The Japanese Pharmaceutical Industry: The New Drug Lag and the Failure of Industrial PolicyThe Japanese Pharmaceutical Industry: The New Drug Lag and the Failure of Industrial Policy, by ThomasL. G.. Cheltenham, UK: Edward Elgar, 2001.

2002 ◽  
Vol 27 (3) ◽  
pp. 462-464
Author(s):  
William C. Bogner
Keyword(s):  
Pharmaceutical Industry ◽  
Industrial Policy ◽  
New Drug ◽  
Drug Lag ◽  
Edward Elgar

The New Drug Lag: EU Lags in Review Times of Monoclonal Antibodies

2019 ◽  
Vol 54 (4) ◽  
pp. 770-774
Author(s):  
Vibha Sharma ◽  
Vivek Dasharath Deore ◽  
Sandhya Vivek Deore ◽  
Irwin G. Martin
Keyword(s):  
Monoclonal Antibodies ◽  
New Drug ◽  
Drug Lag

An industrial policy for the pharmaceutical industry

Japan Forum ◽  
1989 ◽  
Vol 1 (1) ◽  
pp. 19-27 ◽  
Author(s):  
I. J. Neary
Keyword(s):  
Pharmaceutical Industry ◽  
Industrial Policy

Business versus science: High drug prices conspire against oncological research.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14580-e14580
Author(s):  
Felipe G. Gercovich ◽  
Ernesto Gil Deza ◽  
Eduardo L. Morgenfeld ◽  
Marcelo Muino ◽  
Marvin Albert Mizrahi ◽  
...  
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Approval ◽  
Point Of View ◽  
New Drugs ◽  
New Drug ◽  
Drug Registration ◽  
Ethical Point ◽  
Post Marketing ◽  
State Of Affairs ◽  
Drug Approval Process

e14580 Background: It has been consistently proven that pivotal clinical trials (PCT) for drug registration or new drug indications (NDI), sponsored by the pharmaceutical industry, obtain better results than independent confirmatory studies (ICS). The interplay between PCT and ICS has supported better treatment selections and more realistic expectations: hope vs hype.The aim of this paper is to analyze the amount of ICS publications in Oncology within the last decade. Methods: All new FDA approved oncological drugs or NDI for solid tumors between 2005 and 2017 were taken into account. The PCT that led to their approval were identified, and between October and November 2019 a thorough search for related ICS (published or ongoing) was conducted on MEDLINE, ASCO Abstracts, NEJM, Lancet Oncology, JAMA, JCO, Cancer, PLOS ONE, PLOS Medicine and www.Clinicaltrials.gov. Results: Fifty-five new drugs or NDI were analyzed (Abemaciclib, Abiraterone, Ado-trastuzumab emtasine, Afatinib, Alectinib, Atezolizumab, Avelumab, Axitinib, Bendamustine, Bevacizumab, Brigatinib, Cabozantinib, Ceritinib, Cobimetinib, Crizotinib, Dabrafenib, Degarelix, Denosumab, Durvalumab, Eribuline mesylate, Everolimus, Ipilimumab, Irinotecan liposome, Ixabepilone, Lapatinib, Lenvatinib, Necitumumab, Neratinib, Nilotinib, Niraparib, Nivolumab, Olaparib, Osimertinib, Paclitaxel protein bound, Palbociclib, Panitumumab, Pazopanib, Pembrolizumab, Pertuzumab, Ramucirumab, Regorafenib, Ribociclib, Rucaparib, SipuleucelT, Sonidegib, Sorafenib, Sunitinib, Topotecan, Trabectedin, Trametinib, Trastuzumab, Vandetanib, Vemurafenib, Vismodegib, Ziv-afilbercept). Until November 30, 2019, no published or ongoing ICS were found in any of the cases. Conclusions: a) For the past decade, none of the PCT used for approval of new oncological drugs or NDI were replicated by ICS (without pharmaceutical industry sponsorship). b) We ignore the reasons for these approval methods but they raise suspicion and unnecessary discomfort. c) From an ethical point of view, patients’ Informed Consent must specify that expected results for the new drug or NDI are based exclusively on trials sponsored by the selling pharmaceutical company, unless other ICS are published. d) The current state of affairs can only be reverted if regulatory agencies and the scientific community demand ICS as part of the drug approval process or post-marketing duties.

New Drug Legislation: A Response From the Pharmaceutical Industry

1990 ◽  
Vol 9 (3) ◽  
pp. 110-113
Author(s):  
Paul E. Freiman
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Legislation ◽  
New Drug
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