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

Jumping Before They Were Pushed – Kiadis And Aradigm Withdraw EU Filings

A Third Company, Actelion, Has Pulled An Indication Extension Request

Executive Summary

Notice of the withdrawal of pan-EU marketing authorizations applications by Kiadis Pharma and Aradigm are noted in the agenda of the latest meeting of the European Medicines Agency's key scientific committee, the CHMP. 

You may also be interested in...



Roche’s Polivy Among Seven New Drugs On Track For EU-Wide Approval

Seven drugs, including two orphans and two generics, are on track to receive pan-EU approval.

Third Time Lucky for Roche’s Polivy in Europe?

It’s decision time again at the European Medicines Agency and Roche’s Polivy is one of the new drug applications that is up for a potential marketing recommendation.

Kiadis Crushed By EMA Rejection Of T-Cell Therapy

The Dutch company's dataset on its stem cell transplant adjunct ATIR101 is not enough to satisfy European regulators as the standard of care in post-transplant patients has changed since the original filing.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141175

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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