Roche Gets Long-Awaited Green Light For COVID-19 Cocktail In EU
Regulator’s Chief Intervenes To Speed Availability
Key committee was asked to fast-track a decision on the antibody cocktail, but lack of mortality data could mean patchy uptake seen in US repeated in the EU.
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The approved fridge storage time for Pfizer and BioNTech's Comirnaty has been extended to a month, Regeneron's scores with low-dose REGEN-COV, an early win for GSK and CureVac's next-generation mRNA vaccine and more orders of the AstraZeneca vaccine benefits Oxford Biomedica's bank balance.
The company is requesting FDA expand the antibody cocktail to include a COVID prevention claim with a lower 1,200mg dose and a subcutaneously administered formula.
The RECOVERY trial has found Actemra to help cut deaths and speed recovery – and UK doctors are not waiting for Roche to complete own studies.