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Biotech / Medical : biotech firesales

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From: nigel bates	10/17/2013 11:01:13 AM
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AMRN 60%, as fish oil whiffs with the FDA. BEDMINSTER, N.J. and DUBLIN, Ireland, Oct. 16, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc ( AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee has voted 9 to 2 against approval of Vascepa(R) (icosapent ethyl) capsules for use as an adjunct to diet and exercise and in combination with a statin in the treatment of adult patients with high triglycerides (TG 200-499 mg/dL) with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent (the ANCHOR indication) based on the information presented at the committee meeting today. The FDA is scheduled to make its decision on whether to approve the ANCHOR Supplemental New Drug Application (sNDA) on the December 20, 2013 Prescription Drug User Fee Act (PDUFA) goal date for the application. Vascepa is currently approved by the FDA for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe ( >= 500 mg/dL) hypertriglyceridemia...

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