Tuesday, August 28, 2012

Gilead's four-in-one HIV drug Stribild wins FDA approval

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August 28, 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 
 
Gilead Terminates Cicletanine Trial; All Eyes Remain on Quad
Gilead Sciences Inc., of Foster City, CA, has terminated a Phase II trial of cicletanine for pulmonary arterial hypertension (PAH) due to failure of the trial to meet its primary endpoint of improvement in exercise capacity. Gilead acquired cicletanine from Navitas Assets LLC in 2008. Find out the details.

  Health Care & Policy 
  • Immunogen-Roche breast cancer drug meets main goal in trial
    Roche Holding and ImmunoGen said their antibody drug T-DM1, or trastuzumab emtansine, met the primary goal of a late-stage trial by significantly extending the lives of women with HER-2 positive metastatic breast cancer compared with a combination of two standard treatments. Roche's Genentech unit has submitted the drug for FDA review and will soon file a marketing application with European regulators. CBS News/The Associated Press (8/27), Reuters (8/27) LinkedInFacebookTwitterEmail this Story
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  Company & Financial News 
  • Alder receives $3.5M from Bristol for Crohn's drug trial
    Bristol-Myers Squibb paid Alder Biopharmaceuticals a $3.5 million milestone fee for initiating a midstage study of rheumatoid arthritis drug candidate ALD518, or BMS-945429, in patients with Crohn's disease. The trial, which will involve 288 patients, is expected to be finished in November 2015. Xconomy/Seattle (8/27) LinkedInFacebookTwitterEmail this Story
  Global Developments 
  • Australian project will look for mutations that cause melanoma
    Australian researchers began a two-year project designed to identify common genetic mutations associated with melanoma and to find new ways of detecting and treating the disease based on the genetic characteristics of individual melanomas. The $5.7 million initiative, called the Australian Melanoma Genome Project, will involve researchers from the Melanoma Institute Australia and hospitals, universities and institutes in the country. The project "will lead to better diagnostic tests and new drugs which can specifically target the mutations that are causing this particular cancer," said John Thompson, Melanoma Institute Australia's executive director. GenomeWeb Daily News (free registration) (8/24) LinkedInFacebookTwitterEmail this Story
  • Researchers grow lung cells for drug testing
    Canadian researchers have succeeded in producing lung cells from stem cells derived from the skin of patients with cystic fibrosis, according to a study published in the journal Nature Biotechnology. The cells could be used in the testing of medicines and potentially the individualization of treatment as well as the regeneration of lung tissue. CTV.ca (Canada)/The Canadian Press (8/26) LinkedInFacebookTwitterEmail this Story
  Featured Content 
 

  Food & Agriculture 
  • Monsanto's biotech soybean could enter Argentine market next year
    Monsanto plans to start marketing its new insect- and glyphosate-resistant soybean seed Intacta RR2 in Argentina late next year. The plan is contingent on reaching a seed royalty deal with growers, suppliers and exporters, said Pablo Vaquero, Monsanto's director of sustainability and corporate affairs for Latin America south. The nation is developing regulations to patent rights. Fox Business/Dow Jones Newswires (8/24) LinkedInFacebookTwitterEmail this Story
  Industrial & Environmental 
  • BIO, others rebut claims RFS waiver would boost corn availability
    BIO and other members of the Biofuels Producers Coordinating Council wrote a letter to President Barack Obama contesting claims that a Renewable Fuel Standard waiver would increase corn availability. Built-in mechanisms in the RFS are already "working to minimize the consumer impact of lower grain yields," the groups said. Tampering with the RFS would drive up fuel costs, draw investments away from advanced biofuels and hurt the economy, they added. The Hill/E2 Wire blog (8/27), Platts (8/27) LinkedInFacebookTwitterEmail this Story
  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. Sign up for the e-newsletter. LinkedInFacebookTwitterEmail this Story
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  SmartQuote 
It is better to fail in originality than to succeed in imitation."
--Herman Melville,
American writer and poet


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