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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
Gilead has expanded its licensing agreements with eight India-based generic drugmakers to market cheaper copies of its pricey blockbuster hepatitis C therapy Sovaldi in 91 developing countries. Read More
Phase III trials of two Ebola vaccines will kick off in the next few weeks in Liberia, according to the National Institute of Allergy and Infectious Diseases. Read More
As negotiators continue to shape the Trans-Pacific Partnership trade deal, the length of patent protection for biologics remains a sticking point with the U.S. continuing to push for 12 years of protection before a biologic drug can be copied. Read More