Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accord, Applied, Astrazeneca, Azitra, Briacell, Glycomine, Imcheck, Merck, Moderna, Nicox, Novartis, Valneva.
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.
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