Thursday, May 30, 2013

FDA clears GSK's Tafinlar, Mekinist for advanced melanoma

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May 30, 2013
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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 
  • FDA clears GSK's Tafinlar, Mekinist for advanced melanoma
    GlaxoSmithKline obtained the FDA's approval to market Tafinlar, or dabrafenib, and Mekinist, or trametinib, as single agents for treatment of advanced melanoma in patients carrying specific genes. The agency approved the use of Tafinlar in patients with the BRAF V600E mutation, while Mekinist was cleared for patients with either BRAF V600E or V600K. Reuters (5/29) LinkedInFacebookTwitterEmail this Story
  • FDA gives BioMerieux nod on companion Dx to melanoma drugs: BioMerieux has obtained FDA approval for its THxID BRAF system, a polymerase chain reaction-based test used to detect certain BRAF mutations in melanoma cells. The assay is approved as a companion diagnostic test to two advanced melanoma drugs from GlaxoSmithKline, which also concurrently received FDA approval. GenomeWeb Daily News (free registration) (5/29) LinkedInFacebookTwitterEmail this Story
  Health Care & Policy 
  • GSK-Genmab's leukemia drug Arzerra hits main goal in trial
    Genmab and GlaxoSmithKline's Arzerra, or ofatumumab, in combination with chlorambucil, achieved the primary goal of a late-stage trial by extending progression-free survival in patients with previously untreated chronic lymphocytic leukemia, a review found. Patients who took Arzerra survived 9.3 months longer without their disease worsening compared with patients who received chlorambucil alone. RTT News (5/29) LinkedInFacebookTwitterEmail this Story
  • Gilead's HIV-1 drug Stribild gets EU approval
    Gilead Sciences obtained approval from the European Commission to market Stribild as a single-tablet regimen to treat HIV-1. Each tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil. The drug is indicated for adult HIV-1 patients without mutations connected to resistance of any of Stribild's three antiretroviral agents, or HIV-1 patients who have yet to receive antiretroviral therapy. Pharmaceutical Business Review Online (5/29) LinkedInFacebookTwitterEmail this Story
  Company & Financial News 
  • Calif. biotech startup gets $20M funding boost
    Kite Pharma, a California-based biotech focused on developing novel cancer immunotherapies, secured $20 million in its latest funding round. Kite has access to the National Cancer Institute's pipeline of engineered autologous peripheral blood T cells that can be targeted to multiple hematological and solid tumor types. MedCityNews.com (5/29) LinkedInFacebookTwitterEmail this Story
  • GSK strengthens vaccines business with Okairos buy
    GlaxoSmithKline agreed to pay $321 million to acquire Switzerland's Okairos, a Merck & Co. spinoff that uses technology based on chimpanzee viruses to develop vaccines that target the immune system's CD8 T-cells. The purchase is "expected to contribute to the development efforts for an exciting new generation of vaccines," said Christophe Weber, GSK's head of vaccines. Reuters (5/29) LinkedInFacebookTwitterEmail this Story
  Industry Deals 
  • Alethia partners with IBC Generium to develop EMT inhibitor
    Alethia Biotherapeutics agreed to collaborate with International Biotechnology Center Generium to further develop AB-16B5, a monoclonal antibody that inhibits epithelial-to-mesenchymal transition. The deal entitles Alethia to an upfront payment, research funding as well as milestone fees and sales royalties in certain territories. This collaboration gives IBC the opportunity to "accelerate the development of a novel therapy with potential applications in multiple cancer indications," the company's chief business officer, Daniil Talyanskiy, said. Genetic Engineering & Biotechnology News (5/29) LinkedInFacebookTwitterEmail this Story
  Food & Agriculture 
 
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.

  Industrial & Environmental 
  • Researchers report breakthrough in miscanthus pretreatment
    Researchers at the University of Illinois said they have figured out a more efficient way to pretreat miscanthus for biofuel production. The process uses butadiene sulfone, which can be captured and used again, said Hao Feng, one of the researchers. "It's a big advantage in terms of both economy and environmental impact," Feng said. Agweek (5/28) LinkedInFacebookTwitterEmail this Story
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  News from BIO 
  • Save on energy costs through BIO's newest cost-savings program
    BIO has recently aligned with APPI Energy, an energy consulting firm, to assist member companies with reducing their energy expenses. APPI Energy, the preferred energy consultant of 140 trade associations and chambers of commerce nationwide, provides solutions to reduce electricity and natural gas costs at no risk or obligation to member companies. Through this program, APPI Energy offers specialized energy cost reduction services, including the identification of reliable and competitive energy suppliers for member companies and the obtaining of competitive bids from the preferred suppliers in deregulated energy markets. Learn more. LinkedInFacebookTwitterEmail this Story
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