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

Roche Files BLA For Rheumatoid Arthritis Therapy Actemra

This article was originally published in The Pink Sheet Daily

Executive Summary

The novel interleukin-6 receptor-inhibiting mAb has a projected September 2008 action date.

You may also be interested in...



U.S. FDA Approves Roche/Chugai's Actemra For Second-line RA

Roche Japanese subsidiary Chugai's novel interleukin-6 inhibitor Actemra gained U.S. FDA approval Jan. 8 for treating patients with moderately to severely active rheumatoid arthritis for whom TNF blockers aren't working - a good beginning but still a ways from the first-line indication the pharma sought and still hopes to gain using data from its risk management programs and other sources

Roche Will Use REMS Program Data To Show Actemra Is Safe For First-Line RA

Swiss pharma's Genentech unit announced tocilizumab approval for failed TNF patients Jan. 8, saying it is committed to seek earlier uses with post-marketing data, including data from pharmacovigilance and risk plans as well as clinical studies.

Roche Will Use REMS Program Data To Show Actemra Is Safe For First-Line RA

Swiss pharma's Genentech unit announced tocilizumab approval for failed TNF patients Jan. 8, saying it is committed to seek earlier uses with post-marketing data, including data from pharmacovigilance and risk plans as well as clinical studies.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS065403

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