Gentium S.p.A. (Nasdaq:GENT) announced today that it has submitted its responses to the Day 180 List of Outstanding Issues received from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) with respect to its Marketing Authorization Application (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy. Gentium expects to receive an opinion from the CHMP regarding the approval of Defibrotide during 3Q 2012.
StemCells, Inc.(Nasdaq:STEM) announced it has initiated a Phase 1/2 trial of its HuCNS-SC product candidate (purified human neural stem cells) in dry age-related macular degeneration (AMD).
Depomed, Inc.(NASDAQ: DEPO) announced that it has acquired all rights to Zipsor (diclofenac potassium) Liquid Filled Capsules from Xanodyne Pharmaceuticals, Inc. Zipsor is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults. Zipsor had approximately $19 million in sales in the 12 months ended May 31, 2012. Depomed acquired the product in return for $25.9m of cash and potential milestone payments based on sales of Zipsor and assumption of certain liabilities.