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.
An industry group and two drugmakers have filed briefs in the Supreme Court backing Amgen’s request that a federal circuit ruling be partially affirmed to mandate that biosimilar makers share information and wait six months after an FDA approval to launch a therapy. Read More
The FDA has received 150 inquiries from generic companies that have had trouble accessing samples, CDER Director Janet Woodcock told lawmakers at a House oversight subcommittee hearing. 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
In its latest biennial report to Congress on high-risk government programs, the GAO downgraded its rating of the FDA’s action plans, saying CDER, CBER and CDRH’s long-term strategies lack adequate details and performance measures. Read More
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