Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose
The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US
New data from ongoing trial showed increased antibody response against Beta, Delta, Alpha, Gamma and Omicron variants following third dose booster with Vaxzevria
Neutralising antibody levels against Omicron following a third dose boost of Vaxzevria were broadly similar to levels achieved after two doses against the Delta variant
The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research
Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US to prevent Covid-19
Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic Covid-19, with no severe disease or deaths
AZD7442 reduced risk of developing severe Covid-19 or death in Tackle Phase III outpatient treatment trial
Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the U.S. Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE)
The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)
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