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The company’s COVID vaccine could receive UK approval as soon as this month, based off strong UK phase 3 data, and Emergency Use Authorization in the U.S. could occur in May. Read More
New data from Moderna’s phase 3 COVID-19 vaccine trial have shown that the U.S. drugmaker’s two-dose inoculation remains highly effective against the virus six months after the second shot, including for severe infection, the company said Tuesday. Read More
An expert panel of the Centers for Disease Control and Prevention (CDC) is meeting today to review blood-clot incidents reported in a handful of patients who received Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine. Read More
Once a product is on the authorized list, companies must notify the agency at least five business days before they import a designated device. Read More
The Indian government and the Russian Direct Investment Fund reached an agreement that will allow Indian companies to produce 850 million doses of the vaccine per year. Read More
Patients already participating in the study will continue to be assessed, the company said, adding it is developing an experimental inhaled formulation of the antiviral. Read More
AstraZeneca’s heart failure and diabetes drug Farxiga (dapagliflozin) failed to meaningfully reduce the risk of organ dysfunction and death for high-risk, hospitalized COVID-19 patients in a phase 3 study. Read More
Eli Lilly has revised its supply deal with the U.S. government to focus on distributing the company’s COVID-19 antibody bamlanivimab along with another antibody, etesevimab — a combination that has proven to be effective against variant strains of the Sars-CoV-2 virus which causes COVID-19 infections. Read More
Regeneron Pharmaceuticals has said its COVID-19 antibody cocktail, REGEN-COV (casirivimab with imdevimab) reduced the risk of symptomatic infections by 81 percent in a late-stage trial. Read More
In a much-needed development, Johnson & Johnson began delivery of its one-shot COVID-19 vaccine within the EU yesterday as the trade bloc continues to clamor for enough doses to inoculate its 446 million residents. Read More