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Items: 1 to 50 of 382

1.

Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis.

Gyawali B, Tessema FA, Jung EH, Kesselheim AS.

JAMA Netw Open. 2019 Aug 2;2(8):e199570. doi: 10.1001/jamanetworkopen.2019.9570.

PMID:
31469391
2.

Promoting Pediatric Drug Research and Labeling - Outcomes of Legislation.

Bourgeois FT, Kesselheim AS.

N Engl J Med. 2019 Aug 29;381(9):875-881. doi: 10.1056/NEJMhle1901265. No abstract available.

PMID:
31461599
3.

Landscape of Cardiovascular Device Registries in the United States.

Rajan PV, Holtzman JN, Kesselheim AS, Yeh RW, Kramer DB.

J Am Heart Assoc. 2019 Jun 4;8(11):e012756. doi: 10.1161/JAHA.119.012756. Epub 2019 Jun 1.

4.

Why Are Biosimilars Not Living up to Their Promise in the US?

Zhai MZ, Sarpatwari A, Kesselheim AS.

AMA J Ethics. 2019 Aug 1;21(8):E668-678. doi: 10.1001/amajethics.2019.668.

5.

Potential Medicare Savings From Generic Substitution and Therapeutic Interchange of ACE Inhibitors and Angiotensin-II-Receptor Blockers.

Growdon ME, Sacks CA, Kesselheim AS, Avorn J.

JAMA Intern Med. 2019 Aug 5. doi: 10.1001/jamainternmed.2019.3107. [Epub ahead of print] No abstract available.

PMID:
31380893
6.

Competition and price among brand-name drugs in the same class: A systematic review of the evidence.

Sarpatwari A, DiBello J, Zakarian M, Najafzadeh M, Kesselheim AS.

PLoS Med. 2019 Jul 30;16(7):e1002872. doi: 10.1371/journal.pmed.1002872. eCollection 2019 Jul.

7.

Affordability and Price Increases of New Cancer Drugs in Clinical Guidelines, 2007-2016.

Hwang TJ, Kesselheim AS, Gyawali B.

JNCI Cancer Spectr. 2018 Jun 1;2(2):pky016. doi: 10.1093/jncics/pky016. eCollection 2018 Apr.

8.

Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys.

Feldman WB, Hey SP, Franklin JM, Kesselheim AS.

JAMA Netw Open. 2019 Jul 3;2(7):e197591. doi: 10.1001/jamanetworkopen.2019.7591.

9.

Spending on World Health Organization essential medicines in Medicare Part D, 2011-15: retrospective cost analysis.

Li DG, Najafzadeh M, Kesselheim AS, Mostaghimi A.

BMJ. 2019 Jul 17;366:l4257. doi: 10.1136/bmj.l4257.

10.

Price Increases of Protected-Class Drugs in Medicare Part D, Relative to Inflation, 2012-2017.

Hwang TJ, Dusetzina SB, Feng J, Maini L, Kesselheim AS.

JAMA. 2019 Jul 16;322(3):267-269. doi: 10.1001/jama.2019.7521. No abstract available.

PMID:
31310287
11.

Impact of State Laws Restricting Opioid Duration on Characteristics of New Opioid Prescriptions.

Dave CV, Patorno E, Franklin JM, Huybrechts K, Sarpatwari A, Kesselheim AS, Bateman BT.

J Gen Intern Med. 2019 Jul 15. doi: 10.1007/s11606-019-05150-z. [Epub ahead of print] No abstract available.

PMID:
31309407
12.

Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem.

Kesselheim AS, Sinha MS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Avorn J, Dal Pan GJ.

Drug Saf. 2019 Jul 13. doi: 10.1007/s40264-019-00849-8. [Epub ahead of print]

PMID:
31302895
13.

Orphan Drug Designation and Exclusivity for "Same Drugs".

Hong P, Sarpatwari A, Kesselheim AS.

J Law Med Ethics. 2019 Jun;47(2):347-349. doi: 10.1177/1073110519857293. No abstract available.

PMID:
31298092
14.

Reforming the Orphan Drug Act for the 21st Century.

Sarpatwari A, Kesselheim AS.

N Engl J Med. 2019 Jul 11;381(2):106-108. doi: 10.1056/NEJMp1902943. No abstract available.

PMID:
31291512
15.

The Impact Of Price Regulation On The Availability Of New Drugs In Germany.

Stern AD, Pietrulla F, Herr A, Kesselheim AS, Sarpatwari A.

Health Aff (Millwood). 2019 Jul;38(7):1182-1187. doi: 10.1377/hlthaff.2018.05142.

PMID:
31260362
16.

Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs.

Vokinger KN, Kesselheim AS.

Health Policy. 2019 Aug;123(8):721-727. doi: 10.1016/j.healthpol.2019.06.002. Epub 2019 Jun 12.

PMID:
31229275
17.

Pre-market development times for biologic versus small-molecule drugs.

Beall RF, Hwang TJ, Kesselheim AS.

Nat Biotechnol. 2019 Jul;37(7):708-711. doi: 10.1038/s41587-019-0175-2. No abstract available.

PMID:
31213674
18.

Trust and transparency in medical device regulation.

Kramer DB, Kesselheim AS.

BMJ. 2019 Jun 18;365:l4166. doi: 10.1136/bmj.l4166. No abstract available.

PMID:
31213458
19.

Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.

Gyawali B, Hey SP, Kesselheim AS.

JAMA Intern Med. 2019 Jul 1;179(7):906-913. doi: 10.1001/jamainternmed.2019.0462.

PMID:
31135808
20.

Changes in Price for Generic Drugs in the USA, 2008-2016.

Dave CV, Brill G, Kesselheim AS.

J Gen Intern Med. 2019 Sep;34(9):1677-1679. doi: 10.1007/s11606-019-05033-3. No abstract available.

PMID:
31065948
21.

Pharmaceutical Protections in U.S. Trade Deals - What Do Americans Get in Return?

Bollyky T, Kesselheim AS.

N Engl J Med. 2019 May 23;380(21):1993-1995. doi: 10.1056/NEJMp1902240. Epub 2019 May 1. No abstract available.

PMID:
31042823
22.

Approximating Future Generic Entry for New Drugs.

Beall RF, Darrow JJ, Kesselheim AS.

J Law Med Ethics. 2019 Mar;47(1):177-182. doi: 10.1177/1073110519840499. No abstract available.

PMID:
30994060
23.

Pharmacy Benefit Managers: Practices, Controversies, and What Lies Ahead.

Seeley E, Kesselheim AS.

Issue Brief (Commonw Fund). 2019 Mar 1;2019:1-11.

PMID:
30990594
24.

Assessment of the Role of Niacin in Managing Cardiovascular Disease Outcomes: A Systematic Review and Meta-analysis.

D'Andrea E, Hey SP, Ramirez CL, Kesselheim AS.

JAMA Netw Open. 2019 Apr 5;2(4):e192224. doi: 10.1001/jamanetworkopen.2019.2224.

25.

US Food and Drug Administration Approval of New Drugs Based on Noninferiority Trials in Oncology: A Dangerous Precedent?

Gyawali B, Kesselheim AS.

JAMA Oncol. 2019 May 1;5(5):607-608. doi: 10.1001/jamaoncol.2019.0093. No abstract available.

PMID:
30920591
26.

Experiences With and Challenges Afforded by Expedited Regulatory Pathways.

Liu S, Kesselheim AS.

Clin Pharmacol Ther. 2019 Apr;105(4):795-797. doi: 10.1002/cpt.1365. No abstract available.

PMID:
30883712
27.

Major Events in the Life Course of New Drugs, 2000-2016.

Beall RF, Hwang TJ, Kesselheim AS.

N Engl J Med. 2019 Mar 14;380(11):e12. doi: 10.1056/NEJMp1806930. No abstract available.

PMID:
30865793
28.

Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims.

Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly JG, Fischer MA, Kesselheim AS, Gagne JJ.

PLoS Med. 2019 Mar 13;16(3):e1002763. doi: 10.1371/journal.pmed.1002763. eCollection 2019 Mar.

29.

Cost Implications of Escalating Intravenous Acetaminophen Use in Children.

Bourgeois FT, Graham DA, Kesselheim AS, Randolph AG.

JAMA Pediatr. 2019 May 1;173(5):489-491. doi: 10.1001/jamapediatrics.2019.0101. No abstract available.

PMID:
30855654
30.

Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases.

Hwang TJ, Bourgeois FT, Franklin JM, Kesselheim AS.

Health Aff (Millwood). 2019 Feb;38(2):313-319. doi: 10.1377/hlthaff.2018.05330.

PMID:
30715972
31.

New Drug Formulations and Their Respective Generic Entry Dates.

Beall RF, Kesselheim AS, Sarpatwari A.

J Manag Care Spec Pharm. 2019 Feb;25(2):218-224. doi: 10.18553/jmcp.2019.25.2.218.

32.

Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes.

Luo J, Khan NF, Manetti T, Rose J, Kaloghlian A, Gadhe B, Jain SH, Gagne JJ, Kesselheim AS.

JAMA. 2019 Jan 29;321(4):374-384. doi: 10.1001/jama.2018.21364.

33.

Physicians' Perspectives on FDA Approval Standards and Off-label Drug Marketing.

Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM.

JAMA Intern Med. 2019 May 1;179(5):707-709. doi: 10.1001/jamainternmed.2018.8121. No abstract available.

PMID:
30667474
34.

Tepid Steps on Drug Pricing.

Sarpatwari A, Kesselheim AS.

JAMA Intern Med. 2019 Mar 1;179(3):439-441. doi: 10.1001/jamainternmed.2018.6593. No abstract available.

PMID:
30667462
36.

Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs.

Hwang TJ, Jain N, Lauffenburger JC, Vokinger KN, Kesselheim AS.

JAMA Intern Med. 2019 Mar 1;179(3):374-380. doi: 10.1001/jamainternmed.2018.6417.

PMID:
30640379
37.

A Survey of Patients' Perceptions of Pill Appearance and Responses to Changes in Appearance for Four Chronic Disease Medications.

Sarpatwari A, Gagne JJ, Lu Z, Campbell EG, Carman WJ, Enger CL, Dutcher SK, Jiang W, Kesselheim AS.

J Gen Intern Med. 2019 Mar;34(3):420-428. doi: 10.1007/s11606-018-4791-1. Epub 2019 Jan 10.

PMID:
30632102
38.

Assessment of Use of Combined Dextromethorphan and Quinidine in Patients With Dementia or Parkinson Disease After US Food and Drug Administration Approval for Pseudobulbar Affect.

Fralick M, Sacks CA, Kesselheim AS.

JAMA Intern Med. 2019 Feb 1;179(2):224-230. doi: 10.1001/jamainternmed.2018.6112.

PMID:
30615021
39.

An export-only exception to pharmaceutical patents in Europe: should the United States follow suit?

Minssen T, Kesselheim AS, Darrow JJ.

Nat Biotechnol. 2019 Jan 3;37(1):21-22. doi: 10.1038/nbt.4324. No abstract available.

PMID:
30605154
40.

A Method for Approximating Future Entry of Generic Drugs.

Beall RF, Darrow JJ, Kesselheim AS.

Value Health. 2018 Dec;21(12):1382-1389. doi: 10.1016/j.jval.2018.04.1827. Epub 2018 Jun 11.

PMID:
30502781
41.

Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act.

Hwang TJ, Orenstein L, Kesselheim AS, Bourgeois FT.

JAMA Pediatr. 2019 Jan 1;173(1):68-74. doi: 10.1001/jamapediatrics.2018.3416.

PMID:
30452498
42.

Predictors of Drug Shortages and Association with Generic Drug Prices: A Retrospective Cohort Study.

Dave CV, Pawar A, Fox ER, Brill G, Kesselheim AS.

Value Health. 2018 Nov;21(11):1286-1290. doi: 10.1016/j.jval.2018.04.1826. Epub 2018 May 18.

PMID:
30442275
43.

The US Biosimilar Market: Stunted Growth and Possible Reforms.

Sarpatwari A, Barenie R, Curfman G, Darrow JJ, Kesselheim AS.

Clin Pharmacol Ther. 2019 Jan;105(1):92-100. doi: 10.1002/cpt.1285. Epub 2018 Dec 28. Review.

PMID:
30415479
44.

The Tax Cuts and Jobs Act of 2017 and the Pharmaceutical Industry.

Sinha MS, Kesselheim AS.

J Law Med Ethics. 2018 Sep;46(3):806-808. doi: 10.1177/1073110518804246. No abstract available.

PMID:
30336090
45.

The promise of ESCAT: a new system for evaluating cancer drug-target pairs.

Gyawali B, Kesselheim AS.

Nat Rev Clin Oncol. 2019 Mar;16(3):147-148. doi: 10.1038/s41571-018-0110-3. No abstract available.

PMID:
30317250
46.

Internal Medicine Physicians' Financial Relationships with Industry: An Updated National Estimate.

Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM.

J Gen Intern Med. 2019 Feb;34(2):195-197. doi: 10.1007/s11606-018-4688-z. No abstract available.

PMID:
30291605
47.

A Systematic Review Of The Food And Drug Administration's 'Exception From Informed Consent' Pathway.

Feldman WB, Hey SP, Kesselheim AS.

Health Aff (Millwood). 2018 Oct;37(10):1605-1614. doi: 10.1377/hlthaff.2018.0501.

PMID:
30273035
48.

Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012.

Sinha MS, Najafzadeh M, Rajasingh EK, Love J, Kesselheim AS.

JAMA Intern Med. 2018 Nov 1;178(11):1458-1466. doi: 10.1001/jamainternmed.2018.3933.

PMID:
30264138
49.

Changes in Drug Pricing After Drug Shortages in the United States.

Hernandez I, Sampathkumar S, Good CB, Kesselheim AS, Shrank WH.

Ann Intern Med. 2019 Jan 1;170(1):74-76. doi: 10.7326/M18-1137. Epub 2018 Sep 18. No abstract available.

PMID:
30242373
50.

Does Helicobacter pylori eradication therapy to prevent gastric cancer increase all-cause mortality?

Gyawali B, Kesselheim AS, D'Andrea E.

Int J Cancer. 2019 Jan 15;144(2):411-412. doi: 10.1002/ijc.31772. Epub 2018 Oct 26. No abstract available.

PMID:
30152520

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