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April 19, 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 
 
  • Why the FDA needs a chief innovation officer
    The FDA needs an official who can examine whether the agency's drug rejections are justified and whether long waits discourage innovation, BIO President and CEO Jim Greenwood said. The addition of a chief innovation agency is a priority for BIO during the reauthorization process for the Prescription Drug User Fee Act. BIO has also supported the expansion of accelerated drug approvals and revival of informal talks between FDA and companies. American City Business Journals/Boston (4/18) LinkedInFacebookTwitterEmail this Story
EvaluatePharma® ‘s new affordable, one-stop service EP Clinical Trials offers you a confident new world of clinical trial intelligence that's exceptionally faster than doing it yourself. Find out more and request a demo
  Health Care & Policy 
 
  • House version of user-fee reauthorization bill adds jobs to FDA mission
    The House draft of a bill that would reauthorize the Prescription Drug User Fee Act and Medical Device User Fee Act would revise the FDA's mission to include the promotion of "economic growth, innovation, competitiveness and job creation." The heads of the FDA's device and drug centers said the agency's focus should remain on safety and efficacy. MedPage Today (free registration) (4/18) LinkedInFacebookTwitterEmail this Story
  • Qiagen scores regulatory win for 2 diagnostic devices
    The FDA has granted Qiagen 510(k) clearance for Rotor-Gene Q MDx, an automated molecular diagnostic platform tailored for in vitro diagnostic use by clinical laboratories in running nucleic acid tests approved in the U.S. The agency also cleared Qiagen's artus Infl A/B RG RT-PCR kit, an IVD molecular diagnostic assay designed to spot and distinguish the A and B strains of influenza in real time. GenomeWeb Daily News (4/17) LinkedInFacebookTwitterEmail this Story
  • Prolor's obesity and diabetes drug is effective in mice in study
    Once-weekly injection of Prolor Biotech's MOD-6030 fared better than placebo in increasing insulin sensitivity and lowering blood glucose, cholesterol and body weight in obese mice, according to a preclinical trial. The findings are slated for presentation today at the Global Technology Community's Diabetes Drug Discovery and Development Conference in Boston. Globes (Israel) (4/17) LinkedInFacebookTwitterEmail this Story
Capital Formation: Opportunities on the Horizon Offer Biotechs Funding Alternatives
As of Dec. 2, 2011, privately held biotech companies had raised $4.35 billion, almost on par with the $4.39 billion raised in the same period last year. That sounds like good news - until you compare it to the $6.62 billion raised in 2006. Find out what this means for biotech funding in 2012 and beyond inside this special edition.

  Company & Financial News 
  • Roche might drop $6.8 billion hostile bid for Illumina
    Roche Holding threatened to abandon a $6.8 billion hostile offer for Illumina after the gene-sequencing firm rejected the drugmaker's attempt to appoint board members. The bid expires Friday, and Roche said it plans no extension. Illumina said it is pleased with Roche's decision and will return its focus to business expansion. The Wall Street Journal (4/18) LinkedInFacebookTwitterEmail this Story
  Industry Deals 
  PharmaDeals 
  • Key lessons on royalties too often learned the hard way
      
    As the patent cliff looms, the pharmaceutical and biotechnology industry is undergoing considerable change requiring greater innovation and a strong need for successful partnering. Royalties can represent the most valuable component of a deal but are often couched in remote and desensitized terms whereas the upfront and milestone values often grab the headlines in the deal announcement. Understanding the true value of your asset and how royalties are inextricably linked with overall deal value can help you negotiate on the things that really deliver value. You stand to lose more of your hard-earned value through royalty percentages and tier adjustments than any other component of the deal. Read more. 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 
Things alter for the worse spontaneously, if they be not altered for the better designedly."
--Francis Bacon,
British author and statesman


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