Monday, December 24, 2012

Roche wins FDA OK for wider use of flu drug Tamiflu

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December 24, 2012
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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 
 
  • Roche wins FDA OK for wider use of flu drug Tamiflu
    The FDA endorsed the use of Roche Holding's flu treatment Tamiflu, or oseltamivir, for children ages 2 weeks to 1 year who have had symptoms of flu for no more than two days. The drug is not indicated for flu prevention in this age group, according to the agency. Reuters (12/21), HealthDay News (12/21) LinkedInFacebookTwitterEmail this Story
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  Health Care & Policy 
  • FDA OKs NPS Pharmaceuticals' Gattex for short bowel syndrome
    NPS Pharmaceuticals obtained FDA approval for Gattex, or teduglutide, as a treatment for short bowel syndrome, but the agency also asked the firm to conduct a study on the potential side effects of the drug. Gattex may raise a person's risk for cancer, intestinal blockages and polyps, the FDA said. NPS is expected to market the drug in March. Bloomberg Businessweek (12/21) LinkedInFacebookTwitterEmail this Story
  • FDA clears Alexza's Adasuve for agitation
    The FDA approved Alexza Pharmaceuticals' Adasuve Inhalation Powder as an acute treatment for adults with agitation linked to schizophrenia or bipolar disorder. Adasuve uses the company's Staccato system to deliver the antipsychotic loxapine to the lungs as an aerosol. Alexza plans to launch the drug in the third quarter. RTT News (12/21) LinkedInFacebookTwitterEmail this Story
  • EU approves Novartis' iron overload drug Exjade
    The European Commission has granted Novartis approval for Exjade, or deferasirox, to reduce iron overload in patients with nontransfusion-dependent thalassemia syndrome receiving chelation treatment. The approval was based on a study that showed use of deferasirox can lead to significant dose-dependent reduction in iron levels in the body. RTT News (12/21) LinkedInFacebookTwitterEmail this Story
  • 2nd-gen testosterone assay from Abbott gets FDA OK
    Abbott has been cleared by the FDA to market its Architect 2nd Generation Testosterone Assay, which is used to measure testosterone in human plasma and serum quantitatively. The chemiluminescent microparticle immunoassay is designed to help detect and treat conditions such as male impotence, hypogonadism and advanced or delayed puberty. Healio (12/20) LinkedInFacebookTwitterEmail this Story
  Company & Financial News 
  • Nuron raises $80M to advance vaccine and biologic drug candidates
    Nuron Biotech obtained $80 million in private investment from Healthcare Royalty Partners. The amount included a $30 million equity investment and a $50 million "synthetic royalty" deal linked to future sales of Nuron's products. The firm plans to use the money to fund the market launch and expansion of its recently acquired vaccine, Meningitec, and to further develop investigational biologics and vaccines for neurodegenerative and infectious diseases. American City Business Journals/Philadelphia (12/20) LinkedInFacebookTwitterEmail this Story
  Food & Agriculture 
  • Biotech salmon is safe to eat, FDA says
    AquaBounty Technology's transgenic salmon poses no human or environmental health risks, the FDA said in a draft environmental evaluation. The review brings AquAdvantage salmon eggs closer to regulatory approval. "With respect to food safety, FDA has concluded that food from AquAdvantage salmon is as safe as food from conventional Atlantic salmon, and that there is a reasonable certainty of no harm from consumption," according to the draft. Reuters (12/21) LinkedInFacebookTwitterEmail this Story
  Hot Topics 

Top five news stories selected by BIO SmartBrief readers in the past week.

  • Results based on number of times each story was clicked by readers.
  Industrial & Environmental 
  • Expert: Renewable fuels industry abuzz with new projects
    The renewable fuels sector is touting "a splash of new refining projects, and steel in the ground," writes Jim Lane. Renewable fuels developers announced four major development projects in low-cost enzymes and in road and aviation fuels after "a year of dire headlines in government spending, renewable fuel mandates and so on," Lane writes. BiofuelsDigest.com (12/20) LinkedInFacebookTwitterEmail this Story
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  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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  Editor's Note 
  • SmartBrief will not publish Tuesday
    In observance of Christmas, SmartBrief will not publish Tuesday. Publication will resume Wednesday. Enjoy the holiday! LinkedInFacebookTwitterEmail this Story
  SmartQuote 
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--William Blake,
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