Weekly Roundup – 01/25/07

J0400652The Weekly Roundup is a bit more of a lonely trail without Cowboy Heath Ledger.  Sorry to him go. 

Otherwise, it was a pretty busy week, with some bits of good news and quite a few bits of bad news.  Amazingly, January is almost over. 

And here is a bit of what happened this week in our world:

  • New HIV Drug Approved – The agency this week approved etravirine tablets for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals.  Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that helps to block an enzyme which HIV needs to multiply. The drug was approved to be used in combination with other anti-HIV medications. Sold under the trade name Intelence, etravirine received a priority review by the FDA. Etravirine is distributed by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., based in Bridgewater, N.J.  Many in the HIV community commended the manner in which the product is being priced
  • House to Investigate Vytorin Companies and Contacts – The news this week about the Vytorin studies that question the efficacy of product will have impact on a broad spectrum, including lawsuits.  One of them is with the House of Representatives which the New York Times reports, is set to probe company relationships with heart groups. 
  • Oncologic Drugs Advisory Committee Schedules Meeting on EPO – On March 13, ODAC will meet to discuss the risks of erythropoeisis-stimulating agents when administered to patients with cancer, according to today’s Federal Register.  Agents to be discussed include Aranesp, Epogen, Procrit and Mircera and is a follow-up to the meeting from May, 2007.
  • Labopharm Gets Response to Appeal of Approvable Letter – As one might have predicted, it was reported this week that Labopharm‘s appeal to the FDA to reverse its decision to issue an approvable letter for its product Tramadol was turned down by the agency.  That comment doesn’t reflect on the merits of the appeal, but rather that the system of appeals in this regard does not really indicate success for a company seeking to overturn a decision.

That’s it for me this week folks.  Have a good weekend. 

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