Thursday, January 10, 2013

Vertex CF drugs win FDA's first breakthrough therapy designations

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January 10, 2013
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  Today's Top Story 
  • Vertex CF drugs win FDA's first breakthrough therapy designations
    The FDA awarded the first two breakthrough therapy designations to two cystic fibrosis drugs from Vertex Pharmaceuticals. The first designation was given to Kalydeco, or ivacaftor, for potential additional indications. The other designation was granted to a combination of Kalydeco and the experimental drug VX-809. The goal of the breakthrough therapy designation, which was enacted under the 2012 Food and Drug Administration Safety and Innovation Act, is to speed up the development and evaluation of new drugs for serious or life-threatening diseases. PharmaTimes (U.K.) (1/9), Bloomberg (1/9) LinkedInFacebookTwitterEmail this Story
  Health Care & Policy 
  • High court dismisses challenge to federal funding of ESC research
    The Supreme Court rejected without comment a case challenging federal funding for embryonic stem cell research. The challengers, adult stem cell researchers James Sherley and Theresa Deisher, argued that research using human embryonic stem cells was in violation of a federal law. President Barack Obama reversed an earlier ban on federal funding for embryonic stem cell research, though the initial extraction of stem cells still depends on private funds because of a law against creating or destroying embryos for research. LiveScience.com (1/7) LinkedInFacebookTwitterEmail this Story
  • Baxter's hemophilia drug performs well in late-stage trial
    A Phase III clinical trial found that Baxter International's anti-inhibitor coagulant complex treatment for hemophilia lowered bleeding rates by 72.5% in a prophylactic treatment group, the company reported. The study involved patients with hemophilia A or B. The company will use the findings in a biologics license application in this quarter. Reuters (1/8) LinkedInFacebookTwitterEmail this Story
  • Scientists identify "itchy" nerve cells
    University researchers in the U.S. and China identified specific nerve cells in mice that relay the sensation of itchiness, but not pain, from the epidermis to the spinal cord. The findings, reported in the journal Nature Neuroscience, could lead to drugs that alleviate itchiness as well as drugs that do not include itchiness as a side effect. The New York Times (tiered subscription model) (1/7) LinkedInFacebookTwitterEmail this Story
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  Food & Agriculture 
  Industrial & Environmental 
  • UC Davis researchers report breakthrough in algae research
    Researchers at the University of California, Davis reported that they have genetically modified blue-green algae to produce chemicals that can be easily turned into biofuels and other bio-based products. The researchers successfully produced 2.4 grams of 2,3 butanediol per liter of growth medium from the algae, the biggest yield so far for bacteria-derived chemicals. United Press International (1/8) LinkedInFacebookTwitterEmail this Story
  News from BIO 
  • Are you taking full advantage of your membership?
    BIO's cost-savings program, BIO Business Solutions, is helping 2,700 companies nationwide save on the cost of essential products and services. Members of BIO and 43 state and regional biotech associations are eligible to receive preferential pricing and other benefits at no additional cost beyond their membership dues. VWR International, FedEx, Office Depot and Business Wire are just a few of the industry leading providers that offer special pricing through this members-only program. Learn more or enroll here. LinkedInFacebookTwitterEmail this Story
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British writer


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