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Brand drugmakers have been enthusiastic supporters of the FDA’s plans to offer five years of market exclusivity for more fixed-dose combination products — but they want the agency to broaden its new policy so it will cover products already under review. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency and the British Generic Manufacturers Association next month will launch a forum to promote manufacturing quality. Read More
Indian drugmaker Wockhardt has received the regulatory green light to resume manufacturing and selling its combination drug to treat pain, the company said April 28. Read More
European regulators are urging manufacturers of biosimilar insulin-containing products to demonstrate similar pharmacokinetic and pharmacodynamic (PD) profiles as the gold standard in proving efficacy similarity to the reference products. Read More
A new bipartisan caucus on Capitol Hill plans to educate lawmakers and staff on the role that affordable pharmaceuticals and biologics can play in improving health outcomes and lowering healthcare costs. Read More
A federal judge has ruled against generic makers Par Pharmaceuticals and Impax Labs in their patent challenges to Avanir Pharmaceuticals’ pseudobulbar affect drug Nuedexta. Read More
Indian Cabinet Secretary Ajit Seth and other top Indian officials met last month to devise a framework for discussions about intellectual property rights with U.S. drugmakers, a number of whom have lost patent protection in India in recent months. Read More
Indian generics maker Sun Pharmaceutical said that it will close its Detroit, Mich., plant this summer as part of its consolidation of U.S. manufacturing operations. Read More
A federal appeals court has ruled that generic manufacturers of Merck’s osteoporosis drug Fosamax cannot be held liable for “design defect” claims against the product. Read More
Mylan and Actavis are challenging the FDA’s April 24 decision to grant 180-day marketing exclusivity to Teva for a generic version of the blockbuster arthritis drug Celebrex. Read More