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)     

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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)     

• 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)     

• 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)     

• Japanese researchers plan stem cell trial for newborns
  Japan's National Center for Child Health and Development is planning clinical research involving embryonic stem cells to treat serious liver diseases in newborns. The stem cell treatment could serve as bridge to liver transplant for babies with hyperammonemia. The Mainichi (Japan) (4/18)     

• Inspiration seeks FDA approval for hemophilia B drug
  Inspiration Biopharmaceuticals submitted IB1001, its hemophilia B treatment, for consideration by the FDA. The biologics license application will bring a $35 million milestone payment from Ipsen. Mass High Tech (Boston) (4/17)     

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)     

• CIRM commits $30M toward clinical trials for stem cell therapies
  The California Institute for Regenerative Medicine is setting aside up to $30 million to help move stem cell research into early clinical trials. Awards of up to $10 million each will be made to biotech, pharmaceutical or venture capital companies to advance treatments toward FDA approval. American City Business Journals/San Francisco/BiotechSF blog (4/17)     

Industry Deals

• Sequenom pays $1.3M for Helicos' patent-pending technology
  Sequenom has agreed to pay $1.3 million to acquire pending patents covering Helicos' technology for diagnosing fetal abnormalities. The proceeds from the sale will finance ongoing operations of Helicos, which specializes in advanced genetic analysis tools. Mass High Tech (Boston) (4/16)     

• VistaGen secures licensing rights to stem cell culture technology
  The McEwen Centre for Regenerative Medicine in Toronto granted VistaGen Therapeutics licensing rights to its stem cell culture technology. VistaGen will use the technology to improve production of hematopoietic precursor stem cells and develop drug screening tools and cell treatments for blood system disorders. Pharmaceutical Business Review Online (4/17)     

PharmaDeals

Featured Content

Food & Agriculture

• Monsanto: Biotechnology could improve farm production in Pakistan
  Pakistan needs to adopt biotechnology and develop a clear plan for improving agriculture production, according to Monsanto Pakistan's Aamir Mehmood Mirza. Biotech crops could help Pakistan solve its emerging food security problems due to the rising population, Mirza said. Biotech seeds are insect-tolerant and more reliable and cost-effective than other solutions, he said. The News - International (Pakistan) (4/19)     

Industrial & Environmental

• Policies, fuel demand are driving global biofuel growth, report says
  Government incentives, environmental policies and rising fuel demand are key to the growth of the global biofuels market, according to a report from GlobalData. Biofuel production worldwide grew from 8.853 billion gallons in 2003 to 27.899 billion gallons in 2011, the report showed. DomesticFuel.com (4/17)     

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.     

SmartQuote

Things alter for the worse spontaneously, if they be not altered for the better designedly." --Francis Bacon, British author and statesman