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Fujifilm is reportedly considering restarting a study evaluating its antiviral Avigan (favipiravir) for treating COVID-19 patients, after the drug suffered a setback in late 2020. Read More
The House Budget Committee yesterday cleared the pending $1.9 trillion COVID-19 relief legislation, which includes a one-time $500 million in additional FDA funding for coronavirus-related support, paving the way for the bill to be taken up by the House Rules Committee later this week. Read More
GlaxoSmithKline (GSK) and Sanofi have launched a phase 2 study evaluating their adjuvanted recombinant COVID-19 candidate, after delaying the trial by more than two months. Read More
Novavax has announced that it has completed enrolling 30,000 participants in its late-stage U.S./Mexico pivotal trial of its COVID-19 vaccine, bringing its recombinant protein-based vaccine hopeful one step closer to potential FDA authorization. Read More
The FDA has published draft guidance letting COVID-19 vaccine developers that modify authorized vaccines against new viral variants know what they need to present to the agency for amending Emergency Use Authorizations (EUAs), noting that it doesn’t expect large-scale trials will be needed for the altered versions. Read More
Johnson & Johnson (J&J) has filed with the World Health Organization (WHO) for an Emergency Use Listing (EUL) for its COVID-19 vaccine — a listing that would clear the way for the vaccine to be distributed through the WHO’s COVAX vaccine-sharing program. Read More
Pfizer and BioNTech have filed for a revised Emergency Use Authorization (EUA) from the FDA to allow their COVID-19 vaccine to be stored at easier-to-accommodate freezer temperatures. Read More
An analysis by researchers at the University of Oxford has found that the AstraZeneca (AZ)/Oxford coronavirus vaccine appears more effective when its two doses are administered three months apart, results in line with those unveiled by AZ earlier this month. Read More
A study conducted in Israel, which has already vaccinated a large percentage of its population, has found that a single dose of Pfizer/BioNTech’s COVID-19 vaccine is highly effective at reducing infection, lending more support to the strategy of delaying second doses to increase initial vaccinations. Read More
A statistical analysis of multiple clinical trials that assessed Fujifilm’s antiviral Avigan (favipiravir) as a COVID-19 treatment has found that the drug showed limited efficacy in reducing mortality unless given early to infected patients. Read More
Pfizer and BioNTech announced that they have dosed the first patients in a global study evaluating their COVID-19 vaccine in pregnant women 18 years and over. Read More