The European Medicines Agency (EMA) is evaluating remdesivir data submitted by Gilead Sciences to determine whether the antiviral’s indication should be expanded to cover adult COVID-19 patients who don’t need supplemental oxygen. Read More

Pfizer has allegedly demanded that certain Latin American governments put up assets as collateral in order to secure supply deals of its COVID-19 vaccine, a nonprofit investigative news organization in the UK has claimed. Read More

Drug recalls in 2020 climbed to 344, a 2.4 percent increase from the previous year, although that small increase was overshadowed by the amount of drugs actually impacted by the recalls, a new report says. Read More

COVID-19 vaccine makers appearing yesterday before a U.S. House subcommittee pledged to lawmakers they would meet — and in some cases accelerate — their vaccine supply commitments, as the federal government and states clamor for more doses one year into the pandemic. Read More

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The FDA has published draft guidance letting COVID-19 vaccine developers that modify authorized vaccines against new viral variants know what they need to present to the agency for amending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