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

Perseverance, Personnel Change Helped Epix Win Its Vasovist Appeal To FDA

Executive Summary

After a long battle appealing "approvable" letters, Epix now appears to have a clear path to approval for Vasovist (gadofosveset)

You may also be interested in...



NDA Appeals Successful 31% Of Time Under CDER’s Formal Dispute Resolution

Product sponsors are successful almost one third of the time when they enter into the formal dispute resolution process with CDER regarding their applications

Pharma's Reform Bounce: How Big a Bounce Will $80 Bil. Buy?

Drug manufacturers made a pledge to contribute $80 bil. in a mix of savings and revenue-raising initiatives to help fund health reform. In return, they could see a wide range of new business depending on how you look at the numbers.

King's CorVu Gets Reluctant "No" From Advisory Committee

Despite voting that King's CorVu is not equivalent to its study comparator, Cardio-Renal panel sees bright future for the stress agent.

Latest Headlines
See All
UsernamePublicRestriction

Register

PS049592

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