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

Sarcopenia Or Frailty? European, U.S. Definitions Diverge

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

European stakeholders are working toward “physical frailty and sarcopenia” as a geriatric indication, a broader concept than the sarcopenia definition proposed in the U.S.

You may also be interested in...



Catalyzing Sarcopenia Drug Development: Identifying Outcomes, Defining Disease

FDA’s patient-focused drug development initiative and its Drug Development Tool for qualifying endpoints are galvanizing efforts to establish sarcopenia as an indication for clinical development in what could be a very significant market of elderly patients with weakness and functional disability.

Accelerated Approval For Bluebird’s Skysona Gives Teeth To US FDA Data Questions

Two required confirmatory studies will bolster application that relied on historical controls for orphan neurodegenerative disease.

Keeping Track: Terliprez, Sotyktu Keep Up US FDA’s Novel Approvals Pace; Submissions By Pfizer, Chiesi And BioLineRx

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS005733

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