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Eli Lilly’s antiamyloid antibody solanezumab struck out in a highly anticipated phase 3 preclinical treatment study, failing to alter disease progression in people who had amyloid brain plaques but normal cognition.
A single infusion of BioMarin’s Roctavian (valoctocogene roxaparvovec) reduced bleeding rates by 84 percent for two years in patients with hemophilia A, according to a study published in The New England Journal of Medicine (NEJM). Read More
Lagevrio is under Emergency Use Authorization for the treatment of mild-to-moderate COVID-19 adult patients who are at high risk of progression to severe COVID-19.
Reacting to concerns about good clinical practice at sites run by one of its trial contractors — Boston-based Care Access — Pfizer announced it will drop Care Access sites from its phase 3 Lyme disease vaccine trial, losing about 3,500 participants. Read More
Patients currently enrolled in the study will continue taking the investigational drug, but no new patients will be enrolled until the partial hold is lifted. Read More
A single injection of Eiger Biopharmaceuticals’ peginterferon Lambda, an immune defense-stimulating protein, cut the rate of COVID-19 hospitalization by 51 percent compared to placebo, researchers reported in the New England Journal of Medicine. Read More
Galapagos reported disappointing topline results from a phase 3 trial of its Janus kinase (JAK) inhibitor filgotinib for patients with moderate to severe Crohn’s disease (CD) and said it will not file for marketing authorization in Europe. Read More
The European Medicines Agency (EMA) has launched a new pilot program that gives some study leeway to drugmakers working on pediatric investigation plans (PIP) for innovative children’s medicines. Read More
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