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

Orphan Drugs Nefecon, Maribavir & Copanlisib Among New EU Filings

US Filings For The Orphan Drugs Are Under Review

Executive Summary

Marketing applications for two generic versions of the multiple sclerosis blockbuster, Tecfidera, are also under review by the European Medicines Agency.

You may also be interested in...



EU Accelerated Assessment Tracker

In the first half of 2021, just six requests from companies seeking accelerated assessment of their planned EU marketing authorization applications were granted; 11 were rejected. The outcomes of five decided on in July and August are still unknown.

Mobocertinib, Asciminib & Surufatinib Among Latest New Filings In EU

The European Medicines Agency has added nine new products to its latest list of medicines that are under review for potential EU marketing authorization.

Tough Times In Europe For Gene Therapy Companies

bluebird bio's decision to wind down commercial initiatives for its gene therapy business in Europe is a blow for the sector in the region as a whole. 

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS144660

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