Baxter International Inc. and Momenta Pharmaceuticals Inc. jumped on the biosimilars bandwagon with a global collaboration to develop and commercialize up to six follow-on biologics (FOBs). Read More
Acceleron Pharma Inc. raised $30 million in its first major venture round since 2007, tapping a syndicate of existing investors to supplement recent partnering income. Read More
Mirna Therapeutics Inc. will be using Smarticles liposomal delivery technology developed by Marina Biotech Inc. under a new license agreement worth $63 million up front and in milestones, plus royalties on product sales. Read More
If its start-up is an indication of things to come, the National Center for Advancing Translational Sciences (NCATS) will soon be speeding the development of new drugs. Read More
Gilead Sciences Inc., of Foster City, Calif., said the FDA accepted for review its new drug application for the Quad single-tablet HIV regimen containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate. The agency, however, denied the firm's request for priority review. A standard 10-month review sets the PDUFA date at Aug. 27, 2012. Read More
Neuralstem Inc., of Rockville, Md., received approval from the FDA to proceed to Phase Ib testing in an ongoing trial of NSI-189 in major depressive disorder. In Phase Ia, healthy subjects received escalating doses. In the Phase Ib study, 24 depressed patients will receive escalating doses of NSI-189 over 18 daily administrations. Phase Ib will last about six months. Read More