STAT+: Drugmakers ask regulators to change standards on new Covid antibody drugs for most vulnerable
Biotech executives and a handful of academics pleaded with U.S. and European regulators on Thursday to adopt new standards for approving antibody drugs against Covid, particularly for immunocompromised and other vulnerable patients.
The four-hour hearing came as agencies, companies, and researchers face a fundamental mismatch: The virus is evolving faster than our ability to develop interventions under normal — or even normal emergency — procedures.
