Tuesday, June 11, 2013

FDA wants to make "masked" trial data available to outside experts

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June 11, 2013
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  Health Care & Policy 
  • FDA wants to make "masked" trial data available to outside experts
    The FDA is considering giving outside experts the ability to access and analyze "masked" and "de-identified" trial data derived from device and drug approval applications. The agency is seeking comments on the proposal, which it says could offer new opportunities for innovation in drugs, biologics and devices. Clinica (6/7) LinkedInFacebookTwitterEmail this Story
  • Puma Biotechnology's breast cancer drug enters late-stage study
    Puma Biotechnology has begun a late-stage trial of its lead drug candidate neratinib, or PB272, in patients with HER2-positive metastatic breast cancer who do not respond to two or more other drugs. The trial, which will involve around 600 patients, will be carried out at about 150 sites in the Asia-Pacific region, North America and Europe. RTT News (6/7) LinkedInFacebookTwitterEmail this Story
  • Fat can be source of ESC-like MUSE cells, study finds
    Researchers at the University of California, Los Angeles, said they have discovered fat can be a source of stem cells that appear to be pluripotent. They have been named multilineage-differentiating stress-enduring, or MUSE, cells. The study, published in the journal PLOS One, said the cells appear to be more like embryonic stem cells than adult stem cells. The discovery may allow the use of fat from liposuction as a source for MUSE cells. NBC News/Vitals blog (6/5) LinkedInFacebookTwitterEmail this Story
  Company & Financial News 
 
  • Neumedicines wins $8.3M to test radiation-sickness drug
    The Biomedical Advanced Research and Development Authority awarded Neumedicines an additional $8.3 million to continue development of HemaMax, a recombinant human interleukin 12, as a treatment for bone marrow syndrome due to acute radiation sickness. Neumedicines will use the money to support preclinical studies. "With BARDA's continued funding we are moving HemaMax toward a possible pre-Emergency Use Authorization, which, if granted, could allow for its use in a national emergency," Neumedicines President and CEO Lena A. Basile said. Genetic Engineering & Biotechnology News (6/10) LinkedInFacebookTwitterEmail this Story
Analyst brief: Axendia: Lowering the Cost of Healthcare from the Inside Out
Healthcare administrators are seeking ways to manage a mix of Clinical, Biomedical, Facilities, Engineering and Health IT assets. Learn how Healthcare Executives are leveraging an integrated Enterprise Asset Management solution to enhance patient care and improve clinical outcomes, reduce costs and ensure compliance.

  Global Developments 
  • Swiss regulators approve Roche's skin-cancer drug Erivedge
    Swiss regulators granted Roche approval to market Erivedge, or vismodegib, as a treatment for advanced basal cell carcinoma. The drug was approved in the U.S. for the same indication in January. The approval triggers undisclosed milestone payments to partner Curis. Reuters (6/11) LinkedInFacebookTwitterEmail this Story
  Food & Agriculture 
  Industrial & Environmental 
  • Senate OKs farm bill with funding for energy programs
    The Senate voted 66-27 to pass a version of the 2013 farm bill that includes mandatory funding for energy programs. "Farm Bill renewable energy and energy efficiency programs have a solid track record in supporting growth in agriculture, manufacturing, and new employment opportunities in rural America," said Lloyd Ritter, co-director of the Agriculture Energy Coalition. The House of Representatives is expected to take up its version next week. DomesticFuel.com (6/10), The Washington Post/Wonkblog (6/10) LinkedInFacebookTwitterEmail this Story
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  News from BIO 
  • Industrial biotechnology with a French twist!
    Over 1,300 leaders in biofuels, biobased products and renewable chemicals will be in Montreal June 16-19 for the 10th Annual BIO World Congress on Industrial Biotechnology. Join the impressive list of attendees for great food, excellent wine, and a can't miss program which will feature plenary sessions, breakout tracks, workshops, investor sessions, poster presentations, an exhibit hall, networking receptions, and business partnering. BIO is excited to bring this conference to Montreal, highlighting the industry's growth and the importance for generating green jobs and producing greener products and cleaner processes, all aimed at building a biobased economy. Learn more. LinkedInFacebookTwitterEmail this Story
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