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target the same antigens as the investigational bispecific antibody, FDA may request a comparative clinical trial, draft guidance notes.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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: