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BioWorld - Saturday, March 21, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for Dec. 14, 2022

Dec. 14, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bittium, Quantumdx.
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Other news to note for Dec. 14, 2022

Dec. 14, 2022
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Bioxytran, Eva, Exicure, Harrow Ipsen, Lilly.
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Red wooden approved stamp

Shionogi scores emergency approval for Japan’s first domestic COVID-19 oral antiviral

Dec. 13, 2022
By Tamra Sami
Shionogi & Co. Ltd.’s orally administered COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622), scored emergency regulatory approval from Japan’s Ministry of Health, Labor and Welfare for SARS-CoV-2 infection, and the Japanese government has agreed to purchase 1 million courses of Xocova for domestic supply of the antiviral.
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Regulatory actions for Dec. 13, 2022

Dec. 13, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainstorm, Evergreen, Galera, Ideaya, Janssen, Medivir, Pfizer, Recce, Sobi, Vertex.
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Other news to note for Dec. 13, 2022

Dec. 13, 2022
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Asieris, Astrazeneca, Biosion, Calidi, Calliditas, Glycotope, Immunogen, Lantern, Sosei, Therabest, Viatris, Zyversa.
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Infection

Japanese researchers patent new viral 3CLpro inhibitors

Dec. 13, 2022
The National Center for Global Health and Medicine (NCGM) and Tokyo Medical and Dental University have divulged 3C-like protease (3CLpro) (SARS-CoV-2) inhibitors reported to be useful for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections (COVID-19).
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Regulatory actions for Dec. 12, 2022

Dec. 12, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Antengene, Biogen, Braeburn, Janssen, Pfizer, Recce.
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Vaxxas HD-MAP vaccine application

Vaxxas raises $23M to advance needle-free COVID-19 vaccines

Dec. 9, 2022
By Tamra Sami
Vaxxas Pty. Ltd. raised AU$34 million (US$23 million) to advance its needle-free COVID-19 vaccine program, which began in early November, and readouts from the study are expected in late February or early March, Vaxxas CEO David Hoey told BioWorld. The COVID-19 vaccine patch is based on the company’s high-density microarray patch technology that delivers Hexapro, a second-generation version of the spike protein used in all major U.S.-approved COVID-19 vaccines.
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Regulatory actions for Dec. 9, 2022

Dec. 9, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akero, Bioxytran, Bloomsbury Genetic, Brim, Cerecin, Emmaus, In8bio, Liscure, Moderna, Molecular Targeting, Numinus, Quralis, Takeda, VBI, Visiox, Y-mabs.
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In the clinic for Dec. 9, 2022

Dec. 9, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, Anixa, Baudaxbio, Celcuity, Clinigen, Compass, Createrna, Daiichi Sankyo, Design, Diamond, Dragonfly, Federation, Horizon, Ionctura, Kronos, Novadip, Phavaris, Regenxbio, Spago, Spinethera.


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