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Latest From Mapp Biopharmaceutical
US FDA's Ebola Drug Approvals Showcase Efficiencies With Master Protocols
Agency approved Regeneron’s monoclonal antibody cocktail Inmazeb and Ridgeback’s mAB Ebanga on data from a multi-arm, adaptive trial in which several investigational agents were independently compared to a control group. Efficacy for both drugs was demonstrated on a mortality endpoint, with lingering uncertainties to be addressed through postmarketing studies.
Neurology At The Forefront Of US FDA Complex Innovative Trial Design Pilot
Wave’s Duchenne muscular dystrophy drug crashed, but Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.
Vir Advances Antibodies Against COVID-19, CEO Scangos Leads BIO’s Coronavirus Outreach
Scrip talked to George Scangos about his dual roles in the pandemic response, helming Vir as the company tests antibody and siRNA approaches while working with BIO to facilitate coronavirus collaborations.
COVID-19 Study Of Gilead’s Remdesivir Using Ebola-Style Adaptive Platform Trial
First COVID-19 experimental treatment trial in US is a master protocol that echoes NIH’s Ebola treatment approach.
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