I have been temperamental on the Weekly Roundup lately. It is only a reflection of the fact that it has been an extraordinarily busy summer. I will persevere to be more faithful.
In the meantime, here is a bit of what happened this week.
- FDA AdComm Votes for Pain Gain for Cymbalta – Yesterday an AdComm voted 8-6 to favor the expansion to a broader pain indication for Cymbalta. According to the release by Lilly "[t]he committee reviewed efficacy and safety data from three new Cymbalta studies in chronic low back pain and two new studies in chronic pain due to osteoarthritis of the knee…" The release further stated that the submission wasn't designed to support individual indications. However, there were split votes between the back pain and the osteoarthritis pain, with there being support for the former, and not the latter. Ball goes to FDA's court.
- FDA Proposes Withdrawal of Low Blood Pressure Drug – In what seems to be amid growing signs that the FDA is "cleaning house" this week the agency for the first time issued a proposal to withdraw a drug under accelerated approval regulations. The FDA took the action regarding the drug midodrine hydrochloride is used to treat the low blood pressure condition orthostatic hypotension because under the terms of its approval, the drug was to demonstrate its efficacy in post-marketing studies and the agency did not see the data. This seems to be just one of what appears to be many activities recently by the agency to review drugs that have been out on the market to re-evaluate or re-assess.
- Impactivi Launches impact-pharma-networkers Daily – Steve Woodruff over at Impactiviti has put together a pretty neat daily publication that wraps up what several folks who regularly comment on the pharma marketing scene have said in blogs and on twitter. It is a nice way to check out some of the day's stories if you haven't been able to keep your eyes glued to your Hootsuite or Tweetdeck all day. Check it out.
That's it for me this week. Have a good weekend everyone!
