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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.
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Link Between Sleep And Weight Control
Could sleep be a critical component to maintaining a healthy body weight? According to new research presented on Sunday, May 17, at the American Thoracic Society"s 105th International Conference in San Diego, body mass index (BMI) is linked to length and quality of sleep in a surprisingly consistent fashion.
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The Science Of Sedentary Behavior: Too Much Sitting And Too Little Exercise
Sedentary behavior is becoming an important component of the exercise and health equation. There is new evidence that prolonged, unbroken sitting time is related to people"s risk of obesity and type 2 diabetes, according to a lecture presented today at the 56th Annual Meeting of the American College of Sports Medicine (ACSM) in Seattle. Examples of sedentary behaviors include watching television, playing video games, using the computer, reading, and doing homework.
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Emergent BioSolutions Meets With FDA To Review Regulatory Strategy For Recombinant Anthrax Vaccine

Emergent BioSolutions Inc. (NYSE:EBS) announced that it has met with the U.S. Food and Drug Administration (FDA) to review Emergent"s regulatory strategy for the development of its recombinant anthrax (rPA) vaccine. Emergent recently submitted to FDA, among other documents, its rPA Development Plan in response to the Department of Health and Human Services" (HHS) amendment to its request for proposal (RFP) to develop and deliver up to 25 million doses of an rPA vaccine for the Strategic National Stockpile. In amending the RFP, HHS required that all bidders deemed to be in the competitive range submit to FDA a comprehensive plan outlining the regulatory strategy for their rPA vaccine. Emergent completed that submission on May 12, 2009 ahead of the June 15, 2009 submission deadline. "We are extremely pleased with the feedback that we received from FDA regarding our regulatory strategy for the development of our rPA vaccine candidate," stated Daniel Abdun-Nabi, president of Emergent BioSolutions. "This meeting reassured us of the appropriateness of the regulatory strategy that we submitted to FDA and that we can proceed without major modification. As a result of these discussions, Emergent is positioned to advance to the next step in its contract negotiations with HHS for the development and delivery of 25 million doses of an rPA anthrax vaccine to the Strategic National Stockpile." Emergent BioSolutions Inc.


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