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February 13, 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 
 
  • Early trials may be enough for experimental drugs to get FDA OK
    The FDA granted "breakthrough" status to three promising experimental drugs as part of efforts to speed market entry for treatments of life-threatening conditions. "We expect many of these would come available very quickly with Phase 1 data," FDA Center for Drug Evaluation and Research Director Janet Woodcock said. Applications for breakthrough status have been made for 18 other treatments, she said. Bloomberg Businessweek (2/12) LinkedInFacebookTwitterEmail this Story
Genentech Hardly ‘Resistant’: Up to $111M in Deal with RQx
Avalon Ventures scored again for the third time in recent weeks, as antibiotics-focused RQx Pharmaceuticals Inc. is expected to make public a deal worth as much as $111 million with Genentech, part of Roche AG. The agreement comes with an up-front fee, milestone payments and potential royalties, but the firm did not disclose amounts. Find out the details.

  Health Care & Policy 
 
  • Drugmakers, hospitals at odds over 340B discounts
    The pharmaceutical industry and hospitals are fighting over the federally mandated 340B drug discount program. Some hospitals use the program as a revenue source instead of helping poor patients, BIO and other industry groups say in a report. Hospitals argue that 340B was designed to stretch resources and support hospitals that serve the poor. Congressional Republicans and looking into the program. The New York Times (tiered subscription model) (2/12) LinkedInFacebookTwitterEmail this Story
  • EU hastens metastatic melanoma review for GSK drugs
    The European Medicines Agency granted GlaxoSmithKline's request for accelerated review of trametinib as a monotherapy and in combination with dabrafenib for metastatic or unresectable melanoma in people with the BRAF V600 mutation. The accelerated schedule could make the drugs available within six months. PharmaTimes (U.K.) (2/12) LinkedInFacebookTwitterEmail this Story
  • Biosimilars bills fail in Miss.
    Bills that would have restricted pharmacists' ability to substitute biosimilar drugs for brand-name therapies failed to advance out of committees in the Mississippi House and Senate. Proponents say that pharmacists should be allowed to substitute only a biosimilar FDA-approved as "interchangeable" with the brand-name biologic drug for the specific indication and that doctors' orders to dispense as written should override payer policies. Opponents say the federal Public Health Service Act allows automatic substitution and the Mississippi legislation and other bills like it are simply an effort to protect drugmaker profits. Pharmalot.com/Pharma Blog (2/8) LinkedInFacebookTwitterEmail this Story
The New You Starts Here.
Designed for busy healthcare professionals, FIU's online Healthcare MBA is transformative. Graduates emerge ready for a leadership role in healthcare, with a clear vision of how to lead collaboratively and advance the business of healthcare. Classes begin Fall 2015. Start here.

  Company & Financial News 
 
Pay HCPs…Not Penalties!
Receive invoices, process invoices, pay HCP, track payment, report payment, argue with HCP, issue 1099, perform due diligence…start again. Supporting HCP consultants and speakers can be a big task. Watermark has a turnkey solution to meet your needs, support you HCP, and keep you in compliance.

  Food & Agriculture 
 
Clinical Trial Data Transparency Forum: Expert insights
Hear industry and academic thought leaders - from Duke Clinical Research Institute, GlaxoSmithKline, Eli Lilly and more - share valuable insight on their clinical trial data transparency and sharing initiatives. This video covers a number of key perspectives and trends.

  Industrial & Environmental 
  • USDA sees slower demand growth for biofuel feedstocks through 2022
    Global demand for ethanol and biodiesel feedstocks is expected to keep growing through the next decade, but the pace of growth will be slower compared with recent years, according to a Department of Agriculture report issued Monday. The U.S., Brazil, EU member states, Argentina, Canada, China and Indonesia will continue to be the biggest market players, with their combined output expected to increase 40% through 2022, the USDA said. EthanolProducer.com (2/12) LinkedInFacebookTwitterEmail this Story
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  News from BIO 
  • Ship with FedEx
    FedEx is now offering member companies discounts of up to 35% off select FedEx services, both U.S. and international services. The BIO program with FedEx is one of the many cost-savings programs offered by BIO through its Business Solutions program. There is no charge for BIO member companies to participate in any of the BIO Business Solutions programs -- it is a benefit of membership. Learn more about the BIO and FedEx program. LinkedInFacebookTwitterEmail this Story
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  SmartQuote 
Several excuses are always less convincing than one."
--Aldous Huxley,
British author


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