Weekly Roundup – 10/03/08

J0182618Sorry there was no posting yesterday and a late one today… I had to take the train to NY very early, have an all day meeting and got back just in time for the debate last night, then had a slew of things to tend to today.  So I am getting to the Weekly Roundup a bit late.

Here is a bit of what happened this week:

  • Amgen Scores Huge Victory on the EPO FrontReuters reports today that a judge has upheld the Amgen EPO patents, blocking a Roche entry into the market with its EPO compound, Micera.   
  • Melamine – The Sequel – The FDA has issued an interim safety and risk assessment of melamine and melamine-related compounds in food.   A safety/risk assessment is a scientifically based methodology used to estimate the risk to human health from exposure to specified compounds. It is based on available data and certain scientific assumptions in the absence of data. The purpose of the FDA interim safety/risk assessment was to identify the level of melamine and melamine-related compounds in food which would not raise public health concerns. The interim safety/risk assessment evaluated the melamine exposure in infant formula and in other foods.  The safety/risk assessment, prompted by reports of melamine contamination of milk-derived ingredients and finished food products containing milk manufactured in China,  was conducted by scientists from FDA’s Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine.  The FDA reviewed scientific literature on melamine toxicity.
  • FDA Clears Statins of Role in Lou Gehrig’s Disease – A U.S. Food and Drug Administration’s analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig’s Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety.  "The FDA’s review, which began in 2007, is an example of the agency working to analyze products – throughout their lifecycle – to keep health care professionals and patients informed of new and emerging safety data," said Mark Avigan, M.D., director, Division of Pharmacovigilance I, Center for Drug Evaluation and Research, FDA.  The FDA analysis, undertaken after the agency received a higher than expected number of Adverse Event Reporting System reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

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

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