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February 18, 2013News for the food and drug law community

  Drugs & Biologics 
  • FDA accelerates review of ViiV's HIV/AIDS drug dolutegravir
    ViiV Healthcare, a joint venture of GlaxoSmithKline, Pfizer and Shionogi, obtained priority-review status from the FDA for its investigational daily AIDS/HIV treatment dolutegravir. The drug is an integrase inhibitor that keeps the virus out of cells. The FDA is set to decide on the drug's approval by Aug. 17. Yahoo/Reuters (2/16) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  • Lombard Medical gets FDA OK for aneurysm device
    The FDA has granted Lombard Medical Technologies approval for use of its Aorfix stent in treating abdominal aortic aneurysm in patients with up to 90 degrees of angulation at the neck of the aneurysm. The approval gives Lombard access to the U.S. endovascular repair market, which represents over half of the global market. Reuters (2/15) Email this Story
  • FDA gives Dako nod on rapid cancer diagnostic test
    Dako has received approval from the FDA to market its HER2 IQFISH pharmDx test, which is used to cut the turnaround time for cancer diagnosis from the industry standard of two days to three-and-a-half hours. The test, which identifies the HER2 gene in breast cancer diagnosis, is the first FDA-approved test that works with Dako's IQISH system, the company said. GenomeWeb Daily News (free registration) (2/15) Email this Story
  • EU regulators approve ApiFix's scoliosis correction device
    Regulators in Europe have given ApiFix CE mark approval to market a device designed to treat patients with adolescent idiopathic scoliosis. The implantable device has been shown in a pilot clinical study in Europe to be safe and effective in correcting the curvature in participating patients, ApiFix CEO Uri Arnin said. (2/15) Email this Story
  Hot Topics 

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

  • Results based on number of times each story was clicked by readers.
  FDLI Items 
  • 2013 conference calendar -- speak, register & save the dates!
    There are plenty of speaking opportunities available for this year's FDLI conferences. Please e-mail our development team if you are interested in participating or have any session/program ideas. FDLI members routinely receive at least a 20% discount on FDLI conferences, webinars and publications. Upcoming programs include:
    • Medical Device Compliance, Regulation and Litigation Conference | March 4 | Washington, D.C.
    • Introduction to Drug Law and Regulation | April 3-4 | Washington, D.C.
    • Introduction to Medical Device Law and Regulation | April 3-4 | Washington, D.C.
    • FDLI Annual Conference | April 23-24 | Washington, D.C.
    • FDLI International Conference | June 6-7 | Beijing, China. New date!
    • Advertising & Promotion Conference | Sept. 16-17 | Washington, D.C.
    • Food Advertising: Claims, Litigations and Strategies | Oct. 8 | Location TBD
    • FDA Regulation of Tobacco Products | Oct. 17 | Washington, D.C.
    • Enforcement, Litigation and Compliance | Dec. 10-11 | Washington, D.C.
    Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Position TitleCompany NameLocation
Advertising and Promotions CounselPrinceton Legal Search Group, LLCWashington, D.C., DC
Counsel II, Legal (Anti-corruption)Gilead SciencesFoster City, CA
FDA AssociateK&L GatesMultiple Locations, United States
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