U.S. lawmakers to grill Glaxo, FDA on diabetes drug
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U.S. health officials and drugmaker GlaxoSmithKline Plc are likely to face tough questioning from lawmakers on Wednesday over their handling of data suggesting a heart risk with the widely used diabetes pill Avandia.
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A member of the Senate said that a diabetes expert tipped GlaxoSmithKline to the publication of safety questions about Avandia.
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Democratic lawmakers in Congress introduced legislation yesterday that would require makers of drugs and medical devices to register clinical trials of their products in a public database when they start and report the test results on it.
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GlaxoSmithKline Plc will pay a net $3.1   billion to settle an ongoing tax dispute with the U.S.   government, which was to go to trial next year, Europe's   biggest drugmaker said on Monday.
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Drug safety measures pending in the House of Representatives may burden regulators without protecting patients from dangerous medicines, a senior Food and Drug Administration official told lawmakers on Tuesday.
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People with diabetes may soon be able to take a pill to control their condition instead of repeated injections.
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The U.S. Food and Drug Administration is facing new questions about its ability to police the safety of medicines after they reach the market following concerns about a widely used diabetes drug.
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WASHINGTON -- The Internal Revenue Service announced Monday that it had settled a dispute with the pharmaceutical giant GlaxoSmithKline Holdings (Americas) under which Glaxo will pay $3.4 billion in the largest tax dispute in IRS history.
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A top Republican lawmaker raised concerns about the US Food and Drug Administration&#39;s ability to monitor drug safety following Merck &amp; Co.
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GlaxoSmithKline PLC is in talks with the Food and Drug Administration about selling its Fluarix influenza vaccine in the United States this season because of the expected flu vaccine shortage this year.
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The FDA decides to debate the company's lead drug.
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PHILADELPHIA -- GlaxoSmithKline is in talks with the Food and Drug Administration about selling its Fluarix influenza vaccine in the United States this season because of the expected flu vaccine shortage this year.
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The president of U.S. pharmaceuticals at GlaxoSmithKline Plc , Chris Viehbacher, said on Wednesday it was too early to write off the diabetes drug Avandia, which he said could once again return to annual sales of more than $3 billion.
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The government's own preliminary evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week and suggests that as many as 60,000 to 100,000 heart attacks might be linked to its use since it came on the market eight years ago, a leading member of Congress...
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GlaxoSmithKline said on Monday that U.S.  regulators were seeking further information prior to the  possible approval of cervical cancer vaccine Cervarix.
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U.S. lawmakers criticized the Food  and Drug Administration's monitoring of the risks of a  Sanofi-Aventis antibiotic and some other prescription drugs on  Tuesday.
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A U.S. Food and Drug Administration preliminary analysis found a level of heart-attack risk with GlaxoSmithKline Plc'sdiabetes drug Avandia similar to what was reported in a study earlier this week, the agency confirmed on Friday.