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 Asks If PRO Used For Shire's Firazyr Is Clinically Meaningful

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA finds no faults with self-administration for the hereditary angioedema drug as it takes the new molecular entity to a June 23 advisory panel.

You may also be interested in...



Shire Gets Advisory Committee Support For Firazyr Self-Administration Claim

Shire will enter discussions with FDA on labeling for its hereditary angioedema drug Firazyr (icatibant) with backing from an advisory panel for a claim to allow patients to self-administer the product, which is delivered through subcutaneous injection.

Shire Gets Advisory Committee Support For Firazyr Self-Administration Claim

Shire will enter discussions with FDA on labeling for its hereditary angioedema drug Firazyr (icatibant) with backing from an advisory panel for a claim to allow patients to self-administer the product, which is delivered through subcutaneous injection.

FDA’s Benlysta Approval: A Lesson In Overcoming Unvalidated Endpoints

A novel composite primary endpoint created by Human Genome Sciences with FDA’s blessing helped Benlysta (belimumab) obtain approval for lupus – one of contemporary drug development’s most challenging indications – despite the absence of a standard disease outcome measure.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS072399

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