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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
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
China has agreed to streamline its regulatory processes and cut red tape for imports of new drugs, a move that should benefit the U.S. pharmaceutical industry, the U.S. Commerce Department says. Read More
The FDA late Friday approved Cubist Pharmaceuticals’ antibiotic Zerbaxa to treat complicated intra-abdominal infections and urinary tract infections, the latest approval granted through an initiative to encourage antibiotic development. Read More