Moderna, Inc. confirmed that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and […]
Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts […]
Regeneron Pharmaceuticals, Inc. has announced that the FDA has accepted for priority review a Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The FDA has assigned a target action date of April 13, 2022 and informed us that they currently are planning to hold an advisory committee […]
Real-world data looking at biologic treatment and vaccine hesitancy in psoriasis patients is being presented at EADV’s 30th Congress. The findings of two studies are helping to advance understanding of the safety of biological therapies for psoriasis and reasons for COVID-19 vaccine hesitancy in psoriasis patients. Researchers in Spain have studied sentiment towards COVID-19 vaccination in biologic-treated patients with psoriasis […]
Gilead Sciences, Inc. announced positive results from a Phase III randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury(remdesivir) for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression . This late-breaking data will be presented at the IDWeek 2021 virtual conference. In an analysis […]
Johnson & Johnson announced new data reinforcing the strong and long-lasting protection of its COVID-19 vaccine . New data also showed that protection against COVID-19 increases when a booster shot of the Johnson & Johnson vaccine is administered. The safety profile of the vaccine remained consistent and was generally well-tolerated when administered as a booster. The Company has provided available […]
A study conducted in Europe of Gilead’s Verklury (remdesivir) concluded that the antiviral provided no clinical benefit in hospitalized patients with COVID-19 compared to existing treatments . The phase III open-label DisCoVeRy trial included patients admitted to hospital with laboratory-confirmed SARS-CoV-2 and if they had evidence of pneumonia or required oxygen. Participants were randomized to standard of care alone or […]
Moderna, Inc. highlighted a new analysis suggesting that the Moderna COVID-19 vaccine is highly effective against circulating variants of concern , including in a vaccine effectiveness study conducted in partnership with Kaiser Permanente Southern California (KPSC) and in a separate recent publication by the U.S. Centers for Disease Control and Prevention (CDC). Additionally, the Company shared a new analysis of […]
Publication of two separate analyses in The New England Journal of Medicine comes before a meeting of FDA advisers to discuss Pfizer’s application for authorization of a third shot of Comirnaty. The larger dataset published in NEJM comes from an analysis of more than 1 million people in Israel aged 60 or older who received at least two doses of […]
Addition of baricitinib to standard of care (including dexamethasone and remdesivir) was associated with reduced mortality among hospitalized adults with COVID-19, researchers reported on Sept. 1, 2021 in the Lancet Respiratory Medicine. “In this phase 3 trial, baricitinib administered in addition to standard of care (which predominantly included dexamethasone) did not reduce the incidence of a composite endpoint of disease […]
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