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

Cervarix Passes Safety Hurdles; FDA Ponders Breadth of Protection Claim

Executive Summary

GlaxoSmithKline surmounted the final safety hurdles for its human papillomavirus vaccine Cervarix at a landmark September 9 FDA advisory committee review of the adjuvanted product

You may also be interested in...



Gardasil Anal Cancer Indication: CBER Has No Concerns, But What Will ACIP Think?

A Center for Biologics Evaluation and Research clinical reviewer sees no problem with using an anal dysplasia endpoint, or extrapolating male data to females, to support approval of Merck’s human papillomavirus vaccine Gardasil for prevention of anal cancer.

Gardasil Anal Cancer Indication: CBER Has No Concerns, But What Will ACIP Think?

A Center for Biologics Evaluation and Research clinical reviewer sees no problem with using an anal dysplasia endpoint, or extrapolating male data to females, to support approval of Merck’s human papillomavirus vaccine Gardasil for prevention of anal cancer.

Gardasil Anal Cancer Indication: CBER Has No Concerns, But What Will ACIP Think?

Nov. 17 session is product's third before an FDA advisory committee, but review by CDC's immunization practices panel may be key for utilization and reimbursement.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS051474

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