Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atea, Curevac, Hotspot Therapeutics, Immuneering, Moberg, Neurocrine, Vico, Zambon.
Moderna Inc.’s shares (NASDAQ:MRNA) sank 19% to a $64.11 low in early trading Sept. 12 as investors learned during the annual R&D Day event of a $1.1 billion reduction to R&D and the U.S. FDA’s reluctance to support an accelerated approval filing for its individualized neoantigen therapy for melanoma.
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.
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