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FDA Advisory Panel Recommends Approval Of The SEDASYS(R) System
Ethicon Endo-Surgery today announced that the Anesthesiology and Respiratory Therapy Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) voted in favor of approval of the SEDASYS(R) System for use by physician/nurse teams to administer minimal-to-moderate propofol sedation during screening and diagnostic procedures for colorectal cancer (colonoscopy) and the upper gastrointestinal tract (EGD). The SEDASYS(R) System, the first computer-assisted personalized sedation (CAPS) system, integrates drug delivery and patient monitoring to enable propofol sedation personalized to each patient"s needs.

FDA Classifies Previously Announced Medtronic Physician Advisory On Small Subset Of Kappa And Sigma Pacemakers As Class I Recall
Medtronic, Inc. (NYSE: MDT) announced the U.S. Food and Drug Administration (FDA) has classified Medtronic"s previously announced physician advisory about a small subset of Kappa® and Sigma® series pacemakers, identified at increased susceptibility for separation of bonded interconnect wires from the electronic circuit, as a Class I recall. Notification to U.S. FDA, physicians and patients began May 18, 2009. As of the date of this news release, more than 95 percent of physicians following affected devices in the United States have confirmed receipt of the notification. The FDA"s classification of Medtronic"s Important Patient Safety Information does not alter the patient management recommendations already provided in the May 2009 letter, and physicians need not take any new action.
News of the day
Gonorrhoea Down 11%, UK
The Health Protection Agency has reported an 11% decrease in the total number of new gonorrhoea infections diagnosed in the UK last year from 18,649 infections in 2007 to 16,629 in 2008 - the lowest number of new infections recorded since 1999.
Nutrition

AARP Biologics Study Based On Fuzzy Math, Flawed Assumptions

The following statement was issued by the Biotechnology Industry Organization (BIO) regarding a study on biosimilars presented to Congressional staff by the AARP: "The so-called AARP "study" is simplistic, misleading and extremely flawed. It is based on fuzzy math and even fuzzier assumptions. "The study cherry picks the best selling biologic products to draw erroneous conclusions, ignoring the bulk of the biologics market. The real facts show that only a small percentage of biotechnology products have the types of financial returns identified in the AARP study. If AARP had analyzed all of the more than 200 other FDA-approved biologics they conveniently left out of their fact sheet, their analysis would have reached a much different, and more credible, result. That"s because the "break even" point for all the other FDA-approved biologics approaches 50 years. "Greater than 90% of biologic products fail before even getting to clinical trials. Of those entering clinical trials, only 30% get approved by FDA. Of those approved products, only 34% generate profits equal to or greater than the development cost over the product"s lifecycle. "As one of the nation"s largest insurance providers, AARP has a lot to gain financially by using its considerable lobbying muscle to push Congress to pass biosimilars legislation that will benefit insurers by providing short-term cost savings at the risk of jeopardizing the continued development of advanced and breakthrough medicines and cures for patients. Biotechnology medicines extend and improve the quality of life - and provide renewed hope - for patients suffering from debilitating diseases such as cancer, HIV/AIDS, Parkinson"s, Multiple Sclerosis, diabetes and a host of rare diseases. "Congress should not develop public policy based on such a flawed and blatantly biased analysis. Now is the time to implement a pathway to biosimilars that safely increases access to the breakthrough therapies and cures for the patients of today, while preserving the incentives necessary to address the unmet medical needs of the patients of tomorrow." BIO


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