Researchers have identified an unexpected second role for a key protein that normally plays a role in cell division, in cells whose dividing days are long behind them. The cell cycle protein cyclin E is expressed in neurons at high levels, and plays a role in memory formation. Read More
WASHINGTON – With unexpected drug shortages becoming the norm, the FDA needs to reallocate its resources to better handle the crisis and improve how, when and what it communicates about those shortages, a group of stakeholders told the agency. Read More
DUBLIN, Ireland – Two recent but wholly contrasting investments illustrated how the Irish biopharmaceutical sector is facing up to the headwinds that beset the global industry and point the way to how it may develop in the future. Read More
Quark Pharmaceuticals Inc., of Fremont, Calif., withdrew its registration statement for an initial public offering (IPO), citing market conditions. Read More
Talon Therapeutics Inc., of San Mateo, Calif., reported that its new drug application for Marqibo (vincristine sulfate liposomes injection) has been accepted for filing by the FDA under accelerated approval. Prior to the May PDUFA date, Talon plans to begin enrollment in a Phase III confirmatory trial of Marqibo for the treatment of adults, 60 or older, with newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia. Read More
Sunesis Pharmaceuticals Inc., of South San Francisco, began a Phase I trial of its cancer candidate, MLN2480, sponsored by Millennium Pharmaceuticals Inc., of Cambridge, Mass., a unit of Takeda Pharmaceuticals Co. Ltd. Read More
Astex Pharmaceuticals Inc., of Dublin, Calif., said that its HSP90 inhibitor, AT13387, showed activity in in vitro gastrointestinal stromal tumor (GIST) models. The compound was more active than 17-AAG, a first-generation HSP90 inhibitor, in all cell lines tested. Read More
Biotie Therapies Oyj took another step along its growth-by-acquisition pathway by agreeing to take over Newron Pharmaceuticals SpA in a stock-based deal valued at €37.4 million (US$50.7 million) initially, with another possible €7.2 million in share-based milestones on the table. Read More
ATLANTA – Caught between waning investor dollars and a government calling for reduced health care spending, the biotech industry is under more pressure than ever to innovate; the days when firms could create a follow-on molecule that offers only incremental improvements to existing therapies are over. Read More
