Abbott seeks drug-eluting stent approval from FDA
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Abbott Laboratories Inc. on Friday said it submitted its application to the U.S. Food and Drug Administration for its drug-coated stent called Xience and expects to start selling the heart device in the first half of 2008.
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FRANKFURT/CHICAGO  - U.S. regulators have demanded  more clinical studies of a new substance designed to produce  clearer MRI pictures of clogged arteries, Germany's Schering AG  and U.S. partner Epix Pharmaceuticals Inc. said on Friday.
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Most patients with drug-coated stents face an increased risk of heart attacks and death, but it's unclear whether their already poor health or the devices are to blame, federal health advisers said Friday.
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Medical-device maker Boston Scientific Corp. said Thursday that the Food and Drug Administration approved an extended shelf life of nine months for its Taxus Express2 drug-eluting coronary stent system in the United States, up from six months.
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The U.S. Food and Drug Administration is planning to release new testing requirements for drug-coated heart stents in the next few weeks, the regulatory agency's device chief, Daniel Schultz, told the Wall Street Journal.
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Conor MedSystems Inc., a maker of drug-coated coronary stents, on Wednesday filed to sell $70 million worth of common shares in its initial public offering, according to a Securities and Exchange Commission statement.
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The approval of a new drug is a long-term opportunity.
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The Food and Drug Administration said last night it would convene a public panel to examine the risk of blood clots in patients with drug-coated stents, among the world's most frequently implanted medical devices.
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SILVER SPRING, Maryland  - Merck & Co's experimental AIDS drug Isentress merits approval, a panel of expert advisers to the U.S. Food and Drug Administration said on Wednesday.
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GAITHERSBURG, Maryland  - A U.S. advisory panel heard evidence on Thursday about risks of drug-coated stents, the tiny mesh tubes used to prop open arteries in millions of heart patients.
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Vioxx . Ritalin. Drug-eluting stents . Those popular drugs and medical devices are on a growing list of therapies used by millions of people that have shown up on the radar of Dr. Steven E. Nissen , a prominent heart specialist.
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GAITHERSBURG, Maryland  - A U.S. advisory panel began hearing evidence on Thursday about potential risks of drug-coated stents, the tiny tubes used to prop open arteries in millions of heart patients.
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U.S. regulators said on Friday they  would review whether to take action over Merck & Co Inc's   and Schering-Plough Corp's  popular cholesterol  medicine Vytorin after a study showed it was no better than a  generic drug in preventing the build-up of fatty plaque.
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WASHINGTON -- Federal health officials asked experts Thursday whether the drug-coated stents used to prop open the arteries of about 3 million people in the U.S. pose a heightened risk of death or raise other safety concerns that require action.
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GAITHERSBURG, Md. -- Drug-coated stents increase the risk of potentially fatal blood clots and heart attacks in some patients, but not enough to warrant limiting use of the devices, federal advisers said yesterday .
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An experimental HIV drug from Merck &amp; Co. Inc. should be quickly approved for use by patients running out of treatment options, federal advisers recommended Wednesday.
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U.S. health officials said on Friday they would review whether to take regulatory action over Merck & Co Inc and Schering-Plough's cholesterol medicine Vytorin following the drug's failure to work better than a generic drug in a study of plaque build-up in neck arteries.