Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzprotect, Astrocyte, Bavarian Nordic, Clearmind, Cybin, Imunon, Innocare, Pacira, Pepgen, Pfizer, Prilenia, Psyence, Puretech.
Shionogi & Co. Ltd., of Osaka, Japan, gained standard approval from Japan’s Ministry of Health, Labour and Welfare for Xocova (ensitrelvir fumaric acid) on March 5, making it the first COVID-19 antiviral to win full approval in the country.
The research on novel vaccines against SARS-CoV-2 with improved characteristics continues. These ideal features include rapid development to target variants of concern, easy manufacturing, and an excellent safety profile while inducing humoral and cellular immune responses.
Shionogi & Co. Ltd., of Osaka, Japan, gained standard approval from Japan’s Ministry of Health, Labour and Welfare for Xocova (ensitrelvir fumaric acid) on March 5, making it the first COVID-19 antiviral to win full approval in the country.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Atai, Audion, Avidity, Berlin, Biocardia, Neurogene, Novartis, Nrx, Solascure, Ultimovacs, Vaxcyte, Vivoryon.
Macquarie University has identified 3C-like proteinase (3CLpro; Mpro; nsp5) (SARS-CoV-2; COVID-19 virus) inhibitors reported to be useful for the treatment of SARS-CoV-2 infection (COVID-19).
Imunon Inc. has released promising results from a live virus challenge study conducted by the Wistar Institute with IMNN-101 against the SARS-CoV-2 variant XBB.1.5. This study was conducted using the clinical vector that Imunon intends to bring into its phase I study during the second quarter, and showed IMNN-101 immunogenicity and protective activity in a live viral mouse challenge.
Avitar Biosciences Inc. has divulged 3C-like proteinase (3CLpro; Mpro; nsp5) (SARS-CoV-2; COVID-19 virus) inhibitors reported to be useful for the treatment of SARS-CoV-2 infection (COVID-19).
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akston, CG Oncology, Curadev, Healis, Imunon, Janux, Recce, Tonix, Viking.
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