Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Gene Therapy Trial Designs For Bleeding Disorders Could See Patient Input At FDA Meeting

This article was originally published in The Pink Sheet Daily

Executive Summary

During its patient-focused drug development meeting on hemophilia, von Willebrand Disease and other bleeding disorders, the agency will ask patients about how they decide whether to join a clinical trial.

You may also be interested in...



Hemophilia Market Snapshot: Is There Enough Innovation For Patients To Switch?

A cautious patient population with long memories could thwart the potential of new hemophilia A treatments, even as the market leaders promise Wall Street that switching patients will be no problem.

Biogen Plays It Safe With Pricing Of Hemophilia Drug Alprolix

Biogen Idec will price its new hemophilia B drug Alprolix on par with older medicines like Pfizer’s Benefix on an annual basis despite the drug’s dosing advantage. The decision comes as high drug prices have come under increased scrutiny from payers and U.S. legislators.

Disease-Of-The-Quarter Club: FDA Plans 20 Patient Network Meetings Over Five Years

PDUFA V framework to involve patients in the creation of the risk-benefit criteria for various diseases kicks off before the legislation is even enacted.

Topics

Related Companies

UsernamePublicRestriction

Register

PS077529

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