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The FDA has rejected Teva’s seventh citizen petition calling for the agency to boost its scrutiny of any ANDA seeking to make a generic version of the Israeli firm’s blockbuster multiple sclerosis drug Copaxone. Read More
A pan-European health technology assessment body has recommended that EU cost-effectiveness evaluators compare new pharmaceuticals against the most relevant standards of care, in a new framework to harmonize different member states’ individual guidelines on making coverage decisions. Read More
The European Medicines Agency last week approved Boehringer Ingelheim’s lung cancer drug Vargatef for treating non-small cell lung adenocarcinomas. Read More
UK healthcare cost evaluators affirmed their earlier coverage recommendation of Alexion’s rare blood disease drug Soliris, but still expressed concerns over the therapy’s high costs. Read More
Manufacturers of prescription and over-the-counter drugs containing acetaminophen should warn patients about the risk of serious skin reactions, according to an FDA draft guidance. Read More
The European Commission has approved Janssen’s HIV combination drug Rezolsta, which combines the company’s protease inhibitor Prezista and Gilead Sciences’ pharmacokinetic enhancer Tybost. Read More
The FDA has added a warning about risks of a rare brain infection associated with Biogen Idec’s multiple sclerosis drug Tecfidera, after the first confirmed death of a patient taking the drug. Read More
Baxter International has filed a lawsuit against generics maker Mylan over its patent challenge to the brandmaker’s heart rate control drug Brevibloc. Read More
Endo and Bayer are suing generics maker Perrigo’s subsidiary Paddock Laboratories over its patent challenge to the brand firms’ testosterone replacement therapy Aveed. Read More
With drugmakers facing a Jan. 1 deadline to begin complying with new product track-and-trace requirements, the FDA has announced a wide range of options that companies can choose from to satisfy the new law in a short guidance that contains no surprises for industry. Read More
Teva has become the second generics maker to settle a lawsuit alleging that it conspired with AstraZeneca to delay generic entry of its blockbuster heartburn therapy Nexium, a move that comes as the judge overseeing the case continues to dampen plaintiffs’ antitrust claims. Read More