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BioWorld - Friday, September 22, 2023
Home » Topics » Infection » Coronavirus

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Regulatory actions for May 30, 2023

May 30, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biophytis, BMS, Curium, Gilead, Hutchmed, Inventiva, Ipsen, Novavax, Novo Nordisk, Sino, Takeda.
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In the clinic for May 30, 2023

May 30, 2023
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biophytis, Ferring, Genelux, Oxurion, Profoundbio, Structure, Theseus, TME, Xilio.
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Regulatory actions for May 26, 2023

May 26, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accropeutics, Applied Therapeutics, Celltrion, Dyne, Hibio, Janssen, Legend, Pfizer, Sandoz.
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Other news to note for May 26, 2023

May 26, 2023
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adamis, Biontech, DMK, Intercept, Madrigal, Pfizer.
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In the clinic for May 26, 2023

May 26, 2023
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annexon, Antabio, Apellis, Bial, Bioinvent, Bioxcel, Harmony, Immutep, Jaguar, Lynk, Onconova, Stallergenes, Stemcyte, Topas, Transgene, Vanda.
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Oral COVID-19 antiviral Paxlovid wins full FDA approval

May 25, 2023
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Pfizer Inc.’s Paxlovid (nirmatrelvir/ritonavir) became the first oral antiviral to win full U.S. FDA approval for treating COVID-19, cleared for use in adults who are at high risk for progression to severe disease, including hospitalization or death. The nod follows two months after the agency’s Antimicrobial Drugs Advisory Committee voted 16-1 in favor of Paxlovid’s overall benefit-risk assessment.
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In the clinic for May 25, 2023

May 25, 2023
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerami, Allgenesis, Alimera, Alzecure, Clarity, Curium, Cybin, Daiichi, Eloxx, Galapagos, Geovax, Immunos, Immutep, Innovative Cellular, Lassen, Lisata, Mereo, Peptilogics, Pliant, PTC, Quoin, Thermosome, Trialspark.
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COVID-19 vaccine and syringe with flag of China

Cansino steps closer to COVID-19 mRNA vaccine approval in China

May 24, 2023
By Doris Yu
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Cansino Biologics Inc. reported positive data in a phase IIb trial evaluating the heterologous mRNA vaccine CS-2034 booster compared to an inactivated vaccine to prevent SARS-CoV-2 infections.
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In the clinic for May 23, 2023

May 23, 2023
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aiviva, Alnylam, Alpine, Anixa, Apnimed, Atyr, Bridgebio, Candel, Corium, Hanall, Hepion, Immix, Medincell, Milestone, Mink, Mirum, Neurimmune, Novartis, Novo Nordisk, Rain, Redhill, Regeneron, Salubris, Vicore.
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Regulatory actions for May 19, 2023

May 19, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alligator, Antengene, Galera, Immupharma, Pepgen, Vifor, Westvac.
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