It is the mildest winter I can remember. Today was slated to reach 60 degrees in Washington, D.C. No preparation of hot comfort foods, no roaring fires, no ice skating parties, no snow ball fights. DC has moved further south, apparently.
In the meantime, here is a bit of what happened this week that caught my eye:
- Consent Decree Signed with Ranbaxy – A consent decree was filed by the U.S. Department of Justice resulting an injunction against generic manufacturer Ranbaxy addressing current good manufacturing practice (CGMP) as well as data integrity issues in India and CGMP issues at its U.S. facility located in Gloversville, New York, now closed. The company will have to achieve compliance with third party audits to confirm. The decree creates provisions for liquidated damages, among other things.
- FDA Approves First Once Weekly Diabetes Treatment – Amylin Pharmaceuticals announced today that the FDA has approved Bydureon (extended release exenatide) as the first once weekly treatment for diabetes. Bydureon is a glocagon-like peptide-1 (GLP-1) receptor agonist that is indicated in addition to diet and exercise to improve glycemic control in adults with Type 2 diabetes. Bydureon uses proprietary technology from Alkermes to provide the controlled release of exenatide. In addition to the company’s press release on the approval, there is also a link to a multi-media release complete with video.
- FDA Approves Treatment for Advanced Kidney Cancer – Pfizer’s Inlyta (axitinib) was approved this week by FDA for the treatment of advanced kidney cancer – the seventh kidney cancer drug to be approved since 2005. According to the company release, Inlyta is indicated for use after failure of one prior systemic therapy. Inlyta is a kinase inhibitor designed to selectively inhibit VEGF receptors 1, 2, and 3 that influence tumor grown and is an oral therapy.
- FDA Reopens Comment Period on DTC Rule Regarding Major Statements – The FDA is reopening the comment period on specific data related to a proposed rule first published in a March 29, 2010 Federal Register Notice to establish standards that would be considered in determining whether the major statement in DTC TV and radio ads regarding side effects is presented clearly. The agency added a document to the docket entitled “Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in DTC Prescription Drug TV Ads” for which it is seeking further comment.
That’s it for me this week folks. I have been travelling a good deal and posting has been tough, but hopefully I’m around the next few weeks.
Photo taken by friend Anne Hainsworth and used with permission.