Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

First Amendment Challenge Mulled As Amarin Seeks To Unchain ANCHOR Results

Executive Summary

If Amarin can’t get its Vascepa expanded indication through FDA, it could try to get the courts to clarify the scope of free speech protections post-Caronia.

You may also be interested in...



Cholesterol Guidelines Look High And Low: Statin Market Extended At Both Ends

In shifting away from specific targets and non-statin add-on therapies, new ACC/AHA cholesterol guidelines support treatment of people at relatively low risk for events and more intensive therapy for those at higher risk.

FDA Makes It Formal, Rescinds SPA For Amarin’s ANCHOR Study

Agency makes clear that triglyceride levels are no longer an acceptable surrogate for reducing cardiovascular risk.

Cholesterol Drug Approvals May Hinge On Outcomes Studies; FDA Rejects Diabetes-style Tiered Trials

Decreasing cardiovascular events is the only endpoint that matters for cholesterol-lowering drugs, FDA official says at Amarin’s negative Vascepa panel, leaving little room for drug’s expanded approval based on a surrogate endpoint.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS055750

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel