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

Proactive US FDA Propelled Review Of Genentech’s Actemra In Systemic Sclerosis Amid Evolving Regulatory Landscape

Executive Summary

Pink Sheet’s Drug Review Profile series looks at the unusual history of a systemic sclerosis interstitial lung disease indication for Genentech’s Actemra that was revived at the FDA’s behest and vetted by CDER’s high-level CDER policy council.

You may also be interested in...



Boehringer Avoids Further Efficacy Study Of Ofev In SSc-ILD With Full Approval, No Post-Marketing Commitments

Despite concerns from members of US FDA's Arthritis Advisory Committee that the efficacy profile of Boehringer Ingelheim's Ofev needs more study in the SSc-ILD indication, the company does not have any such postmarketing requirements or commitments.

Actemra CAR-T-Related Indication Comes With Help From Novartis, Kite, US FDA

Genentech's interleukin-6 inhibitor got bonus approval based on data from development programs for Novartis' and Kite's chimeric antigen receptor T-cell therapies; CAR-T developers allowed FDA to access the Actemra-related data in their applications and conduct its own pooled analysis.

GSK Coreg Labeling Cites 23% Mortality Risk Reduction In Post-MI Indication

GlaxoSmithKline's Coreg labeling states that data show a mortality risk reduction of 23% in patients taking the drug after suffering a myocardial infarction

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS145984

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