Weekly Roundup – 5/29/09

J0401613 Oh gosh.  The pollen count is off the charts.  Summer storms are overanxious and overabundant. The first tropical depression has appeared off the Atlantic just prior to the official beginning of the Hurricane Season.  A diabetic is ascending to the Supreme Court.  Washington is crowded with tourists and their horrible big buses.  And here is a little of what happened in our world:

  • Excellent Overview of Comparative Effectiveness Research – My buddy Kip Piper writes a Weblog called The Piper Report.  This week he had a posting entitled "Comparative Effectiveness Research:  Definition, Prioritization Criteria, and Implementation Plans for Federal Comparative Effectiveness Research" and I highly recommend reading it to understand all of those things.   You'll thank me.  Kip knows of what he speaks. 
  • Google Announces Wave – Get ready.  And speaking of the future, while FDA's DDMAC struggles to understand the basics about the Internet in its current form, there is about to be a big leap forward with the announcement by Google of Google Wave which, according to Mashable, offers a hybrid of email, chat and IMing, and project management tools to name a few,that will allow much faster interaction and collaboration.  There is even a Twitter extension called Twave.  Start thinking about the marketing possibilities now.  Don't wait for DDMAC to catch up.  Look at it, analyze it, plan for it. 
  • FDA Issues Complete Response Letter for Riboroxavan Even though Riboroxavan is way fun to say, the FDA issued a CRL this week to J&J for its oral, once a day anticoagulent.  The Cardiovascular and Renal Drugs Advisory Committee voted 15-2 in favor of the drug in March, and the company did say in its very brief statement was that the FDA did not ask for new clinical studies for either safety or efficacy, but did not state what the precise reason for the CRL.   
  • Bausch & Lomb Received FDA Approval of Besivance for Treatment of Bacterial Conjunctivitis ("Pink Eye") Besivance is a new topical opththalmic antibacterial, administered by drops, that treats one of the most common bacterial forms of conjunctivitis has been approved by FDA Bausch & Lomb announced today.   The approval follows a unanimous recommendation by advisory committee in December, 2008.   

That's it for me this week.  Have a good weekend everyone! 

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