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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exthera Medical, Icad, Quidel.
The U.S. isn’t the only country tossing COVID-19 vaccines due to potential cross-contamination of the drug substances manufactured at an Emergent Biosolutions Inc. plant.
LONDON – The Delta variant of SARS-CoV-2 originally identified in India is causing more serious illness and reducing the effectiveness of vaccines compared to the Alpha (Kent) variant, according to a nationwide study covering Scotland’s whole population of 5.4 million.
New phase III data on Celltrion Inc.'s COVID-19 therapy, regdanvimab, showed it reduced the risk of hospitalization or death related to the disease for high-risk patients to 3.1% vs. 11.1% for placebo by day 28 of the study. The treatment also proved beneficial to participants across all risk categories, reducing their risk of hospitalization or death to 2.4% vs. 8% for placebo at the same time point.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Gilead, Incyte, Kyowa Kirin, RDIF, Rhovac, Vicore.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adamis, Astrazeneca, Celltrion, Daiichi, Eyegate, G1, Immvira, Novan, Novavax, Oxthera, Precigen, Roche, Scholar Rock, Terns, Tyme, Vertex, Zynerba.
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