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Items: 1 to 20 of 32

1.

Prescription Opioid Epidemic and Trends in the Clinical Development of New Pain Medications.

Hwang TJ, Sinha MS, Dave CV, Kesselheim AS.

Mayo Clin Proc. 2019 Nov 1. pii: S0025-6196(19)30481-1. doi: 10.1016/j.mayocp.2019.05.015. [Epub ahead of print]

PMID:
31685265
2.

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.

3.

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
4.

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
5.

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
6.

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
7.

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
8.

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
9.

Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines.

Pregelj L, Hwang TJ, Hine DC, Siegel EB, Barnard RT, Darrow JJ, Kesselheim AS.

Health Aff (Millwood). 2018 May;37(5):724-731. doi: 10.1377/hlthaff.2017.1580.

PMID:
29733717
10.

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.

Hwang TJ, Franklin JM, Chen CT, Lauffenburger JC, Gyawali B, Kesselheim AS, Darrow JJ.

J Clin Oncol. 2018 Jun 20;36(18):1805-1812. doi: 10.1200/JCO.2017.77.1592. Epub 2018 Apr 24.

PMID:
29688832
11.

Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis.

Sinha MS, Freifeld CC, Brownstein JS, Donneyong MM, Rausch P, Lappin BM, Zhou EH, Dal Pan GJ, Pawar AM, Hwang TJ, Avorn J, Kesselheim AS.

JMIR Public Health Surveill. 2018 Jan 5;4(1):e1. doi: 10.2196/publichealth.7823.

12.

The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016.

Hwang TJ, Darrow JJ, Kesselheim AS.

JAMA. 2017 Dec 5;318(21):2137-2138. doi: 10.1001/jama.2017.14896. No abstract available.

13.

Value-Based Pricing and State Reform of Prescription Drug Costs.

Hwang TJ, Kesselheim AS, Sarpatwari A.

JAMA. 2017 Aug 15;318(7):609-610. doi: 10.1001/jama.2017.8255. No abstract available.

PMID:
28692713
14.

Challenges in the Development of Novel Cardiovascular Therapies.

Hwang TJ, Kesselheim AS.

Clin Pharmacol Ther. 2017 Aug;102(2):194-196. doi: 10.1002/cpt.703. Epub 2017 Jun 23. Review.

PMID:
28643861
15.

Ensuring Access to Injectable Generic Drugs - The Case of Intravesical BCG for Bladder Cancer.

Davies BJ, Hwang TJ, Kesselheim AS.

N Engl J Med. 2017 Apr 13;376(15):1401-1403. doi: 10.1056/NEJMp1615697. No abstract available.

PMID:
28402764
16.

Effect of US Food and Drug Administration's Cardiovascular Safety Guidance on Diabetes Drug Development.

Hwang TJ, Franklin JM, Kesselheim AS.

Clin Pharmacol Ther. 2017 Aug;102(2):290-296. doi: 10.1002/cpt.705. Epub 2017 May 27. Review.

PMID:
28390139
17.

Public referendum on drug prices in the US: will it bring relief?

Hwang TJ, Kesselheim AS.

BMJ. 2016 Oct 31;355:i5657. doi: 10.1136/bmj.i5657. No abstract available.

PMID:
27799143
18.

Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results.

Hwang TJ, Carpenter D, Lauffenburger JC, Wang B, Franklin JM, Kesselheim AS.

JAMA Intern Med. 2016 Dec 1;176(12):1826-1833. doi: 10.1001/jamainternmed.2016.6008.

PMID:
27723879
19.

Temporal Trends and Factors Associated With Cardiovascular Drug Development, 1990 to 2012.

Hwang TJ, Lauffenburger JC, Franklin JM, Kesselheim AS.

JACC Basic Transl Sci. 2016 Aug 29;1(5):301-308. doi: 10.1016/j.jacbts.2016.03.012. eCollection 2016 Aug. Review.

20.

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