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A federal judge tossed out Novartis’ lawsuit against generic firm Alvogen’s challenge to its dementia treatment Exelon Patch, claiming the brand firm failed to show the generic product contained a patented antioxidant. Read More
A federal judge has dismissed conspiracy claims against four generic drugmakers and a brand firm in a class-action lawsuit that alleges the companies colluded to keep generic versions of Cephalon’s wakefulness drug Provigil off the market. Read More
Avanir Pharmaceuticals has settled with generic firm Ranbaxy over its bid to produce a version of the brand manufacturer’s Nuedexta, the first drug approved in the U.S. to treat pseudobulbar affect (PBA). Read More
Pfizer-subsidiary Wyeth is claiming immunity in a long-running antitrust lawsuit involving an alleged pay-for-delay generics scheme with Teva, but a group of pharmaceutical purchasers aren’t buying the argument. Read More
The FDA has slapped two generic manufacturers with separate warning letters for not paying registration fees on their facilities under GDUFA. Read More
The FTC gave generics makers a boost last week in their fight to stop brand drugmakers from using REMS restrictions to block access to sample drugs the generics industry needs to prepare ANDAs. Read More
Federal and state lawmakers are questioning whether the FDA’s Expanded Access program, which allows terminally ill patients to use experimental drugs in certain cases, adequately addresses the current need, with several states considering legislation that would let patients bypass the agency in acquiring investigational therapies. Read More
Each year, up to 20 percent of the U.S. population gets the flu, resulting in more than 200,000 flu-related hospitalizations and 36,000 deaths. Read More