Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ampio, Ascentage, Asieris, Autolus, Beigene, Cerevel, Eton, Immunitybio, Jounce, Oryzon, Pharmather, Verisim.
LONDON – Regeneron Pharmaceuticals Inc.’s antibody cocktail, Regen-Cov, has been shown to significantly reduce mortality in seriously ill hospitalized COVID-19 patients who have failed to mount their own immune response against the SARS-CoV-2 virus. Among these seronegative patients, the casirivimab/imdevimab monoclonal antibody mixture reduced deaths by 20% (p=0.001) in the U.K. Recovery trial.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kheiron Medical Technologies, Letsgetchecked, Liquiglide, Livanova.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Attralus, Bioprotect, Novadip, Proven Pharmaceuticals.
Noticeably lacking in the G7 communique following its recent U.K. summit is support for a proposed World Trade Organization waiver on intellectual property related to drugs and other medical products used to prevent, contain or treat COVID-19 infections.
There’s been a mixed bag of data from Astrazeneca plc’s efforts against COVID-19, after data suggested Pfizer Inc.’s rival vaccine is more effective against the Delta variant and the failure of a trial involving its long-acting antibody therapy.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alx, Amylyx, Ascendis, Avenue, Enochian, GBT, Gesynta, Humanigen, Istari, Jasper, Lipocine, Moderna, Sorrento, Tilt.
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