Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Amarin Adrift: Vascepa Label Expansion Doubtful After FDA Drops ANCHOR

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s decision not to reinstate a Special Protocol Assessment for the ANCHOR trial suggests a “complete response” letter on the related sNDA is not far behind.

You may also be interested in...



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.

CDER Medical Policy Council Balances “Breakthrough” Requests With Broader Issues

FDA is seeking public input on cross-cutting policy issues to bring before the senior-level group, which is also facing the challenge of reviewing dozens of “breakthrough therapy” designation requests relevant to CDER-regulated products.

ODAC Report Card: Six Takeaways From Accelerated Approval Reviews Of Checkpoint Inhibitors

US FDA’s expedited pathway remains alive and well in oncology, but ‘dangling’ indications may be subject to more regular public scrutiny going forward; negative votes for two of six indications reflected the influence of Oncology Center of Excellence director Richard Pazdur.

Topics

Related Companies

UsernamePublicRestriction

Register

PS077651

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