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Two years after the EU implemented landmark pharmacovigilance legislation, European regulators are offering manufacturers and other interested parties a comprehensive look at how the region’s drug safety system actually operates. Read More
The U.S. House passed a bill this week that aims to prevent prescription drug abuse and diversion, while ensuring patient access to needed medications, by fostering greater collaboration between drug manufacturers, distributors and regulators. Read More
European regulators have approved Roche’s Gazyvaro in combination with chlorambucil as a first-line treatment for chronic lymphocytic leukemia (CLL) patients who are unable to tolerate more intensive therapies. Read More
An FDA inspection of Impax Laboratories’ Taiwan plant has uncovered apparent manufacturing violations, raising new questions about the company’s plans to launch its proposed Parkinson’s disease drug Rytary. Read More
The European Commission has approved an expanded indication for the blood thinner Eliquis to treat deep vein thrombosis and pulmonary embolism and to prevent recurrent DVT and PE in adults, Bristol-Myers Squibb and Pfizer said Tuesday. Read More
The FDA is continuing its push to help drugmakers better understand how they can use the agency’s expedited approval programs, releasing new details on how agency staff will review certain drugs in the breakthrough therapy pathway. Read More
Indian pharmaceutical authorities have enacted price controls on scores of branded-generic drugs to treat diabetes and cardiovascular disorders, a decision that one industry observer warns will also have a chilling effect on the introduction of patented drugs into the country as branded companies worry that price controls may soon come to their sector as well. Read More
Colorado-based Allos Therapeutics and three research organizations are suing Dr. Reddy’s over its proposed generic version of the brand manufacturer’s orphan lymphoma drug Folotyn. Read More
Canadian trade officials are pushing back against Eli Lilly’s $500 million damages claim against the government in an international trade dispute, claiming the brand manufacturer demonstrates a fundamental lack of understanding for Canada’s patent laws and treaty obligations. Read More
Massachusetts-based Cubist Pharmaceuticals is suing Fresenius Kabi over its proposed generic version of Cubist’s profitable antibiotic Cubicin. Read More