Cold has blown its way in, not only here but in Europe for sure. We have experienced a week with one foot still in the Thanksgiving holidays, perhaps clearing out the guestroom from our guests, using up or disposing of the leftovers, and one foot in the Christmas season, addressing our cards, buying our gifts and decorating the house. It is a time for the year to wind down and continue down the pathway of the second decade of the still new millenium.
The folks at FDA were actually pretty quiet this week, but here is a bit of what else happened in our world:
- Cell Therapeutics Files Appeal to FDA Decision – I have always been a skeptic about the act of filing an appeal to an FDA decision on an NDA. But this past November, Johnson & Johnson filed an appeal on a decision by FDA and it was granted, though that involved a PMA (Sedasys) and not an NDA. This week, Cell Therapeutics announced it would be filing an appeal regarding the NDA decision for Pixantrone, an investigative treatment for relapsed/refractory aggressive non-Hodgkins Lymphoma (NHL).
- FDA Issues Complete Response Letter for Epilepsy Treatment – GSK and Valeant received a Complete Response Letter from FDA for ezogabine, an investigative treatment for epilepsy. The release of the news did not relay the nature of the issues that kept FDA from approving the NDA, but did say that the issues were “non-clinical” and expressed an aim to submit a response in 2011.
- Food Safety and Modernization Bill Passes Senate – During a time when there is nothing but pessimism in Washington that anything can be accomlished, S.510 – the Food Safety and Modernization Act – defied the gravity of that sentiment by passing the Senate 74-25. Under its provisions, the FDA will have greater authority over recalls and to take steps to bolster the safety of food imports. The bill will have to reconciled with the House version and sent to the President’s desk by year-end.
- Healthy Thinkers Launched – Jonathan Richman who writes Dose of Digital and who brought us the great resource of the Social Media Healthcare and Pharma Wiki has hatched a new idea called Healthy Thinkers. Essentially this is an online community comprised of people who work in various areas of healthcare where questions can be submitted or problems posed and the community can offer ideas and solutions which can then be voted on by members of the community.
That’s it for me this week folks. I’m going home tonight to decorate the tree. Have a good weekend everyone.