Search Results for: amarin

Amarin Begins Legal Off-Label Promotion Of Vascepa

Barely a month after a big victory in a federal court over the FDA, Amarin Pharma has started off-label promotion of Vascepa, its much-disputed prescription fish-oil product, Medical Marketing & Media reports. Vascepa was first approved by the FDA in 2012 as as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG > 500mg/dL),…

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The Amarin Decision: Free Speech Or Truthiness?

Amarin, which makes the prescription fish oil product Vascepa, won a big victory last Friday in its ongoing battle against the FDA. The bottom line: a federal judge ruled that the FDA can’t restrict Amarin’s first amendment right to disseminate off-label information about Vascepa providing it is neither false nor misleading. (You can read a detailed description…

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Secret Letter To Doctors Shows That The Amarin Lawsuit Is About Marketing, Not Free Speech

A confidential letter sent by top Amarin executives to doctors clearly demonstrates that the primary motive for the lawsuit the company filed yesterday against the FDA has far more to do with marketing than free speech. Amarin said it is suing the FDA to gain the right to disseminate information about Vascepa that would support use…

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Amarin Says It Will Complete Cardiovascular Outcomes Trial For Its Fish Oil Pill

After nearly a year of uncertainty, Amarin  announced  its commitment to complete REDUCE-IT  (Reduction of Cardiovascular Events with EPA – Intervention Trial). The trial is designed to test the effects on cardiovascular outcomes of Vascepa, the company’s high EPA omega-3 prescription fish oil product, in people with moderately elevated triglyceride levels between 200-499 mg/dL. Last year the company…

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FDA Throws More Cold Water On Amarin’s Hopes For Vascepa

Any remaining hopes for an expanded indication for Amarin’s Vascepa were largely dashed today by the FDA. Although it hasn’t yet rejected the proposed indication, the FDA today essentially overturned the foundation of the application, leaving little doubt as to the ultimate fate of the proposed new indication. As veteran biotechnology reporter Adam Feuerstein tweeted: “The…

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Why The FDA Probably Won’t Approve An Expanded Indication For Amarin’s Vascepa

On Wednesday an FDA advisory  panel will consider an expanded indication for Amarin Pharmaceuticals’ Vascepa, an EPA fish oil product currently indicated only for people with severe hypertriglyceridemia (>500 mg/dl). The new indication would greatly expand the patient population eligible to receive Vascepa, from the relatively few people with severe hypertriglyceridemia to the many millions…

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FDA Approves Vascepa, A New Fish Oil Pill From Amarin

The FDA has approved a new prescription formulation of fish oils for the treatment of very high levels of triglycerides. The news was  first reported by The Street reporter Adam Feuerstein. The drug will be sold under the brand name Vascepa. According to the company, it will be indicated as an adjunct to diet to reduce triglyceride…

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Controversial Pharma CEO To Chair AHA Charity Ball

–The Wizard of Oz-themed ball seeks to raise $2 million on the yellow brick road. The American Heart Association’s annual Heart & Stroke Ball will be chaired by John Thero, the CEO of Amarin Corporation, the controversial pharmaceutical company. Amarin manufactures the prescription fish oil product Vascepa for which it is aggressively seeking an expanded indication…

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Dollars For Heart Docs: 2015 Edition

–Cardiologists received more than $200 million from industry in 2015. In 2015 cardiologists and other cardiovascular specialists received more than $200 million dollars from industry, according to new data released by Medicare. More than 30,000 physicians in cardiovascular medicine received industry payments in 2015, though many of these payments were relatively small amounts. But more…

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The Door Opens Wider For Drug Companies To Make Off-Label Claims

The FDA has finally reached a settlement in its long dispute with Amarin Corporation, manufacturer of the prescription fish oil product Vascepa. Last year a US judge ruled against the FDA.  The settlement brings an end to the litigation and will permit Amarin to promote off-label usage of Vascepa as long as its statements are…

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2015: The Year We Finally Cured Heart Disease!

Editor’s note: Larry was too depressed to write the 2015 yearly review. Veteran healthcare journalist and eternal optimist Candide Corn volunteered to take over the task this year. Candide’s motto is “all is for the best in the best of all possible worlds.” What a great year for cardiology! The year brought us an unending…

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Why Rob Califf Running The FDA May Be Like Nixon In China

(Updated)– There’s a widespread belief that only a conservative like Nixon could have opened up US relations with China. Any attempt by a Democrat to do the same would have been political suicide, but for Nixon it was politically feasible, and today it is recognized as one of his very few untarnished genuine achievements. I want to suggest that…

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FDA Advisory Panel: No Expanded Indication For Vascepa Without Outcomes Trial

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%…

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MARINE: New Fish Oil Pill Slashes High Triglycerides

A new prescription-grade formulation of ethyl-EPA, an omega-3 fatty acid, significantly lowers triglycerides but doesn’t increase LDL. These were the top line results of the MARINE trial released on Monday by Amarin Corporation, which is developing the drug, now known as AMR101. MARINE randomized 229 patients with triglyceride levels of 500 mg/dl or greater to…

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