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

US FDA Panel Weighs Design Of A Pre-approval Safety Study For Janssen's Sirukumab

Executive Summary

IL-6 inhibitor should be compared to another biologic to exclude a multi-fold increase in the risk of death, advisers say; FDA assures the panel's industry representative it is not considering an across-the-board requirement for large safety studies of rheumatoid arthritis treatments.

You may also be interested in...



Non-Inferiority Trials, Please, US FDA Implores Rheumatoid Arthritis Sponsors

RA drug development has been slow to revise the trial design paradigm despite agreement on the drawbacks of placebo controls and crossover elements, but FDA biostatistician Levin sees promise in non-inferiority designs.

Keeping Track: An RMAT, Two QIDPs, And Some Bad News Too

The latest drug development news and highlights from our FDA Performance Tracker.

JAK Inhibitors Could Face Scrutiny Over Cholesterol Effects

As positive efficacy data rolls in for the janus kinase inhibitors in rheumatoid arthritis, like Pfizer’s Phase III tasocitinib, elevated lipid levels are emerging as an issue worth keeping an eye on.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS121280

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