Drugs & Biologics

• FDA approves generic drugs for type 2 diabetes by Aurobindo
  Aurobindo Pharma received FDA approval to market its pioglitazone tablets in three strengths and its pioglitazone hydrochloride and metformin hydrochloride tablets in two doses. Both drugs are indicated as added therapy, alongside exercise and diet, to assist with glycemic control in patients with type 2 diabetes. Pharmaceutical Business Review Online (2/15)

• FDA widens OK of Novartis transplant drug
  Novartis' Zortress obtained FDA approval for use in the prevention of liver rejection among patients who receive the transplanted organs. The drug is already approved for kidney transplant patients. Pharmaceutical Business Review Online (2/18)

• 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)

• Merck agrees to settle 2 suits tied to cholesterol drug for $668M
  Merck & Co. agreed to settle for $668 million two class actions involving investors who say it didn't properly disclose a cholesterol drug's failure to meet goal in a key study. A federal trial was set to start next month in New Jersey. The Philadelphia Inquirer (2/16)

• Increase limits on pain drugs, lawmakers say to FDA
  The FDA should increase restrictions on painkillers, a bipartisan group of senators and representatives says in a letter to the agency. The lawmakers want to see a time frame for the reclassification of hydrocodone drugs from Schedule III to Schedule II. "The American people have waited too long for action from this agency," the lawmakers wrote. The Hill/RegWatch blog (2/15), Pharmalot.com/Pharma Blog (2/15)

Food & Dietary Supplements

• Marshals confiscate supplements with active ingredient
  Federal law enforcement officials have confiscated dietary supplements produced by Globe All Wellness. Some of the supplements include sibutramine hydrochloride, the active ingredient in an obesity drug that was pulled from U.S. shelves over stroke and heart risks. United Press International (2/16)

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)

• 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)

• FDA clearance sought for Affymetrix's cytogenetics platform
  Affymetrix has submitted an FDA clearance application for its CytoScan cytogenetics platform in hopes of expanding into clinical diagnostics, translational medicine and applied markets, a company official said. The company said earlier that it anticipates releasing an FDA-cleared cytogenetics product by midyear, but it has not disclosed when it expects the FDA OK for CytoScan. GenomeWeb Daily News (free registration) (2/15)

• 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. MedGadget.com (2/15)

Hot Topics

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

• HHS faults FDA for inadequate oversight of REMS (Pharmalot.com)

• FDA's CDER names deputy director for science operations (Forbes)

• Footnote in court hints at new FDA rules for generic warnings (Pharmalot.com)

• Early trials may be enough for innovative drugs to win FDA approval (Bloomberg Businessweek)

• Analysis: Diclofenac's heart risks warrant caution (TheHeart.org (Montreal) (free registration))

• 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.
  

Position Title Company Name Location Advertising and Promotions Counsel Princeton Legal Search Group, LLC Washington, D.C., DC Counsel II, Legal (Anti-corruption) Gilead Sciences Foster City, CA FDA Associate K&L Gates Multiple Locations, United States

Click here to view more job listings.

SmartQuote

Paradise is here or nowhere: you must take your joy with you or you will never find it." --Orison Swett Marden, American author