Camargo

DECEMBER 13, 2021

Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

Development 161

Development Production Immune Response Licensing 161

Worldwide Clinical Trials

MAY 30, 2024

Approval has been based on bioequivalence with the FDA stating that the effectiveness of Radicava ORS is based on a study showing comparable levels of Radicava ORS in the bloodstream to the levels from the IV formulation of Radicava. This is administered according to the same treatment regimen as for the IV infusion.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

The Pharma Data

DECEMBER 27, 2020

Vir Biotechnology and GlaxoSmithKline dosed the first patient in a new sub-trial of a Phase III study of monoclonal antibody VIR-7831 for hospitalized adults with COVID-19. The drug is a humanized IgG4 monoclonal antibody that blocks CCR5 and is being developed for COVID-19, HIV and metastatic triple-negative breast cancer.

Trials 52

Trials Antibody Gene Therapy Gene 52