More than 240 million surgeries are performed worldwide each year, yet there is no approved product on the market to prevent the dermal scarring that can frequently occur.
The modest reduction in menopause-related vasomotor symptoms (VMS) recorded in three Phase III trials was not sufficient to warrant the side-effect risk associated with gabapentin, according to the FDA's Reproductive Health Drugs Advisory Committee, which voted 12-2 Monday to recommend against Depomed Inc.'s Sefelsa (formerly Serada).
Briefing documents released ahead of Tuesday's FDA advisory meeting to discuss the risk-benefit profile of calcitonin-containing drugs in osteoporosis said that the cancer risk associated with the polypeptide hormone "appears plausible" and "cannot be ignored," signaling another potential blow to the drug class, which has seen its share of the osteoporosis market decline over the past decade.
The central nervous system (CNS) disease space has been riddled with high-profile drug failures over the past decades and its difficulty has even prompted big pharmas such as GlaxoSmithKline plc and AstraZeneca plc to jettison programs in psychiatry, pain and neuroscience.
Though decried as an overreaction by analysts at the time, Affymax Inc.'s intraday share drop earlier this month on reports of mild allergic reactions in a pilot study of erythropoiesis-stimulating agent (ESA) Omontys (peginesatide) turned out to be an omen of bad news to come.
NEW YORK – Last month's readout of Celgene Corp.'s successful Phase III study testing Abraxane (nab-paclitaxel) in combination with gemcitabine in pancreatic cancer is expected to change the standard of care for patients with metastatic disease, but its modest improvement in overall survival leaves plenty of room for new players in this notoriously difficult therapeutic space – assuming researchers can figure how to attack it.
NEW YORK – How does a biotech company look to set itself up as a potential acquisition target down the road? The answer, according to a panel at this year's BIO CEO & Investor Conference, is that it depends.
NEW YORK – After kicking off last month's J.P. Morgan Healthcare Conference in San Francisco, Celgene Corp. sounded the starter pistol for this year's BIO CEO & Investor Conference, with CEO Bob Hugin taking the seat in the meeting's first fireside chat Monday morning at the Waldorf-Astoria hotel.
The weekend "snowmageddon" deterred few from attending this year's BIO CEO & Investor Conference – a BIO rep, in fact, said only one speaker had to cancel – and attendees made their way to the Waldorf-Astoria hotel on Park Avenue through slush-filled sidewalks on a rainy Monday morning.
The recent spike in Hyperion Therapeutics Inc.'s stock proved to be warranted Friday, when the FDA issued an approval for Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders (UCDs) in patients, ages 2 and older.
