Coronavirus Update: Trial Of Lilly's Antibody Is Next To Be Paused
Plus: Hyperimmune Globulin Trial Launched
NIH study of monoclonal antibody therapy in combination with Gilead's remdesivir paused for safety reasons.
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Global research consortium to investigate the use of immunoglobulin as a COVID-19 therapy ends following disappointing results from a Phase III trial. Meanwhile, Russian vaccine producer RDIF is snapping up more production capacity in India, where interferon has also progressed as a possible treatment.
Gilead's remdesivir is first drug fully approved by FDA to treat COVID-19. Roche and Atea team up on an investigational direct acting antiviral while Moderna reaches the 30,000-patient enrollment target for its Phase III COVE study of the company's investigational mRNA vaccine.
Agenda for Thursday’s meeting on coronavirus vaccine development and approval includes lots of background, which may help public confidence, but not necessarily FDA assessors as they weigh the tough decisions ahead of them.