March 16 COVID Quick Takes: FDA launches adverse events dashboard; plus Kintor, Boehringer, Apeiron, Moderna and more

FDA launched an FDA Adverse Event Reporting System (FAERS) public dashboard for COVID-19 drugs and biologics with emergency use authorization (EUA). The launch comes as EMA’s Pharmacovigilance Risk Assessment Committee reviews data on COVID-19 Vaccine AstraZeneca amid concerns over thromboembolic events.

Androgen receptor antagonist reduces mortality
Kintor Pharmaceuticals Ltd. (HKEX:9939) said the Phase III Brazil trial investigating proxalutamide (GT0918) in hospitalized COVID-19 patients met the primary endpoint, showing a reduction of 4.01 by the WHO COVID-19 ordinal scale in the therapy arm vs. a reduction of 0.25 in the control arm at day 14 (p<0.0001). The androgen receptor antagonist also reduced mortality risk by 92% and shortened the median hospital stay from 14 days to 5 days...