November 6th, 2013
Why Amarin Has To Finish Its Big Fish Oil Study
CardioExchange Editors, Staff
The following post is by Matt Herper, who covers science and medicine for Forbes magazine. When a panel of experts appointed by the Food and Drug Administration said the agency should deny Amarin Pharmaceuticals a broader marketing approval for its fish oil pill Vascepa, the company’s shares tanked 60%, making it the worst-performing biotechnology stock on […]
October 16th, 2013
FDA Advisory Panel: No Expanded Indication for Vascepa Without Outcomes Trial
Larry Husten, PHD
An FDA advisory panel today failed to recommend an expanded indication for Vascepa, the purified EPA fish-oil product from Amarin. Vascepa is currently indicated only for the relatively small number of people with severe hypertriglyceridemia (>500 mg/dL). The proposed new indication would have greatly expanded the patient population eligible to receive Vascepa to the 20% of […]
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