BioSante gets PDUFA date for Bio-T-Gel

BioSante Pharmaceuticals’ (NASDAQ:BPAX) Bio-T-Gel, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals (NASDAQ:TEVA), has been assigned a new PDUFA date of Feb. 14, 2012 by the FDA, BioSante said in its third quarter report. Teva is responsible for all regulatory and marketing activities for Bio-T-Gel. BioSante also said it expects to announce top-line [...]

Paladin eyes Mexico and Brazil for expansion

Pharmaceutical distributor Paladin Labs (TSX:PLB) has set its sights on moving into Mexico and Brazil as it continues its strategy of expanding internationally to complement its growth in Canada. “I would like to be in more geographies, and we’re keenly interested in Mexico and Brazil and looking to do something there,” CEO Jonathan Goodman says [...]

OncoGenex begins pivotal prostate cancer trial

OncoGenex Pharmaceuticals (NASDAQ: OGXI) has initiated a Phase 3 trial of its OGX-011/TV-1011 drug candidate for the treatment of castrate-resistant prostate cancer (CRPC), the first of three pivotal trials under a collaboration and license agreement with Teva Pharmaceutical (NASDAQ: TEVA). The international Phase 3 trial will be conducted at about 50 cancer centers and will [...]

Biotech’s new normal is search for efficiency

Coming out of a harrowing financial crisis and recession, the outlines of a “new normal” are starting to emerge in the general economy and biotech industry, Ernst & Young says in its global biotechnology report for 2010, Beyond Borders. On the surface, E&Y says it would appear that the worst is indeed over for biotech. [...]