PhRMA and EFPIA issue joint principles that urge firms to release the synopses of clinical study reports; PhRMA objects to FDA’s proposal to release masked, de-identified data on the grounds of patient privacy, competitive secrecy.
The pharmaceutical industry is trying to change the direction of clinical trial data disclosure so companies can retain control over who has access to the information.
On July 24, the European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America issued joint principles for clinical trial data sharing that call for...
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.
