FDA approves Protein Sciences' flu vaccine Flublok

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January 17, 2013 More than 2,700 companies nationwide are saving on lab supplies, shipping, news distribution, office products and more through the BIO Business Solutions cost-savings program. Find out how. 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  FDA approves Protein Sciences' flu vaccine Flublok Protein Sciences received FDA approval for its new flu vaccine, Flublok, for patients aged 18 to 49. The vaccine "offers the potential for faster startup of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus," an agency official said. The production method uses recombinant DNA and insect virus expression technology, which have been used in other vaccines. HealthDay News (1/16)        Health Care & Policy  IOM: Most approved biologics have been studied in children Institute of Medicine researchers looked at 96 biologics and 55 vaccines approved by the FDA between 1997 and 2010 and found that about 90% of biologics and 95% of vaccines were either labeled for pediatric use, had been included in pediatric trials or had pediatric information in the label. The study was published in the journal Pediatrics. PhysiciansBriefing.com/HealthDay News (1/15)      FDA OKs infectious gastroenteritis test from Luminex The FDA has cleared Luminex to market its xTAG Gastrointestinal Pathogen Panel. The nucleic acid assay is said to have the ability to identify seven bacteria, two viruses and two parasites commonly linked to infectious gastroenteritis simultaneously from a single patient specimen. Medscape (free registration) (1/15)      FDA expedites review of Boehringer's lung cancer drug afatinib Boehringer Ingelheim's experimental drug afatinib obtained priority-review status from the FDA as a treatment for locally advanced or metastatic nonsmall-cell lung cancer in patients with epidermal growth factor receptor mutations. A decision is expected by the third quarter. PharmaTimes (U.K.) (1/16)      Biogen, Elan seek expanded approval for MS drug Tysabri Biogen Idec and Elan have applied to the FDA and the European Medicines Agency for approval to market Tysabri as a first-line therapy for patients with relapsing forms of multiple sclerosis who were negative for antibodies to the JC virus. "A first-line approval would allow people with MS access to a highly efficacious treatment earlier in the course of the disease, potentially leading to better outcomes," Biogen Chief Medical office Alfred Sandrock said. The agencies' decisions are expected to come in 2013. Reuters (1/16)      Qiagen seeks FDA OK for companion Dx to cancer drug Qiagen has filed a premarket approval application with the FDA for its therascreen EGFR RGQ PCR kit to be used as a companion diagnostic for afatinib, Boehringer Ingelheim's drug for non-small cell lung cancer. The company aims to use the test to help identify which patients would most likely benefit from the drug. GenomeWeb Daily News (free registration) (1/15)        Company & Financial News  Onyx hopes to raise more than $358M via stock sale Onyx Pharmaceuticals, maker of liver and kidney cancer drug Nexavar and multiple myeloma treatment Kyprolis, plans to sell 4.4 million shares to raise more than $358 million. The money will support research and development including clinical studies. Proceeds will also go toward worldwide sales and marketing efforts for Kyprolis. American City Business Journals/San Francisco/BiotechSF blog (1/16)        Industry Deals    Galapagos hits milestone in rheumatoid arthritis drug collaboration Galapagos received about $5.3 million from Janssen Pharmaceutica after hitting a milestone related to their rheumatoid arthritis drug collaboration. The identification of a second preclinical drug candidate triggered the milestone payment. Genetic Engineering & Biotechnology News (1/16)      Earn 30,000 American Airlines AAdvantage® Bonus Miles* Plus... • First Checked Bag Free* • Priority Boarding Privileges* • Double Miles on Eligible Business Purchases* • 25% savings on Eligible in-flight Purchases* *Learn more.   Food & Agriculture  Moth's genome may lead to better pest control methods An international team of researchers sequenced the genome of the diamondback moth, or Plutella xylostella, and they believe they have identified the genes that make the pest resistant to many insecticides. Data from the project, published in the journal Nature Genetics, could allow the development of new methods to track insecticide resistance and manage pests. GenomeWeb Daily News (free registration) (1/14)        Industrial & Environmental  U.S. appeals court stands by decision allowing E15 sale A federal appeals court tossed out petitions filed by oil and food industry groups challenging the Environmental Protection Agency's decision to allow E15 into the market. The petitioners, including the American Petroleum Institute, pledged to continue their efforts to dismantle the Renewable Fuel Standard, which API called "unworkable." Bob Dinneen, president and CEO of the Renewable Fuels Association, dismissed API's comments, saying the RFS is a "proven success" and a "highly flexible, effective, proven energy policy." DomesticFuel.com (1/15), Bloomberg Businessweek (1/15), Politico (Washington, D.C.) (1/16), FuelFix.com (1/15)        News from BIO  BIOtechNOW BIOtechNOW is the first in a number of new products from BIO intended to enhance our communications with the biotech community -- not only with our members, but with other stakeholders as well. This e-newsletter, combined with its website, serves as our flagship in that effort. BIOtechNOW will offer original content that emphasizes the business needs of the industry; highlight BIO's advocacy efforts; and provide a portal to all BIO activities and events. Most importantly, it will spotlight for those outside the industry the value of biotechnology. 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