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


Roche's Actemra Approved For RA After Year's Delay - To Craft A REMS?

Executive Summary

Roche's novel interleukin-6 inhibitor Actemra won FDA approval Jan. 8 for second-line use in rheumatoid arthritis - after an FDA "complete response" letter set the product's regulatory process back more than a year

You may also be interested in...

Drug Approval Briefs: Cubist, Iroko, Merck Serono, UCB, Genentech, Allergan, GE Healthcare, Zogenix

UCB’s Cimzia wins ankylosing spondylitis claim, but axial spondyloarthritis is not looking good; GE’s Vizamyl joins Amyvid on list of underemployed amyloid imagers; Cubist stretches Entereg label a bit; Iroko builds a safer NSAID; and more.

Oral Dosing May Not Be Enough To Win Speedy Adoption Of Pfizer’s RA Pill Xeljanz

Pfizer’s newly approved oral RA therapy Xeljanz has an oral advantage over established immune modulators, which all are delivered by needle, but safety questions may slow its adoption.

Roche To Appeal NICE's Rejection Of Herceptin For HER2-positive Stomach Cancer

The latest appraisals from NICE include the rejection of Herceptin use in gastric cancer but give positive recommendations to RoActemra and TNF-inhibitors in rheumatoid arthritis.

Related Content





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