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The Patent Trial and Appeal Board has invalidated a patent for Novartis’ multiple sclerosis drug Gilenya, in one of the first successful uses of the inter partes review process by generics drugmakers. Read More
Democrats on the House Oversight and Government Reform Committee are demanding answers on Valeant Pharmaceuticals’ massive price increases on two heart disease drugs. Read More
The FDA has banned imports of drugs made by Mumbai, India- based Polydrug Laboratories, citing good manufacturing practice violations at its Ambernath plant. Read More
Amgen is hoping a Delaware judge will be more agreeable than a California court as it sues Hospira to prevent the biosimilar maker from marketing its challenger to cancer treatment Epogen. Read More
The two frontrunners for the Democratic presidential nomination, Hillary Clinton and Sen. Bernie Sanders of Vermont, released prescription drug policy proposals Sept. 22 that would cut prices and end pay-for-delay deals. Read More
Drugmakers are challenging the legality of FDA final guidance, calling for the design of generic tablets and capsules to be similar in size and shape to the reference drug to ensure patient acceptance. Read More
PhRMA has named longtime medical device industry executive and healthcare advocate Stephen Ubl to be its next president and CEO, taking over for John Castellani, who is retiring at the end of the year. Read More