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New Jersey federal judges validated patents on Sunovion Pharmaceuticals’ schizophrenia drug Latuda and Helsinn’s nausea therapy Aloxi, dealing a blow to sponsors looking to launch generic versions of the drugs. Read More
In a loss for Shire, a three-judge panel for the U.S. Court of Appeals for the Federal Circuit ruled Actavis did not infringe a patent covering the ulcerative colitis drug Lialda, reversing a lower court decision. Read More
Teva Pharmaceuticals has been named in a patent infringement lawsuit as it attempts to develop a generic version of Belbuca, a long-acting opioid painkiller sponsored by BioDelivery Sciences International and Arius Two. Read More
The U.S. solicitor general, the biosimilar industry, and several generics makers have filed U.S. Supreme Court briefs in support of reversing a Federal Circuit ruling that orders sponsors to wait six months after an FDA approval to launch a biosimilar. Read More
International generic drug regulators have published a report template for biowaiver assessments to better reconcile varying biowaiver requirements among regulatory authorities. Read More
Twenty states have joined an antitrust lawsuit accusing six generics makers of colluding to fix the price of generic versions of antibiotic doxycycline hyclate and the diabetes drug glyburide. Read More
The FDA’s Office of Generic Drugs received 57 ANDAs in January, marking a nearly 76 percent decrease in submissions from the previous month, when the agency experienced a surge in applications. Read More
The head of the brand-name pharmaceutical industry’s trade group called for streamlining the generics approval process, and a greater shift to value-based payments. Read More
The FDA officially unveiled its recommendations for the second generation of user fee agreements covering generics and biosimilars, with commitments to eight-month reviews of priority generics. Read More