AVEO Pharmaceuticals Inc. and partner Astellas Pharma Inc. reported top-line data from the global, randomized Phase III TIVO-1 trial indicating that lead compound tivozanib demonstrated superiority over Nexavar (sorafenib, Onyx) in advanced renal cell carcinoma (RCC), meeting the primary endpoint of progression-free survival (PFS). Read More
Researchers from the University of North Carolina at Chapel Hill have gained new insights into why the hepatitis C virus needs the microRNA miR-122 as a partner in crime – and in doing so, have described a new general mechanism by which miRNAs can act on their targets to affect gene expression. Read More
Bionovo Inc., of Emeryville, Calif., said it entered a $5 million securities purchase agreement with Socius CG II Ltd., a Bermuda-based subsidiary of Socius Capital Group LLC. Under the terms, the company has the right, at its discretion, to sell to Socius up to a total of $5 million of redeemable Series A preferred stock, payable in tranches, over a two-year period. Read More
Rexahn Pharmaceuticals Inc., of Rockville, Md., received U.S. Patent No. 8,034,829, titled "5, 6, or 7-Substituted-3-(hetero) arylisoquinolinamine derivatives and therapeutic use therof." It covers several new isoquinolinamine compounds and their pharmaceutical composition and method for producing an antitumor effect. Read More
Astex Pharmaceuticals Inc., of Dublin, Calif., said the FDA's Oncologic Drugs Advisory Committee will discuss its supplemental new drug application for Dacogen (decitabine) for Injection at its Feb. 9, 2012, meeting. The proposed indication for the application is elderly acute myelogenous leukemia. Read More
Agile Therapeutics Inc., of Princeton, N.J., completed the final Phase III trial of AG200-15 and is on track to submit the new drug application (NDA) for the combination hormonal contraceptive patch to the FDA during the first quarter. The patch, in two Phase III trials enrolling more than 2,000 women, demonstrated its ability to deliver a low dose of ethinyl estradiol and a dose of levonorgestrel consistent with the efficacy and safety profiles of low-dose oral contraceptives. Read More