Goodness, we are on the edge of the first day of Fall which will occur on Sunday. Where, one asks, did the summer go? Tanlines are beginning to fade, sweet potato vines are beginning to pull back, and mums are beginning their fall colors as a prelude to the falling leaves. The days, alas, grow shorter. And here’s some of what happened this week:
- House Passes Compromise Bill on PDUFA – The FDA Revitalization Act (FDARA) as it is now called, passed the House yesterday and is headed to the Senate where it will likely be passed in short order and sent to the White House for signature. The bill is a compromise between the House and Senate versions passed earlier and launches PDUFA IV. The bill retains six month exclusivity for pediatric studies, unless the drug is a blockbuster earning more than $1 billion, in which case it gets only 3. It also contains a weird provision on conflict of interest waivers, calling for an annual reduction in the number given to advisory committee members over ensuing years. It also creates a clinical trials registry. The next round of PDUFA comes in 5 years.
- FluMist Approved for Use in Children – The FDA announced approval of MedImmune‘s FluMist for use in children between the ages of 2 and 5.
- Encysive Class Action Lawsuit Dismissed – Disgruntled shareholders take note – Encysive Pharmaceuticals announced yesterday the dismissal of a class action lawsuit brought in September 2006. In March of that year, Encysive received the first of what would be three approvable letters for Thelin.
That’s it for me this week. Over the next few weeks, I hope to launch a few new resources. Have a good weekend everyone.