US scientist casts doubt on AstraZeneca&#39;s Crestor
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AstraZeneca was dealt a blow yesterday when an official from the US&#39;s drugs watchdog questioned whether one of its key products ought to be sold in the world&#39;s largest pharmaceuticals market.
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An FDA review of AstraZeneca Plc&#39;s (AZN.L: Quote, Profile, Research) (AZN.N: Quote, Profile, Research) Exanta questioned the experimental drug&#39;s
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FDA whistle-blower David Graham says Crestor is the only cholesterol-lowering medication, or statin, that causes acute kidney failure, and that it carries a higher risk of rhabdomyolysis, a potentially life-threatening muscle disorder, than other statins.
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Shares of AstraZeneca Plc and GlaxoSmithKline Plc, the UK&#39;s two biggest drugmakers, fell after a US health official said two of their best-selling treatments need closer safety reviews.
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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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Edwards Lifesciences Corp. (EW.N: Quote, Profile, Research) on Friday said it does not expect the US Food and Drug Administration to provide an answer on whether it can conduct a clinical
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DRUGS group AstraZeneca today suffered a massive setback after tests showed its blockbuster Iressa cancer treatment did not allow patients to live longer.
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The Food and Drug Administration has asked the maker of cholesterol-lowering medication Crestor to stop running an advertisement that makes &quot;false or misleading&quot; claims about the drug&#39;s safety.
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THE future of AstraZenecaâs blood-thinning medicine, Exanta, was thrown into fresh doubt last night after Franceâs leading drugs regulator confirmed that it was reviewing the medicineâs approval status.
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AstraZeneca Plc's cholesterol-lowering drug Crestor performed better than Pfizer Inc's Lipitor in an AstraZeneca-funded study of patients with metabolic syndrome, according to results released on Monday.
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Shares in AstraZeneca Plc fell as much as 10 percent on Friday after regulators in the United States and Europe raised safety concerns about the Anglo-Swedish drug maker&#39;s anti-cholesterol treatment Crestor.
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Twenty-nine patients who took AstraZeneca Plc's   anti-cholesterol drug Crestor have developed kidney damage, a U.S. consumer group said on Friday as it called again for a ban on the medicine.
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AstraZeneca&#39;s newest advertisements for its cholesterol-lowering drug Crestor are misleading and should be pulled from the market, consumer group Public Citizen says.
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NEW YORK - Today at the UBS Global Life Sciences Conference, AtheroGenics was met with pointed skepticism over trial results for its drug, AGI-1067.
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The FDA has asked makers of Crestor to stop publishing an ad aimed at patients. The FDA sent a letter to Astra Zeneca on 21st December saying it was concerned that the ad may play down the risks associated with Crestor.
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Chiron Corp, one of only two flu jab suppliers to the USA, says that next year&#39;s supply may be in doubt. Health experts and business analysts have been asking for some time that the US authorities add other suppliers to their approvals list.
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Shionogi Co. shares fell as much as 14.4 percent in Tokyo on concerns in the European Union and US about the safety of Crestor, a cholesterol-reducing drug developed by the Japanese company and sold by AstraZeneca Plc.