Young infants show strong immune responses to SARS-CoV-2, new research has found. In particular, compared with adults, young infants produce relatively high levels of antibodies and immune cells that can specifically protect against COVID-19. The study led by academics and paediatricians at the University of Bristol and Bristol Royal Hospital for Children is published in Cell Reports…

The FDA on Monday expanded the label for Alexion Pharmaceuticals’ Ultomiris (ravulizumab-cwvz) to include treatment of paroxysmal nocturnal haemoglobinuria (PNH) in children as young as one month old and adolescents, making it the first PNH drug cleared in the US for paediatric patients. Alexion stated that the long-acting C5 inhibitor has “become the standard of care” for adults…

AB Science said Tuesday that all clinical studies of masitinib will be voluntarily suspended after the identification of a potential risk of ischemic heart disease associated with the orally administered tyrosine kinase inhibitor. The company noted that the signal was detected in a retrospective analysis of controlled and unblinded studies of masitinib. The drugmaker indicated…

The Institute for Clinical and Economic Review (ICER) on Tuesday released details about how it intends to compile the first of what it says will be an annual assessment looking into drug coverage policies that pose barriers to fair access. The goal of the report, which is due out in October, is to spark “dialogue and action…by providing an independent analysis of whether or not…

Amgen and AstraZeneca on Thursday reported more results from the Phase III NAVIGATOR trial of tezepelumab, showing that the TSLP-targeting monoclonal antibody was superior to placebo across subgroups of patients with severe asthma. The new readout, published in the NEJM and scheduled for presentation at the American Thoracic Society (ATS) conference, follows AstraZeneca’s filing…

The FDA extended reviews of marketing applications seeking approval of several JAK inhibitors as the regulator continues to scrutinise the safety of the drug class. Pfizer said Wednesday that the target review date of its filing for abrocitinib to treat adults and adolescents with moderate-to-severe atopic dermatitis (AD), as well as an application to expand the label for…

GlaxoSmithKline announced Thursday that the first patient has been dosed in a Phase III study investigating the experimental drug GSK3511294 in severe eosinophilic asthma. Results from the late-stage programme for the next-generation anti-IL-5 monoclonal antibody are expected in 2024. The company currently markets the anti-IL-5 biologic Nucala (mepolizumab) as a once-monthly…