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The White House in its fiscal 2016 budget proposal Monday asked Congress to appropriate $486 million for CDER, a bump in funding of less than one percent, and $215 million for CBER, an increase of two percent. Read More
The Delhi high court on Friday set aside a government order rejecting Gilead’s patent for hepatitis C treatment Sovaldi, saying the Office of Patents Designs and Trademark had made procedural errors in issuing its decision. Read More
The FDA has green-lighted Eli Lilly and Boehringer Ingelheim’s combination treatment Glyxambi as an adjunct to diet and exercise for adults with type 2 diabetes. Read More
Japanese regulators are weighing whether the agency will need to begin approving some drugs based on Phase II trial data as they implement approval processes for personalized drug products. Read More
The average price of generic drugs rose 4.9 percent in 2014, while prices for their branded counterparts jumped 14.8 percent, a new study finds. Read More
Canadian drugmaker Valeant Pharmaceuticals has agreed to pay $296 million to acquire cash-strapped Dendreon’s prostate-cancer drug Provenge and other assets. Read More
A federal court has ruled that any payment from a brand drugmaker to settle a patent infringement case that results in delay of a competitive generic product is enough to support a pay-for-delay claim, lowering the bar for such lawsuits. Read More
The FDA on Thursday approved two fixed-dose combination therapies aimed at lowering viral loads and reducing treatment failure rates in patients with HIV. Read More
The Senate is joining the effort to make the FDA more efficient at approving new drugs, laying out criticisms that the agency is slow and inefficient in a report released yesterday and planning hearings on the issue in the spring. Read More
European regulators this week approved a complicated three-part transaction that would see Novartis and GlaxoSmithKline swapping parts of their companies and creating a consumer healthcare joint venture. Read More