News briefs: US priority review for regorafenib; Ph IIb blisibimod data

29 June 2012

Bayer HealthCare, a US unit of Germany’s Bayer (BAYN: DE) and partner Onyx Pharmaceuticals (Nasdaq: ONXX) said yesterday that the US Food and Drug Administration has granted priority review designation for the New Drug Application filed end of April 2012 for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies.

Under the Prescription Drug User Fee Act (PDUFA), the FDA will complete its review within six months from the receipt of the NDA submission, rather than the standard 10-month review cycle. The submission was based upon data from the pivotal, global Phase III CORRECT study, noted Bayer.

Anthera blisibimod disappoints

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