Well, another week gone by. Congress is in the throes of things with the White House. But otherwise, it has not been the kind of hot, humid summer we are used to here in Washington. And yet still, it has been a long, hot summer, and the year is already more than half over. Wow.
But as for the week, this is a little bit of what happened:
- I Made a Mistake – Yes, one of those things that I have to admit now and then… it refreshes me to remind me of my fallibility. This time I said no word on Wyeth’s Torisel ™ but I was mistaken – after the company saw an extension of the PDUFA date, they did win approval from the FDA on May 30, as I was corrected by a faithful reader. Sorry about that!
- Death in a Gene Therapy Trial – An area of research with great promise experienced a setback. The FDA announced a death in a clinical trial involving gene therapy. According to the FDA release – "Targeted Genetics notified FDA earlier that a patient in its trial experienced a serious adverse event. Even though the cause of the illness wasn’t known, and is still uncertain, the agency immediately placed the trial on clinical hold–meaning no further product can be administered and no new patients can be enrolled…FDA is not aware of similar adverse events occurring in other gene therapy trials either with this specific product or with those that use other genes in AAV vectors. However, as a precaution, the agency is further reviewing all ongoing trials involving any use of AAV."
- FDA Nanotechnology Report – The agency issued a report on nanotechnology this week recommending that "the agency consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology " The press release contains important links to other elements of FDA and nanotechnology.
That is all for this week, friends. I wish you all a good weekend. It has been a challenging summer.
