Onyx-Bayer colorectal cancer drug Stivarga gains FDA approval

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September 28, 2012 BIO has teamed up with FedEx to offer member companies discounts of up to 35% off select FedEx Express, FedEx Ground and FedEx Home Delivery services through the BIO Business Solutions cost-savings program. Learn more. 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    Onyx-Bayer colorectal cancer drug Stivarga gains FDA approval The FDA approved Onyx Pharmaceuticals and Bayer HealthCare's Stivarga, or regorafenib, to treat patients whose colorectal cancer has metastasized and progressed after therapy. The drug, also being reviewed for gastrointestinal stromal tumors, will be marketed jointly. CNBC/The Associated Press (9/27)      LES Meeting: Network with Top Licensing & BD Execs 10/14-17 in Toronto! Meet your next partner and connect with execs from Bayer, Lilly, GSK, Merck, Pfizer, Roche, Shire, Takeda and more! Featuring Dr. Eric Topol on the Convergence of Life Sciences and High Tech plus sessions on royalty rates, dealmaking and more. Save $100 with code BIONews. Register now!   Health Care & Policy  White House pushes faster FDA approvals for high-risk patients The President's Council of Advisors on Science and Technology advised the FDA to fast-track approvals of drugs that could help high-risk patients in a plan that would double the annual number of prescription drugs put on the market. It's not clear how the FDA would limit such drugs to high-risk patients. The Wall Street Journal (9/25)      Bristol and Pfizer resubmit anticlotting drug Eliquis for FDA OK The FDA received Pfizer and Bristol-Myers Squibb's application for blood thinner Eliquis as preventive treatment for embolism and stroke in patients with atrial fibrillation. An approval decision is expected by March 17, the drugmakers said. The FDA already postponed approval twice. The Boston Globe/The Associated Press (tiered subscription model) (9/26)      NanoString's breast cancer test gets approval in Europe NanoString Technologies has received CE mark approval to market its nCounter breast cancer diagnostic test in Europe. The firm plans to commercialize the system early next year. Xconomy/Seattle (9/27)      Study: Biogen's hemophilia drug controls bleeding in trial Biogen Idec's investigational hemophilia B treatment controlled 90.4% of bleeding episodes in a late-stage clinical trial involving 123 males age 12 and older. Biogen plans to submit the long-lasting clotting factor for FDA review in the first half of next year. A European application could follow completion of a trial involving patients younger than 12. Reuters (9/26)      Achillion's hepatitis C drug shows promise in early-stage study A Phase I trial showed that Achillion Pharmaceuticals' ACH-3102, an experimental hepatitis C drug, was safe and effective in lowering virus level. Based on the study's success, Achillion is initiating a Phase II study to assess the efficacy of ACH-3102 in combination with antiviral drug ribavirin. CNBC/The Associated Press (9/27)        Company & Financial News  Colorectal cancer research project gets $13M in federal funding The National Cancer Institute awarded the Fred Hutchinson Cancer Research Center $13 million in funding to support its genetics research into colorectal cancer. The four-year project will try to find genetic links to colorectal cancer using advanced sequencing. BeckersASC.com (9/27)      Protein Potential will develop malaria vaccine using NIH grants Protein Potential received from the NIH three Phase I Small Business Innovation Research grants worth $1.8 million for three-stage development of a malaria vaccine against Plasmodium falciparum. The first stage will involve development of a dual-component vaccine that induces antibodies and protective T-cell mechanism against the parasite's asymptomatic liver stage. The second stage will develop a vaccine that prevents the parasite's infection of red blood cells. The third stage will develop a recombinant protein-based vaccine to prevent against three parasite life cycle stages. Genetic Engineering & Biotechnology News (9/26)        Featured Content    GoDaddy Shows How to Best Recover From a Crisis Barry Moltz How 3 Hours on the Clock Can Cost You Courtney Rubin A Dozen Ways to Boost Cash Flow Barbara Weltman Drive Good Reviews With Social Media Ashley Lutz Discovering In-N-Out Burger's Secret Sauce Matthew E. May   Food & Agriculture  Distortions of science are used to stoke fear of biotech food Anti-biotech campaigners rely on scare tactics to get the public's attention and create fear of biotech foods, writes Keith Kloor. He cites a recently published study that linked biotech corn to development of large tumors and early death in rats. Experts said the study had big flaws that should have been noticed in peer review. One scientist said the research was "designed to frighten" the public. Slate (9/26)          Industrial & Environmental  Fuels America coalition backs Renewable Fuel Standard Biofuel groups and companies formed a coalition called Fuels America to support the Renewable Fuel Standard's benefits to the environment, economy and U.S. energy security. The campaign will initially target Washington, D.C., and a number of states including Colorado, Ohio, Delaware and Montana. "Fuels America is built around one core idea: Renewable fuel is essential to the U.S. economy, our nation's energy security, our rural communities and the environment," BIO President and CEO Jim Greenwood said. Hoosier Ag Today (Clermont, Ind.) (9/27), DomesticFuel.com (9/27)          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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