Weekly Roundup – 06/01/07

J0185010_2 Sorry no posting yesterday, bad week.

And oh dear.   Who can believe it?  It is already June of 2007.  Today every time I went to write the date today I wrote it as 2005.  What’s that about? 

It could have something to do that 2005 was when I had a magical birthday.  Ugh.   For those of you interested, the highlight of last week’s lobster fest was actually my barbecued oysters.  Yum.  I used a blackberry barbecue sauce and put those little toasties on the grill.  When the popped open, I poured in the sauce and let them poach in that for a while.  Just a little lesson – there are more important things in life than what is happening inside the Beltway.  Still for those of you who are interested, here is what happened this week – and there was a lot.

  • FDA Finalizes Guidances for Pandemic and Seasonal Influenza Vaccines – According to the FDA release, [b]oth guidances recommend using recent technologies such as cell culture and recombinant manufacturing to enhance the development and evaluation of vaccines. They also recommend adding substances that improve the immune response from the vaccine (novel adjuvants).   The guidances describe conventional and accelerated approval pathways to vaccine licensure. Companies selecting the conventional pathway must provide clinical evidence that the vaccine prevents influenza. Adequate and well-controlled clinical trials are also required for accelerated approval but companies may use a biological indicator — such as immune response to the vaccine — to predict effectiveness, an approach that may reduce the vaccine’s development time. Further clinical studies are then required to verify the vaccine’s clinical benefit.
  • FDA Approves New Drug for Advanced Kidney Cancer – The agency approved Torisel (temsirolimus) for the treatment of a certain type of advanced kidney cancer known as renal cell carcinoma. Torisel was approved based on a study that showed use of the drug prolonged survival of patients with renal cell carcinoma. Torisel is manufactured by Philadelphia-based Wyeth Pharmaceuticals, Inc.
  • Another Approvable Letter Issued – And I absolutely PROMISE that this weekend I will update the approvable letter list.  I’m sorry about that, I have been swamped!  As stated by the company, "[t]he FDA has informed TopoTarget that a technical issue remains to be resolved with respect to the approval, and thus TopoTarget has received an“approvable” reply instead of the expected “approved”. "  According to the release, "Savene™ is the only approved treatment of the serious tissue damage that may result from accidents with chemotherapy. Despite the utmost caution being taken when anthracyclines are used in chemotherapy, accidents occurring up to 1% of all treatments. This may damage a patient’s tissue and cause painful scarring, leading to severe injury and malformations. In addition, it may lead to a postponement of the chemotherapy."
  • Second Approvable Letter for Tramadol – Labopharm received an approvable letter for the second time for Tramdol, according to the comany’s press release," [i]n the second approvable letter (dated May 30, 2007), the FDA stated that Labopharm has not demonstrated the efficacy of its once-daily formulation of tramadol because the statistical methods used to analyze data from Labopharm’s clinical trials did not adequately address missing data relating to subjects who dropped out of the trials. The FDA did not provide guidance with respect to how the statistical methods were not adequate. The Company will seek to clarify the issue with the FDA at the earliest possible opportunity. "
  • Avandia Hearing May Reveal FDA Issues – According to a New York Times Report, the upcoming Congressional hearing on Avandia may reveal more cracks in the FDA thinking on safety versus efficacy.  The fur has been flying on this issue and maybe it is time everyone took a step back, stopped examining motives and started examining science. 
  • Avanir Gets the Nod – Quoting the press release – AVANIR Pharmaceuticals (NASDAQ:AVNR) today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for a new formulation of the currently marketed antipsychotic drug FazaClo® (clozapine, USP) Orally Disintegrating Tablets.
  • And a correction! – I like to admit when I am wrong, because it humbles me and that is a treasure inside the Beltway.  A reader informed me that I was incorrect in yesterday’s assertion that there has not been study on Black Box Warnings.  He cites his own study – located at Goldman SA. Communication of medical product risk: how effective is effective enough? Drug Safety 2004;27:519-534 - Not electronic, so you must find the material on your own. 

That’s all I have to say about this week.  For a short one, it has been a long one as far as I’m concerned.  I hope everyone has a good and restful weekend. 

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