Amgen, Inc. (NASDAQ:AMGN)
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A biotechnology company which discovers, develops, manufactures and markets human therapeutics based on advances in cellular and molecular biology.
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A biotechnology company which discovers, develops, manufactures and markets human therapeutics based on advances in cellular and molecular biology.
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After watching the FDA advisory meeting for denosumab, I believe Amgen will be lucky to get an osteoporosis indication as a second line treatment for women with a high risk of fractures (the PDUFA date is October 19). Amgen was literally pounded by the panel on safety. Lilly's Forteo (even though a once a day injection) is a better drug).
Yesterday's Wall Street Journal had an article expecting the review period to be extended by three months due to additional time required to perform safety review for denosumab. I am beginning to believe this drug will not approval for any indication.
http://online.wsj.com/article/BT-CO-20091014-711848.html