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The European Medicines Agency (EMA) said it will complete its review of the Pfizer/BioNTech COVID-19 vaccine by Dec. 21 — a week ahead of schedule — and the EU is poised to grant emergency approval by Dec. 23, allowing vaccinations to begin by year’s end. Read More
Supported by promising phase 1 data, CureVac announced Monday that it has enrolled the first participant in the pivotal phase 2b/3 study of its messenger-RNA based coronavirus vaccine, CVnCoV. Read More
Researchers with the UK’s multi-armed RECOVERY trial have determined that the widely used antibiotic azithromycin was not beneficial for patients hospitalized with COVID-19 and are discontinuing their evaluation of the drug. Read More
Canada administered its first shots of Pfizer/BioNTech’s COVID-19 vaccine to frontline healthcare workers Monday as coronavirus vaccinations also got underway in the U.S. Read More
Saudi Arabia’s drug regulator has given full approval to the Pfizer/BioNTech COVID-19 vaccine, BNT162b2, following Emergency Use Authorizations for the vaccine in the UK, Canada and Bahrain. Read More
A conference the neuroscience biotech company Biogen held in a Boston hotel Feb. 26-27 appears to have been a “superspreader event” for COVID-19, ultimately leading to hundreds of thousands of cases, according to a new study. Read More
COVID-19 patients treated with Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) in combination with Gilead Sciences’ antiviral Veklury (remdesivir) were less likely to die after 28 days than those receiving remdesivir alone, according to peer-reviewed phase 3 trial results published online Friday in the New England Journal of Medicine. Read More
AstraZeneca (AZ) will soon launch a study evaluating a double-dose regimen of its COVID-19 candidate AZD1222 in combination with adenovirus-based vaccine Sputnik V, developed by Russia’s sovereign wealth fund and using the same technology as the AZ vaccine. Read More
Sanofi and GlaxoSmithKline (GSK) have decided to push back the phase 2b trial of their adjuvanted COVID-19 vaccine after finding it produced only a weak immune response in older patients, delaying the potential delivery of a vaccine that could contribute to the mass vaccination effort in the U.S. Read More
The first U.S. COVID-19 vaccinations are to be given today using Pfizer/BioNTech’s vaccine, following the announcement late Friday that the FDA had granted the first emergency clearance for a coronavirus vaccine, a pivotal and unprecedented moment in the battle against the pandemic. Read More