Shares of Gentium SpA slid Thursday after the company revealed it had voluntarily withdrawn the new drug application (NDA) for lead product candidate defibrotide. Read More
If the FDA doesn't release its overdue guidance on social media soon, biopharma may beat it to the door with industry best practices for communicating directly with patients in interactive neighborhoods like Facebook. Read More
LONDON – Another divide over patents is opening up between the U.S. and Europe as biomarkers are coming into more widespread use. Public sector genetic testing laboratories in Europe are ignoring intellectual property (IP) rights both because they do not think they are enforceable and because of a belief that such patents are not justified. Read More
NPS Pharmaceuticals Inc., of Bedminster, N.J., submitted the chemistry, manufacturing and controls section of its new drug application (NDA) for Gattex (teduglutide), a recombinant analogue of human glucagon-like peptide 2, for use in short bowel syndrome (SBS). The rolling NDA follows positive data from a 24-week Phase III study testing Gattex's ability to reduce parenteral nutrition and intravenous fluid requirements in adults with SBS. Read More
Cell Therapeutics Inc., of Seattle, opened enrollment for a Phase II trial of Opaxio (paclitaxel poliglumex, or PPX) and radiation in comparison to temozolomide (TMZ) and radiation in glioblastoma. Read More
