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

Therapeutic Cancer Vaccines Can Use Adjuvants, FDA Says

Executive Summary

But even though the agency’s final guidance on cancer vaccines adds a section on adjuvants, the additional data requirements that FDA will request remain relatively vague.

You may also be interested in...



Sign Of The Times: Late-Stage Cancer Vaccines On Display At ASCO

Vindicated by the approvals of Provenge and Yervoy, a host of therapeutic cancer vaccines is working through late-stage trials with the regulatory finish line in sight, and some of those companies will be presenting data at the American Society of Clinical Oncology meeting in Chicago June 1-5.

Adjuvants Need Approval Pathway Separate From Vaccines, Industry Tells FDA

Industry is calling on FDA to write separate rules for assessing adjuvants. This would encourage innovation in immunotherapies, the Biotechnology Industry Organization and Pharmaceutical Research and Manufacturers of America contend.

Adjuvanted Flu Vaccines Get Booster: House Report Presses FDA On Approval

House appropriators are pressing FDA to license adjuvanted seasonal influenza vaccines that have a proven safety record.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS053956

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