COVID-19 Quick Takes: FDA expands remdesivir EUA; plus Warp Speed, Abbott, Moderna-Japan, CanSino-Canada, BeiGene-Singlomics, Sinovac, UNC, Daiichi, Laurent

Remdesivir authorized for mild patients
FDA expanded an emergency use authorization for remdesivir to include all patients hospitalized with COVID-19. The antiviral from Gilead Sciences Inc. (NASDAQ:GILD) had previously been limited to patients with blood oxygen saturation <94% on room air, requiring supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

Warp Speed clarifies vaccine timeline, year-end expectations
HHS’s Deputy Chief of Staff for Policy Paul Mango provided an update on Operation Warp Speed’s vaccine development timeline at a media briefing Friday. A pair of Phase III trials for vaccines from  BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE), and from Moderna Inc. (NASDAQ:MRNA), have each enrolled more than half the total 30,000 volunteers, and two more vaccines are expected to start Phase III testing by mid-September. Mango also clarified that Warp Speed’s stated goal of having 300 million vaccine doses by year-end referred to the manufacturing of those doses, not their authorization, which he estimated could come between October and December, depending on Phase III data. The Data Safety and Monitoring Board overseeing the trials will review safety and efficacy data after 150-175 infection events have occurred, Mango said (see “Trump Administration Lays out Path to 300M COVID-19 Doses”)...