FDA says more action possible on J&J, Amgen drugs
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U.S. regulators said on Thursday they were reviewing two recent studies that provided more evidence of serious risks for some cancer patients treated with anemia drugs sold by Amgen Inc and Johnson & Johnson.
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Biotechnology giant Amgen is selling the Japanese rights to some drugs to Takeda Pharmaceutical of Japan in a deal that might bring Amgen more than $1 billion.
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The Food and Drug Administration told Merck &amp; Co. that the company needs to supply more data for its Arcoxia pain treatment to gain approval, the pharmaceutical company said Friday.
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New reports suggest another drug company moved too slowly to pull a dangerous medication from the market and question the Food and Drug Administration&#39;s ability to protect the public.
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The FDA decides to debate the company's lead drug.
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Merck &amp; Co., which withdrew the Vioxx painkiller last month because of a heart risk, said yesterday that US regulators have asked for more safety data before they will approve the medicine&#39;s successor, Arcoxia.
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The Food and Drug Administration told Merck &amp; Co. that it requires further safety and efficacy data before it will approve its successor drug to now defunct pain reliever Vioxx, the pharmaceutical maker announced Friday.
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U.S. regulators need more clinical trials before they can approve heart-scan contrast agent MS-325 from Germany's Schering and U.S. partner Epix Pharmaceuticals, the companies said on Friday.
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A senior Medicare official said the case for cutting the use of controversial anemia drugs sold by Amgen Inc and Johnson &amp; Johnson has become stronger since the agency decided last year to cut payments for their use in cancer patients.
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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.
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NEW YORK/WHITEHOUSE STATION, New Jersey  - Merck & Co.  expects to seek U.S. approval in 2007 for drugs to treat HIV, cholesterol and insomnia, and it aims to have another four products in late-stage trials by mid-year, the company said on Tuesday.
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The U.S. Food and Drug Administration on Friday asked an outside group to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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The Food and Drug Administration announcement comes as a response to criticism that the government has reacted too slowly to the dangers posed by popular supplements.
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Enbrel, the rheumatoid arthritis drug sold by Amgen Inc. and Wyeth, can stop joint damage when given to patients in combination with an older drug, researchers said on Monday.
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Biotech giant Inc. Amgen and the pharmaceuticals division of health-care products company Wyeth said Tuesday the Food and Drug Administration approved their arthritis treatment Enbrel to induce a major clinical
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Greater numbers of seriously ill patients could get experimental medicines under proposed federal guidelines released Monday that also would allow drug companies to charge for the medicines.
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Anemia drugs sold by Amgen Inc. and Johnson & Johnson will carry a new boxed warning advising doctors to choose the lowest dose needed to avoid blood transfusions, the U.S. Food and Drug Administration said on Friday.