Vascepa

23 results

John Thero: “We’re taking the approach of make it [Vascepa] affordable, and hopefully we can help millions of patients and make some money along the way”

Stunning they called it. And it was, as Irish-American pharma group Amarin announced the results of a key clinical trial for its cholesterol drug last(...)

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

Amarin, the Irish biotech that has developed a drug to help reduce very high blood fat levels, saw sales jump 59 per cent last year. However, the com(...)

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(...)

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(...)

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 (...)

Advisers to the Food and Drug Administration had in October recommended that the agency not approve Vascepa for the new use until the larger 8,000-patient trial shows that lowering blood fats leads to reduced cardiovascular risk. The Irish drugmaker said it planned to appeal the decision.

Shares in Irish drugmaker Amarin haver fallen almost 30 per cent in two days after US health regulators rejected a preset testing process that was cri(...)

Amarin chief executive Joseph Zakrzewski said the company had reduced staff levels by half as announced in the aftermath of its failure to secure support from a Food and Drug Administration (FDA) advisory panel for its proposal to expand its target market. Photograph: Cyril Byrne /The Irish Times

Future prospects for Irish biopharma group Amarin are uncertain after it raised doubts last night about its ability to fund a key trial to extend the (...)

It may not quite be throwing in the towel, but Irish biopharma Amarin is definitely taking a step back after its calamitous loss before an FDA advisory panel.

It may not quite be throwing in the towel, but Irish biopharma Amarin is definitely taking a step back after its calamitous loss before an FDA advisor(...)

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