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.
Astrazeneca plc has confirmed it is working with Oxford University to produce a vaccine against the Omicron variant of the SARS-CoV-2 virus. The Cambridge, U.K.-based pharma was one of the first to get a COVID-19 vaccine okayed by regulators, after acquiring rights to the shot from Vaccitech plc, a spin-out from Oxford University’s Jenner Institute specialist vaccine unit.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avacta, Phillips, Sight Sciences.
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