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
