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Federal Register: Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket

Published in September 11th, 2008
Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health
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The FDA is announcing the opening of a public docket to receive information and comments on laser-assisted in situ keratomileusis (LASIK).

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Rituxan Linked to Fatal PML Case

Published in September 11th, 2008
Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News
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Clinicians advised to consider PML in rituximab-treated patients presenting with new-onset neurologic manifestations.
Medscape Medical News

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Methadone Dosages Correlate Poorly with Serum Levels

Published in September 11th, 2008
Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News
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A new study shows a poor correlation between dosages of methadone given to chronic pain patients and resulting serum levels. The findings, researchers say, complicate any cause-and-effect conclusions in the rising number of deaths associated with methadone use.
Medscape Medical News

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FDA Safety Changes: Viramune, Agrylin, Keflex, Furadantin, Mycobutin

Published in September 11th, 2008
Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News
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The FDA has approved revisions to the safety labeling for nevirapine tablets and oral solution, anagrelide HCl capsules, cephalexin capsules, nitrofurantoin oral suspension, and rifabutin capsules.
Medscape Medical News

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Ten Years Later, UKPDS Shows Intensive Glucose Lowering, but Not Tight BP Control, Reduces MI, All-Cause Mortality

Published in September 11th, 2008
Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News
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Monitoring from a landmark study indicates that intensive glucose lowering has significant effects on major diabetes endpoints and on the risks for myocardial infarction and all-cause mortality.
Medscape Medical News

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Pain May Be a Nonmotor Feature of Parkinson’s Disease

Published in September 11th, 2008
Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News
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Results of case-control study suggest that pain begins at the clinical onset of Parkinson’s disease and support the hypothesis that pain should be considered a nonmotor feature of the disease.
Medscape Medical News

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Alpharma Urges Shareholders to Take No Action with Respect to King Pharmaceuticals’ Announced Intent to Commence a Tender Offer

Published in September 11th, 2008
Posted by Drugs.com - Pharma News in Drugs and Food Information, Pharmaceutical Industry News
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BRIDGEWATER, N.J.–(BUSINESS WIRE)–Sep 11, 2008 - The Board of Directors of Alpharma Inc. (NYSE: ALO), a global specialty pharmaceutical company, today urged shareholders to take no action with respect to the announcement by King Pharmaceuticals,…

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FDA MedWatch- Rituxan (rituximab)- Important New Safety Information Regarding Progressive Multifocal Leukoencephalopathy With The Use Of Rituxan

Published in September 11th, 2008
Posted by Drugs.com - Pharma News in Drugs and Food Information, Pharmaceutical Industry News
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ROCKVILLE, Md., Sept. 11, 2008–Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid…

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Trubion Pharmaceuticals Wins Patent Opposition - Genentech / Biogen Idec European Patent Revoked

Published in September 11th, 2008
Posted by Drugs.com - Pharma News in Drugs and Food Information, Pharmaceutical Industry News
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SEATTLE, September 11, 2008 /PRNewswire-FirstCall/ — Trubion Pharmaceuticals, Inc. , today announced that the Opposition Division (OD) of the European Patent Office (EPO) has revoked Genentech and Biogen Idec’s European Patent 1176981, in its…

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FDA: West Virginia Livestock Owner Sentenced in Criminal and Civil Contempt Case

Published in September 11th, 2008
Posted by Food and Drug Administration Press Releases in Drugs and Food Information
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The U.S. Food and Drug Administration announced today that a West Virginia cattle dealer has been sentenced to six months probation for refusing to obey court orders in 2006 and 2008 that prohibited her from introducing animals into the food supply until the FDA had approved her record-keeping system. The FDA initiated the case after illegal levels of drug residue were found repeatedly in calves that Shirley A. Rhodes of Sandyville sold for use as human food.

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