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BioWorld - Tuesday, May 30, 2023
Home » Topics » Infection » Coronavirus

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Regulatory actions for March 6, 2023

March 6, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aptorum, BMS, Merck, Ractigen, Valeo.
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Colorized transmission electron micrograph of SARS-CoV-2 (UK B.1.1.7 variant).
Infection

Researchers report discovery of TKB-245 and TKB-248, novel potent SARS-CoV-2 Mpro inhibitors

March 6, 2023
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Researchers from the National Center for Global...
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3D printed model of a human papillomavirus particle
Immuno-oncology

Virally driven cancers are mRNA vaccines’ first, and next, frontier

March 6, 2023
By Nuala Moran
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In a striking demonstration of how the success of mRNA vaccines against COVID-19 has opened up the potential of the technology in cancer, mice that cleared a tumor after a single administration of an mRNA vaccine, also cleared a second tumor without receiving further immunization. This display of potent immunogenicity formed part of a head-to-head study of three different mRNA technology platforms in human papillomavirus (HPV)-16 associated tumors.
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FDA rejects EUA for Veru’s sabizabulin, at least for now

March 3, 2023
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Shares of Veru Inc. hit a 52-week low March 3 after the U.S. FDA declined to grant an emergency use authorization (EUA) for sabizabulin for use in hospitalized adults with moderate to severe COVID-19 who are at high risk for acute respiratory distress syndrome. The decision comes as little surprise, given the negative advisory panel vote in November, but the agency’s wording might suggest potential use for the microtubule disruptor in the future.
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Regulatory actions for March 3, 2023

March 3, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Alvotech, Astrazeneca, Checkpoint, Genenta, Intellia, Santhera, Serda, Valneva.
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In the clinic for March 3, 2023

March 3, 2023
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amniotics, Biovie, BMS, Brim, Inovio, Janssen, Organogenesis, Poolbeg, Sanofi, Sobi.
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Regulatory actions for March 2, 2023

March 2, 2023
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bigfoot Biomedical, Boomerang Medical, Convatec, Cordx, Neuro20.
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In the clinic for March 2, 2023

March 2, 2023
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: 23andme, AB, Ambrx, Atom, Cidara, CSL, Deciphera, Emalex, Imcyse, Iveric, Kancera, Karolinska, Lumos, Merck & Co., Moleculin, PDS, Tachyon.
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Regulatory actions for Feb. 28, 2023

Feb. 28, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amo, Asklepios, Biophytis, Glaukos, Orchard, PDS, Priothera, Replimune, Springworks.
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Regulatory actions for Feb. 27, 2023

Feb. 27, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Astrazeneca, Beigene, Chiesi, Daiichi Sankyo, Incyte, Janssen, Merck, Protalix, Regeneron, Ridgeback, Servier, Sobi, Timber.
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