Alder Biopharmaceuticals Inc., of Bothell, Wash., said researchers will present findings from a randomized, double-blind, placebo-controlled proof-of-concept trial of lead compound ALD403 in preventing frequent episodic migraine at the American Academy of Neurology meeting in Philadelphia next month. Read More
Bristol-Myers Squibb Co. (BMS), of New York, and Samsung Biologics, of Seoul, South Korea, said they will increase the scope of their existing manufacturing agreement in which Samsung will manufacture commercial drug substances and drug product for several BMS biologic medicines at its Incheon manufacturing site. Read More
Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., said it started the process required to establish an expanded access program to make its investigational potassium channel inhibitor, Firdapse (amifampridine phosphate or 3,4-DAP phosphate), available to patients in the U.S. diagnosed with Lambert-Eaton myasthenic syndrome through their neuromuscular disease specialists. Read More
Sarepta Therapeutics Inc., of Cambridge, Mass., said it is offering to sell, subject to market and other conditions, up to $100 million of its common stock in an underwritten public offering. Read More
Billions of dollars may be riding on when the FDA finalizes a draft guidance that would make more fixed-dose combination (FDC) drugs eligible for five-year new chemical entity (NCE) exclusivity. Read More
Neos Therapeutics Inc.'s upsized series C financing – from $15.5 million to $18 million – along with a $20 million loan facility with Hercules Technology Growth Capital Inc. means the firm will "not only have enough money to hit the key regulatory milestones over the next 12-15 months, but to give us financial flexibility into 2016," said Victor Miller, vice president of finance. Read More
Spectrum Pharmaceuticals Inc. looked toward another win in its late-stage pipeline as Captisol-enabled (propylene glycol-free) melphalan met the primary endpoints in a pivotal phase II safety and efficacy study. The company plans to file a new drug application (NDA) in the third quarter under the 505(b)(2) pathway for the high-dose intravenous formulation of CE melphalan as a conditioning treatment in autologous stem cell transplantation (ASCT) in multiple myeloma. Read More
Kala Pharmaceuticals Inc. has completed a $22.5 million financing to fund four trials of the company's mucous-penetrating nanoparticle platform and its lead application in fighting inflammation after cataract surgery. Read More
LONDON – A study of the genome of a woman who lived to the age of 115 years has revealed that people develop many different mutations in their somatic cells during their lifetimes, and that these mutations may not be harmful to health. Read More
