FDA accepts REGEN-COV for priority review for treatment and prophylaxis of COVID-19 – Regeneron Pharma

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 […]

Veklury significantly reduced risk of hospitalization in high-risk patients with COVID-19 – Gilead Sciences

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 announces real-world evidence and phase III data confirming strong and long-lasting protection of single-shot COVID-19 vaccine in the U.S.

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 […]

DisCoVeRy trial of Verklury concluded there was no clinical benefit in hospitalised patients with COVID 19 – Gilead Sciences

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 highlights new clinical data on SpikeVax, its COVID-19 vaccine

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 […]

Analyses published in NEJM of a third booster shot of the Comirnaty messenger RNA vaccine from Pfizer

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 […]

Moderna announces submission of initial data to the FDA for mRNA-1273 at the 50 µg dose level

Moderna, Inc., announced it has initiated its submission to the FDA for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level. The Company expects to submit data to the European Medicines Agency (EMA) and other regulatory authorities around the world in the coming days. </p. The Phase II study of mRNA-1273 […]

Positive new data for Johnson & Johnson single-shot COVID-19 vaccine on activity against Delta variant and long-lasting durability of response

Johnson & Johnson announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date. The two preprint study summaries have been […]

MHRA approves Ad26.COV2-S [recombinant] for active immunisation against COVID-19 within the United Kingdom – Janssen

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