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An advisory panel of the European Medicines Agency last week recommended approval of two AbbVie drugs for hepatitis C, a Genzyme drug for type 1 Gaucher disease, and a change in classification of HRA Pharma’s emergency contraceptive. Read More
The FDA touted its approval of an abuse-deterrent, single-entity opioid yesterday and sought to beat back congressional criticism it has done little to curb prescription drug abuse. Read More
UK’s healthcare cost watchdog says Novartis must provide significantly more clinical trial data on its hives drug Xolair before the group can recommend the therapy for national coverage. Read More
The FDA’s citizen petition process is overloaded with meritless petitions whose only purpose is to try to delay competition from generic drugs, despite past efforts at reforming it, the agency says. Read More
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drug Concerta may not be therapeutically equivalent to the brand, a decision that could result in the products being withdrawn.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