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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
Drug recalls increased for the third straight year, with companies pulling 4 percent more products in 2014 than the previous year and foreign particles being the top culprit. Read More
The FDA warned that counterfeit versions of Eli Lilly’s popular erectile dysfunction drug Cialis were found in the mail to a U.S. customer — marking the first major counterfeit incident of 2015. 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
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
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