AstraZeneca Recognised for Clinical Research Excellence at US Clinical Researcher of the Year Competition
AstraZeneca secured first position as the top clinical research team after competing in the US Clinical Researcher of the Year competition, hosted by fellow pharmaceutical company Shire. The US Clinical Researcher of the Year competition focused on a range of competencies including innovation, collaboration, leadership, compliance and oversight to determine the industry’s finest researchers. Increasing […]
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Center for Regulatory Effectiveness: A Senator’s Unilateral Recommendation To Ban Menthol is Inconsistent with the Recommendations of the FDA
WASHINGTON, April 25, 2011 /PRNewswire/ — Senator Blumenthal states that his recommendation to ban menthol cigarettes is based on the report of the FDA Tobacco Product Scientific Advisory Committee. Unfortunately he must have not read the report in its entirety. The TPSAC made it clear that no action can be taken on a ban until […]
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EASL European Congress March 30 – April 3, 2011, Berlin, Germany: VCTE(TM) Developed by Echosens, the Leading Technique for Evaluation of Liver Disease
EASL European Congress March 30 – April 3, 2011, Berlin, Germany: VCTE(TM) Developed by Echosens, the Leading Technique for Evaluation of Liver Disease PARIS, April 22, 2011 /PRNewswire/ — On the occasion of the 46th Congress of the European Association for the Study of the Liver, the VCTE(TM) (Vibration Controlled Transient Elastography) from Echosens stood […]
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Daiichi Sankyo Receives First Market Approval in Japan for LIXIANA®
Daiichi Sankyo Receives First Market Approval in Japan for LIXIANA® (edoxaban), a Direct Oral Factor Xa Inhibitor, for the Prevention of Venous Thromboembolism after Major Orthopedic Surgery TOKYO, April 22, 2011 /PRNewswire/ — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), announced today that the company has received its first marketing approval for LIXIANA® (JAN: Edoxaban […]
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Baxa Corporation Demonstrates End-to-End Environmental Stewardship
IV automation innovator continues to uncover ways to reduce its carbon footprint. ENGLEWOOD, Colo., April 22, 2011 /PRNewswire/ — In conjunction with Earth Day 2011, Baxa Corporation today announced its continued strides to reduce the environmental impact of business operations – from manufacturing efficiency to packaging design and office processes. Since 2008 the company’s recycling […]
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Pfizer makes China plans with Shanghai Pharma
Pfizer Inc., the world’s largest drugmaker, plans to pursue increased business in China with Shanghai Pharmaceutical Co. Ltd. The companies said in a statement that they signed a memorandum of understanding that includes selling and distributing “an innovative Pfizer product” in China. Pfizer would not say what the product is or offer other details. The […]
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Biogen, Genentech score FDA OK for autoimmune disease drug
A drug co-developed by Weston-based Biogen Idec Inc. and California-based Genentech has won approval by the U.S. Food and Drug Administration as part of a new treatment for Wegener’s Granulomatosis and Microscopic Polyangiitis, two rare and potentially fatal diseases. Rituxan – a drug already FDA-approved to treat rheumatoid arthritis, chronic lymphocytic leukemia and non-Hodgkin’s lymphoma […]
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FDA ‘Strategic Priorities 2011 – 2015’ Now Available
SILVER SPRING, Md., April 20, 2011 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today released the final version of a strategic priorities document outlining the goals that will guide the agency and its 12,000 employees through 2015. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) “It’s no secret that the FDA’s responsibilities have increased significantly over the past several years,” […]
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FDA ‘Strategic Priorities 2011-15’ Now Available
SILVER SPRING, Md., April 20, 2011 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today released the final version of a strategic priorities document outlining the goals that will guide the agency and its 12,000 employees through 2015. “It’s no secret that the FDA’s responsibilities have increased significantly over the past several years,” said FDA […]
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FDA warns companies to stop making MRSA claims for over-the-counter products
The U.S. Food and Drug Administration issued four warning letters to companies that manufacture and market over-the-counter (OTC) drug products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylococcus aureus bacteria (MRSA). Warning Letter #1 Warning Letter #2 Warning Letter #3 Warning Letter #4 May 19 – Webinar – Former FDA Chief Council […]
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