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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
Brand manufacturer Acorda is fending off at least six different generic challenges filed in the last few weeks to its multiple sclerosis drug Ampyra. Read More
In a blow to AbbVie’s efforts to head off generic competition on its AndroGel 1%, the FDA said Irish drugmaker Perrigo’s testosterone gel product is bioequivalent and interchangeable. Read More
A federal court has granted Mylan’s request for a temporary restraining order to halt all sales of competitor Apotex’s generic version of Paxil CR, the latest step in Mylan’s claim to generic exclusivity on GlaxoSmithKline’s blockbuster antidepressant. Read More
After asking drugmakers in 2011 to voluntarily withdraw pain medications containing more than 325 milligrams of acetaminophen over safety issues, the FDA has pulled the remaining ANDAs from firms that either failed to submit sufficient data with their withdrawal applications or didn’t submit an application at all. Read More
A group of third-party pharmaceutical payers is moving to settle part of a class action lawsuit against Pfizer-subsidiary King Pharmaceuticals and generics maker Mutual Pharmaceutical over their alleged collusion to delay a generic of the muscle relaxant Skelaxin. Read More