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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
The European Medicines Agency is recommending halting sales of 700 drugs that were approved based on testing data provided by CRO GVK Biosciences, following an inspection that found the Hyderabad, India, firm manipulated echocardiogram data. Read More
The Supreme Court wasted no time in acting on the precedent it set last month in its Copaxone ruling, sending several patent cases, including one Hatch-Waxman dispute, back to the appellate level just a week later. Read More
The U.S. Supreme Court on Jan. 20 upheld Teva Pharmaceuticals’ patent on its multiple sclerosis drug Copaxone, overturning an appeals court ruling and preventing Sandoz from launching a generic of the drug. Read More
Teva is asking a federal court to bar any generic versions of Copaxone from entering the market until the last of the blockbuster MS drug’s patents expires in September. 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
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