Moderna Inc. has received conditional authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency for its bivalent COVID-19 booster vaccine mRNA-1273.214 (Spikevax bivalent original/omicron). The conditional approval, which covers adults aged 18 years and older, marks a new phase in the ongoing global effort to curb the COVID-19 pandemic, as the new vaccine represents the first commercial product to incorporate omicron-specific epitopes. It contains 25 micrograms each of the spike proteins of the omicron BA.1 variant and the original Wuhan strain of SARS-CoV-2.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alx, Astrazeneca, Blueprint, Clene, Gilead, Immunogenx, Novartis, Passage, Plus, Roche, Sanofi, Viridian and Virios.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Ceapro, Fortress, Ginkgo, Homology, Nanopharmaceutics, Pasithea, Synlogic, Teneotwo.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alpine Immune, Intron, Evotec, Proqr, Psilera, SAB, Starpharma, Tetra, Vir, Volitionrx, Zai Lab.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avenda, Bodyport, Bot Image, Cerevasc, Imspex Diagnostics, Medalliance, Neuroone.
Following the readout of a phase II trial evaluating its COVID-19 oral antiviral Pentarlandir (SNB-01), Taiwan’s Syneurx International Corp. said it expects to launch a phase III test of the candidate in the next few months.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akebia, Cognition, Dizal, H. Lundbeck, Kazia, Otsuka, Tarsus, United.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genbody, Vieworks, Wision.
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