Literature DB >> 28538133

Accelerated Approval and Expensive Drugs - A Challenging Combination.

Walid F Gellad1, Aaron S Kesselheim1.   

Abstract

Mesh:

Year:  2017        PMID: 28538133     DOI: 10.1056/NEJMp1700446

Source DB:  PubMed          Journal:  N Engl J Med        ISSN: 0028-4793            Impact factor:   91.245


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  17 in total

1.  Conditional approval of cancer drugs in Canada: accountability and impact on public funding.

Authors:  S K Andersen; N Penner; A Chambers; M E Trudeau; K K W Chan; M C Cheung
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2.  Accelerated approval of medicines: fit for purpose?

Authors:  Alasdair Breckenridge; Lawrence Liberti
Journal:  Nat Rev Drug Discov       Date:  2018-01-05       Impact factor: 84.694

3.  Cost-Effectiveness of Chimeric Antigen Receptor T-Cell Therapy in Pediatric Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia.

Authors:  Reith R Sarkar; Nicholas J Gloude; Deborah Schiff; James D Murphy
Journal:  J Natl Cancer Inst       Date:  2019-07-01       Impact factor: 13.506

4.  Using GRADE methodology to assess innovation of new medicinal products in Italy.

Authors:  Filomena Fortinguerra; Giovanni Tafuri; Francesco Trotta; Antonio Addis
Journal:  Br J Clin Pharmacol       Date:  2019-11-21       Impact factor: 4.335

5.  Gene therapy for Duchenne muscular dystrophy: balancing good science, marginal efficacy, high emotions and excessive cost.

Authors:  Marinos C Dalakas
Journal:  Ther Adv Neurol Disord       Date:  2017-06-28       Impact factor: 6.570

Review 6.  Antisense oligonucleotides in neurological disorders.

Authors:  Claudia D Wurster; Albert C Ludolph
Journal:  Ther Adv Neurol Disord       Date:  2018-05-23       Impact factor: 6.570

7.  Pharmaceutical Drugs of Uncertain Value, Lifecycle Regulation at the US Food and Drug Administration, and Institutional Incumbency.

Authors:  Matthew Herder
Journal:  Milbank Q       Date:  2019-08-12       Impact factor: 4.911

Review 8.  Late translational research: putting forward a new model for developing new anti-cancer treatments that addresses the needs of patients and society.

Authors:  Denis Lacombe; Jan Bogaerts; Bertrand Tombal; François Maignen; Leeza Osipienko; Richard Sullivan; Vassilis Golfinopoulos
Journal:  Mol Oncol       Date:  2019-01-19       Impact factor: 6.603

9.  Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe.

Authors:  Rick A Vreman; Huseyin Naci; Wim G Goettsch; Aukje K Mantel-Teeuwisse; Sebastian G Schneeweiss; Hubert G M Leufkens; Aaron S Kesselheim
Journal:  Clin Pharmacol Ther       Date:  2020-04-20       Impact factor: 6.875

10.  Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs.

Authors:  Rick A Vreman; Jacoline C Bouvy; Lourens T Bloem; Anke M Hövels; Aukje K Mantel-Teeuwisse; Hubert G M Leufkens; Wim G Goettsch
Journal:  Clin Pharmacol Ther       Date:  2018-11-08       Impact factor: 6.875

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