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

UCB’s Cimzia Could Be Delayed Until 2008 Or Later For Crohn’s

This article was originally published in The Pink Sheet Daily

Executive Summary

A key regulatory concern for the biologic is a lack of induction evaluation criteria in one of two pivotal Crohn’s trials, the firm tells “The Pink Sheet” DAILY.

You may also be interested in...



Centocor President Neal Fowler: An Interview With “The Pink Sheet” DAILY (Part 1 of 2)

Exec discusses the anti-TNF market and the entry of Abbott’s Humira – the first competitor for Remicade – in Crohn’s disease.

Humira Clears FDA As First Self-Administered Biologic For Crohn’s Disease

Abbott’s adalimumab will compete with Johnson & Johnson’s Remicade in the Crohn’s market following approval of an sBLA for the indication.

UCB Receives “Complete Response” Letter For Cimzia

Firm says FDA seeks new information and clarification regarding the BLA.

Related Content

Topics

UsernamePublicRestriction

Register

PS065805

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