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The European Commission this week approved Gilead’s hepatitis C drug Harvoni, a decision that comes on the heels of approvals in the U.S., Canada and New Zealand. Read More
House lawmakers introduced bipartisan legislation yesterday that would give manufacturers of Ebola drugs a voucher that can be used to get priority review for a separate product. Read More
Citing quality problems at two of Ranbaxy’s Indian manufacturing facilities, the FDA has revoked its tentative approvals for two of the company’s ANDAs, one for a generic of AstraZeneca blockbuster Nexium and the other for Hoffman-LaRoche AIDS drug Valycte. Read More
The FDA said two generic versions of Janssen’s attention deficit hyperactivity disorder drug Concerta may not be therapeutically equivalent to the brand, a decision that could result in the products being withdrawn. Read More
Amgen is asking the FDA to require that all biosimilar filers send a full copy of their application to the innovator company, a position that parallels the company’s lawsuit opposing Sandoz’s bid to make a version of its chemotherapy product Neupogen. Read More
Ranbaxy is fighting to reclaim its first-filer generic exclusivity on AstraZeneca’s blockbuster heartburn drug Nexium with a lawsuit challenging the FDA’s recent decision to rescind tentative ANDA approval for the therapy over manufacturing violations. Read More
The FDA has proposed criteria for how an ANDA can receive an expedited review under the “first generic” review prioritization category, a move the agency hopes will ease industry confusion over the generic drug incentive. Read More
The FDA has approved an expanded indication for Genzyme’s leukemia drug Lemtrada to treat relapsing multiple sclerosis, 11 months after it initially turned down the company’s sBLA due to safety concerns. Read More