The holiday last rush is on. I'm late with the Weekly Roundup because wrapping gifts took precedence. Traffic is sadistic. The weather, unpredictable. The guests are on the road and on their way here, and there are still menus to plan and cards to send.
- FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer - FDA approved Gleevec (imatinib mesylate) for a new indication – keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor or GIST. Gleevec, manufactured by Novartis, was first approved by the FDA in 2001, is one of the first drugs in a class of agents that block cellular communications that result in tumor growth.
- Amgen Submits BLA for FDA Approval of Denosumab in Women with Postmenopausal Osteoporosis in Patients Undergoing Hormone Ablation for Either Prostate or Breast Cancer - Amgen Inc. (Nasdaq: AMGN) announced submission of a BLA for denosumab, an investigational RANK Ligand inhibitor for indications for the treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA submission contains data from a total of six Phase 3 trials involving more than 11,000 patients.
- FDA Issues Complete Response Letter to Centocor for Ustekinumab BLA – In what is a growing number of CRLs in response to applications, the FDA issued one to Centocor for an NDA filed in late 2007 which sought approval of ustekinumab as a subcutaneous therapy to treat adult patients with chronic moderate to severe psoriasis. According the the company's press release, the FDA is seeking a proposal for a REMS program, signaling once again that companies do not have a good idea of what should be going into a REMS program since the change was required by FDAAA. The press release indicates that FDA is seeking other information as well, and interestingly, asks for a communications plan, which demonstrates the increasing role of communications in risk management strategies. Centocor states that the FDA has not requested any new non-clinical or clinical studies to evaluate safety or efficacy. I think FDA may also be stumped on how to pronounce ustekinumab, I know I am.
That's it for me this week and for the holiday I will be taking a brief hiatus.