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Irish biopharma group Amarin has reported 85 per cent growth in net revenue from its heart drug Vascepa. The company reported sales of $32.8 million(...)

Irish pharma company Amarin has reported a 62 per cent rise in fourth quarter sales of its sole drug, Vascepa.

Irish pharma company Amarin has reported a 62 per cent rise in fourth quarter sales of its sole drug, Vascepa. The refined omega-3 fish oil drug red(...)

Without FDA approval, no drug or medical device can access what is by some distance the world’s largest market for pharma and medtech. Photograph: Roel Smart/Getty Images/iStockphoto

In what was truly a case of David vs Goliath, Irish pharma minnow Amarin comprehensively saw off the might of the US drug regulator, the Food and Drug(...)

Amarin chief executive and president  John Thero. Photograph: Cyril Byrne / THE IRISH TIMES

A small one-product Irish pharmaceutical company has secured a landmark victory over the US drugs regulator in a New York court. US district ju(...)

Janet Woodcock, FDA director of the agency’s Center for Drug Evaluation and Research: Amarin has taken a pre-emptive First Amendment case, accusing the FDA of restricting its right to free speech

The US Food and Drug Administration seems mildly discomfited. It’s not a state that one usually associates with the most powerful regulator of the pha(...)

Amarin chief executive John Thero: Irish pharma group is suing US regulator FDA over first amendment rights. Photograph: Cyril Byrne / THE IRISH TIMES

Drugmakers have long argued they should have the right to talk to doctors about unapproved uses for their products, as long as they are being truthful(...)

Irish pharmaceuticals group Amarin has secured $52.8 million in new capital through the placement of shares with new and existing investors.The compan(...)

Out Wednesday: Abercrombie & Fitch results
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TODAY Results: FBD; Sotheby’s; Thorntons. Indicators: Euro zone CPI (Feb) and unemployment rate (Jan); US ISM manufacturing PMI (Feb), ISM prices paid(...)

Amarin told the market the US Food and Drug Administration’s office of new drugs had denied its appeal of the decision to withdraw approval of its Anchor clinical trial, designed to expand its market for Vascepa by including patients with lower but still elevated levels of blood fats.

Shares in Irish pharmaceuticals group Amarin slumped more than 20 per cent yesterday as the US regulator shut the door on the company’s plans to exten(...)

John Thero, Amarin chief executive. Photograph: Cyril Byrne / The Irish Times

Amarin has today asked a federal court to order the US Food and Drug Administration to give the company’s Vascepa fish oil pill five years of (...)

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