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AstraZeneca Files Suit Against FDA; Pfizer, Biocon Terminate Biosimilar Alliance; and More.
AstraZeneca filed a lawsuit against FDA in the United States District Court for the District of Columbia to overturn the FDA’s Mar. 7, 2012 denial of Citizen Petitions filed by AstraZeneca with regard to the Seroquel (quetiapine fumarate) tablets and Seroquel XR extended-release tablets, a treatment for bipolar disorder. AstraZeneca seeks an injunction which would bar FDA from granting final marketing approval of generic quetiapine until Dec. 2, 2012, when regulatory exclusivity expires on important clinical trial data, or at least until a federal court has a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications. Read More
The biotechnology company Biocon and Pfizer have ended their alliance to commercialize Biocon’s biosimilar versions of Insulin and Insulin analog products. The companies have agreed that, due to the individual priorities for their respective biosimilars businesses, it is in their best interest to move forward independently. Read More
DSM, the custom manufacturing business of Royal DSM, and the biopharmaceutical company Agennix have signed a new contract under which DSM will manufacture the oral dendritic cell mediated immunotherapy talactoferrin for Agennix at commercial levels in anticipation of positive Phase III clinical-data and product approval. DSM is currently manufacturing talactoferrin for use in ongoing clinical trials, including the Fortis-M trial in nonsmall cell lung cancer, and will continue to supply talactoferrin for clinical trials as well as to support a potential commercial launch. Read More
The Generic Pharmaceutical Association (GPhA) has pledged its support to the Pharmaceutical Traceability Enhancement Code (RxTEC), a new system for ensuring the security of the US pharmaceutical supply chain. The RxTEC model, which was developed by the Pharmaceutical Distribution Security Alliance, a multistakeholder initiative designed to increase patient access to safe medicines while improving the security of the American drug-distribution system. Read More
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More