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


Erbitux sBLA For Head And Neck Cancer Delayed By "Independent Review" Process

This article was originally published in The Pink Sheet Daily

Executive Summary

ImClone and Bristol-Myers Squibb originally intended to submit supplemental BLA by second-quarter 2005. ImClone now anticipates filing in the fourth quarter following an additional review of the Phase III study's primary endpoint. Delay means ImClone will miss milestone payment.

You may also be interested in...

Erbitux Head And Neck Cancer Application Slated For Third Quarter Filing

Firms originally planned a second quarter submission, but delayed to allow for an independent review of the Phase III trial. The review confirms the study met its primary efficacy endpoint of locoregional control.

India Highlights "Public Interest" To Reign In Prices For Non-Scheduled Drugs

Dr. Reddy's, GSK, Ranbaxy and UCB among manufacturers that could see prices reduced under government order that reflects issues raised in Gleevec patent dispute.





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