.2217/fon-2019-0150. Epub 2019 Jun 4.

PMID: 31161801

 

Indirect comparison of nivolumab ± ipilimumab (CheckMate 032) versus other treatments for recurrent small-cell lung cancer.

Cope S, Keeping ST, Goldgrub R, Ayers D, Jansen JP, Penrod JR, Korytowsky B, Juarez-Garcia A, Yuan Y.

J Comp Eff Res. 2019 Jul;8(10):733-751. doi: 10.2217/cer-2018-0130. Epub 2019 Jun 25.

PMID: 31237143

 

Economic burden of chemotherapy-treated recurrent and/or metastatic squamous cell carcinoma of the head and neck in France: real-world data from the permanent sample of national health insurance beneficiaries.

Lafuma A, Cotté FE, Le Tourneau C, Emery C, Gaudin AF, Torreton E, Gourmelen J, Bonastre J.

J Med Econ. 2019 Jul;22(7):698-705. doi: 10.1080/13696998.2019.1594837. Epub 2019 Apr 2.

PMID: 30895832

 

Overall survival, costs, and healthcare resource use by line of therapy in Medicare patients with newly diagnosed metastatic urothelial carcinoma.

Aly A, Johnson C, Yang S, Botteman MF, Rao S, Hussain A.

J Med Econ. 2019 Jul;22(7):662-670. doi: 10.1080/13696998.2019.1591424. Epub 2019 Mar 25.

PMID: 30836812

 

International normalized ratio control and subsequent clinical outcomes in patients with atrial fibrillation using warfarin.

Guimarães PO, Lopes RD, Alexander JH, Thomas L, Hellkamp AS, Hijazi Z, Hylek EM, Gersh BJ, Garcia DA, Verheugt FWA, Hanna M, Flaker G, Vinereanu D, Granger CB.

J Thromb Thrombolysis. 2019 Jul;48(1):27-34. doi: 10.1007/s11239-019-01858-1.

PMID: 30972712

 

A Phase I/II Open-Label Study of Nivolumab in Previously Treated Advanced or Recurrent Nasopharyngeal Carcinoma and Other Solid Tumors.

Ma Y, Fang W, Zhang Y, Yang Y, Hong S, Zhao Y, Tendolkar A, Chen L, Xu D, Sheng J, Zhao H, Zhang L.

Oncologist. 2019 Jul;24(7):891-e431. doi: 10.1634/theoncologist.2019-0284. Epub 2019 May 2.

PMID: 31048330

 

The humanistic burden of advanced non-small cell lung cancer (NSCLC) in Europe: a real-world survey linking patient clinical factors to patient and caregiver burden.

Wood R, Taylor-Stokes G, Smith F, Chaib C.

Qual Life Res. 2019 Jul;28(7):1849-1861. doi: 10.1007/s11136-019-02152-6. Epub 2019 Mar 2.

PMID: 30825160

 

Analysis of exposure margins in developmental toxicity studies for detection of human teratogens.

Andrews PA, Blanset D, Costa PL, Green M, Green ML, Jacobs A, Kadaba R, Lebron JA, Mattson B, McNerney ME, Minck D, Oliveira LC, Theunissen PT, DeGeorge JJ.

Regul Toxicol Pharmacol. 2019 Jul;105:62-68. doi: 10.1016/j.yrtph.2019.04.005. Epub 2019 Apr 11.

PMID: 30981719

 

An IQ Consortium Perspective on The Scientific Committee on Health, Environmental and Emerging Risks Final Opinion on the Need for Nonhuman Primates in Biomedical Research, Production and Testing of Products and Devices (Update 2017).

Adams K, Clemons D, Impelluso LC, Lee D, Maguire S, Myers A, Petursson C, Schulingkamp R, Trouba K, Wright M.

Toxicol Pathol. 2019 Jul;47(5):649-655. doi: 10.1177/0192623319857976. Epub 2019 Jul 7.

PMID: 31280699

Apixaban for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation in France: The PAROS cross-sectional study of routine clinical practice.

Falissard B, Picard F, Mahe I, Hanon O, Touzé E, Danchin N, Lamy FX, Ricci L, Steg PG.

Arch Cardiovasc Dis. 2019 Jun - Jul;112(6-7):400-409. doi: 10.1016/j.acvd.2019.02.003. Epub 2019 Apr 20.

PMID: 31014991

Utilizing Native Directing Groups: Mechanistic Understanding of a Direct Arylation Leads to Formation of Tetracyclic Heterocycles via Tandem Intermolecular, Intramolecular C-H Activation.

Wisniewski SR, Savage SA, Romero EO, Eastgate MD, Tan Y, Simmons EM, Plata RE, Sowa JR Jr, Blackmond DG.

J Org Chem. 2019 Jun 21;84(12):7961-7970. doi: 10.1021/acs.joc.9b00823. Epub 2019 Jun 4.

PMID: 31117568

Four Yellow Monoterpenoid Quinoline Alkaloids from the Stem of Tabernaemontana bovina.

Wu J, Yu Y, Wang Y, Bao MF, Shi BB, Schinnerl J, Cai XH.

Org Lett. 2019 Jun 21;21(12):4554-4558. doi: 10.1021/acs.orglett.9b01453. Epub 2019 Jun 10.

PMID: 31179705

 

Risk of Biologics and Glucocorticoids in Patients With Rheumatoid Arthritis Undergoing Arthroplasty: A Cohort Study.

George MD, Baker JF, Winthrop K, Alemao E, Chen L, Connolly S, Hsu JY, Simon TA, Wu Q, Xie F, Yang S, Curtis JR.

Ann Intern Med. 2019 Jun 18;170(12):825-836. doi: 10.7326/M18-2217. Epub 2019 May 21.

PMID: 31108503

 

Effectiveness and safety of direct oral anticoagulants compared to warfarin in treatment naïve non-valvular atrial fibrillation patients in the US Department of defense population.

Gupta K, Trocio J, Keshishian A, Zhang Q, Dina O, Mardekian J, Nadkarni A, Shank TC.

BMC Cardiovasc Disord. 2019 Jun 13;19(1):142. doi: 10.1186/s12872-019-1116-1.

PMID: 31195999

 

Trends in kidney function testing in UK primary care since the introduction of the quality and outcomes framework: a retrospective cohort study using CPRD.

Feakins B, Oke J, McFadden E, Aronson J, Lasserson D, O'Callaghan C, Taylor C, Hill N, Stevens R, Perera R.

BMJ Open. 2019 Jun 12;9(6):e028062. doi: 10.1136/bmjopen-2018-028062. Erratum in: BMJ Open. 2019 Jul 1;9(7):e028062corr1.

PMID: 31196901

 

Cooperation between Constitutive and Inducible Chemokines Enables T Cell Engraftment and Immune Attack in Solid Tumors.

Dangaj D, Bruand M, Grimm AJ, Ronet C, Barras D, Duttagupta PA, Lanitis E, Duraiswamy J, Tanyi JL, Benencia F, Conejo-Garcia J, Ramay HR, Montone KT, Powell DJ Jr, Gimotty PA, Facciabene A, Jackson DG, Weber JS, Rodig SJ, Hodi SF, Kandalaft LE, Irving M, Zhang L, Foukas P, Rusakiewicz S, Delorenzi M, Coukos G.

Cancer Cell. 2019 Jun 10;35(6):885-900.e10. doi: 10.1016/j.ccell.2019.05.004.

PMID: 31185212

 

Polymersome nanoreactors with tumor pH-triggered selective membrane permeability for prodrug delivery, activation, and combined oxidation-chemotherapy.

Mukerabigwi JF, Yin W, Zha Z, Ke W, Wang Y, Chen W, Japir AAMM, Wang Y, Ge Z.

J Control Release. 2019 Jun 10;303:209-222. doi: 10.1016/j.jconrel.2019.04.032. Epub 2019 Apr 23.

PMID: 31026547

 

Targeting CLDN18.2 by CD3 Bispecific and ADC Modalities for the Treatments of Gastric and Pancreatic Cancer.

Zhu G, Foletti D, Liu X, Ding S, Melton Witt J, Hasa-Moreno A, Rickert M, Holz C, Aschenbrenner L, Yang AH, Kraynov E, Evering W, Obert L, Lee C, Sai T, Mistry T, Lindquist KC, Van Blarcom T, Strop P, Chaparro-Riggers J, Liu SH.

Sci Rep. 2019 Jun 10;9(1):8420. doi: 10.1038/s41598-019-44874-0. Erratum in: Sci Rep. 2019 Nov 8;9(1):16735.

PMID: 31182754

 

Safety of abatacept compared with other biologic and conventional synthetic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis: data from an observational study.

Ozen G, Pedro S, Schumacher R, Simon TA, Michaud K.

Arthritis Res Ther. 2019 Jun 7;21(1):141. doi: 10.1186/s13075-019-1921-z.

PMID: 31174592

 

Persistence rates of abatacept and TNF inhibitors used as first or second biologic DMARDs in the treatment of rheumatoid arthritis: 9 years of experience from the Rhumadata® clinical database and registry.

Choquette D, Bessette L, Alemao E, Haraoui B, Postema R, Raynauld JP, Coupal L.

Arthritis Res Ther. 2019 Jun 6;21(1):138. doi: 10.1186/s13075-019-1917-8.

PMID: 31171024

 

Catalytic Ring Expansions of Cyclic Alcohols Enabled by Proton-Coupled Electron Transfer.

Zhao K, Yamashita K, Carpenter JE, Sherwood TC, Ewing WR, Cheng PTW, Knowles RR.

J Am Chem Soc. 2019 Jun 5;141(22):8752-8757. doi: 10.1021/jacs.9b03973. Epub 2019 May 23.

PMID: 31117664

 

Interlaboratory Comparison of Hydrogen-Deuterium Exchange Mass Spectrometry Measurements of the Fab Fragment of NISTmAb.

Hudgens JW, Gallagher ES, Karageorgos I, Anderson KW, Filliben JJ, Huang RY, Chen G, Bou-Assaf GM, Espada A, Chalmers MJ, Harguindey E, Zhang HM, Walters BT, Zhang J, Venable J, Steckler C, Park I, Brock A, Lu X, Pandey R, Chandramohan A, Anand GS, Nirudodhi SN, Sperry JB, Rouse JC, Carroll JA, Rand KD, Leurs U, Weis DD, Al-Naqshabandi MA, Hageman TS, Deredge D, Wintrode PL, Papanastasiou M, Lambris JD, Li S, Urata S.

Anal Chem. 2019 Jun 4;91(11):7336-7345. doi: 10.1021/acs.analchem.9b01100. Epub 2019 May 14.

PMID: 31045344

 

Induction of a Th17 Phenotype in Human Skin-A Mimic of Dermal Inflammatory Diseases.

Garrett SM, Zhao Q, Feghali-Bostwick C.

Methods Protoc. 2019 Jun 4;2(2). pii: E45. doi: 10.3390/mps2020045.

PMID: 31164624

 

Investigations on the Relationship between Ovarian, Endocrine, and Renal Findings in Nonclinical Safety Studies of the γ-secretase Inhibitor Avagacestat.

Simutis FJ, Sanderson TP, Pilcher GD, Graziano MJ.

Toxicol Sci. 2019 Jun 4. pii: kfz129. doi: 10.1093/toxsci/kfz129. [Epub ahead of print]

PMID: 31165171

 

Dissecting the Contribution of OATP1B1 to Hepatic Uptake of Statins Using the OATP1B1 Selective Inhibitor Estropipate.

Zhang Y, Panfen E, Fancher M, Sinz M, Marathe P, Shen H.

Mol Pharm. 2019 Jun 3;16(6):2342-2353. doi: 10.1021/acs.molpharmaceut.8b01226. Epub 2019 May 13.

PMID: 31039308

 

A survey of core replacements in indole-based HIV-1 attachment inhibitors.

Wang T, Wallace OB, Zhang Z, Fang H, Yang Z, Robinson BA, Spicer TP, Gong YF, Blair WS, Shi PY, Lin PF, Deshpande M, Meanwell NA, Kadow JF.

Bioorg Med Chem Lett. 2019 Jun 1;29(11):1423-1429. doi: 10.1016/j.bmcl.2019.03.018. Epub 2019 Mar 28.

PMID: 30940396

 

Long-term treatment with atazanavir (ATV) in real life in Belgium: a retrospective observational cohort of 2264 HIV patients.

De Wit S, Florence E, Vandekerkhove L, Goffard JC, Vandercam B, Van Wijngaerden E, Moutschen M, Demeester R, Lacor P, Delforge M, van Frankenhuijsen M, Lacante P.

Acta Clin Belg. 2019 Jun;74(3):143-150. doi: 10.1080/17843286.2018.1462753. Epub 2018 May 2.

PMID: 29718781

 

Optimization of microflow LC-MS/MS and its utility in quantitative discovery bioanalysis.

Zhang J, Shou W, Ogura T, Li S, Weller H.

Bioanalysis. 2019 Jun;11(11):1117-1127. doi: 10.4155/bio-2019-0076.

PMID: 31251100

 

Oncology Therapy Drugs in China, Japan, and the United States: Pharmacokinetic Characteristics, Dose Regimens, and Development Strategies.

Zhou L, Higashimori M, Shen K, Zhang Z, Sheng J, Xu H, Horiuchi M, Ichikawa K, Al-Huniti N, Zhou D.

Clin Pharmacol Ther. 2019 Jun;105(6):1303-1320. doi: 10.1002/cpt.1352. Epub 2019 Feb 25. Review. No abstract available.

PMID: 30802932

 

Association of Changes in Anticitrullinated Protein Antibody Levels With Resource Use and Disease Activity Measures in Rheumatoid Arthritis Patients a US Observational Cohort.

Alemao E, Iannaccone CK, Weinblatt ME, Shadick NA.

Clin Ther. 2019 Jun;41(6):1057-1065.e3. doi: 10.1016/j.clinthera.2019.04.029. Epub 2019 May 23.

PMID: 31130229

 

 A Flexible Approach for Context-Dependent Assessment of Quantitative Systems Pharmacology Models.

Ramanujan S, Chan JR, Friedrich CM, Thalhauser CJ.

CPT Pharmacometrics Syst Pharmacol. 2019 Jun;8(6):340-343. doi: 10.1002/psp4.12409. Epub 2019 May 14. No abstract available. Erratum in: CPT Pharmacometrics Syst Pharmacol. 2020 Feb;9(2):124.

PMID: 30983158

 

Cyt-Geist: Current and Future Challenges in Cytometry: Reports of the CYTO 2018 Conference Workshops.

Czechowska K, Lannigan J, Wang L, Arcidiacono J, Ashhurst TM, Barnard RM, Bauer S, Bispo C, Bonilla DL, Brinkman RR, Cabanski M, Chang HD, Chakrabarti L, Chojnowski G, Cotleur B, Degheidy H, Dela Cruz GV, Eck S, Elliott J, Errington R, Filby A, Gagnon D, Gardner R, Green C, Gregory M, Groves CJ, Hall C, Hammes F, Hedrick M, Hoffman R, Icha J, Ivaska J, Jenner DC, Jones D, Kerckhof FM, Kukat C, Lanham D, Leavesley S, Lee M, Lin-Gibson S, Litwin V, Liu Y, Molloy J, Moore JS, Müller S, Nedbal J, Niesner R, Nitta N, Ohlsson-Wilhelm B, Paul NE, Perfetto S, Portat Z, Props R, Radtke S, Rayanki R, Rieger A, Rogers S, Rubbens P, Salomon R, Schiemann M, Sharpe J, Sonder SU, Stewart JJ, Sun Y, Ulrich H, Van Isterdael G, Vitaliti A, van Vreden C, Weber M, Zimmermann J, Vacca G, Wallace P, Tárnok A.

Cytometry A. 2019 Jun;95(6):598-644. doi: 10.1002/cyto.a.23777. No abstract available.

PMID: 31207046

 

 Cost-effectiveness analysis of Daclatasvir/Sofosbuvir for the treatment of the HCV patients failed after the first line with second generation of DAAs in Italy.

Ruggeri M, Rolli FR, Kondili LA, Drago C, De Solda F, Nappi C, Cicchetti A.

Expert Rev Pharmacoecon Outcomes Res. 2019 Jun;19(3):363-374. doi: 10.1080/14737167.2019.1537784. Epub 2018 Oct 31.

PMID: 30351994

 

Cohort versus patient level simulation for the economic evaluation of single versus combination immuno-oncology therapies in metastatic melanoma.

Gibson EJ, Begum N, Koblbauer I, Dranitsaris G, Liew D, McEwan P, Yuan Y, Juarez-Garcia A, Tyas D, Pritchard C.

J Med Econ. 2019 Jun;22(6):531-544. doi: 10.1080/13696998.2019.1569446. Epub 2019 Jan 30.

PMID: 30638416

 

 Combination anti-CXCR4 and anti-PD-1 immunotherapy provides survival benefit in glioblastoma through immune cell modulation of tumor microenvironment.

Wu A, Maxwell R, Xia Y, Cardarelli P, Oyasu M, Belcaid Z, Kim E, Hung A, Luksik AS, Garzon-Muvdi T, Jackson CM, Mathios D, Theodros D, Cogswell J, Brem H, Pardoll DM, Lim M.

J Neurooncol. 2019 Jun;143(2):241-249. doi: 10.1007/s11060-019-03172-5. Epub 2019 Apr 25.

PMID: 31025274

 

Probing the Tryptophan Environment in Therapeutic Proteins: Implications for Higher Order Structure on Tryptophan Oxidation.

Barnett GV, Balakrishnan G, Chennamsetty N, Hoffman L, Bongers J, Tao L, Huang Y, Slaney T, Das TK, Leone A, Kar SR.

J Pharm Sci. 2019 Jun;108(6):1944-1952. doi: 10.1016/j.xphs.2018.12.027. Epub 2019 Jan 11.

PMID: 30639740

 

Safety of the tau-directed monoclonal antibody BIIB092 in progressive supranuclear palsy: a randomised, placebo-controlled, multiple ascending dose phase 1b trial.

Boxer AL, Qureshi I, Ahlijanian M, Grundman M, Golbe LI, Litvan I, Honig LS, Tuite P, McFarland NR, O'Suilleabhain P, Xie T, Tirucherai GS, Bechtold C, Bordelon Y, Geldmacher DS, Grossman M, Isaacson S, Zesiewicz T, Olsson T, Muralidharan KK, Graham DL, O'Gorman J, Haeberlein SB, Dam T.

Lancet Neurol. 2019 Jun;18(6):549-558. doi: 10.1016/S1474-4422(19)30139-5.

PMID: 31122495

 

Applications of machine learning in drug discovery and development.

Vamathevan J, Clark D, Czodrowski P, Dunham I, Ferran E, Lee G, Li B, Madabhushi A, Shah P, Spitzer M, Zhao S.

Nat Rev Drug Discov. 2019 Jun;18(6):463-477. doi: 10.1038/s41573-019-0024-5. Review.

PMID: 30976107

 

High Proportion of Subjective Component to the Disease Activity Score is Associated with Favorable Response to Abatacept in Rheumatoid Arthritis.

Lee JS, Ahmad H, Shim SC, Bae SC, Song YW, Lee EY.

Patient. 2019 Jun;12(3):319-326. doi: 10.1007/s40271-018-0347-z.

PMID: 30484084

 

Comparative Effectiveness of Abatacept Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis Who Are Anti-CCP Positive in the United States Corrona Registry.

Harrold LR, Litman HJ, Connolly SE, Alemao E, Kelly S, Rebello S, Hua W, Kremer JM.

Rheumatol Ther. 2019 Jun;6(2):217-230. doi: 10.1007/s40744-019-0149-3. Epub 2019 Mar 13.

PMID: 30868550

 

Abatacept initiation in rheumatoid arthritis and the risk of serious infection: A population-based cohort study.

Montastruc F, Renoux C, Hudson M, Dell'Aniello S, Simon TA, Suissa S.

Semin Arthritis Rheum. 2019 Jun;48(6):1053-1058. doi: 10.1016/j.semarthrit.2019.01.009. Epub 2019 Jan 25.

PMID: 30772001

 

Scientific and Regulatory Policy Committee Points to Consider*: Review of Scientific and Regulatory Policy Committee Points to Consider: Review of Current Practices for Ultrastructural Pathology Evaluations in Support of Nonclinical Toxicology Studies.

Keirstead ND, Janovitz EB, Meehan JT, LeRoy BE, Megill JR, Peterson RA, Masson RG, Marxfeld HA.

Toxicol Pathol. 2019 Jun;47(4):461-468. doi: 10.1177/0192623319835170. Epub 2019 Apr 24.

PMID: 31018785

 

Effect of pretreatment regimens of 1-aminobenzotriazole on metabolism and gastric emptying of probe compounds in rat.

Padmanabhan S, Kaur H, Rao A, Saxena A, Gupta YK, Mariappan TT, Holenarsipur VK.

Xenobiotica. 2019 Jun;49(6):646-654. doi: 10.1080/00498254.2018.1489166. Epub 2018 Sep 7.

PMID: 29898636

 

Treatment patterns and economic outcomes in patients with juvenile idiopathic arthritis.

Marshall A, Gupta K, Pazirandeh M, Bonafede M, McMorrow D.

Clinicoecon Outcomes Res. 2019 May 31;11:361-371. doi: 10.2147/CEOR.S197117. eCollection 2019.

PMID: 31213863

 

Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis.

Arroyo R, Bury DP, Guo JD, Margolin DH, Melanson M, Daizadeh N, Cella D.

Mult Scler. 2019 May 30:1352458519849796. doi: 10.1177/1352458519849796. [Epub ahead of print]

PMID: 31144568

 

Body mass index and treatment response to subcutaneous abatacept in patients with psoriatic arthritis: a post hoc analysis of a phase III trial.

McInnes IB, Ferraccioli G, D'Agostino MA, Le Bars M, Banerjee S, Ahmad HA, Elbez Y, Mease PJ.

RMD Open. 2019 May 30;5(1):e000934. doi: 10.1136/rmdopen-2019-000934. eCollection 2019.

PMID: 31245054

 

Safety of Abatacept Versus Placebo in Rheumatoid Arthritis: Integrated Data Analysis of Nine Clinical Trials.

Simon TA, Soule BP, Hochberg M, Fleming D, Torbeyns A, Banerjee S, Boers M.

ACR Open Rheumatol. 2019 May 29;1(4):251-257. doi: 10.1002/acr2.1034. eCollection 2019 Jun.

PMID: 31777801

 

Application of ultrasound-guided cholecystocentesis to the evaluation of the metabolite profiling in bile of dogs and cynomolgus monkeys.

Dierks EA, Luk CE, Cai H, MacGuire J, Fox M, Smalley J, Fancher RM, Janovitz E, Foster K, Sun Q.

Pharmacol Res Perspect. 2019 May 27;7(3):e00488. doi: 10.1002/prp2.488. eCollection 2019 Jun.

PMID: 31149343

 

Toward a comprehensive view of cancer immune responsiveness: a synopsis from the SITC workshop.

Bedognetti D, Ceccarelli M, Galluzzi L, Lu R, Palucka K, Samayoa J, Spranger S, Warren S, Wong KK, Ziv E, Chowell D, Coussens LM, De Carvalho DD, DeNardo DG, Galon J, Kaufman HL, Kirchhoff T, Lotze MT, Luke JJ, Minn AJ, Politi K, Shultz LD, Simon R, Thórsson V, Weidhaas JB, Ascierto ML, Ascierto PA, Barnes JM, Barsan V, Bommareddy PK, Bot A, Church SE, Ciliberto G, De Maria A, Draganov D, Ho WS, McGee HM, Monette A, Murphy JF, Nisticò P, Park W, Patel M, Quigley M, Radvanyi L, Raftopoulos H, Rudqvist NP, Snyder A, Sweis RF, Valpione S, Zappasodi R, Butterfield LH, Disis ML, Fox BA, Cesano A, Marincola FM; Society for Immunotherapy of Cancer (SITC) Cancer Immune Responsiveness Task Force and Working Groups.

J Immunother Cancer. 2019 May 22;7(1):131. doi: 10.1186/s40425-019-0602-4. Review. Erratum in: J Immunother Cancer. 2019 Jul 4;7(1):167.

PMID: 31113486

 

Pan-TAM Tyrosine Kinase Inhibitor BMS-777607 Enhances Anti-PD-1 mAb Efficacy in a Murine Model of Triple-Negative Breast Cancer.

Kasikara C, Davra V, Calianese D, Geng K, Spires TE, Quigley M, Wichroski M, Sriram G, Suarez-Lopez L, Yaffe MB, Kotenko SV, De Lorenzo MS, Birge RB.

Cancer Res. 2019 May 15;79(10):2669-2683. doi: 10.1158/0008-5472.CAN-18-2614. Epub 2019 Mar 15.

PMID: 30877108

 

Efficacy and Safety of Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Extremes in Body Weight.

Hohnloser SH, Fudim M, Alexander JH, Wojdyla DM, Ezekowitz JA, Hanna M, Atar D, Hijazi Z, Bahit MC, Al-Khatib SM, Lopez-Sendon JL, Wallentin L, Granger CB, Lopes RD.

Circulation. 2019 May 14;139(20):2292-2300. doi: 10.1161/CIRCULATIONAHA.118.037955.

PMID: 30773022

 

Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study.

Inoue H, Umeyama M, Yamada T, Hashimoto H, Komoto A, Yasaka M.

J Arrhythm. 2019 May 9;35(3):506-514. doi: 10.1002/joa3.12184. eCollection 2019 Jun.

PMID: 31293700

 

Small-Scale Tools to Assess the Impact of Interfacial and Shear Stress on Biologic Drug Products.

Ogunyankin MO, Deshmukh S, Krause ME, Carvalho T, Huang M, Ilott A, Remy B, Khossravi M.

AAPS PharmSciTech. 2019 May 6;20(5):184. doi: 10.1208/s12249-019-1378-z.

PMID: 31062111

 

Identification of RIPK3 Type II Inhibitors Using High-Throughput Mechanistic Studies in Hit Triage.

Hart AC, Abell L, Guo J, Mertzman ME, Padmanabha R, Macor JE, Chaudhry C, Lu H, O'Malley K, Shaw PJ, Weigelt C, Pokross M, Kish K, Kim KS, Cornelius L, Douglas AE, Calambur D, Zhang P, Carpenter B, Pitts WJ.

ACS Med Chem Lett. 2019 May 6;11(3):266-271. doi: 10.1021/acsmedchemlett.9b00065. eCollection 2020 Mar 12.

PMID: 32184955

 

Discovery of a Lead Triphenylethanamine Cholesterol Ester Transfer Protein (CETP) Inhibitor.

Finlay HJ, Jiang J, Rampulla R, Salvati ME, Qiao JX, Wang TC, Lawrence RM, Harikrishnan LS, Kamau MG, Taylor DS, Chen AYA, Yin X, Huang CS, Chang M, Chen XQ, Sleph PG, Xu C, Li J, Levesque P, Adam LP, Wexler RR.

ACS Med Chem Lett. 2019 May 6;10(6):911-916. doi: 10.1021/acsmedchemlett.9b00086. eCollection 2019 Jun 13.

PMID: 31223447

 

And They Said It Couldn't Be Done: Predicting Known Driver Mutations From H&E Slides.

Montalto MC, Edwards R.

J Pathol Inform. 2019 May 6;10:17. doi: 10.4103/jpi.jpi_91_18. eCollection 2019. No abstract available.

PMID: 31149368

 

Deamidation Can Compromise Antibody Colloidal Stability and Enhance Aggregation in a pH-Dependent Manner.

Alam ME, Barnett GV, Slaney TR, Starr CG, Das TK, Tessier PM.

Mol Pharm. 2019 May 6;16(5):1939-1949. doi: 10.1021/acs.molpharmaceut.8b01311. Epub 2019 Apr 16.

PMID: 30916563

 

The impact of increased post-progression survival on the cost-effectiveness of interventions in oncology.

Retzler J, Davies H, Jenks M, Kiff C, Taylor M.

Clinicoecon Outcomes Res. 2019 May 3;11:309-324. doi: 10.2147/CEOR.S191382. eCollection 2019.

PMID: 31118714

 

Treatment Patterns in Patients with Chronic-Phase Chronic Myeloid Leukaemia in Routine Clinical Practice: the SIMPLICITY Italian Population.

Abruzzese E, Bosi A, Breccia M, D'Adda M, Di Renzo N, Liberati AM, Porrini R, Orlandi EM, Pane F, Pungolino E, Sorà F, Stagno F, Sen GP, Gentilini F, De Solda F, Gambacorti-Passerini C.

Mediterr J Hematol Infect Dis. 2019 May 1;11(1):e2019025. doi: 10.4084/MJHID.2019.025. eCollection 2019.

PMID: 31205629

 

Phase II study of carfilzomib and dexamethasone therapy for newly diagnosed multiple myeloma.

Forsberg PA, Rossi AC, Boyer A, Tegnestam L, Pearse RN, Perry A, Pekle KA, Jayabalan D, Ely S, Boussi L, Sherbenou DW, Williams C, Allan JN, Coleman M, Niesvizky R, Mark TM.

Am J Hematol. 2019 May;94(5):539-545. doi: 10.1002/ajh.25435. Epub 2019 Feb 25.

PMID: 30740766

 

Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair: Insights from the ARISTOTLE trial.

Guimarães PO, Pokorney SD, Lopes RD, Wojdyla DM, Gersh BJ, Giczewska A, Carnicelli A, Lewis BS, Hanna M, Wallentin L, Vinereanu D, Alexander JH, Granger CB.

Clin Cardiol. 2019 May;42(5):568-571. doi: 10.1002/clc.23178. Epub 2019 Apr 9.

PMID: 30907005

 

Correction to: Predictors of abatacept retention over 2 years in patients with rheumatoid arthritis: results from the real-world ACTION study.

Alten R, Mariette X, Lorenz HM, Nüßlein H, Galeazzi M, Navarro F, Chartier M, Heitzmann J, Poncet C, Rauch C, Le Bars M.

Clin Rheumatol. 2019 May;38(5):1535. doi: 10.1007/s10067-019-04545-x.

PMID: 30972577

 

Predictors of abatacept retention over 2 years in patients with rheumatoid arthritis: results from the real-world ACTION study.

Alten R, Mariette X, Lorenz HM, Nüßlein H, Galeazzi M, Navarro F, Chartier M, Heitzmann J, Poncet C, Rauch C, Le Bars M.

Clin Rheumatol. 2019 May;38(5):1413-1424. doi: 10.1007/s10067-019-04449-w. Epub 2019 Feb 21. Erratum in: Clin Rheumatol. 2019 Apr 11;:.

PMID: 30790095

 

Immune Checkpoint Inhibition in Sepsis: A Phase 1b Randomized, Placebo-Controlled, Single Ascending Dose Study of Antiprogrammed Cell Death-Ligand 1 Antibody (BMS-936559).

Hotchkiss RS, Colston E, Yende S, Angus DC, Moldawer LL, Crouser ED, Martin GS, Coopersmith CM, Brakenridge S, Mayr FB, Park PK, Ye J, Catlett IM, Girgis IG, Grasela DM.

Crit Care Med. 2019 May;47(5):632-642. doi: 10.1097/CCM.0000000000003685.

PMID: 30747773

 

Immune-checkpoint inhibitors and candidate surrogate endpoints for overall survival across tumour types: A systematic literature review.

Branchoux S, Bellera C, Italiano A, Rustand D, Gaudin AF, Rondeau V.

Crit Rev Oncol Hematol. 2019 May;137:35-42. doi: 10.1016/j.critrevonc.2019.02.013. Epub 2019 Mar 1.

PMID: 31014514

 

Some observations on the liquid crystalline and gel behaviors of aqueous dispersions of a prodrug.

Tao L, Li J, Pinamanenni S, Raghavan K.

Drug Dev Ind Pharm. 2019 May;45(5):819-825. doi: 10.1080/03639045.2019.1576721. Epub 2019 Feb 13.

PMID: 30715959

 

The changing face of venous thromboembolism management in England.

Ramagopalan SV, Carroll R, Ulvestad M, Mehmud F, Alikhan R.

Future Cardiol. 2019 May;15(3):183-185. doi: 10.2217/fca-2019-0003. Epub 2019 Mar 25. Review.

PMID: 30907131

 

I-O Optimise: a novel multinational real-world research platform in thoracic malignancies.

Ekman S, Griesinger F, Baas P, Chao D, Chouaid C, O'Donnell JC, Penrod JR, Daumont M, Lacoin L, McKenney A, Khovratovich M, Munro RE, Durand-Zaleski I, Johnsen SP.

Future Oncol. 2019 May;15(14):1551-1563. doi: 10.2217/fon-2019-0025. Epub 2019 Mar 11.

PMID: 30852916

 

Comparative efficacy of combination immunotherapy and targeted therapy in the treatment of BRAF-mutant advanced melanoma: a matching-adjusted indirect comparison.

Atkins MB, Tarhini A, Rael M, Gupte-Singh K, O'Brien E, Ritchings C, Rao S, McDermott DF.

Immunotherapy. 2019 May;11(7):617-629. doi: 10.2217/imt-2018-0208. Epub 2019 Mar 11.

PMID: 30852924

 

Whose Benchmark Is Right? Validating Venous Thromboembolism Events Between Trauma Registries and Hospital Administrative Databases.

Miano TA, Abelian G, Seamon MJ, Chreiman K, Reilly PM, Martin ND.

J Am Coll Surg. 2019 May;228(5):752-759.e3. doi: 10.1016/j.jamcollsurg.2019.02.037. Epub 2019 Feb 15.

PMID: 30772443

 

Treatment patterns and outcomes for patients with unresectable stage III and metastatic melanoma in the USA.

Tarhini A, Atzinger C, Gupte-Singh K, Johnson C, Macahilig C, Rao S.

J Comp Eff Res. 2019 May;8(7):461-473. doi: 10.2217/cer-2019-0003. Epub 2019 Mar 5.

PMID: 30832505

 

Nivolumab Versus Docetaxel in a Predominantly Chinese Patient Population With Previously Treated Advanced NSCLC: CheckMate 078 Randomized Phase III Clinical Trial.

Wu YL, Lu S, Cheng Y, Zhou C, Wang J, Mok T, Zhang L, Tu HY, Wu L, Feng J, Zhang Y, Luft AV, Zhou J, Ma Z, Lu Y, Hu C, Shi Y, Baudelet C, Cai J, Chang J.

J Thorac Oncol. 2019 May;14(5):867-875. doi: 10.1016/j.jtho.2019.01.006. Epub 2019 Jan 17.

PMID: 30659987

 

Anticoagulant selection for patients with VTE-Evidence from a systematic literature review of network meta-analyses.

Cohen AT, Berger SE, Milenković D, Hill NR, Lister S.

Pharmacol Res. 2019 May;143:166-177. doi: 10.1016/j.phrs.2019.03.017. Epub 2019 Mar 21.

PMID: 30905806

Diagnostic Performance of 4D CT and Sestamibi SPECT/CT in Localizing Parathyroid Adenomas in Primary Hyperparathyroidism.

Yeh R, Tay YD, Tabacco G, Dercle L, Kuo JH, Bandeira L, McManus C, Leung DK, Lee JA, Bilezikian JP.

Radiology. 2019 May;291(2):469-476. doi: 10.1148/radiol.2019182122. Epub 2019 Mar 5.

PMID: 30835187

 

Correction to: On-drug and drug-free remission by baseline symptom duration: abatacept with methotrexate in patients with early rheumatoid arthritis.

Bykerk VP, Burmester GR, Combe BG, Furst DE, Huizinga TWJ, Ahmad HA, Emery P.

Rheumatol Int. 2019 May;39(5):945. doi: 10.1007/s00296-018-4232-9.

PMID: 30721326

 

The humanistic burden associated with caring for patients with advanced non-small cell lung cancer (NSCLC) in three European countries-a real-world survey of caregivers.

Wood R, Taylor-Stokes G, Lees M.

Support Care Cancer. 2019 May;27(5):1709-1719. doi: 10.1007/s00520-018-4419-3. Epub 2018 Aug 18.

PMID: 30121787

 

Pharma Collaboration for Transparent Medical Information (phactMI) Benchmark Study: Trends, Drivers, Success Factors, and Value of Globalization in Medical Information.

Giffin SA, Shah R, Soloff A, Vaysman AM, Oreper J, Gažo A, Gandhi P, Shah I, Malieckal T, Boulos D, Flowers T, Stevens CA, Rocco MS, Patel AS, Albano D.

Ther Innov Regul Sci. 2019 May;53(3):332-339. doi: 10.1177/2168479018779920. Epub 2018 Jun 19.

PMID: 29916261

 

PREVAPIX-ALL: Apixaban Compared to Standard of Care for Prevention of Venous Thrombosis in Paediatric Acute Lymphoblastic Leukaemia (ALL)-Rationale and Design.

O'Brien SH, Li D, Mitchell LG, Hess T, Zee P, Yee DL, Newburger JW, Sung L, Rodriguez V.

Thromb Haemost. 2019 May;119(5):844-853. doi: 10.1055/s-0039-1679938. Epub 2019 Mar 12.

PMID: 30861550

Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study.

Hara R, Umebayashi H, Takei S, Okamoto N, Iwata N, Yamasaki Y, Nakagishi Y, Kizawa T, Kobayashi I, Imagawa T, Kinjo N, Amano N, Takahashi Y, Mori M, Itoh Y, Yokota S.

Pediatr Rheumatol Online J. 2019 Apr 30;17(1):17. doi: 10.1186/s12969-019-0319-4.

PMID: 31039807

 

A Radical Approach to Anionic Chemistry: Synthesis of Ketones, Alcohols, and Amines.

Ni S, Padial NM, Kingston C, Vantourout JC, Schmitt DC, Edwards JT, Kruszyk MM, Merchant RR, Mykhailiuk PK, Sanchez BB, Yang S, Perry MA, Gallego GM, Mousseau JJ, Collins MR, Cherney RJ, Lebed PS, Chen JS, Qin T, Baran PS.

J Am Chem Soc. 2019 Apr 24;141(16):6726-6739. doi: 10.1021/jacs.9b02238. Epub 2019 Apr 16.

PMID: 30943023

 

Role of Cdc23/Mcm10 in generating the ribonucleotide imprint at the mat1 locus in fission yeast.

Singh B, Bisht KK, Upadhyay U, Kushwaha AC, Nanda JS, Srivastava S, Saini JK, Klar AJS, Singh J.

Nucleic Acids Res. 2019 Apr 23;47(7):3422-3433. doi: 10.1093/nar/gkz092.

PMID: 30759238

 

First-Line Nivolumab Plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer (CheckMate 568): Outcomes by Programmed Death Ligand 1 and Tumor Mutational Burden as Biomarkers.

Ready N, Hellmann MD, Awad MM, Otterson GA, Gutierrez M, Gainor JF, Borghaei H, Jolivet J, Horn L, Mates M, Brahmer J, Rabinowitz I, Reddy PS, Chesney J, Orcutt J, Spigel DR, Reck M, O'Byrne KJ, Paz-Ares L, Hu W, Zerba K, Li X, Lestini B, Geese WJ, Szustakowski JD, Green G, Chang H, Ramalingam SS.

J Clin Oncol. 2019 Apr 20;37(12):992-1000. doi: 10.1200/JCO.18.01042. Epub 2019 Feb 20.

PMID: 30785829

 

Sustainability Challenges in Peptide Synthesis and Purification: From R&D to Production.

Isidro-Llobet A, Kenworthy MN, Mukherjee S, Kopach ME, Wegner K, Gallou F, Smith AG, Roschangar F.

J Org Chem. 2019 Apr 19;84(8):4615-4628. doi: 10.1021/acs.joc.8b03001. Epub 2019 Mar 22.

PMID: 30900880

 

Utilizing Native Directing Groups: Synthesis of a Selective I_Kur Inhibitor, BMS-919373, via a Regioselective C-H Arylation.

Wisniewski SR, Stevens JM, Yu M, Fraunhoffer KJ, Romero EO, Savage SA.

J Org Chem. 2019 Apr 19;84(8):4704-4714. doi: 10.1021/acs.joc.8b02254. Epub 2018 Nov 15.

PMID: 30395712

C-H Arylation in the Formation of a Complex Pyrrolopyridine, the Commercial Synthesis of the Potent JAK2 Inhibitor, BMS-911543.

Fox RJ, Cuniere NL, Bakrania L, Wei C, Strotman NA, Hay M, Fanfair D, Regens C, Beutner GL, Lawler M, Lobben P, Soumeillant MC, Cohen B, Zhu K, Skliar D, Rosner T, Markwalter CE, Hsiao Y, Tran K, Eastgate MD.

J Org Chem. 2019 Apr 19;84(8):4661-4669. doi: 10.1021/acs.joc.8b02383. Epub 2018 Nov 12.

PMID: 30388009

 

Effects of Multiple Catalyst Deactivation Pathways and Continuous Ligand Recycling on the Kinetics of Pd-Catalyzed C-N Coupling Reactions.

Strotman NA, Soumeillant MC, Zhu K, Markwalter CE, Wei CS, Hsiao Y, Eastgate MD.

J Org Chem. 2019 Apr 19;84(8):4653-4660. doi: 10.1021/acs.joc.8b02214. Epub 2018 Oct 24.

PMID: 30336032

 

Synthesis of 2'-Methyl-6-methoxyguanosine from the Parent Ribonucleoside Guanosine.

Yuan C, Chen K, Eastgate M.

J Org Chem. 2019 Apr 19;84(8):4646-4652. doi: 10.1021/acs.joc.8b02194. Epub 2018 Oct 11.

PMID: 30253104

 

Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation.

Lopes RD, Heizer G, Aronson R, Vora AN, Massaro T, Mehran R, Goodman SG, Windecker S, Darius H, Li J, Averkov O, Bahit MC, Berwanger O, Budaj A, Hijazi Z, Parkhomenko A, Sinnaeve P, Storey RF, Thiele H, Vinereanu D, Granger CB, Alexander JH; AUGUSTUS Investigators.

N Engl J Med. 2019 Apr 18;380(16):1509-1524. doi: 10.1056/NEJMoa1817083. Epub 2019 Mar 17.

PMID: 30883055

 

A robust data-driven genomic signature for idiopathic pulmonary fibrosis with applications for translational model selection.

Ammar R, Sivakumar P, Jarai G, Thompson JR.

PLoS One. 2019 Apr 18;14(4):e0215565. doi: 10.1371/journal.pone.0215565. eCollection 2019.

PMID: 30998768

 

Report on the AAPS Immunogenicity Guidance Forum.

Myler H, Gorovits B, Phillips K, Devanarayan V, Clements-Egan A, Gunn GR, Kirshner S, DeSilva B, Shah VP.

AAPS J. 2019 Apr 16;21(4):55. doi: 10.1208/s12248-019-0328-8.

PMID: 30993501

 

Quadrupole Dalton-Based Controlled Proteolysis Method for Characterization of Higher Order Protein Structure.

Cao X, Flagg SC, Li X, Chennamsetty N, Balakrishnan G, Das TK.

Anal Chem. 2019 Apr 16;91(8):5339-5345. doi: 10.1021/acs.analchem.9b00306. Epub 2019 Apr 4.

PMID: 30915848

 

CD28 Signaling Controls Metabolic Fitness of Pathogenic T Cells in Medium and Large Vessel Vasculitis.

Zhang H, Watanabe R, Berry GJ, Nadler SG, Goronzy JJ, Weyand CM.

J Am Coll Cardiol. 2019 Apr 16;73(14):1811-1823. doi: 10.1016/j.jacc.2019.01.049.

PMID: 30975299

 

Safety of Apixaban Administered via Nasogastric Tube.

Odell K, Costello J.

Cardiology. 2019 April 12;142(1):39. doi: 10.1159/000495577. Epub 2019 Apr 12. No abstract available.

PMID: 30982047

Discovery of Branebrutinib (BMS-986195): A Strategy for Identifying a Highly Potent and Selective Covalent Inhibitor Providing Rapid in Vivo Inactivation of Bruton's Tyrosine Kinase (BTK).

Watterson SH, Liu Q, Beaudoin Bertrand M, Batt DG, Li L, Pattoli MA, Skala S, Cheng L, Obermeier MT, Moore R, Yang Z, Vickery R, Elzinga PA, Discenza L, D'Arienzo C, Gillooly KM, Taylor TL, Pulicicchio C, Zhang Y, Heimrich E, McIntyre KW, Ruan Q, Westhouse RA, Catlett IM, Zheng N, Chaudhry C, Dai J, Galella MA, Tebben AJ, Pokross M, Li J, Zhao R, Smith D, Rampulla R, Allentoff A, Wallace MA, Mathur A, Salter-Cid L, Macor JE, Carter PH, Fura A, Burke JR, Tino JA.

J Med Chem. 2019 Apr 11;62(7):3228-3250. doi: 10.1021/acs.jmedchem.9b00167. Epub 2019 Mar 29.

 

Aryl hydrocarbon receptor acts as a tumor suppressor in a syngeneic MC38 colon carcinoma tumor model.

Yakkundi P, Gonsalves E, Galou-Lameyer M, Selby MJ, Chan WK.

Hypoxia (Auckl). 2019 Apr 10;7:1-16. doi: 10.2147/HP.S196301. eCollection 2019.

PMID: 31119183

 

Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial.

Lebbé C, Meyer N, Mortier L, Marquez-Rodas I, Robert C, Rutkowski P, Menzies AM, Eigentler T, Ascierto PA, Smylie M, Schadendorf D, Ajaz M, Svane IM, Gonzalez R, Rollin L, Lord-Bessen J, Saci A, Grigoryeva E, Pigozzo J.

J Clin Oncol. 2019 Apr 10;37(11):867-875. doi: 10.1200/JCO.18.01998. Epub 2019 Feb 27.

PMID: 30811280

 

Pharmacological Optimization for Successful Traumatic Brain Injury Drug Development.

Poloyac SM, Bertz RJ, McDermott LA, Marathe P.

J Neurotrauma. 2019 Apr 10. doi: 10.1089/neu.2018.6295. [Epub ahead of print]

PMID: 30816062

 

Recent advances in 3Rs and laboratory animal science: Report on the International Conference of LASA (India).

Singh VP, Yadav S, Joshi H, Devan SRK, Yadav DK, Singh RP.

ALTEX. 2019 April 10;36(2):322-328. doi: 10.14573/altex.1901041. No abstract available.

PMID: 31032864

 

High-Throughput Analysis of Clinical Flow Cytometry Data by Automated Gating.

Lee H, Sun Y, Patti-Diaz L, Hedrick M, Ehrhardt AG.

Bioinform Biol Insights. 2019 Apr 3;13:1177932219838851. doi: 10.1177/1177932219838851. eCollection 2019.

PMID: 30983860

Major pathologic response on biopsy (MPRbx) in patients with advanced melanoma treated with anti-PD-1: evidence for an early, on-therapy biomarker of response.

Stein JE, Soni A, Danilova L, Cottrell TR, Gajewski TF, Hodi FS, Bhatia S, Urba WJ, Sharfman WH, Wind-Rotolo M, Edwards R, Lipson EJ, Taube JM.

Ann Oncol. 2019 Apr 1;30(4):589-596. doi: 10.1093/annonc/mdz019.

PMID: 30689736

irRECIST for the Evaluation of Candidate Biomarkers of Response to Nivolumab in Metastatic Clear Cell Renal Cell Carcinoma: Analysis of a Phase II Prospective Clinical Trial.

Pignon JC, Jegede O, Shukla SA, Braun DA, Horak CE, Wind-Rotolo M, Ishii Y, Catalano PJ, Grosha J, Flaifel A, Novak JS, Mahoney KM, Freeman GJ, Sharpe AH, Hodi FS, Motzer RJ, Choueiri TK, Wu CJ, Atkins MB, McDermott DF, Signoretti S.

Clin Cancer Res. 2019 Apr 1;25(7):2174-2184. doi: 10.1158/1078-0432.CCR-18-3206. Epub 2019 Jan 22.

PMID: 30670497

Abatacept initiation in rheumatoid arthritis and the risk of cancer: a population-based comparative cohort study.

Montastruc F, Renoux C, Dell'Aniello S, Simon TA, Azoulay L, Hudson M, Suissa S.

Rheumatology (Oxford). 2019 Apr 1;58(4):683-691. doi: 10.1093/rheumatology/key352.

PMID: 30535094

 

Phase I study of single-dose pharmacokinetics and pharmacodynamics of belatacept in adolescent kidney transplant recipients.

Moudgil A, Dharnidharka VR, Feig DI, Warshaw BL, Perera V, Murthy B, Roberts ME, Polinsky MS, Ettenger RB.

Am J Transplant. 2019 Apr;19(4):1218-1223. doi: 10.1111/ajt.15236. Epub 2019 Jan 22.

PMID: 30582294

Assessment of CE-based baseline disturbances using simulation and targeted experimental evaluation-impact on the purity determination of therapeutic proteins.

Gu Y, Voronov S, Ding J, Mussa N, Li ZJ.

Anal Bioanal Chem. 2019 Apr;411(11):2425-2437. doi: 10.1007/s00216-019-01704-6. Epub 2019 Mar 18.

PMID: 30880351

 

Perspectives on gender parity in bioanalysis: an interview with Binodh DeSilva.

De Silva B.

Bioanalysis. 2019 Apr;11(7):663-664. doi: 10.4155/bio-2019-0068. Epub 2019 Apr 18.

PMID: 30997822

 

Critical reagent screening and characterization: benefits and approaches for protein biomarker assays by hybrid LC-MS.

Santockyte R, Zeng J, Zheng N.

Bioanalysis. 2019 Apr;11(8):785-795. doi: 10.4155/bio-2018-0277. Epub 2019 Apr 17.

PMID: 30994008

 

Population pharmacokinetics analysis of nivolumab in Asian and non-Asian patients with gastric and gastro-esophageal junction cancers.

Osawa M, Hasegawa M, Bello A, Roy A, Hruska MW.

Cancer Chemother Pharmacol. 2019 Apr;83(4):705-715. doi: 10.1007/s00280-019-03771-z. Epub 2019 Jan 21.

PMID: 30666395

 

CD96 Is an Immune Checkpoint That Regulates CD8₊ T-cell Antitumor Function.

Mittal D, Lepletier A, Madore J, Aguilera AR, Stannard K, Blake SJ, Whitehall VLJ, Liu C, Bettington ML, Takeda K, Long GV, Scolyer RA, Lan R, Siemers N, Korman A, Teng MWL, Johnston RJ, Dougall WC, Smyth MJ.

Cancer Immunol Res. 2019 Apr;7(4):559-571. doi: 10.1158/2326-6066.CIR-18-0637. Epub 2019 Mar 20.

PMID: 30894377

 

Elbasvir/Grazoprevir in People With Hepatitis C Genotype 1 Infection and Child-Pugh Class B Cirrhosis: The C-SALT Study.

Jacobson IM, Poordad F, Firpi-Morell R, Everson GT, Verna EC, Bhanja S, Hwang P, Caro L, Robertson M, Charles ED, Platt H.

Clin Transl Gastroenterol. 2019 Apr;10(4):e00007. doi: 10.14309/ctg.0000000000000007.

PMID: 30939489

 

Real-world systemic therapy treatment patterns for squamous cell carcinoma of the head and neck in Canada.

Byrne K, Hallworth P, Monfared AAT, Moshyk A, Shaw JW.

Curr Oncol. 2019 Apr;26(2):e167-e174. doi: 10.3747/co.26.3946. Epub 2019 Apr 1.

PMID: 31043823

 

A Comparison of Total and Plasma Membrane Abundance of Transporters in Suspended, Plated, Sandwich-Cultured Human Hepatocytes Versus Human Liver Tissue Using Quantitative Targeted Proteomics and Cell Surface Biotinylation.

Kumar V, Salphati L, Hop CECA, Xiao G, Lai Y, Mathias A, Chu X, Humphreys WG, Liao M, Heyward S, Unadkat JD.

Drug Metab Dispos. 2019 Apr;47(4):350-357. doi: 10.1124/dmd.118.084988. Epub 2019 Jan 8.

PMID: 30622164

 

Idealhalers Versus Realhalers: Is It Possible to Bypass Deposition in the Upper Respiratory Tract?

Weers JG, Son YJ, Glusker M, Haynes A, Huang D, Kadrichu N, Le J, Li X, Malcolmson R, Miller DP, Tarara TE, Ung K, Clark A.

J Aerosol Med Pulm Drug Deliv. 2019 Apr;32(2):55-69. doi: 10.1089/jamp.2018.1497. Epub 2018 Dec 6.

PMID: 30481087

 

Safety Exposure-Response Analysis for Daclatasvir, Asunaprevir, and Beclabuvir Combinations in HCV-Infected Subjects.

Osawa M, Ueno T, Shiozaki T, Li H, Garimella T.

J Clin Pharmacol. 2019 Apr;59(4):557-565. doi: 10.1002/jcph.1347. Epub 2018 Dec 19.

PMID: 30566237

 

Discontinuation and primary care visits in nonvalvular atrial fibrillation patients treated with apixaban or warfarin.

Ramagopalan SV, Graham S, Carroll R, Raluy-Callado M, Nordstrom BL, Donaldson R, Colby C, Mehmud F, Alikhan R.

J Comp Eff Res. 2019 Apr;8(6):371-379. doi: 10.2217/cer-2019-0005. Epub 2019 Feb 8.

PMID: 30734571

 

A Real-World Claims Analysis of Costs and Patterns of Care in Treated Patients with Glioblastoma Multiforme in the United States.

Norden AD, Korytowsky B, You M, Kim Le T, Dastani H, Bobiak S, Singh P.

J Manag Care Spec Pharm. 2019 Apr;25(4):428-436. doi: 10.18553/jmcp.2019.25.4.428.

PMID: 30917077

 

Economic Evaluation of Anticyclic Citrullinated Peptide Positivity in Rheumatoid Arthritis.

An J, Bider-Canfield Z, Kang J, Alemao E, Connolly SE, Lin AT, Cheetham TC.

J Manag Care Spec Pharm. 2019 Apr;25(4):469-477. doi: 10.18553/jmcp.2019.25.4.469.

PMID: 30917075

 

The economic burden of switching targeted disease-modifying anti-rheumatic drugs among rheumatoid arthritis patients.

Shahabi A, Shafrin J, Zhao L, Green S, Curtice T, Marshall A, Paul D.

J Med Econ. 2019 Apr;22(4):350-358. doi: 10.1080/13696998.2019.1571498. Epub 2019 Feb 12.

PMID: 30653389

 

Expectations for Phase-Appropriate Drug Substance and Drug Product Specifications for Early-Stage Protein Therapeutics.

Kretsinger J, Frantz N, Hart SA, Kelley WP, Kitchen B, Novick S, Rellahan B, Stranges D, Stroop CJM, Yin P, Gastens MH.

J Pharm Sci. 2019 Apr;108(4):1442-1452. doi: 10.1016/j.xphs.2018.11.042. Epub 2018 Dec 6.

PMID: 30528942

 

Representative Scale-Down Lyophilization Cycle Development Using a Seven-Vial Freeze-Dryer (MicroFD_®).

Goldman JM, Chen X, Register JT, Nesarikar V, Iyer L, Wu Y, Mugheirbi N, Rowe J.

J Pharm Sci. 2019 Apr;108(4):1486-1495. doi: 10.1016/j.xphs.2018.11.018. Epub 2018 Nov 20.

PMID: 30468831

 

Unmasking of oestrogen-dependent changes in left ventricular structure and function in aged female rats: a potential model for pre-heart failure with preserved ejection fraction.

Bustamante M, Garate-Carrillo A, R Ito B, Garcia R, Carson N, Ceballos G, Ramirez-Sanchez I, Omens J, Villarreal F.

J Physiol. 2019 Apr;597(7):1805-1817. doi: 10.1113/JP277479. Epub 2019 Feb 12.

PMID: 30681142

 

Interacting medication use and the treatment effects of apixaban versus warfarin: results from the ARISTOTLE Trial.

Washam JB, Hohnloser SH, Lopes RD, Wojdyla DM, Vinereanu D, Alexander JH, Gersh BJ, Hanna M, Horowitz J, Hylek EM, Xavier D, Verheugt FWA, Wallentin L, Granger CB; ARISTOTLE Committees and Investigators.

J Thromb Thrombolysis. 2019 Apr;47(3):345-352. doi: 10.1007/s11239-019-01823-y.

PMID: 30790160

 

Immune associated LncRNAs identify novel prognostic subtypes of renal clear cell carcinoma.

Khadirnaikar S, Kumar P, Pandi SN, Malik R, Dhanasekaran SM, Shukla SK.

Mol Carcinog. 2019 Apr;58(4):544-553. doi: 10.1002/mc.22949. Epub 2018 Dec 21.

PMID: 30520148

 

Single-cell transcriptomic analysis of the lateral hypothalamic area reveals molecularly distinct populations of inhibitory and excitatory neurons.

Mickelsen LE, Bolisetty M, Chimileski BR, Fujita A, Beltrami EJ, Costanzo JT, Naparstek JR, Robson P, Jackson AC.

Nat Neurosci. 2019 Apr;22(4):642-656. doi: 10.1038/s41593-019-0349-8. Epub 2019 Mar 11.

PMID: 30858605

A changing landscape: Temporal trends in incidence and characteristics of patients hospitalized with venous thromboembolism 2006-2015.

Münster AM, Rasmussen TB, Falstie-Jensen AM, Harboe L, Stynes G, Dybro L, Hansen ML, Brandes A, Grove EL, Johnsen SP.

Thromb Res. 2019 Apr;176:46-53. doi: 10.1016/j.thromres.2019.02.009. Epub 2019 Feb 13.

PMID: 30776687

 

A mouse model of heart failure exhibiting pulmonary edema and pleural effusion: Useful for testing new drugs.

Ma X, Tannu S, Allocco J, Pan J, Dipiero J, Wong P.

J Pharmacol Toxicol Methods. 2019 Mar - Apr;96:78-86. doi: 10.1016/j.vascn.2019.02.001. Epub 2019 Feb 6.

PMID: 30738210

 

Toxicity of Pexacerfont, a Corticotropin-Releasing Factor Type 1 Receptor Antagonist, in Rats and Dogs.

White MR, Graziano MJ, Sanderson TP.

Int J Toxicol. 2019 Mar/Apr;38(2):110-120. doi: 10.1177/1091581819827501. Epub 2019 Feb 13.

PMID: 30760067

 

Assessing the risk of drug crystallization in vivo.

Ruepp S, Janovitz E, Brodie T, White R, Santella J, Hynes J, Carman J, Pan D, Wu Y, Hanumegowda U, Gemzik B, Megill J, DiPiero J, Drexler D, Su CC, Hageman M.

J Pharmacol Toxicol Methods. 2019 Mar - Apr;96:1-8. doi: 10.1016/j.vascn.2018.12.003. Epub 2018 Dec 13.

PMID: 30553974

Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing.

Weber J, Hauschild J, Ijzerman-Boon P, Forng RY, Horsch J, Yan L, Prasad A, Henry RB, Claassen M, Villari P, Shereefa S, Wyatt J, Bolden JS, Pycke JT, Dassu D.

PDA J Pharm Sci Technol. 2019 Mar-Apr;73(2):121-134. doi: 10.5731/pdajpst.2018.008722. Epub 2018 Oct 25.

PMID: 30361285

 

Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing.

Barone PW, Avgerinos S, Ballard R, Brussel A, Clark P, Dowd C, Gerentes L, Hart I, Keumurian FJ, Kindermann J, Leung JC, Ly N, Mink S, Minning S, Mullberg J, Murphy M, Nöske K, Parriott S, Shum B, Wiebe ME, Springs SL.

PDA J Pharm Sci Technol. 2019 Mar-Apr;73(2):191-203. doi: 10.5731/pdajpst.2018.008862. Epub 2018 Oct 25.

PMID: 30361281

Case-control Indian buffet process identifies biomarkers of response to Codrituzumab.

Pradier MF, Reis B, Jukofsky L, Milletti F, Ohtomo T, Perez-Cruz F, Puig O.

BMC Cancer. 2019 Mar 28;19(1):278. doi: 10.1186/s12885-019-5472-0.

PMID: 30922327

 

Congruent release of drug and polymer: A "sweet spot" in the dissolution of amorphous solid dispersions.

Saboo S, Mugheirbi NA, Zemlyanov DY, Kestur US, Taylor LS.

J Control Release. 2019 Mar 28;298:68-82. doi: 10.1016/j.jconrel.2019.01.039. Epub 2019 Feb 4.

PMID: 30731151

 

Impact of Preexisting Hepatitis C Virus Genotype 6 NS3, NS5A, and NS5B Polymorphisms on the In Vitro Potency of Direct-Acting Antiviral Agents.

McPhee F, Ueland J, Vellucci V, Bowden S, Sievert W, Zhou N.

Antimicrob Agents Chemother. 2019 Mar 27;63(4). pii: e02205-18. doi: 10.1128/AAC.02205-18. Print 2019 Apr.

PMID: 30718256

 

Interfacial Stress in the Development of Biologics: Fundamental Understanding, Current Practice, and Future Perspective.

Li J, Krause ME, Chen X, Cheng Y, Dai W, Hill JJ, Huang M, Jordan S, LaCasse D, Narhi L, Shalaev E, Shieh IC, Thomas JC, Tu R, Zheng S, Zhu L.

AAPS J. 2019 Mar 26;21(3):44. doi: 10.1208/s12248-019-0312-3.

PMID: 30915582

 

Critical role of kinase activity of hematopoietic progenitor kinase 1 in anti-tumor immune surveillance.

Liu J, Curtin J, You D, Hillerman S, Li-Wang B, Eraslan R, Xie J, Swanson J, Ho CP, Oppenheimer S, Warrack BM, McNaney CA, Nelson DM, Blum J, Kim T, Fereshteh M, Reily M, Shipkova P, Murtaza A, Sanjuan M, Hunt JT, Salter-Cid L.

PLoS One. 2019 Mar 26;14(3):e0212670. doi: 10.1371/journal.pone.0212670. eCollection 2019.

PMID: 30913212

 

Effectiveness and safety of oral anticoagulants in older adults with non-valvular atrial fibrillation and heart failure.

Amin A, Garcia Reeves AB, Li X, Dhamane A, Luo X, Di Fusco M, Nadkarni A, Friend K, Rosenblatt L, Mardekian J, Pan X, Yuce H, Keshishian A.

PLoS One. 2019 Mar 25;14(3):e0213614. doi: 10.1371/journal.pone.0213614. eCollection 2019.

PMID: 30908512

 

Stability behaviour of antiretroviral drugs and their combinations. 9: Identification of incompatible excipients.

Kurmi M, Sahu A, Ladumor MK, Kumar Bansal A, Singh S.

J Pharm Biomed Anal. 2019 Mar 20;166:174-182. doi: 10.1016/j.jpba.2019.01.009. Epub 2019 Jan 8.

PMID: 30654205

 

Relative value assessment: characterizing the benefit of oncology therapies through diverse survival metrics from a US perspective.

Macaulay R, Ahuja A, Ademisoye E, Juarez-Garcia A, Shaw JW.

Clinicoecon Outcomes Res. 2019 Mar 19;11:199-219. doi: 10.2147/CEOR.S177343. eCollection 2019.

PMID: 30936729

 

Development and validation of an in vitro 3D model of NASH with severe fibrotic phenotype.

Mukherjee S, Zhelnin L, Sanfiz A, Pan J, Li Z, Yarde M, McCarty J, Jarai G.

Am J Transl Res. 2019 Mar 15;11(3):1531-1540. eCollection 2019.

PMID: 30972180

 

Correction to: Safety and efficacy of nivolumab in combination with sunitinib or pazopanib in advanced or metastatic renal cell carcinoma: the CheckMate 016 study.

Amin A, Plimack ER, Ernstoff MS, Lewis LD, Bauer TM, McDermott DF, Carducci M, Kollmannsberger C, Rini BI, Heng DYC, Knox J, Voss MH, Spratlin J, Berghorn E, Yang L, Hammers HJ.

J Immunother Cancer. 2019 Mar 14;7(1):73. doi: 10.1186/s40425-019-0559-3.

PMID: 30871617

 

Identification and Preclinical Pharmacology of ((1 R,3 S)-1-Amino-3-(( S)-6-(2-methoxyphenethyl)-5,6,7,8-tetrahydronaphthalen-2-yl)cyclopentyl)methanol (BMS-986166): A Differentiated Sphingosine-1-phosphate Receptor 1 (S1P₁) Modulator Advanced into Clinical Trials.

Gilmore JL, Xiao HY, Dhar TGM, Yang MG, Xiao Z, Xie J, Lehman-McKeeman LD, Gong L, Sun H, Lecureux L, Chen C, Wu DR, Dabros M, Yang X, Taylor TL, Zhou XD, Heimrich EM, Thomas R, McIntyre KW, Borowski V, Warrack BM, Li Y, Shi H, Levesque PC, Yang Z, Marino AM, Cornelius G, D'Arienzo CJ, Mathur A, Rampulla R, Gupta A, Pragalathan B, Shen DR, Cvijic ME, Salter-Cid LM, Carter PH, Dyckman AJ.

J Med Chem. 2019 Mar 14;62(5):2265-2285. doi: 10.1021/acs.jmedchem.8b01695. Epub 2019 Mar 6.

PMID: 30785748

 

New epitopes in ovalbumin provide insights for cancer neoepitopes.

Karandikar SH, Sidney J, Sette A, Selby MJ, Korman AJ, Srivastava PK.

JCI Insight. 2019 Mar 14;5. pii: 127882. doi: 10.1172/jci.insight.127882.

PMID: 30869653

 

Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: is aromatic N-oxide a structural alert for predicting DNA-reactive mutagenicity?

Amberg A, Anger LT, Bercu J, Bower D, Cross KP, Custer L, Harvey JS, Hasselgren C, Honma M, Johnson C, Jolly R, Kenyon MO, Kruhlak NL, Leavitt P, Quigley DP, Miller S, Snodin D, Stavitskaya L, Teasdale A, Trejo-Martin A, White AT, Wichard J, Myatt GJ.

Mutagenesis. 2019 Mar 6;34(1):67-82. doi: 10.1093/mutage/gey020.

PMID: 30189015

 

Exceptional response and multisystem autoimmune-like toxicities associated with the same T cell clone in a patient with uveal melanoma treated with immune checkpoint inhibitors.

Rapisuwon S, Izar B, Batenchuk C, Avila A, Mei S, Sorger P, Parks JM, Cooper SJ, Wagner D, Zeck JC, Charabaty AJ, Atkins MB.

J Immunother Cancer. 2019 Mar 4;7(1):61. doi: 10.1186/s40425-019-0533-0.

PMID: 30832716

 

Linking (Pyr)₁apelin-13 pharmacokinetics to efficacy: Stabilization and measurement of a high clearance peptide in rodents.

Onorato JM, Xu C, Chen XQ, Rose AV, Generaux C, Lentz K, Shipkova P, Arthur S, Hennan JK, Haskell R, Myers MC, Lawrence RM, Finlay HJ, Basso M, Bostwick J, Fernando G, Garcia R, Hellings S, Hsu MY, Zhang R, Zhao L, Gargalovic P.

Anal Biochem. 2019 Mar 1;568:41-50. doi: 10.1016/j.ab.2018.12.022. Epub 2018 Dec 31.

PMID: 30605634

IL-17A Recruits Rab35 to IL-17R to Mediate PKCα-Dependent Stress Fiber Formation and Airway Smooth Muscle Contractility.

Bulek K, Chen X, Parron V, Sundaram A, Herjan T, Ouyang S, Liu C, Majors A, Zepp J, Gao J, Dongre A, Bodaszewska-Lubas M, Echard A, Aronica M, Carman J, Garantziotis S, Sheppard D, Li X.

J Immunol. 2019 Mar 1;202(5):1540-1548. doi: 10.4049/jimmunol.1801025. Epub 2019 Jan 25.

PMID: 30683702

Author Correction: A shape-shifting redox foldase contributes to Proteus mirabilis copper resistance.

Furlong EJ, Lo AW, Kurth F, Premkumar L, Totsika M, Achard MES, Halili MA, Heras B, Whitten AE, Choudhury HG, Schembri MA, Martin JL.

Nat Commun. 2019 Mar 1;10(1):976. doi: 10.1038/s41467-019-08920-9.

PMID: 30824772

 

Bioanalytical challenges and unique considerations to support pharmacokinetic characterization of bispecific biotherapeutics.

Ma M, Colletti K, Yang TY, Leung S, Pederson S, Hottenstein CS, Xu X, Warrino D, Wakshull E.

Bioanalysis. 2019 Mar;11(5):427-435. doi: 10.4155/bio-2018-0146. Epub 2019 Mar 19.

PMID: 30887822

 

Systematic Interpolation Method Predicts Antibody Monomer-Dimer Separation by Gradient Elution Chromatography at High Protein Loads.

Creasy A, Reck J, Pabst T, Hunter A, Barker G, Carta G.

Biotechnol J. 2019 Mar;14(3):e1800132. doi: 10.1002/biot.201800132. Epub 2018 Jun 11.

PMID: 29809318

 

Association of Tumor Microenvironment T-cell Repertoire and Mutational Load with Clinical Outcome after Sequential Checkpoint Blockade in Melanoma.

Yusko E, Vignali M, Wilson RK, Mardis ER, Hodi FS, Horak C, Chang H, Woods DM, Robins H, Weber J.

Cancer Immunol Res. 2019 Mar;7(3):458-465. doi: 10.1158/2326-6066.CIR-18-0226. Epub 2019 Jan 11.

PMID: 30635271

 

The use of fast photochemical oxidation of proteins coupled with mass spectrometry in protein therapeutics discovery and development.

Li J, Chen G.

Drug Discov Today. 2019 Mar;24(3):829-834. doi: 10.1016/j.drudis.2018.12.008. Epub 2018 Dec 21. Review.

PMID: 30583089

 

Clinical and economic outcomes associated with treatment sequences in patients with BRAF-mutant advanced melanoma.

Tarhini A, McDermott D, Ambavane A, Gupte-Singh K, Aponte-Ribero V, Ritchings C, Benedict A, Rao S, Regan MM, Atkins M.

Immunotherapy. 2019 Mar;11(4):283-295. doi: 10.2217/imt-2018-0168. Epub 2018 Dec 19.

PMID: 30563395

 

Population Pharmacokinetics and Exposure - Safety Analyses of Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma.

Wang X, Ludwig EA, Passarell J, Bello A, Roy A, Hruska MW.

J Clin Pharmacol. 2019 Mar;59(3):364-373. doi: 10.1002/jcph.1324. Epub 2018 Oct 19.

PMID: 30339279

 

Impact of earlier versus later monitoring on disease progression and healthcare costs among patients with chronic myeloid leukemia in the United States.

Jabbour EJ, Siegartel LR, Lin J, Lingohr-Smith M, Menges B, Makenbaeva D.

Leuk Lymphoma. 2019 Mar;60(3):668-674. doi: 10.1080/10428194.2018.1492124. Epub 2018 Aug 20.

PMID: 30124372

 

Preclinical assessment of an antibody-PBD conjugate that targets BCMA on multiple myeloma and myeloma progenitor cells.

Kinneer K, Flynn M, Thomas SB, Meekin J, Varkey R, Xiao X, Zhong H, Breen S, Hynes PG, Fleming R, Bezabeh B, Chen CT, Wetzel L, Chen R, Dimasi N, Tai YT, Anderson KC, Herbst R, Howard PW, Hurt EM, Tice DA.

Leukemia. 2019 Mar;33(3):766-771. doi: 10.1038/s41375-018-0278-7. Epub 2018 Oct 12. No abstract available.

PMID: 30315237

 

A single dose of neoadjuvant PD-1 blockade predicts clinical outcomes in resectable melanoma.

Huang AC, Orlowski RJ, Xu X, Mick R, George SM, Yan PK, Manne S, Kraya AA, Wubbenhorst B, Dorfman L, D'Andrea K, Wenz BM, Liu S, Chilukuri L, Kozlov A, Carberry M, Giles L, Kier MW, Quagliarello F, McGettigan S, Kreider K, Annamalai L, Zhao Q, Mogg R, Xu W, Blumenschein WM, Yearley JH, Linette GP, Amaravadi RK, Schuchter LM, Herati RS, Bengsch B, Nathanson KL, Farwell MD, Karakousis GC, Wherry EJ, Mitchell TC.

Nat Med. 2019 Mar;25(3):454-461. doi: 10.1038/s41591-019-0357-y. Epub 2019 Feb 25.

PMID: 30804515

 

On estimands and the analysis of adverse events in the presence of varying follow-up times within the benefit assessment of therapies.

Unkel S, Amiri M, Benda N, Beyersmann J, Knoerzer D, Kupas K, Langer F, Leverkus F, Loos A, Ose C, Proctor T, Schmoor C, Schwenke C, Skipka G, Unnebrink K, Voss F, Friede T.

Pharm Stat. 2019 Mar;18(2):166-183. doi: 10.1002/pst.1915. Epub 2018 Nov 20.

PMID: 30458579

 

Correction to: Can We Accurately Predict Cost Effectiveness Without Access to Overall Survival Data? The Case Study of Nivolumab in Combination with Ipilimumab for the Treatment of Patients with Advanced Melanoma in England.

Lee D, Amadi A, Sabater J, Ellis J, Johnson H, Kotapati S, McNamara S, Walker A, Cooper M, Patterson K, Roskell N, Meng Y.

Pharmacoecon Open. 2019 Mar;3(1):127. doi: 10.1007/s41669-018-0096-x.

PMID: 30206825

 

Can We Accurately Predict Cost Effectiveness Without Access to Overall Survival Data? The Case Study of Nivolumab in Combination with Ipilimumab for the Treatment of Patients with Advanced Melanoma in England.

Lee D, Amadi A, Sabater J, Ellis J, Johnson H, Kotapati S, McNamara S, Walker A, Cooper M, Patterson K, Roskell N, Meng Y.

Pharmacoecon Open. 2019 Mar;3(1):43-54. doi: 10.1007/s41669-018-0080-5. Erratum in: Pharmacoecon Open. 2018 Sep 11;:.

PMID: 29790020

 

Pharmaceutical industry perspective on combination toxicity studies: Results from an intra-industry survey conducted by IQ DruSafe Leadership Group.

Birkebak J, Buckley LA, Dambach D, Musvasva E, Price K, Ralston S, Sacaan A.

Regul Toxicol Pharmacol. 2019 Mar;102:40-46. doi: 10.1016/j.yrtph.2018.12.012. Epub 2018 Dec 19.

PMID: 30576687

 

Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses.

Amberg A, Andaya RV, Anger LT, Barber C, Beilke L, Bercu J, Bower D, Brigo A, Cammerer Z, Cross KP, Custer L, Dobo K, Gerets H, Gervais V, Glowienke S, Gomez S, Van Gompel J, Harvey J, Hasselgren C, Honma M, Johnson C, Jolly R, Kemper R, Kenyon M, Kruhlak N, Leavitt P, Miller S, Muster W, Naven R, Nicolette J, Parenty A, Powley M, Quigley DP, Reddy MV, Sasaki JC, Stavitskaya L, Teasdale A, Trejo-Martin A, Weiner S, Welch DS, White A, Wichard J, Woolley D, Myatt GJ.

Regul Toxicol Pharmacol. 2019 Mar;102:53-64. doi: 10.1016/j.yrtph.2018.12.007. Epub 2018 Dec 15.

PMID: 30562600

 

Xenobiotic Transporters in the Kidney: Function and Role in Toxicity.

Shen H, Scialis RJ, Lehman-McKeeman L.

Semin Nephrol. 2019 Mar;39(2):159-175. doi: 10.1016/j.semnephrol.2018.12.010. Review.

PMID: 30827339

 

Kidney Safety Assessment: Current Practices in Drug Development.

Troth SP, Simutis F, Friedman GS, Todd S, Sistare FD.

Semin Nephrol. 2019 Mar;39(2):120-131. doi: 10.1016/j.semnephrol.2018.12.002. Review.

PMID: 30827335

 

Assessing seizure liability using multi-electrode arrays (MEA).

Fan J, Thalody G, Kwagh J, Burnett E, Shi H, Lewen G, Chen SJ, Levesque P.

Toxicol In Vitro. 2019 Mar;55:93-100. doi: 10.1016/j.tiv.2018.12.001. Epub 2018 Dec 4.

PMID: 30528373

Structure, heterogeneity and developability assessment of therapeutic antibodies.

Xu Y, Wang D, Mason B, Rossomando T, Li N, Liu D, Cheung JK, Xu W, Raghava S, Katiyar A, Nowak C, Xiang T, Dong DD, Sun J, Beck A, Liu H.

MAbs. 2019 Feb/Mar;11(2):239-264. doi: 10.1080/19420862.2018.1553476. Epub 2018 Dec 17. Review.

PMID: 30543482

 

Adherence to recommended clinical guidelines in extensive disease small-cell lung cancer across the US, Europe, and Japan.

DiBonaventura MD, Shah-Manek B, Higginbottom K, Penrod JR, Yuan Y.

Ther Clin Risk Manag. 2019 Feb 28;15:355-366. doi: 10.2147/TCRM.S183216. eCollection 2019.

PMID: 30881001

 

Structure-based Discovery of Phenyl (3-Phenylpyrrolidin-3-yl)sulfones as Selective, Orally Active RORγt Inverse Agonists.

Duan JJ, Lu Z, Jiang B, Stachura S, Weigelt CA, Sack JS, Khan J, Ruzanov M, Galella MA, Wu DR, Yarde M, Shen DR, Shuster DJ, Borowski V, Xie JH, Zhang L, Vanteru S, Gupta AK, Mathur A, Zhao Q, Foster W, Salter-Cid LM, Carter PH, Dhar TGM.

ACS Med Chem Lett. 2019 Feb 26;10(3):367-373. doi: 10.1021/acsmedchemlett.9b00010. eCollection 2019 Mar 14.

PMID: 30891142

 

Role of FcγRs in Antibody-Based Cancer Therapy.

Graziano RF, Engelhardt JJ.

Curr Top Microbiol Immunol. 2019 Feb 22;423:13-34. doi: 10.1007/82_2019_150. Review.

PMID: 30790079

 

First-Principles and Empirical Approaches to Predicting In Vitro Dissolution for Pharmaceutical Formulation and Process Development and for Product Release Testing.

Zaborenko N, Shi Z, Corredor CC, Smith-Goettler BM, Zhang L, Hermans A, Neu CM, Alam MA, Cohen MJ, Lu X, Xiong L, Zacour BM.

AAPS J. 2019 Feb 21;21(3):32. doi: 10.1208/s12248-019-0297-y. Review.

PMID: 30790200

 

Identification of Imidazo[1,2-b]pyridazine Derivatives as Potent, Selective, and Orally Active Tyk2 JH2 Inhibitors.

Liu C, Lin J, Moslin R, Tokarski JS, Muckelbauer J, Chang C, Tredup J, Xie D, Park H, Li P, Wu DR, Strnad J, Zupa-Fernandez A, Cheng L, Chaudhry C, Chen J, Chen C, Sun H, Elzinga P, D'arienzo C, Gillooly K, Taylor TL, McIntyre KW, Salter-Cid L, Lombardo LJ, Carter PH, Aranibar N, Burke JR, Weinstein DS.

ACS Med Chem Lett. 2019 Feb 21;10(3):383-388. doi: 10.1021/acsmedchemlett.9b00035. eCollection 2019 Mar 14.

PMID: 30891145

 

Optimal design, anti-tumour efficacy and tolerability of anti-CXCR4 antibody drug conjugates.

Costa MJ, Kudaravalli J, Ma JT, Ho WH, Delaria K, Holz C, Stauffer A, Chunyk AG, Zong Q, Blasi E, Buetow B, Tran TT, Lindquist K, Dorywalska M, Rajpal A, Shelton DL, Strop P, Liu SH.

Sci Rep. 2019 Feb 21;9(1):2443. doi: 10.1038/s41598-019-38745-x.

PMID: 30792442

 

Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study.

Ansell SM, Minnema MC, Johnson P, Timmerman JM, Armand P, Shipp MA, Rodig SJ, Ligon AH, Roemer MGM, Reddy N, Cohen JB, Assouline S, Poon M, Sharma M, Kato K, Samakoglu S, Sumbul A, Grigg A.

J Clin Oncol. 2019 Feb 20;37(6):481-489. doi: 10.1200/JCO.18.00766. Epub 2019 Jan 8.

PMID: 30620669

 

A convenient strategy to overcome interference in LC-MS/MS analysis: Application in a microdose absolute bioavailability study.

Yuan L, Huang C, Liu-Kreyche P, Voronin K, Fancher RM, Allentoff A, Zheng N, Iyer R, Zhu L, Pillutla R, Ji QC.

J Pharm Biomed Anal. 2019 Feb 20;165:198-206. doi: 10.1016/j.jpba.2018.12.014. Epub 2018 Dec 10.

PMID: 30553110

 

Targeting DDR2 enhances tumor response to anti-PD-1 immunotherapy.

Tu MM, Lee FYF, Jones RT, Kimball AK, Saravia E, Graziano RF, Coleman B, Menard K, Yan J, Michaud E, Chang H, Abdel-Hafiz HA, Rozhok AI, Duex JE, Agarwal N, Chauca-Diaz A, Johnson LK, Ng TL, Cambier JC, Clambey ET, Costello JC, Korman AJ, Theodorescu D.

Sci Adv. 2019 Feb 20;5(2):eaav2437. doi: 10.1126/sciadv.aav2437. eCollection 2019 Feb.

PMID: 30801016

 

Identification and Preclinical Evaluation of the Bicyclic Pyrimidine γ-Secretase Modulator BMS-932481.

Boy KM, Guernon JM, Zuev DS, Xu L, Zhang Y, Shi J, Marcin LR, Higgins MA, Wu YJ, Krishnananthan S, Li J, Trehan A, Smith D, Toyn JH, Meredith JE, Burton CR, Kimura SR, Zvyaga T, Zhuo X, Lentz KA, Grace JE, Denton R, Morrison JS, Mathur A, Albright CF, Ahlijanian MK, Olson RE, Thompson LA, Macor JE.

ACS Med Chem Lett. 2019 Feb 17;10(3):312-317. doi: 10.1021/acsmedchemlett.8b00541. eCollection 2019 Mar 14.

PMID: 30891132

 

A practical workflow for capillary microsampling in nonclinical studies.

Wang L, Wang B, Chadwick KD, Su T, Mangipudy R, Pillutla RC, Ji QC.

Bioanalysis. 2019 Feb 15. doi: 10.4155/bio-2018-0224. [Epub ahead of print]

PMID: 30767556

 

Discovery of new indole-based acylsulfonamide Na_v1.7 inhibitors.

Wu YJ, Venables B, Guernon J, Chen J, Sit SY, Rajamani R, Knox RJ, Matchett M, Pieschl RL, Herrington J, Bristow LJ, Meanwell NA, Thompson LA, Dzierba C.

Bioorg Med Chem Lett. 2019 Feb 15;29(4):659-663. doi: 10.1016/j.bmcl.2018.12.013. Epub 2018 Dec 6.

PMID: 30638874

 

Discovery of a JAK1/3 Inhibitor and Use of a Prodrug To Demonstrate Efficacy in a Model of Rheumatoid Arthritis.

Spergel SH, Mertzman ME, Kempson J, Guo J, Stachura S, Haque L, Lippy JS, Zhang RF, Galella M, Pitt S, Shen G, Fura A, Gillooly K, McIntyre KW, Tang V, Tokarski J, Sack JS, Khan J, Carter PH, Barrish JC, Nadler SG, Salter-Cid LM, Schieven GL, Wrobleski ST, Pitts WJ.

ACS Med Chem Lett. 2019 Feb 13;10(3):306-311. doi: 10.1021/acsmedchemlett.8b00508. eCollection 2019 Mar 14.

PMID: 30891131