We at BioWorld actually contemplated putting out a zany blog about biotech to commemorate April Fools’ Day – i.e. biotech firm develops drug for childhood cooties, or something equally ridiculous – but, in the end, we decided to pass. And a good thing, too, because we never would have been able to top a spoof press release sent out by antibody firm ImaginAb. The Ingelwood, Calif.-based firm said it was changing its name to “AmaginAb,” because most of the successful firms in biotech have names that start with the letter ‘A” and “we were forced to acknowledge that we might...
Just days after winning a thumbs-up from the European Committee for Medicinal Products for Human Use, Biogen Idec Inc.'s much-lauded Tecfidera (dimethyl fumarate) was approved by the FDA, and analysts have said the drug has a good shot going up against the two oral multiple sclerosis (MS) therapies already on the market.
Hepatitis C virus (HCV) player Enanta Pharmaceuticals Inc. priced a $56 million initial public offering (IPO) and received a warm welcome from Wall Street, as its newly listed shares shot up 22.7 percent on its first day of trading.
Swedish firm Active Biotech AB nearly doubled its cash position and brought on board a new investor in a SEK270 million (US$42.6 million) fundraising this week.
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.
