Here is what happened this week that was interesting to me and I hope will be to you too.
- FDA Sets Transparency Meeting –
The agency is on a transparency tear – taking down the curtains, raising the window shades and letting in the light. After establishing a Transparency Task Force (though ironically, we don't know the names of the people on the Task Force) and a Transparency Web page, and a Transparency Blog (though we don't know who is writing it), the agency has set a date for a Transparency Meeting, which will be held June 24 in Washington, D.C.
- First Drug Approved for Cancer in Dogs – The FDA approvedPalladia, a tyrosine kinase inhibitor that kills tumor cells and cuts off the blood supply to a tumor. The drug is brought to us dog lovers by Pfizer Animal Health. For those of us who have been through this with our best friends, it may come as a surprise to know that current cancer treatments used on dogs are used off-label and have been approved for humans. Palladia is the first that is canine-approved. Thanks Pfizer!
- Complete Response Letter Issued to ViroPharma- In response to the sBLA for its acute attacks of hereditary angioedema, ViroPharma received a Complete Response Letter asking for an additional clinical trial. Though no safety concerns were mentioned, the motive on the part of the FDA was due to a stated "lack of robustness" in the Phase III clinical trial.
Typepad is being highly temperamental today and hard to work with, so that is it for me this week. Have a good and sunny weekend wherever you are.