A phase II/III trial testing Inflarx NV's vilobelimab, a monoclonal antibody the company is developing to control inflammatory response, showed a relative reduction in 28-day all-cause mortality of 23.9% vs. placebo (p=0.094) for mechanically ventilated COVID-19 patients, but missed statistical significance on the measure, the study's primary endpoint.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abionyx, Antengene, ASC, Biogen, Guerbet, Hipra, Nurix, Realta, Receptor, Taiho, Viiv.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acer, Adagio, Ascletis, Cellphire, Concentric, Genentech, Immutep, Prometheus, Revelation.
Adagio Therapeutics Inc. plans to file for emergency use authorization in the second quarter of 2022 for its lead candidate, a monoclonal antibody (MAb) for preventing and treating COVID-19. With plenty of competing vaccines around, the company now thinks it has found the right group to receive it: the immunocompromised.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Masimo, O'Brien, Synchron, University of Portsmouth.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antares, Astrazeneca, BMS, Canbridge, CSL, Daewoong, Enanta, Immunogen, Mitsubishi Tanabe, Neurocrine, Novo Nordisk, Noxopharm, Reveragen, Santhera, Takeda, Urogen, Telix.
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