Weekly Roundup – 10/17/08

lI have been totally dismal about posting this week, but have been occupied with family issues in addition to a trip out of town to Princeton to speak at the Second Annual ExL Pharma Digital Healthcare conference where I spoke about the use of digital in crisis.  It seems to be the season for speaking gigs and I have several coming up. 

In the meantime, here is a little bit of what happened this week of interest:

  • Daiichi Sankyo and Eli Lilly Issue Press Release on NDA – It is worth noting that this week two sponsors of an NDA issued an unusal press release about the status of an NDA .  It is unusual for a company to comment on the status of an application, but these are unusual times.  The FDA in August began issuing Complete Response Letters (CRL’s) in place of approvable letters or non-approvable letters.  The agency has its hands full implementing FDAAA and is clearly unable to meet PDUFA deadlines, by its own admission.  The companies issued a press release to respond to rumors swirling around the status of Prasugrel.  Given the state of the FDA and the rate of approvals, one might expect companies to have to issue more of these types of press releases. 
  • Big Night for Pharma – While held last month, I recently got a heads up from Patrick Clinton at Pharmaceutical Executive of the Prix Galien Awards held in New York City where Patrick was able to do video interviews with the winners and where a slide show is available.  Here was the roster of categories and winners:
  • Best Pharmaceutical Agent (Small Molecule)

    Best Biotechnology Agent

    Special Therapeutic Development

    Pro Bono Humanum Award

That’s it for this week.  Have a good weekend all.


Notice of correction:  I was in error in the original posting that Prasugrel had received a Complete Response Letter.  I was operating from memory (always risky) but in fact, the companies did not receive a CRL.  Therefore any references to a CRL have been edited from the original text.  Apologies to all.   

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