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

Bispecific Antibodies: US FDA May Require Comparison To Approved Monospecific Product

Executive Summary

When approved therapies target the same antigens as the investigational bispecific antibody, FDA may request a comparative clinical trial, draft guidance notes.

You may also be interested in...



China's EpimAb Advances Bispecific Antibody To Rival Janssen Candidate

EpimAb's business development officer tells Scrip dosing has started in a Phase I/II trial assessing the China-based biotech's lead cancer molecule EMB01, an EGFR-cMET bispecific antibody.

Deal Watch: Xencor Adds New Bispecific Partner In Agreement With Genentech

Genentech will pay $120m up front to co-develop Xencor’s preclinical IL-15 candidate; deal also includes IL-15 R&D. Taiho licenses lung cancer candidate to Cullinan; Celgene and Triphase partner again.

Deal Watch: Sanofi Retains Options To Two Bispecifics While Exiting Antibody Pact With Regeneron

Sanofi and Regeneron terminate the immuno-oncology partnership signed in 2015, but will continue to collaborate on Libtayo. Biogen signs a pair of partnerships in CNS disorders, with C4 and Skyhawk, and more deals from the first day of the J.P. Morgan conference.

Topics

Related Companies

UsernamePublicRestriction

Register

LL1134044

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