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Sens. Joe Manchin (D-W.Va) and Edward Markey (D-Mass.) will maintain their holds on the nomination of Robert Califf for the top job at the FDA, despite the agency’s announcement Thursday that it would overhaul its opioid policies. Read More
FDA reviewers have given their support to Celltrion’s proposed biosimilar for Remicade, finding no clinically meaningful differences between the copy and the original. Read More
Massachusetts Attorney General Maura Healey is mulling legal action against Gilead Sciences over its sky-high prices for two hepatitis C medications, alleging that the company’s approach could violate the state’s antitrust laws. Read More
The war on high pharmaceutical prices continues, with PBM Express Scripts taking aim at what it calls an excessive price jump for Valeant Pharmaceuticals’ diabetes drug Glumetza. Read More
After serving as Gilead Sciences’ CEO for 20 years, John C. Martin has announced that he is stepping down and will assume the role of executive chairman of the company. Read More
The EMA’s Committee for Medicinal Products for Human Use has recommended six new medicines for marketing authorization, including three innovators and three generics. Read More
The FDA is asking Sun Pharmaceuticals to conduct tests and turn over reams of paperwork in response to a warning letter alleging more than a dozen cGMP violations. Read More
With 12 nations signing off on the Trans-Pacific Partnership on Wednesday, the clock has started on ratification of the treaty providing up to eight years of exclusivity for biologics. Read More
The FDA is re-examining its approval, REMS and postmarket policies for opioids in response to a growing abuse epidemic and calls to action from lawmakers. Read More
House members are growing impatient with the FDA over a lack of guidance on biosimilars, with several venting their frustrations during a hearing Thursday. Read More