LONDON – Biontech SE announced positive preliminary data from the ongoing phase I/II trial of one of the four COVID-19 vaccines it is developing with Pfizer Inc., with participants in each of three dose groups mounting immune responses that were greater than seen in patients who recovered from COVID-19 infections.
CAJICA, Colombia – Aided by federal funds from the Brazilian government, the University of Sao Paulo is moving forward with developing a precision SARS-CoV-2 vaccine that is about to start preclinical trials.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bavarian, Blueprint, EMD, Golden, Hangzhou Yuyuan, Isa, Janssen, Medicinova, Mezzion, Pfizer, Revive, Rhythm, Scpharmaceuticals, Sun, TC, Obseva, Ultragenyx, Y-mabs.
The push for a vaccine for the COVID-19 pandemic may have no parallel in pharmaceutical history, and FDA commissioner Stephen Hahn vowed in a Senate hearing that the agency will rely on the agency’s traditional standards for scientific evidence in premarket reviews of those vaccines.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerus, Ancora Heart, Corelink, Endra Life Sciences, Illuminoss Medical, Kardium, Livsmed, Qure.ai, Seegene.
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