Biotechs nod as senators urge caution on generics
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WASHINGTON -- Local biotech powerhouses were comforted by yesterday's congressional testimony that urged federal regulators to take a cautious approach to approving generic versions of biologics, including mandatory human clinical trials.
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Democrats Hillary Rodham Clinton of  New York and Henry Waxman of California will introduce  legislation on Wednesday that would give the Food and Drug  Administration the legal authority to approve cheaper, generic  versions of biotech drugs known as biologics, the lawmakers  said.
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Cheaper versions of biologic drugs can be made safely, a U.S. Senate panel heard on Thursday, but brand-name makers of the pricey therapies for cancer and other diseases warned substitutes could be risky.
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The Food and Drug Administration would have a legal path to approve cheaper, generic copies of biotech medicines under legislation in Congress.
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Mylan Laboratories Inc., the largest US maker of generic drugs, cautioned investors Friday that Thursday&#39;s jump in share price was likely driven by investor Carl Icahn&#39;s clearance to buy a large amount of company stock and fails to reflect &quot;negative ...
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The company is ready to handle competition from generics.
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Doctors have been taking calls from anxious patients ever since a Senate hearing on Vioxx last week at which an FDA scientist expressed concerns about the safety of five other drugs on the market.
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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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Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite
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U.S. regulators said on Friday they would review a study showing a Merck and Schering-Plough cholesterol drug worked no better than a generic in preventing the build-up of arterial plaque.
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Concerns over the approval of drugs that turned out to be dangerous have led Republicans and Democrats in the House and the Senate to call for investigations.
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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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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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Despite calls from medical experts and a prominent Republican senator for an independent office to monitor drug safety, the idea, prompted by the Food and Drug
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U.S. lawmakers criticized the Food  and Drug Administration's monitoring of the risks of the  antibiotic Ketek (Sanofi-Aventis) and some other prescription  drugs on Tuesday.
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Senators trying to promote human  stem cell research rebuked a team of corporate scientists on  Wednesday, saying their claims to have produced human embryonic  stem cells without harming the embryo had misrepresented their  work and hurt the cause.
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U.S. regulators said on Friday they  would review a study showing a Merck and Schering-Plough  cholesterol drug worked no better than a generic in preventing  the build-up of arterial plaque.