Phase III
Amgen’s CD19-directed antibody Uplizna in a late-stage study showed it can suppress the risk of flares by nearly 90% in patients with IgG4-related disease, the company announced Wednesday.
Gilead Sciences’ primary biliary cholangitis candidate seladelpar and Ipsen’s PBC asset elafibranor both showed encouraging Phase III results Wednesday, as they face looming FDA decision dates.
Annexon’s late-stage Guillain-Barré syndrome trial has hit its primary endpoint and laid the foundation for a filing for approval next year, the company said Tuesday.
BMS presented late-stage results on Tuesday at the ASCO annual meeting which showed the combination of Opdivo and Yervoy lowered the risk of death by 21% in patients with unresectable hepatocellular carcinoma, compared to two kinase inhibitors.
Agios Pharmaceuticals’ Pyrukynd met both the primary and secondary endpoints in patients with transfusion-dependent alpha- or beta-thalassemia.
Regeneron and Sanofi will have to wait until September 2024 for the FDA to decide whether to expand Dupixent’s label to include uncontrolled chronic obstructive pulmonary disease.
In addition to missing the mark in overall survival, Gilead reported Thursday a higher number of deaths in the Trodelvy arm of the confirmatory metastatic urothelial cancer study.
Novartis’ Scemblix posted stronger results with fewer discontinuation rates than both its own Gleevec and a stronger second-generation TKI, positioning it for a potential first-line indication in chronic myeloid leukemia.
Additional analyses from BridgeBio Pharma’s late-stage study show the oral drug candidate improved clinical outcomes in transthyretin amyloid cardiomyopathy patients.
Johnson & Johnson on Wednesday reported late-stage trial data showing its first-in-class orexin receptor antagonist reduced major depressive disorder symptoms as an adjunctive treatment in patients with insomnia.
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