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

Meningococcal Serogroup B Vaccines Can Be Approved With Surrogate Endpoints, FDA Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Traditional placebo-controlled trials would require an impractically large patient population, the agency says as it seeks advisory committee input on post-marketing requirements.

You may also be interested in...



Pfizer, Novartis Get Advisory Panel Backing For General Methods Of Meningococcal Vaccine Trials

Pfizer appears to be slightly ahead of Novartis in planning a Phase III clinical trial of a vaccine against meningococcal serogroup B, with an anticipated start date later this year.

Pfizer, Novartis Get Advisory Panel Backing For General Methods Of Meningococcal Vaccine Trials

Pfizer appears to be slightly ahead of Novartis in planning a Phase III clinical trial of a vaccine against meningococcal serogroup B, with an anticipated start date later this year.

Pediatric Meningococcal Vaccine's Approval Pathway May Work For Other Disease Areas

FDA suggests serum bactericidal antibody measurements to predict protection from meningococcal diseases in children under age 2.

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS072012

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