WASHINGTON – Optimism, and eight years of hard work, paid off for Optimer Pharmaceuticals Inc. Tuesday when an FDA advisory committee unanimously recommended approval of Dificid (fidaxomicin) as a treatment for Clostridium difficile infection (CDI). Read More
It might be called the cancer patient's theory of relativity: Even when drug development moves at record speed, that speed is still glacial from the perspective of the patient with cancer whose life expectancy may, in the worst cases, be measured in months. Read More
It took Cephalon Inc. less than a week to decide that Valeant Pharmaceutical International Inc.'s unsolicited offer to buy the biotech was undervalued. Read More
Cubist Pharmaceuticals Inc. has settled its lawsuit with Teva Pharmaceutical Industries Ltd. and will soon see less money going to litigation and more going to innovation. The lawsuit, filed in 2009 by Cubist, alleged that Jerusalem-based Teva had infringed on Cubist's patent for Cubicin (daptomycin for injection) by filing for FDA approval of a generic version of Cubicin. Read More
Millennium, of Cambridge Mass., has rescued the kinase inhibitor program in oncology at Sunesis Pharmaceuticals Inc. after development partner Biogen Idec exited the oncology market last fall. Millennium, a unit of Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, inked a licensing agreement that covers the development of Sunesis' oral, Phase I-ready selective pan-Raf kinase inhibitor and an additional preclinical kinase inhibitor program with an undisclosed oncology target. Read More
ProMetic Life Sciences Inc., of Montreal, entered an agreement with Celgene Corp., of Summit, N.J., for the worldwide rights to a commercial application of ProMetic's protein technologies. Under the terms, Abraxis BioScience Inc., a wholly owned subsidiary of Celgene, will forgive a $10 million long-term debt from 2010, effectively terminating the loan agreement four years prior to its original term, in return for intellectual property rights to specific commercial application of the technology within restricted fields of use. Read More
Champions Oncology, Inc., of Baltimore, said that it grossed $9.4 million through the private placement of 12.5 million shares of common stock at 75 cents per share. The company said proceeds will be used for sales resources, its Tumorgraft bank and technology platform and to repurchase shares. Read More
Neurocrine Biosciences Inc., of San Diego, completed dosing and preliminary assessment of its initial cohort of patients in an open-label, Phase IIa trial of NBI-98854 for tardive dyskinesia. NBI-98854 is a vesicular monoamine transporter 2 inhibitor (VMAT2). After 12 days of treatment with the drug, test subjects showed improvement in the abnormal hyperkinetic movements caused by tardive dyskinesia. Read More
