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The Association of the British Pharmaceutical Industry found four drugmakers — Celgene, Takeda, Vifor Pharma and Pierre Fabre — violated the group’s code of practice by engaging in activities ranging from inadequate quality management to deceptive drug promotion. Read More
Republican leaders from the House Energy and Commerce Committee have asked the FDA to provide all documents related to the agency’s criminal investigations into the heparin contamination crisis. 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