Weekly Roundup – 04/18/08

J0406498It was an incredibly beautiful week here inside the Beltway with crystal blue skies and today temperatures are going into the mid-80s.  A lot has been happening on many fronts, and here is a little of what has happened in our corner of the world:

  • I’m a Twittering Fool – I have added a Twitter application to Eye on FDA.  You will find it over in the upper left hand corner under my handsome face.  In that space I’m posting news as I see it that I think you might be interested in.  I will also, when at conferences, Hill hearings or FDA Advisory Committee meetings be able to provide on-site instant updates.  If you are really interested, get yourself a Twitter account and follow my twittering!
  • Approvable Letter Turns into an ApprovalPozen and GlaxoSmithKline scored a victory this week when the FDA issued an approval for the migraine treatment Treximet.  The news sent Pozen’s stock up considerably, by about 34%.   According to the press release – "Treximet is the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of migraine-specific medicines pioneered by GSK, and an anti-inflammatory pain reliever in a single tablet."  Previously the companies had two, count ’em, two approvable letters for the drug.  Persistence pays off. 
  • JAMA Publishes Report on Merck and Ghostwriting – I will write more on this on Monday, and Derek Lowe over at In the Pipeline has an excellent posting on this subject today, but in the meantime, if you are interested in this rather disillusioning development, you can go to the JAMA study called Guest Authorship and Ghostwriting in Publications Related to Rofecoxib.  It is an eye-opening account of writing and shopping for authors.

That’s it for me this week.  Have a wonderful weekend. 

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