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
UsernamePublicRestriction

GSK’s Bird Flu Vaccine Approval May Hinge On Pandemic Postmarketing Study

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA will ask its Vaccines and Related Biological Products Advisory Committee to talk about how to verify and describe the clinical benefit of the vaccine under the accelerated approval regulations.

You may also be interested in...



Possibility Of A Pandemic Helped GSK’s Q-Pan H5N1 Flu Vaccine Get Panel Support

FDA’s Vaccines and Related Biological Products Advisory Committee said in twin 14-0 votes that immunogenicity and safety data are sufficient to support approval.

GSK’s Pandemic Vaccine Will Test Swine-To-Bird Approval Transmission

FDA agreed to infer GSK’s H5N1 vaccine’s effectiveness from the effectiveness of the adjuvanted H1N1 vaccine; agency’s Vaccines and Related Biological Products Advisory Committee will weigh in – and consider Dynavax’s hep B vaccine Heplisav – on Nov. 14.

Protein Sciences "Dumbfounded" After Committee Votes Down FluBlok

Cell-based seasonal influenza vaccine needs both additional safety data in general and considerably more efficacy data in older patients, FDA advisory panel says.

Topics

Related Companies

UsernamePublicRestriction

Register

PS073487

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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