BioCrist Jumps on FDA Ruling
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Shares in BioCrist (BCRX :Nasdaq - news - research) jumped in premarket trading Tuesday after regulators granted orphan status to the company&#39;s lead anti-cancer drug, forodesine hydrochloride, boosting the Alabama-based biotech&#39;s prospects.
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The recent decision by the Food and Drug Administration to strengthen warnings on labels for mifepristone, more widely know as RU-486, appears sound.
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Shares of Boston Scientific (BSX:NYSE - news - research) rose Monday following the announcement that the Food and Drug Administration had approved its product to reduce the risk of a heart attack following heart bypass surgery.
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Shares of Biocryst Pharmaceuticals Inc. (BCRX.O: Quote, Profile, Research) rose on Tuesday after the company received &quot;orphan drug&quot; status for an anti-cancer compound.
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The Food and Drug Administration strongly endorsed Biogen Idec Inc.&#39;s new multiple sclerosis treatment, putting the Cambridge firm in position to expand the market for MS drugs and win greater market share.
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The company is ready to handle competition from generics.
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The FDA will review its new cholesterol drug.
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Startling testimony by an FDA drug safety reviewer about five popular medications has the medical world buzzing about how tightly the agency should be regulating new medications.
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WASHINGTON -- Biotechnology lobbyists attempting to slow the development of cheap generic versions of the world's most expensive drugs have been emphasizing questions about their safety in an effort to win support among the new Democratic leaders of Congress.
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What do you call a biotech company that files a patent on the first artificial bacterium, potentially paving the way for a monopoly on synthetic life-forms? Microbesoft.
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SAN FRANCISCO -- Billionaire investor Carl C. Icahn was given clearance by US antitrust regulators to purchase shares in Biogen Idec Inc., the world's biggest maker of drugs for multiple sclerosis.
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Provenge supporters weigh in on an FDA decision.
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Novartis AG chief executive Daniel Vasella yesterday said that he ''wouldn't be surprised&quot; if US regulators ease rules limiting the importation of cheaper drugs from Canada, but cautioned that would damage the industry's financial footing and wouldn't help patients much.
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Encysive gets set for a showdown with the FDA.
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Hard-earned tips from a biotech investor.
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Mylan Pharmaceuticals vowed yesterday to refile what it says will be a stronger federal complaint against the Food and Drug Administration over a ruling that has forced the company to compete with so-called &quot;authorized generics.&quot;
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WASHINGTON -- Some influential members of Congress are renewing their pledge to help speed generic versions of the world's most expensive drugs to market.