Five years after Gilead Sciences Inc. gave up on momelotinib in the wake of two phase III failures in myelofibrosis, the JAK1/2 and ACVR1 inhibitor has found its way to the market in the hands of GSK plc. Branded Ojjaara, the drug gained U.S. FDA approval for use in intermediate- or high-risk myelofibrosis patients with anemia regardless of prior administration with JAK inhibitors such as Jakafi (ruxolitinib, Incyte Corp.). Read More
Anthos Therapeutics Inc.’s phase II study of abelacimab in treating atrial fibrillation in patients at moderate to high risk of stroke has met its primary endpoint. The data monitoring committee stopped the study early as the fully human monoclonal antibody targeting factor XI/XIa reduced bleeding when compared to a leading standard of care, direct oral anticoagulant, Xarelto (rivaroxaban, Johnson & Johnson). Read More
If the U.S. FDA has its way, biosimilars and interchangeable biosimilars would no longer be a difference with a distinction – at least when it comes to labeling. Instead of distinguishing between the two, the agency is recommending that the labeling for both follow-ons include a “biosimilarity statement.” Read More
Iveric Bio Inc.’s regulatory win Aug. 4 drew attention to the already hot eye-disease space, where intriguing new developments include the possibility of an oral therapy for Stargardt disease. Belite Bio Inc. in late July finished enrollment of a phase III study with once daily tinlarebant, a retinol binding protein 4 antagonist for Stargardt’s. Data from 90 adolescent subjects in the study called Dragon are due in mid-2024. Read More
By creating a new mouse model of Alzheimer’s disease that better recapitulated how the disease plays out in humans, investigators at KU Leuven have gained new insights into how amyloid plaques, tau tangles and neuronal death are related at the molecular level. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Athebio, Atriva, Biocure, Biontech, Boundless Bio, Novvae, Pharmanovia, Point Biopharma, Sanofi, Taiho, Virpax. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Almirall, Argenx, Ascendis, Astrazeneca, Daiichi Sankyo, Hemogenyx, Iovance, Merck, Moderna, PTC, UCB, Vertex. Read More
