We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
The FDA’s top drug official slammed the current clinical trial system as a major barrier to rapid drug development and urged the drug industry to adopt clinical trial networks as a better way to evaluate new products. Read More
AstraZeneca said the FDA has approved its fish oil-based cardiovascular drug Epanova (omega-3-carboxylic acids) for the treatment of adults with very high triglyceride levels. Read More