Genta has initiated a new clinical study to evaluate its Bcl-2 inhibitor Genasense (oblimersen) in patients with advanced melanoma, the company announces Nov. 29. The trial is the first follow-on study to Genta's Phase III advanced melanoma trial of Genasense plus dacarbazine. The new pilot study will evaluate safety, efficacy and pharmacokinetics of Genasense combined with Abraxis BioScience's Abraxane (paclitaxel protein-bound particles) and Schering-Plough's Temodar (temozolomide). Meanwhile, Genta saw a setback Dec. 8 when preliminary results of a Phase III study of Genasense in acute myeloid leukemia failed to reach the overall survival primary endpoint. The company's NDA for chronic lymphocytic leukemia has a user fee date of Jan. 29 (1Pharmaceutical Approvals Monthly November 2006, In Brief)...

A report from the US FDA says the agency will focus on updating its premarket submission portal, training staff and taking additional steps to start taking in applications for ASCA pilot participant sponsors.

With a late-stage compound on its hands, MGB is currently in discussions with several biotech and pharma companies and also with venture capitalists to continue late-stage development of a novel antibiotic which could transform treatment of Clostridium difficile.