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Regulators pushing for greater international cooperation cautioned that relying on other countries’ inspections would require overcoming crucial hurdles such as incompatible technology, language barriers and keeping trade secrets secret. Read More
Teva is pointing to the Supreme Court’s recent ruling in a soft drink labeling case to claim immunity from GlaxoSmithKline’s lawsuit alleging the Israeli firm falsely advertised its generic antidepressant budeprion XL as bioequivalent to GSK’s Wellbutrin XL. Read More
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