Drugs & Biologics

• OTC decongestant gets FDA support amid criticism
  An FDA advisory panel decided 11-1 to support the efficacy of over-the-counter decongestants with 10 milligrams phenylephrine, in spite of opposition from researchers who claim the oral compound is ineffective. Johnson & Johnson and Wyeth manufacture OTC decongestants with this ingredient. The Wall Street Journal (free content) (12/17), CNNMoney.com (12/14)

• GSK's Cervarix faces regulatory setback
  The FDA has issued a complete response letter to GlaxoSmithKline for its cervical cancer vaccine Cervarix, delaying the drug's approval by at least six months. GSK declined to elaborate on the details of the letter, but a company executive said they have begun looking into the FDA's queries and will coordinate with the agency on the issue. The Guardian (London) (12/17)

• Duramed sues drug firms for patent infringement
  Duramed Pharmaceuticals has filed suit against Watson Pharmaceuticals and Novartis subsidiary Sandoz in U.S. District Court in New Jersey, saying the two companies have violated its patent for Seasonale, an extended-cycle birth control drug. Watson introduced its generic product to the market in 2006, while Sandoz has filed an Abbreviated New Drug Application with the FDA to make its version. Reuters (12/14), American City Business Journals/Cincinnati (12/14)

• Commentary: The politics behind off-label drugs
  Drugmakers can be convicted of a crime for influencing medical experts to employ their products for off-label uses, even when there's good evidence of the benefits, writes Scott Gottlieb, a fellow at the American Enterprise Institute and former FDA deputy commissioner. Eli Lilly and Co. was convicted for promoting Evista for off-label use, but its "crime" could be seen as public service, Gottlieb says. The Wall Street Journal (tiered subscription model) (12/17)

• Computational method predicts drug toxicity
  U.S. researchers have developed a computational technique that can help scientists identify the toxicity of drug candidates and predict side effects of existing drugs without resorting to laboratory experiments. The method uses the Protein Data Bank, a database of more than 10,000 protein structures, to identify "off-targets" of drugs. M.I.T. Technology Review (12/15)

• Other News

• New Jersey mandates flu shots for preschoolers
  The Philadelphia Inquirer (12/15) CNN/Associated Press (12/14)

Biotechnology

• Harvard scientists warn of risks in stem cell breakthrough
  The successful "reprogramming" of adult skin tissue into stem cells may have been a major scientific development, but scientists at Harvard and other universities warn that the technique may be too dangerous to be used in medical treatment. The process creates cells that are unpredictable and could cause cancer, making it important to maintain research into other methods, the experts say. The Boston Globe (free registration) (12/17)

Food & Dietary Ingredients

• Senate leaves out nutrition proposal for school foods
  The Senate on Thursday dropped an amendment to the farm bill that aims to restrict high-calorie beverages and fatty foods in school vending machines and snack bars, and regulate the serving sizes and calorie content of all beverages. The amendment would have been the first revision to the nutrition standards since 1979. The Washington Post (12/15)

• N.D. meat inspector gets USDA power
  A North Dakota Department of Agriculture inspector became the first state employee authorized to put the USDA stamp of approval on a beef product under a cooperative agreement between the state and the agency. "This provides a new marketing opportunity for North Dakota state-inspected processing plants, as well as the federally-inspected plants within the state," Agriculture Commissioner Roger Johnson said. Minot Daily News (N.D.) (12/15)

Medical Devices

• FDA OKs Varian Medical's proton-scanning device
  The FDA has granted Palo Alto, Calif.-based Varian Medical Systems approval to market its proton-scanning algorithm system used to treat tumors and other abnormalities. The device allows doctors to target tumors with greater control. American City Business Journals/Silicon Valley/San Jose (12/14)

• Device claims stripped from Web sites amid federal scrutiny
  Operators and distributors have removed questionable health claims related to the use of EPFX and PAP-IMI -- unproven medical devices that are now under federal scrutiny -- from their Web sites, according to The Seattle Times. The FDA and a U.S. House Energy and Commerce subcommittee are conducting investigations on the devices, following the newspaper's series of investigative reports. The Seattle Times (12/16)

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Hot Topics

Top five news stories selected by FDLI SmartBrief readers in the past week.

• Bug in milk linked to Crohn's disease, study found (The Daily Mail (London))

• D.C. ponders measure on licensing pharma sales reps (The Washington Post)

• Study links Avandia to heart, death risks (NYTimes.com)

• Downsizing good for Big Pharma, analysts say (CNNMoney.com/Fortune)

• Merck, Schering drop suggested changes to ENHANCE trial (NYTimes.com)

• Results based on number of times each story was clicked by readers.

FDLI Items

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