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

BMS Files Ipilimumab With FDA And EMA, Positioning It For Launch Next Year

This article was originally published in The Pink Sheet Daily

Executive Summary

If approved, the CTLA-4 inhibitor would be the first new drug for the treatment of metastatic melanoma in over a decade.

You may also be interested in...



Bristol Melanoma Drug's Advisory Panel Delayed Following Review Date Delay

Additional Phase III data for ipilimumab might be available by next year, and an early March advisory committee date now looks likely, given the rescheduled PDUFA date of March 26, 2011.

Bristol Melanoma Drug's Advisory Panel Delayed Following Review Date Delay

Additional Phase III data for ipilimumab might be available by next year, and an early March advisory committee date now looks likely, given the rescheduled PDUFA date of March 26, 2011.

Advisory Committee Review Will Test Whether One Trial Will Do The Trick For Bristol's Ipilimumab

Panelists may want to wait for results from a second Phase III trial and, given severe side effects, are likely to want a robust risk management plan.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS070942

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