Biotech Supreme Court watchers are looking at the what ifs ahead of Monday's arguments in a case that could overturn 30 years of established precedent, undoing isolated DNA claims and possibly threatening thousands of patents on proteins and other compounds that could be deemed "products of nature." Read More
Somewhere around 10 percent of the U.S. population suffers from chronic insomnia, and around a third of those take drugs to help them sleep. Scientists from Merck & Co. Inc. have reported scientific data in support of their contention that a new type of insomnia drug can give sweet dreams without the side effects that dog the current crop of sleep-inducing agents. Read More
Pity the poor drug developer that thinks using the combination drug/device regulatory pathway through the FDA's Office of Combination Products (OCP) could be a shortcut to approval, bypassing the sometimes unpredictable regulatory oversight of the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). Read More
• OxiGene Inc., of South San Francisco, entered agreements with institutional investors for a private placement of $5 million of zero coupon convertible preferred stock, convertible into approximately 1.38 million shares of common stock at a price of $3.63 apiece, and two series of warrants that may be exercised for up to approximately 2.76 million additional shares of common stock at a price of $3.40 apiece. Read More
• Amyris Inc., of Emeryville, Calif., said its scientists published in Nature the details of a breakthrough in the field of synthetic biology that allows for the production of a key precursor to Artemisinin, the key ingredient to the preferred drug for combating malaria. Read More
• Cardio3 BioSciences SA, of Mont-Saint-Guibert, Belgium, published results of its Phase II (C-CURE) trial in the Journal of the American College of Cardiology showing that therapy with C3BS-CQR-2 is feasible and safe with signals of benefit in chronic heart failure, and merits further evaluation. Read More
• Sanofi Pasteur Ltd., of Lyon, France, the vaccines division of Sanofi SA, said a decentralized marketing authorization application has been accepted for review in the European Union (EU) countries for a quadrivalent formulation of Vaxigrip, Sanofi Pasteur's seasonal inactivated split-virion influenza vaccine produced at its facility in Val de Reuil, France. Read More
• Neuralstem Inc., of Rockville, Md., was issued a U.S. Patent notice of allowance for application No. 12/404,841, for a method that uses expanded spinal cord stem cells, including NSI-566 stem cells, for the treatment of amyotrophic lateral sclerosis, or Lou Gehrig's disease. Read More
• PharmaMar SA, of Barcelona, Spain, presented several posters, including data showing that Aplidin, its second most advanced product, triggers the activation of molecular components of the unfolded protein response as part of its pro-apoptotic program in tumor cells. Read More
