Biogen Idec Inc.'s immune modulator BG-12 (dimethyl fumarate) yielded better-than-expected top-line data in its first Phase III trial, news that bodes well for the Cambridge, Mass.-based firm's foray into the oral multiple sclerosis (MS) drug market and may help stave off competitive threats to its lucrative MS franchise.
Assuming an agreement between the House and the Senate halts a government shutdown, the FDA's Oncologic Drugs Advisory Committee is slated to meet Tuesday to review Pfizer Inc.'s Sutent (sunitinib) and Novartis AG's Afinitor, both of which are seeking expanded approval for pancreatic neuroendocrine tumors (pNET).
A small biotech boasting a technology aimed at targeting difficult-to-drug glycans and a big pharma firm continuing to make inroads in the orphan disease space came together in an early stage deal to develop small molecules against lysosomal storage disorders (LSDs) such as mucopolysaccharidoses.
Formed earlier this year to marry U.S. innovation and Chinese capital, start-up Ascletis Inc. pulled in a whopping $100 million in committed Series A funding, with the first $50 million tranche expected to support its dual operation strategy for about five years.
Cardiovascular data presented for obesity candidates Qnexa (phentermine/topiramate) and Contrave (naltrexone/bupropion) at the American College of Cardiology (ACC) meeting in New Orleans might have boosted shares of Vivus Inc. and Orexigen Therapeutics Inc. Monday, but those results are unlikely to ease the path to approval for either drug.
Bristol-Myers Squibb Co. is planning a quick rollout of ipilimumab following its Friday approval as the first drug to demonstrate improvement in overall survival in metastatic melanoma.