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

US FDA Open To Cell Therapy ‘Assessment Aid’ That Could Speed Development Of Next-Gen Cancer Drugs

Executive Summary

A framework for sponsors and the FDA to discuss ways to extrapolate existing data to support a new cell therapy could cut the time to approval.

You may also be interested in...



Gene And Cell Therapy Clinical Holds Decline While Those For Drugs Hit 12-Year High

FDA’s Center for Biologics Evaluation and Research saw IND clinical holds for gene and cell therapies dropped to 70 in calendar year 2022, a 52% decline from 2018. Center for Drug Evaluation and Research’s total clinical holds in fiscal year 2022 were 380, the highest number in the past 12 years.

Cell Therapy Development: White Paper Urges US FDA To Allow Some Shortcuts

A Friends of Cancer Research working group suggests that the US FDA can learn lessons from the approval of Gilead/Kite’s second CAR-T therapy Tecartus that can help expedited iterative development of cell therapies more broadly.

Cell Therapy Manufacturing Hurdles Could Be Solved Through AI; ‘Great Advancements’ In Next 10 Years

Artificial intelligence could be the solution to some of the process challenges with cell therapies; CBER Director Marks also suggests AI to identify safety issues with a particular vector.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147875

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