Coronavirus Update: Veklury Shows Mortality Benefit In Real-World Data Analyses
Vir/GSK Announce Positive Phase III Data For Sotrovimab
Sotrovimab data could help with uptake, though the market remains challenging as infections fall. Plus RedHill presents encouraging Phase II data for oral drug to treat COVID-19 infection and inflammation after completing Phase II/III study enrollment and Japan taps its world-leading supercomputer.
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New draft guidance offers recommendations for translating real-world data from claims or EHR sources to meet FDA data requirements.
Japan approves a second antibody therapy for COVID-19 in short order, while India gives the go-ahead to a local clinical program for Novavax/Serum Institute's recombinant protein vaccine candidate.
GSK could soon see an approval in Japan for its antibody therapy following a filing for emergency use, while South Korea looks to build its mRNA vaccine capabilities through a new consortium.