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

FDA Panel Will Weigh Mixed Efficacy Data For GSK’s Breo Ellipta In COPD

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency says data supporting the relative contribution of the combination drug’s corticosteroid component, fluticasone, are “less robust” than data supporting the bronchodilatory effects of the long-acting beta-agonist component, vilanterol.

You may also be interested in...



Relovair Data Raises Respiratory Stakes For GSK And Theravance

Mixed Phase III data results on GSK/Theravance’s once-daily follow-up to Advair raises the regulatory and commercial stakes for the drug, a crucial pipeline product for both companies

US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios

Forthcoming guidance is expected to describe areas of “low-hanging fruit” and those that are more challenging for use of the expedited pathway, Center for Biologics Evaluation and Research Director Peter Marks said.

Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works

FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS075527

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