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

Janssen’s Spravato Clears Hurdles To Secure EU Approval

Written Interventions By Third Parties Had Earlier Raised Uncertainty

Executive Summary

Spravato has been approved for treatment-resistant depression in the EU notwithstanding last-minute objections by third parties.

You may also be interested in...



Blow For Janssen As England's NICE Rejects Depression Spray Spravato

Uncertainties over clinical and cost effectiveness are behind the health technology assessment body’s recommendation against Spravato's use on the National Health Service.

Last-Minute Pushback On Janssen’s EU Spravato Approval

What is in store for esketamine after third parties submit written interventions to the European Medicines Agency?

EU Regulators Explain How To Ensure Transitioned Trials Align With CTR

Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS141417

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