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

• Public health, medical research to suffer from sequestration
  Sequestration will hit hard in public health and medical research, both of which have been restricted by years of underfunding or retrenchment. "These cuts are going to have a real impact," Washington state Health Secretary Mary Selecky said. "In the next six to eight weeks, we're going to have to say we're closed on Fridays or we can't provide this or that service anymore." Researchers who depend on NIH grants have also expressed concern that their work will have to be scaled back. Los Angeles Times (tiered subscription model) (2/27)     

Health Care & Policy

• Draft on electronic submissions raises concerns for BIO
  Draft guidelines from the FDA on the electronic submission of data from clinical sites don't ensure that industry can rely on technical specifications to allow long-term planning, BIO said. The guidelines should address duplicative submissions that can delay site inspections, Pharmaceutical Research and Manufacturers of America said. OutSourcing-Pharma.com (2/28)     

• Baxter submits hemophilia drug for FDA approval
  Baxter International filed a biologics license application with the FDA for approval to use FEIBA NF Nanofiltered and Vapor Heated, its anti-inhibitor coagulant complex treatment, in patients with hemophilia A or B and inhibitors. The application was based on a late-stage trial that found routine prophylactic treatment was associated with a 72.5% decrease in bleeding rates. Pharmaceutical Business Review Online (2/28)     

• FDA plans to create new pharma quality office
  The FDA Center for Drug Evaluation and Research is establishing a new drug quality office, FDA Commissioner Dr. Margaret Hamburg announced at the annual conference of the Generic Pharmaceutical Association. The new office will enforce existing quality standards instead of creating new quality requirements, she added. "Quality is one of our highest priorities" this year, she said. Bloomberg BNA (free content)/Pharmaceutical Law & Industry Report (2/27)     

• Amarin seeks expanded FDA approval for heart drug Vascepa
  Amarin filed a supplemental new drug application with the FDA for approval to market Vascepa, or icosapent ethyl, for adult patients with high triglycerides with mixed dyslipidemia. The firm expects the agency's decision on whether to accept the application within 74 days. Pharmaceutical Business Review Online (2/27)     

• Natera signs deal with Bio-Reference for prenatal test
  Natera has agreed to allow Bio-Reference Laboratories to market its Panorama prenatal test through the latter's GenPath division. The noninvasive assay is designed to diagnose trisomy 13, 18 and 21 as well as specific sex-chromosome disorders. GenomeWeb Daily News (free registration) (2/27)     

• Roche agrees to release clinical trial studies
  Swiss pharmaceutical firm Roche Holding has agreed to establish a procedure for releasing data from its clinical trials, including its highly successful flu medicine, Tamiflu. The company will use a process that enables access to trial data without compromising patient confidentiality or publishing misleading results, according to pharmaceuticals unit head Daniel O'Day. Earlier, British-owned GlaxoSmithKline agreed to publish its own clinical study reports and trial results. Reuters (2/27)     

Company & Financial News

• Mass. biotech pulls in $11.5M in Series A round
  A Series A funding round has brought in $11.5 million to Waltham, Mass.-based biotech Kala Pharmaceuticals, which has a drug delivery platform that can diffuse treatments into mucosal barriers. The firm plans to use its technology to develop a treatment for wet age-related macular degeneration. American City Business Journals/Boston/bioflash blog/Mass High Tech (2/28)     

Food & Agriculture

• Secure site for biotech crop trials created in Switzerland
  The Swiss government plans to establish a protected site for biotech crop trials to allow research without fear of vandalism. The site at the Reckenholz research station near Zurich will first be used for a wheat test. Lawmakers believe trials "should be protected and that the research agenda should not be determined by vandals," said Reckenholz senior researcher Michael Winzeler. ScienceMag.org (2/28)     

Industrial & Environmental

• DuPont Pioneer exec hopeful cellulosic sector will meet RFS goals
  The U.S. produced 20,000 gallons of cellulosic biofuels last year and is projected to produce 250 million gallons in 2015, short of the Renewable Fuel Standard's 2012 target of 500 million gallons and one billion gallons this year. But Andy Heggenstaller, agronomy research manager for DuPont Pioneer, is optimistic that the industry will rise to the challenge. "I think what we're going to see is that DuPont and some other companies are going to make this happen in that 2015 timeframe," Heggenstaller said. Brownfield (2/28), The Hartford Courant (Conn.) (2/26)     

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