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

European CHMP Opinions and MAA Updates

Executive Summary

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

You may also be interested in...



Bristol/Agios AML’s Idhifa Fails In Phase III, But Approval Seems Secure

Idhifa is already approved in the US for relapsed or refractory AML patients with IDH2 mutations based on Phase I/II complete responses, but did not meet the overall survival endpoint in the Phase III IDHENTIFY.

Bristol/Agios AML Drug Idhifa Fails In Phase III

Idhifa is approved in the US for relapsed or refractory AML patients with IDH2 mutations based on Phase I/II complete responses but did not meet the overall survival endpoint in the Phase III IDHENTIFY.

Sobi To Appeal Against EMA Rejection For Emapalumab

The company says its drug has demonstrated a positive benefit-risk profile in primary HLH in a post-approval real-life setting in the US since Food and Drug Administration approval in 2018.

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS142623

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