• Amgen Inc., of Thousand Oaks, Calif., said the European Committee for Medicinal Products for Human Use recommended marketing approval for Vectibix (panitumumab) in patients with refractory metastatic colorectal cancer with non-mutated KRAS genes. The European Commission will take the CHMP opinion into consideration for final approval. The positive opinion was based on a positive benefit/risk assessment of the drug in the specific non-mutated KRAS genes patient population. Vectibix previously gained approved in the European Union as a monotherapy for treating metastatic colorectal carcinoma expressing endothelial growth factor receptor (EGFR) with non-mutated KRAS tumors and after failure of fluoropyrimidine, oxaliplatin and irinotecan chemotherapy regimens.

• Cepheid Inc., of Sunnyvale, Calif., said its contract has been terminated with the Centers for Disease Control and Prevention for the development of a rapid point-of-care diagnostic to detect influenza viruses A and B, and the H5N1 avian influenza virus in human respiratory specimens. Details of the termination were not provided, but Cepheid said the news should not affect its 2007 financial guidance.

• Exelixis Inc., of South San Francisco, extended its research collaboration with New York-based Bristol-Myers Squibb Co. to develop and commercialize drugs targeted against the liver X receptor, a nuclear hormone receptor implicated in several cardiovascular and metabolic disorders. The companies signed the potential $317.5 million LXR agonist deal in December 2005. The extension provides Exelixis additional research funding of $7.5 million, and extends the collaboration timeline through Jan. 12, 2009, with BMS retaining the option to add another year. Exelixis and BMS have been working together since 2000 and have a separate ongoing cancer collaboration valued at up to $120 million. (See BioWorld Today, Dec. 7, 2005.)

• Onyx Pharmaceuticals Inc., of Emeryville, Calif., and Bayer HealthCare Pharmaceuticals, of Wayne, N.J., said the European Committee for Medicinal Products for Human Use recommended marketing authorization of Nexavar (sorafenib) tablets in hepatocellular carcinoma. The positive opinion was based on Phase III data showing that Nexavar extended overall survival by 44 percent over placebo, and that opinion will be forwarded to the European Commission for final approval. Onyx and Bayer previously filed a supplemental new drug application with the FDA. Nexavar already is approved in both the U.S. and Europe to treat advanced kidney cancer.

• Pipex Pharmaceuticals Inc., of Ann Arbor, Mich., said it completed a series of meetings with the FDA regarding its planned submission of a new drug application for Coprexa (oral tetrathiomolybdate). Based on feedback at those meetings, the company expects to file an NDA in November for the treatment of initially presenting neurologic Wilson's disease. Coprexa is an oral, small-molecule, anticopper agent in development for central nervous system diseases in which abnormal serum and CNS copper homeostasis are implicated. In addition to Wilson's disease, Pipex is investigating the drug against fibrotic disorders.

• Sequenom Inc., of San Diego, reported that research conducted under the cancer program at the Australian-based Garvan Institute of Medical Research demonstrated the successful use of the company's MassArray EpiTyper technology for providing detailed DNA methylation analysis critical for comprehensive profiling of normal and disease DNA methylation patterns. Details from the research study were published in Nucleic Acids Research.

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