Data still conflicts on Glaxo diabetes drug: FDA
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All studies so far provide inconsistent results about the potential heart risks of GlaxoSmithKline Plc's diabetes drug Avandia, the head of the U.S. Food and Drug Administration told lawmakers on Wednesday.
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GlaxoSmithKline PLC, the world's second-largest drug maker, began a campaign to challenge a report that linked its diabetes drug Avandia to heart risks and caused its stock to decline 11 percent in the eight days through Tuesday. The shares rose yesterday.
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Controversy over popular diabetes pill Avandia took center stage on Monday at a meeting of the world's experts on the disease, where researchers debated findings that the drug could boost heart-attack risk.
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Patients should not haphazardly stop taking the controversial diabetes drug Avandia, even though it has been linked to heart risks, an early critic of the drug said on Sunday.
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GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) has agreed to disclose information on all clinical studies of its drugs to settle a lawsuit that accused it of withholding negative information about the antidepressant Paxil, the
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WASHINGTON - About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency&#39;s monitoring of the safety of prescription drugs now being sold, according to an FDA internal survey.
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GlaxoSmithKline Plc (GSK.L) has agreed to release all clinical studies of its drugs to settle a lawsuit that accused it of withholding negative information about the antidepressant Paxil, the New York Attorney General's office said on Thursday.
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Drug maker GlaxoSmithKline's medical director said the company's study of the heart risk associated with its Avandia diabetes treatment may be in jeopardy because patients have dropped out following reports of the drug's risks, The New York Times reported on Saturday.
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The panel is examining claims that GlaxoSmithKline tried to suppress a doctorâs criticism of its drug Avandia.
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A top Food and Drug Administration official said on Thursday she disagrees with an agency scientist&#39;s warning that five drugs on the market have significant safety risks.
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Drugmaker GlaxoSmithKline agreed Thursday to settle charges that it hid and misrepresented unfavorable data about the effectiveness and safety of its top-selling anti
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WASHINGTON - GlaxoSmithKline PLC's Avandia, the world's best-selling diabetes drug last year, will carry US regulators' strongest warning on the risk of heart attacks.
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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. regulators have asked for more data  on Novartis AG's  diabetes drug Galvus, possibly  delaying approval of the potential blockbuster by a year, which  dented its shares while boosting its main rival's.
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The acting Food and Drug Administration (FDA) commissioner on Monday disputed a published report that said agency officials knew before Oct. 5 that British health authorities might suspend
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New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the federal Food and Drug Administration to protect the public from such risks.
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The maker of the controversial diabetes pill Avandia pointed to early results of its own study Tuesday, saying they offered reassuring evidence the drug doesn't raise heart risks. However, outside experts called the results inconclusive at best and a sign of greater risk at worst.