Pioneering botulism antitoxin from Cangene gets FDA nod

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March 26, 2013 Starting to plan your BIO International Convention experience for next month in Chicago? Learn about the top 10 "can't miss" sessions on BIOtechNOW. The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com.   Today's Top Story  Pioneering botulism antitoxin from Cangene gets FDA nod The FDA approved Cangene's Botulism Antitoxin Heptavalent to treat patients with suspected or documented exposure to all known botulinum neurotoxin serotypes. The horse plasma-based antitoxin is the only botulism treatment available for adults and for infants whose illness was caused by toxins other than types A and B. Because the drug holds an orphan-drug designation, it will get seven years of market exclusivity. Medscape (free registration) (3/25), Reuters (3/22)      CHMP's Latest Opinions: Seven Positive, One Negative The European Medicines Agency's Committee for Medicinal Products for Human use issued opinions for eight drugs of interest to the biopharma sector, including thumbs up for multiple sclerosis (MS) drugs from Biogen Idec Inc. and Genzyme Corp. It was good news, too, for Halozyme Therapeutics Inc.'s immunodeficiency drug HyQvia, Ariad Pharmaceuticals Inc.'s Iclusig and others. Find out the details.   Health Care & Policy  Supreme Court holds hearing on patent settlement agreements The Supreme Court held a hearing on Monday to consider whether drugmakers can settle patent lawsuits with generic-drug makers by making arrangements to block generics. The court seemed conflicted after an hour of oral arguments, with some justices worrying that the practice would delay cheaper drugs coming to the market and hurt competition, while the court also noted that sometimes the arrangements are valid. The Federal Trade Commission has been fighting the practice for more than 10 years and contributed a brief to the Supreme Court challenge. Drugmakers are defending such deals to avert patent litigation. FoxNews.com/Dow Jones Newswires (3/25), Reuters (3/22)      FDA OKs antibiotic inhaler for cystic fibrosis patients The FDA has approved Novartis' TOBI Podhaler, an inhaler that releases powdered tobramycin, for the treatment of Pseudomonas aeruginosa infections in adults and children 6 years and older. Among the adverse reactions linked to the use of the antibiotic inhaler were cough, shortness of breath, headache and fever. PhysiciansBriefing.com/HealthDay News (3/25), Drug Store News (3/25)      Boehringer, Lilly submit diabetes drug empagliflozin for FDA approval Boehringer Ingelheim and Eli Lilly and Co. filed a new drug application with the FDA for empagliflozin, a sodium-glucose co-transporter 2 inhibitor, as a treatment for type 2 diabetes. The drug prevents glucose reabsorption in the kidneys and removes excess glucose via the urine. Pharmaceutical Business Review Online (3/26)      FDA extends review of GSK's H5N1 flu vaccine The FDA has said it needs more time to consider whether to approve GlaxoSmithKline's H5N1 flu vaccine intended for use in the event of a pandemic. GSK said the delay was not because of questions raised about its H1N1 flu vaccine Pandemrix and narcolepsy. The agency asked for more time "due to an administrative matter that has recently been rectified," the drugmaker said. Reuters (3/25)      Affymetrix to analyze 500,000 DNA samples for UK Biobank UK Biobank has enlisted Affymetrix for the genotyping of 500,000 DNA samples as part of a study to identify new ways to prevent, diagnose and treat complex illnesses such as cancer, cardiovascular disease and diabetes. GenomeWeb Daily News (free registration) (3/22)      Va. law places restrictions on biosimilars Virginia has passed legislation permitting the substitution of biosimiliar drugs for brand-name biologics -- but with restrictive conditions. Similar legislation has passed or is pending in several other states, and a key point in the bills is the requirement that the FDA certify that a biosimilar is interchangeable with the prescribed biologic medication. Pharmalot.com/Pharma Blog (3/22)        Company & Financial News  Shire boosts ophthalmology business with SARcode buy Shire agreed to pay $160 million upfront plus additional milestone fees to acquire SARcode Bioscience as part of efforts to strengthen its presence in the ophthalmology drug market. SARcode is developing Lifitegrast, a late-stage compound for dry eye disease. The acquisition is expected to be finalized in the next quarter. Genetic Engineering & Biotechnology News (3/25)        Food & Agriculture  Senate passes measure governing USDA response to biotech crop rulings A six-month Senate budget provision would direct the Department of Agriculture to allow farmers to continue cultivating their biotech crops in the event of a court ruling that challenges their use. The rider, called the Farmer Assurance Provision, was included in a short-term resolution designed to prevent a government shutdown. The provision is in line with past court rulings, and it gives growers greater certainty, supporters said. Daily News (New York) (3/25), Politico (Washington, D.C.) (3/25)        Industrial & Environmental  Calif. farmers to develop demo beet-to-ethanol plant A group of farmers, backed by experts and a $5 million grant from California, is planning to build a demonstration-scale sugar-beet-to-ethanol plant in Fresno County. If the project is successful, the group aims to develop the first commercial-scale facility in the U.S. to convert sugar beets into ethanol. The Washington Post/The Associated Press (3/23)      The Buzz(CORPORATE ANNOUNCEMENTS) Allele Publishes mNeonGreen as the Brightest Monomeric Fluorescent Protein for Super-resolution Imaging Interested in learning more about advertising in BIO SmartBrief? 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