Weekly Roundup – 3/16/07

The daffodils have pushed their little heads up and are presenting green bunches pregnant with yellow tips in flower beds all around our fair city – the crocuses are spreading little purple and yellow blossoms across the lawns.   Woodpeckers are lustily knocking themselves silly on tree branches and the daylight now lasts a blessed hour longer – true relief for those of us always who are always sorry to see the sun set.  And yet, all around these harbingers of a burgeoning Spring, events that affect the world of the pharmaceutical business continue to swirl around us with fierce determination.  And here’s some of what happened this week:

  • Finally – FDA Postings of  von Eschenbach Congressional Testimony – At long last, three new installments of Congressional testimony appeared on the FDA Web site.  There was talk of my favorite topic – food, as well as PDUFA.  Dr. von Eschenbach gave an overview of PDUFA in his remarks, before the Committee on Health, Education, Labor and Pensions on March 14 , 2007 to which the agency has provided "highlights".   For those interested, I came across information this week that I didn’t know – nearly three-quarters of the EMEA budget comes from user fees, as does all of the budget for UK efforts in this area.  On a related topic, he also outlined budget issues before the Senate Agriculture, Rural Development,and Related   Agencies Appropriations Subcommittee on February 27, which was not posted until this week.   Lastly, he offered testimony on food safety before the Senate Agriculture, Rural Development, and Related Agencies
      Appropriations Subcommittee on March 12.
  • New FDA Pandemic Flu Site Announced – The FDA announced a new site that covers Pandemic Flu preparedness.  Ironically, while there is less media around this potential this year, there is probably more cause for concern.  The FDA Pandemic  site compiles FDA activities, issues for consumers and issues for industry, as well as background materials. 
  • FDA Approves Tykerb for Advanced Breast Cancer Patients –   The agency announced this week the approval of Tykerb
    (lapatinib), a new targeted anti-cancer treatment, to be used in
    combination with capectabine (Xeloda), another cancer drug, for
    patients with advanced, metastatic breast cancer that is HER2 positive
    (tumors that exhibit HER2 protein). The combination treatment is
    indicated for women who have received prior therapy with other cancer
    drugs, including an anthracycline, a taxane, and trastuzumab
    (Herceptin).   Tykerb will be distributed by GlaxoSmithKline
  • Study Shows Uninsured Receive Inferior Care – In the vein of "tell me something I don’t know already" the Journal of the American Medical Association (JAMA) released a study on the uninsured by the Kaiser Family Foundation demonstrating that (hold your breath) shows that the uninsured receive inferior care and have worse outcomes than people with insurance.   

And that’s it for this week.  Have a pleasant St. Patrick’s Day for those of you so inclined and a good weekend to all.

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