ARTICLE | Company News

Onyx delays carfilzomib submission

October 7, 2010 11:44 PM UTC

Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) will delay an NDA submission for multiple myeloma (MM) candidate carfilzomib to as early as mid-2011 after FDA requested additional CMC information related to commercial-scale manufacturing during a pre-NDA meeting. The company had previously planned to submit the NDA by year end. Onyx said it observed minor variations during a manufacturing-scale run, which the company said are believed to be primarily related to equipment temperature variances. ...