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

Myeloma BCMA Therapy In Spotlight: EMA Considers Fast Tracking GSK Filing

EU Filing Understood To Be Expected in H1 2020

Executive Summary

The European Medicines Agency is this week deciding whether GlaxoSmithKline’s planned EU marketing application for its BCMA-targeting therapy merits an accelerated assessment.

You may also be interested in...



Celgene Gets Another Myeloma CAR-T Accepted Onto EMA’s PRIME

Bristol-Myers Squibb’s newly acquired company Celgene is one of two drug sponsors that this month made it onto the European Medicines Agency’s priority medicines scheme. The other is Achillion Pharmaceuticals, which is developing a treatment for paroxysmal nocturnal hemoglobinuria.

EU Accelerated Assessment Tracker

Janssen’s two investigational Ebola vaccines are among four new products recently granted fast-track review by the European Medicines Agency. GlaxoSmithKline and Viiv Healthcare are not disclosing the outcomes of accelerated assessment requests they have made.

ViiV Seeks Speedy EMA Review For Last-Resort HIV Drug

ViiV Healthcare has asked the European Medicines Agency to accelerate its review of fostemsavir when the company files for pan-EU market approval of the product.

Topics

Related Companies

UsernamePublicRestriction

Register

PS141181

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