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 to unveil guidance for follow-on biologics this year
  The FDA likely will release this year a set of guidelines for drugmakers applying for market approval of follow-on biologics, said Janet Woodcock, head of the agency's Center for Drug Evaluation and Research. The FDA is "meeting with companies individually right now and giving them advice on their programs," and the agency is "very interested in providing competition where we have a mandate," Woodcock said. Separately, the FDA is seeking feedback on a proposal to charge a fee before a generic biotech medicine is reviewed. Reuters (5/9), The Hill/Healthwatch blog (5/9)

Health Care & Policy

• FDA expects gradual increase in drug approvals, official says
  FDA official Janet Woodcock said the agency is seeing more promising treatments and expects drug approvals to increase gradually. "What we think we are seeing is the nadir has been reached and we're coming up the other side," Woodcock said. The annual number of approvals remains far lower than the 53 reported in 1996, during an industry boom. Reuters (5/9)

• Surgeons develop blood vessel using the patient's own stem cells
  Surgeons at a hospital in Sweden said they were able to treat a 10-year-old girl with a potentially fatal blood clot after transplanting a new blood vessel made from a donor vessel stripped of cells and DNA and treated with the patient's own bone marrow stem cells. The patient is showing no signs of serious complications and is not using anti-rejection drugs, said Dr. Michael Olausson, one of the surgeons. Olausson added the findings might lead to the development of methods to create new organs and arteries. Bloomberg (5/9)

• Genetic discovery in zebrafish could offer insight on cancer spread
  Mayo Clinic scientists reported in the journal Nature Methods that they were able look at protein function and expression from about 350 loci in zebrafish's protein-encoding genes after turning on and off genes in the fish. The findings might help shed light on cancer metastasis and factors that make some people susceptible to heart attacks, among other issues. MedCity News (Cleveland) (5/9)

Company & Financial News

• Alkermes acquires Elan's drug-technology unit for $960 million
  Elan agreed to sell drug-technology division EDT to Alkermes for $960 million in cash and shares, allowing Elan to operate as a biotech company focused on neurology. Elan CEO Kelly Martin said the sale "allows us to reduce debt and have a lot of cash for investment in the research and development part of the business." The Wall Street Journal (tiered subscription model) (5/9)

• Series B round brings Caprotec's total funding to $7.2 million
  Caprotec bioanalytics, which makes the capture compound mass spectrometry used in proteomics and small molecule research, has brought its total financing raised in a Series B round to $7.2 million. Caprotec CEO Hubert Koster said the Germany-based firm would use the proceeds to fund potential partnerships with large drugmakers. Mass High Tech (Boston) (5/9)

Global Developments

• Analysis: Drugmakers increasingly move clinical trials overseas
  Large pharmaceutical firms increasingly are turning to Asia, Latin America and Eastern Europe for clinical research because of reduced costs and access to "treatment-naive" patients, according to this Reuters report. Such globalization raises concerns, including ethical standards, data quality and clinical effects on patients with different genetic profiles or lifestyles. Reuters (5/6)

• European panel clears pediatric trial of Biogen's hemophilia B drug
  A European Medicines Agency panel has given Biogen Idec and Swedish Orphan Biovitrum the green light to test in pediatric patients their drug candidate for hemophilia B, Factor IX Fc fusion protein. The companies plan to begin the pediatric study once results from a clinical trial of the drug in adult patients are obtained. Mass High Tech (Boston) (5/9)

• Merrimack licenses a cancer drug candidate from PharmaEngine
  Merrimack Pharmaceuticals bought development, manufacturing and commercialization rights to PharmaEngine's investigational cancer compound MM-398. The deal covers Europe and Asia except Taiwan. PharmaEngine is entitled to $10 million upfront and as much as $210 million in milestone fees, plus tiered royalties. American City Business Journals/Boston (5/9)

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Featured Content

Industrial & Environmental

• USDA designates 50,000 acres in 2 states for bioenergy crops
  The Department of Agriculture said it has identified 50,000 acres across 39 contiguous counties in Missouri and Kansas for the production of feedstocks for electricity, heat generation and transport biofuels. The USDA's Biomass Crop Assistance Program Project Area will improve development of advanced biofuels, said Agriculture Secretary Tom Vilsack. "By encouraging production of feedstocks that can be converted into next-generation biofuels we are boosting the rural economy, creating jobs, contributing to America's energy security and protecting our planet," he said. SustainableBusiness.com (5/6)

News from BIO

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SmartQuote

A good question is never answered. It is not a bolt to be tightened into place but a seed to be planted and to bear more seed toward the hope of greening the landscape of idea." --John Anthony Ciardi, American poet, translator and etymologist