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

Incyte/MorphoSys Await EU Verdict On Tafasitamab For DLBCL

Updated Results From Monoclonal Antibody’s Phase II Trial Released In June

Executive Summary

Is the benefit-risk profile of tafasitamab good enough for it to be recommended for EU-wide marketing approval? Codevelopers Incyte and MorphoSys may find out this week.

You may also be interested in...



First Lucentis Biosimilar Among Drugs Awaiting Verdict On EU Approval Filings

Sponsors of several new medicines, including the first ever CAR-T for multiple myeloma, will find out this week if their products are on track to get EU marketing authorizations. Also, three sponsors might be asked to address outstanding issues about their products in the final stages of review.

BMS/bluebird’s Ide-Cel: EU Decision Time On First CAR-T For Multiple Myeloma

The European Medicines Agency will decide this week whether BMS and bluebird bio’s cell-based gene therapy for multiple myeloma should be approved for use in the EU. 

EU Review Time Lengthens for BMS’s CAR-T Therapy Liso-Cel

Bristol Myers Squibb's marketing application for liso-cel is in the final stages of the review process at the European Medicines Agency. The agency’s drug evaluation committee, the CHMP, adopted in mid-April the list of concerns it has with the application.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS144527

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