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November 21, 2012News for the food and drug law community

  Drugs & Biologics 
  • FDA OKs first seasonal flu vaccine made using animal cell cultures
    The FDA has approved the use of Novartis' seasonal influenza vaccine for people ages 18 and older. The vaccine, which will be marketed under the brand name Flucelvax, is the first seasonal flu vaccine produced using animal cell cultures instead of the traditional chicken egg method, which allows for a faster production process. Reuters (11/20) Email this Story
  • Bristol-Pfizer's blood thinner Eliquis wins expanded EU approval
    Bristol-Myers Squibb and Pfizer received approval from the European Commission to market their anti-clotting drug Eliquis, or apixaban, for stroke and blood clot prevention in patients with atrial fibrillation. The OK is Eliquis' first for the indication. The FDA is expected to decide on an application for the same condition by March 17. Reuters (11/20) Email this Story
  • Why FDA needs track-and-trace for biosimilars
    The FDA should establish a track-and-trace system to monitor biosimilars, as well as a naming system to distinguish biologics from biosimilars to protect patients, writes Dr. Bert Petersen of the New York University School of Medicine. Tracking can help the health system identify and respond to issues such as the recent meningitis outbreak. Furthermore, doctors must decide the suitable biologic drug for a patient, a decision that can't be overridden by an insurance company or a pharmacist, Petersen writes. The Hill/Congress Blog (11/20) Email this Story
 
  • Attorneys: No evidence of NECC owners' direct involvement in outbreak
    There is no evidence that New England Compounding Center's owners directly participated in events leading to the meningitis outbreak, attorneys told a federal judge Tuesday. "Due process should not be washed away in a sea of newspaper articles and conjecture," attorney Alan Winchester said. The owners' attorneys sought to block a motion by plaintiffs in the meningitis outbreak to freeze the assets of NECC and its owners. Reuters (11/20) Email this Story
How Much Do You Really Need to Make? The Answer May Shock You
Rather than focus on what you can afford to pull out of the business to cover your living expenses, you need to focus on how much you need to earn at your business in order to afford the lifestyle you want to have. This is where the Personal Earnings Goal, or PEG, comes into play. Learn how to calculate your PEG and find out how much you really need to make.

  Food & Dietary Supplements 
  • 2 senators seek to meet Hamburg on safety of energy drinks
    Sens. Richard Blumenthal, D-Conn., and Dick Durbin, D-Ill., have asked to talk with FDA Commissioner Dr. Margaret Hamburg about what the FDA is doing to ensure the safety of popular energy drinks and energy shots. "Over the past year, there has been alarming evidence that energy drinks pose a potential threat to the public's health," the senators wrote. "We request a meeting with you on the steps FDA is taking regarding highly caffeinated energy drinks and to ensure they are safe for their intended use and in combination with other energy drink ingredients." CSP (11/21) Email this Story
  Medical Devices 
  • HeartWare gains FDA approval for cardiac pump
    HeartWare has obtained approval from the FDA for its left ventricular assist device, a cardiac pump designed to aid blood flow in end-stage heart failure patients awaiting transplants. The life-saving benefits of the system have been shown in a clinical study to outweigh the risks, according to the FDA. Reuters (11/20) Email this Story
  • Imagine's eye imaging device wins approval in Europe
    Imagine Eyes has earned CE mark approval in Europe for its rtx1 retinal camera, which the firm says is the first adaptive optics platform technology cleared for clinical use. The device allows cellular imaging of the retina to help doctors view structures that are often tied to vision-degrading conditions. MassDevice.com (Boston) (11/19) Email this Story
  • Blood cell preparation device lands wider EU approval
    European regulators have granted Harvest Technologies broader CE mark approval for its SmartPReP 2 Bone Marrow Aspiration Concentration System. The device is now approved for processing concentrated blood cells at the point of care to be used in patients with end-stage critical limb ischemia. Mass High Tech (Boston) (11/19) Email this Story
  Editor's Note 
  • SmartBrief will not publish Thursday and Friday
    In observance of Thanksgiving in the U.S., SmartBrief will not be published Thursday and Friday, Nov. 22 and 23. Publication will resume Monday, Nov. 26. Email this Story
 
Position TitleCompany NameLocation
Attorney ISMC/MHS Contracts Team ManagerMcKesson CorporationSan Francisco, CA
director quality assurance, Regulatory - Seattle, WAStarbucksSeattle, WA
Sr. Director, Regulatory Affairs ConfidentialBucks County, PA
Senior Corporate CounselMedivationSan Francisco, CA
PCH Planning & Reporting MgrPfizer inc.Manila, Philippines
Regulatory CounselBecton DickinsonFranklin Lakes, NJ
Sr. Brand AttorneyNovo NordiskPrinceton, NJ
Health & FDA Business AssociateGreenberg TraurigWashington, DC
Click here to view more job listings.

  SmartQuote 
We can only be said to be alive in those moments when our hearts are conscious of our treasures."
--Thornton Wilder,
American playwright and novelist


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