Drugs & Biologics

• FDA seeks more data on Novo Nordisk's Tresiba insulin
  More data is needed on cardiovascular risks before Novo Nordisk's long-acting insulin Tresiba can be approved by the FDA. Chief Scientific Officer Mads Thomsen said the company could meet with the FDA in the coming days to discuss possible next steps. Reuters (2/11), The Wall Street Journal/Dow Jones Newswires (2/11)

• Report: Potential cuts are threat to FDA's future success
  Possible cuts to FDA funds are the primary obstacle to the agency's ability to do its job well, according to this blog post. The task at hand is to expand and preserve financial support for the FDA. Poor funding is a weakness for the agency and a threat to the public's well-being, Steven Grossman writes. FDA Matters blog (2/7)

• Celgene's multiple myeloma drug Pomalyst wins FDA approval
  The FDA has approved Celgene's Pomalyst, or pomalidomide, as treatment for patients with multiple myeloma who have stopped responding to other therapies. Pomalyst is intended to strengthen the immune system in blocking and eliminating cancer cells. The drug's label will include a warning that it can cause clots and that it should not be used by pregnant women because of the risk for birth defects. HealthDay News (2/8), Reuters (2/8)

• Macleods gets FDA nod for generic Actos
  Macleods Pharma received FDA approval for its pioglitazone hydrochloride tablets in three strengths: 15 mg, 30 mg and 45 mg. The drug is a generic formulation of the diabetes treatment Actos, made by Takeda. Drug Store News (2/8)

• GSK submits metastatic melanoma drugs for EU approval
  GlaxoSmithKline filed an application with the European Medicines Agency seeking approval to market trametinib alone, and in combination with dabrafenib as a treatment for metastatic melanoma. The application was based on positive results of two trials involving patients with the BRAF V600 mutation. Pharmaceutical Business Review Online (2/8)

Global Focus

• EU approves prostate cancer test from True Diagnostics
  European regulators have granted True Diagnostics CE mark approval to market a quantitative test for prostate-specific antigen. The TrueDXPSA is designed to allow doctors to measure patients' PSA levels quickly and at the point of care. Pharmaceutical Business Review Online (2/8)

Food & Dietary Supplements

• White House issues memo on sequester's effects on food safety
  A memorandum issued by the White House stated that food safety would be at risk once Congress allows sequestration to start on March 1. "These reductions could increase the number and severity of safety incidents, and the public could suffer more foodborne illness," the White House said in the memo. FoodSafetyNews.com (2/11)

Medical Devices

• FDA could erase OTC exemption from device identifier rule
  Over-the-counter medical technologies might not be excluded from the unique device identifier rule being prepared for publication in June by the FDA. "There's a lot of interest in not seeing this exemption in the final rule so we're taking this into account," said Jay Crowley, senior adviser on patient safety for the FDA. Clinica (subscription required) (2/8)

• FDA submits device data gathering proposal for OMB review
  The FDA has submitted for approval by the Office of Management and Budget a proposal to renew its program for gathering data about medical devices as part of its system to identify and ban devices that are harmful or risky. The agency also is requesting public comment on its process for banning medical technologies. MassDevice.com (Boston) (2/8)

• Zoll gets FDA OK for fully automatic external defibrillator
  The FDA has given Zoll Medical, an Asahi Kasei unit, 510(k) clearance to market its AED Plus system. The newly approved automated external defibrillator, which improves on the semi-automatic version, enables emergency responders to help victims of sudden cardiac arrest by allowing them to preprogram a shock, rather than pressing the "shock" button. MassDevice.com (Boston) (2/8)

Hot Topics

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

• Work curtailed at 11 pharmacies after Mass. inspections (The Boston Globe (tiered subscription model))

• FDA warns against excessive use of acetaminophen (HealthDay News)

• FDA seeks ways to reward quality (Pharmalot.com)

• Biosimilars, CMOs on FDA's list for guidelines coming this year (In-PharmaTechnologist.com)

• Agency releases final Sunshine Act rule (Modern Healthcare (subscription required))

• 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:
  • Pharmacy Compounding: An FDLI Dialogue | Feb. 12 | Washington, D.C., or via teleconference. Last chance to register!
  • 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 Sales Engineer 108473-02 UTC Climate, Controls & Security Carrier Corporation Austin, TX FDA Associate K&L Gates Multiple Locations, United States FDA/ORA/Asst Commissioner for Operations, Food and Drug Administration, Office of Regulatory Affairs Food and Drug Administration Rockville, MD FDA/ORA/Regional Food and Drug Director Food and Drug Administration/Office of Regulatory Affairs Multiple Locations, United States Food and Drug Associate Hunton & Williams LLP Washington, DC

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SmartQuote

If Columbus had an advisory committee he would probably still be at the dock." --Arthur Goldberg, American statesman and jurist