Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim Immunotech, Arecor, Apollomics, Avistone, Briacell, Biogen, Biothera, Bridgebio, Eli Lilly, Eupraxia, GSK, Hightide, Innovent, Johnson & Johnson, Merck, Oneness, Regeneron, Sanofi, Telix.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abdera, Advanz, Lisata, Moderna, Perspective, Simcere, Vivet.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanz, Azurity, Emergent Biosolutions, Hutchmed, Kalvista, Moderna, Novavax, Obsidian, Prilenia, Seabelife SAS, Skyline.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avanzanite, Basilea, Bavarian Nordic , Camp4, Invivyd, Johnson & Johnson, JW Therapeutics, Roche, Soleno.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bioarctic AB, Biovie, Invivyd, Lexaria, Spago Nanomedical, Vaderis.
About two months after Astrazeneca plc said its application for sipavibart (AZD-3152) had been accepted by the EMA for pre-exposure prophylaxis (PrEP) against COVID-19 in immunocompromised people, Invivyd Inc. unveiled positive 180-day exploratory efficacy data from the company’s ongoing Canopy phase III trial with Pemgarda (pemivibart) in the same indication – and made known less happy news from regulators on the other side of the pond.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, I2o, Intarcia, Janssen, Moderna, Pfizer.
Armed with $55 million in series A funds and a U.S. government contract, Cambridge, Mass.-based Red Queen Therapeutics Inc. launched operations this week, with plans to advance its novel stapled lipopeptide platform, which creates new antiviral therapies that do not rely on the immune system to work.
Vir Biotechnology Inc.’s focus will look a little different for the latter half of 2024, as the San Francisco-based firm disclosed a restructuring that will cut about a fourth of its workforce and phase out programs targeting influenza and COVID-19 as well as vaccines developed using its T-cell-based viral vector platform.
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