Weekly Roundup – 3-23-07


It is that singular time of year when, in the morning while walking the dogs, the air is heavily scented with burning fireplaces as neighbors gather around the fireplace on a chilly morning to have their oatmeal, coffee and read the paper.  Then, in the early evening on the very same dog walk, one’s hunger is stirred by the occasional fired up barbecue.  And here is what else happened this week:

  • Speaking of Dogs – There is every indication that the situation with the recall on pet food is much worse than previously thought.  According to ABC News, veterinarians around the country are reporting an alarming number of deaths from acute kidney failure and the impact of the possibly tainted food would appear to be growing exponentially.  Meanwhile, FDA has opened up a Hot Topics page on their Web site devoted to this topic. 
  • Waxman Introduces New Safety Legislation – Speaking of safety, Congressman Henry Waxman (D-CA) has introduced legislation that goes further than other proposed models of FDA safety reform.  H.R. 1561, The Enhancing Drug Safety and Innovation Act of 2007 would, according to the Congressman’s press release(1) strengthen FDA’s post-market drug safety system; (2) establish the Reagan-Udall Institute for Applied Biomedical Research, a new public-private partnership to advance FDA’s Critical Path Initiative; (3) establish mandatory clinical trials registry and results databases; and (4) reform procedures to manage conflicts of interest on FDA’s advisory Committees. H.R. 1561 builds upon those provisions to further increase FDA’s post-market drug safety authority, provide greater FDA transparency, and enhance the mandatory clinical trial registry and results databases.
  • FDA Clears Rapid Test for Meningitis – This week a new test was approved that uses molecular biology to quickly detect the presence of viral meningitis.  The Xpert EV test, when used in combination with other laboratory tests, will help physicians distinguish between viral meningitis and the less-common, but more severe, version of meningitis caused by bacteria. The Xpert EV test was developed by Cepheid.
  • FDA Approves First-of-its-Kind Drug to Treat Rare Blood Disorder – The agency this week approved Soliris (eculizumab), the first product for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare type of blood disorder that can lead to disability and premature death. Soliris is classified as an Orphan Drug and is a new molecular entity containing an ingredient not previously marketed in the United States.  Soliris is manufactured by Alexion Pharmaceuticals, Inc.

That is it for this week folks.  Wherever you are, I hope your weekend is lovely.  Cheers.

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