Janssen Pharmaceutica Inc.
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The EU and UK have approved the same COVID-19 vaccines but the review pathways have not always been the same.
Roche’s Foundation Medicine still leads Guardant Health in terms of total companion-diagnostic US FDA approvals as both companies announced new PMA supplements.
Prices for J&J and Pfizer’s COVID-19 vaccines will be watched closely as India permits private sales. While demand is set to spike with age criteria for those eligible to receive the shots expanded, local manufacturers Serum Institute and Bharat Biotech are ramping up capacities with the government’s help.
Senior members of three key regulatory and health bodies this week gave their assessments of the protection that existing COVID-19 vaccines may offer against future strains of the virus, and the requirements for developing and assessing modified vaccines.