LONDON – A suite of papers rushed through peer review and published in Nature late on Dec. 23, 2021 contain data indicating approved monoclonal antibody drugs designed to neutralize SARS-COV-2 have substantially weaker activity against the Omicron variant.
The FDA went from zero to two oral antivirals to treat COVID-19 in the space of two days, granting emergency use authorizations last week to Pfizer Inc.’s Paxlovid and Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s molnupiravir. Both five-day regimens are authorized for use, within five days of COVID-19 symptom onset, in individuals at high risk of progressing to severe disease, including hospitalization and death.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Akston, Alphamab, Amo, Bausch, Medicenna, Mereo, Moleculin, Nervgen, Redx, Vallon.
The FDA has posted two draft guidances for the transition of policies from the pandemic to more normal times. One of these is the long-awaited draft for transitioning a device from an emergency use authorization (EUA) to a conventional premarket status, which offers a 180-day grace period for an EUA after the agency identifies a date on which the EUA will be terminated.
LONDON – The latest cut of data from a study tracking the COVID-19 pandemic in near real time in Scotland indicates the Omicron variant of SARS-CoV-2 is two-thirds less likely to result in hospitalization than the Delta variant.
With Omicron spreading rapidly, U.S. COVID-19 vaccine producers are facing increasing pressure to up their production and to do more to ensure their vaccines are accessible globally.
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