Bispecific Antibodies: US FDA May Require Comparison To Approved Monospecific Product
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target the same antigens as the investigational bispecific antibody, FDA may request a comparative clinical trial, draft guidance notes.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...
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.
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.
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.