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November 21, 2012
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  Today's Top Story 
  • FDA OKs first seasonal flu vaccine made using animal cell cultures
    The FDA has approved the use of Novartis' seasonal influenza vaccine for people ages 18 and older. The vaccine, which will be marketed under the brand name Flucelvax, is the first seasonal flu vaccine produced using animal cell cultures instead of the traditional chicken egg method, which allows for a faster production process. Reuters (11/20) LinkedInFacebookTwitterEmail this Story
  Health Care & Policy 
  • EU expands approval of Bayer-J&J's anti-clotting drug Xarelto
    The European Commission approved expanded use of Bayer and Johnson & Johnson's anticoagulant Xarelto, or rivaroxaban, as a therapy for pulmonary embolism and to prevent the recurrence of deep vein thrombosis. This makes Xarelto the first oral blood thinner approved for this indication in Europe. PharmaTimes (U.K.) (11/20) LinkedInFacebookTwitterEmail this Story
  • Bristol-Pfizer's blood thinner Eliquis wins expanded EU approval
    Bristol-Myers Squibb and Pfizer received approval from the European Commission to market their anti-clotting drug Eliquis, or apixaban, for stroke and blood clot prevention in patients with atrial fibrillation. The OK is Eliquis' first for the indication. The FDA is expected to decide on an application for the same condition by March 17. Reuters (11/20) LinkedInFacebookTwitterEmail this Story
  • FDA needs track-and-trace system for biosimilars
    The FDA should establish a track-and-trace system to monitor biosimilars, as well as a naming system to distinguish biologics from biosimilars to protect patients, writes Dr. Bert Petersen of the New York University School of Medicine. Tracking can help the health system identify and respond to issues such as the recent meningitis outbreak. Furthermore, doctors must decide the suitable biologic drug for a patient, a decision that can't be overridden by an insurance company or a pharmacist, Petersen writes. The Hill/Congress Blog (11/20) LinkedInFacebookTwitterEmail this Story
  • Organovo advances 3D biologic printing
    Organovo is developing 3D printing of tissues and organs for drug development as well as for therapeutic use. "I can tell you that we are progressing active research in the areas of liver, blood vessel, bone and cartilage, cardiac and kidney," said Michael Renard, the San Diego-based company's executive vice president of commercial operations. (11/19) LinkedInFacebookTwitterEmail this Story
  • Big Pharma firms work together on clinical databank
    Johnson & Johnson, Merck & Co. and Eli Lilly & Co. are pooling information about clinical investigators in an effort to speed the clinical trial process and avoid repeating one another's efforts. The databank will make information on investigators' clinical practice training available across the three firms, allowing investigators looking into a new indication or disease to forgo training at one firm if they have already had the appropriate training at another. Reducing the administrative burden will effectively expand the pool of investigators, said Dr. Andreas Koester, chief of clinical trial innovation at J&J unit Janssen Research & Development. Blog (11/16) LinkedInFacebookTwitterEmail this Story
  Company & Financial News 
  Food & Agriculture 
  • Panel asks USDA to study insurance
    A USDA advisory committee urged the department to first study whether there is a need for insurance against commingling of biotech and traditional crops. The Advisory Committee on Biotechnology and 21st Century Agriculture consensus "refutes the theory that there is a war in the countryside," farmer Leon Corzine said. The report calls for increased education and research on coexistence. (11/21) LinkedInFacebookTwitterEmail this Story
  Industrial & Environmental 
  • Researchers seek to make algae biofuel production more efficient
    Researchers at the University of Toledo were awarded grants from the Department of Energy and the National Science Foundation to help continue their work on making the production of biofuels from algae more efficient. Algae's advantage is that it is not used for human consumption and doesn't require high-quality water or much space or fertilizers to grow, said one of the researchers. Montana State University, the University of North Carolina at Chapel Hill, the city of Logan, Utah, and a private company in Cleveland are also involved in the project. The Blade (Toledo, Ohio) (11/19) LinkedInFacebookTwitterEmail this Story
  News from BIO 
  • Ship with FedEx
    FedEx is now offering member companies discounts of up to 35% off select FedEx services, both U.S. and international services. The BIO program with FedEx is one of the many cost-savings programs offered by BIO through its Business Solutions program. There is no charge for BIO member companies to participate in any of the BIO Business Solutions programs -- it is a benefit of membership. Learn more about the BIO and FedEx program. LinkedInFacebookTwitterEmail this Story
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  Editor's Note 
  • SmartBrief will not publish Thursday and Friday
    In observance of Thanksgiving in the U.S., SmartBrief will not be published Thursday and Friday. Publication will resume Monday. Enjoy the holiday! LinkedInFacebookTwitterEmail this Story
If the only prayer you said in your whole life was 'thank you,' that would suffice."
--Meister Eckhart,
German theologian and philosopher

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