Less than two months after an advisory panel unanimously recommended approval of Gilead Sciences Inc.'s Hepsera (adefovir dipivoxil) for chronic hepatitis B, the FDA has given its expected nod and the company plans to ship the drug this week - with a price tag that was higher than some analysts had forecast.
ATLANTIC CITY, N.J. - Cheerful hordes of excited people converged on this gambling city over the weekend for the annual Miss America pageant, with all of its royally sequined pomp and circumstance. (Bioworld Financial Watch)
Although its treatment for Crohn's disease missed the primary endpoint in a Phase II trial, Millennium Pharmaceuticals Inc. said the drug hit a secondary endpoint and the company is awaiting results from another Phase II study, this one for ulcerative colitis, with the monoclonal antibody MLN02. (BioWorld Today)
With the dropping of the Avastin (bevacizumab) shoe last week - Genentech Inc. disclosed Phase III data showing the breast cancer drug missed its primary efficacy endpoint - came a renewed focus not only on vascular endothelial growth factor treatments but also on the disease itself. (BioWorld Financial Watch)
On the heels of an encouraging meeting with the FDA regarding Phase III trials of the company's drug for ovarian cancer and non-small-cell lung cancer, Telik Inc. said it plans to pull down cash through an offering of about 5 million shares under a shelf registration filed in June. (BioWorld Today)
Anxiously awaited news regarding Avastin data from a Phase III study in breast cancer broke Tuesday, and - although many analysts had predicted mixed results at best - investors' faith in Genentech Inc.'s drug may have developed a few cracks. (Bioworld Today)
