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India has finalized the formulas that drugmakers must use to determine compensation for patients who are injured while in clinical trials, but one expert says the move will do little to attract industry back to the country to conduct trials. Read More
Genentech bolstered its case that Gazyva is more effective at treating front-line leukemia than the company’s older drug Rituxan, which is set to face stiff biosimilar competition in a few years. Read More
The FDA has warned a Mississippi compounder for not disinfecting its clean room equipment and for other serious manufacturing violations, capping a busy year for the agency’s compounding pharmacy enforcement. Read More
The FDA on Monday published 28 new product-specific guidances and revised testing recommendations on another 15 therapies to aid ANDA filers in designing bioequivalence studies for their applications. Read More
The FDA has pledged to delay enforcement of key elements of its new track and trace regulations for drugmakers, promising that until May 1 it will take no action against companies that do not capture and transmit product information. Read More
Manufacturers of pandemic flu vaccines will have more leeway in what they submit to the European Medicines Agency, according to final guidance that consolidates the requirements for premarket submissions for all types of influenza vaccines. Read More
The FDA is proposing revisions to an adverse events reporting form that includes, for the first time, a section for large compounders to submit events. Read More
The FDA plans to consolidate its 16 districts overseeing pharmaceutical imports into either four or five districts under a reorganization plan that aims to make inspection policies and procedures more uniform, regardless of port of entry. Read More
The European Medicines Agency released a comprehensive report detailing steps to better prevent and detect fraud and biased medical product reviews by 2016. Read More
Boehringer Ingelheim’s advanced lung cancer drug Vargatef is too expensive to justify the modest benefit it provides patients, according to the UK’s healthcare cost watchdog that recommended against coverage. Read More