The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Artesunate Amivas, intended for initial treatment of severe malaria in adults and children. The applicant for this medicinal product is Amivas Ireland Ltd. Artesunate Amivas will be available as 110 mg powder and solvent for solution […]
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 […]
Data from two papers published in The Lancet Infectious Diseases demonstrated that the Johnson & Johnson (the Company) Ebola vaccine regimen, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo), generated robust humoral (antibody) immune responses in adults and children (ages 1-17) with the immune responses persisting in adults for at least two years. The data also showed that booster vaccination with Ad26.ZEBOV, administered […]
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 […]
In a new study by Yale Cancer Center, researchers show stem-like T cells within certain lymph nodes could be natural cancer fighters. Targeting these T cells, which are a type of white blood cells, with immunotherapy drugs could increase the number of cancer patients that respond to treatment. The findings were reported online today in the journal Science Immunology. “Therapies that […]
Moderna announced it has submitted for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level. The Phase II study of mRNA 1273 was amended to offer a booster dose of mRNA 1273 at the 50 µg dose level to […]
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