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BioWorld - Saturday, January 24, 2026
Home » Topics » Coronavirus, BioWorld

Coronavirus, BioWorld
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Regulatory actions for Dec. 19, 2023

Dec. 19, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anheart, Arcutis, Avstera, Catalyst, Checkpoint, Cyclo, GC Pharma, Innovent, Irlab, Lexeo, Merck & Co., Novavax, Nrx, Pfizer, Santhera, Sirnaomics.
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In the clinic for Dec. 19, 2023

Dec. 19, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Aulos, Azura, BMS, Cara, CNS, Cyclacel, Daiichi, Ethris, GSK, Highfield, Innocare, Invivyd, Lantheus, Mirum, Mithra, Nectin, Neuren, Nicox, Oculis, Pepgen, Sensorion, Structure, Ultimovacs, Viridian, Windtree, Yoltech.
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Invivyd stock spikes as MAb shows strength against COVID

Dec. 18, 2023
By Lee Landenberger
Invivyd Inc.’s VYD-222 produced positive initial top-line results in the ongoing pivotal phase III Canopy study for preventing symptomatic COVID-19. The results could reach a vulnerable population of patients who are immunocompromised and don’t get the same protection as other patients, the company’s CEO, Dave Hering, told BioWorld.
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Regulatory actions for Dec. 12, 2023

Dec. 12, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzamend, Ascendis, Astellas, Basilea, Erasca, Geneuro, GSK, Orchard, Revbio, Shuttle, Skye.
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Regulatory actions for Dec. 7, 2023

Dec. 7, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptimmune, Antengene, CG Oncology, Century, Zhejiang Jingxin, Mymd, Neurocrine, Novartis, Novavax, Optinose, Phathom, PTC, Ractigen, Systimmune.
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Coronavirus, mRNA and syringe

Off-target immune response from modified mRNA impacts future development

Dec. 6, 2023
By Nuala Moran
The Nobel Prize-winning modification that prevents the innate immune system from recognizing injected mRNA as foreign and blocking transcription of the protein it encodes has been found on some occasions to cause ribosomal frameshifting.
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In the clinic for Nov. 30, 2023

Nov. 30, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Alvotech, Asc, Belhaven, Biomx, Bio-Thera, Biovie, Clairvoyant, Cocrystal, Coherus, Dyadic, Entera, Ferring, Halia, Longboard, Olix, Opsido, Oncoresponse, Panbela, Qnovia, Regenxbio, SAB, Sellas, Taysha.
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COVID-19 mRNA vaccine vials, syringe

Japan approves first self-amplifying mRNA COVID-19 vaccine from CSL, Arcturus

Nov. 29, 2023
By Tamra Sami
In a global first, Japan's Ministry of Health, Labor and Welfare has approved CSL Ltd.’s and Arcturus Therapeutics Inc.’s self-amplifying messenger RNA (sa-mRNA) vaccine (ARCT-154) for COVID-19 in adults. The approval marks the first milestone for a November 2022 licensing deal under which CSL subsidiary CSL Seqirus in-licensed Arcturus’ late-stage sa-mRNA vaccine platform technology.
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Regulatory actions for Nov. 29, 2023

Nov. 29, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Arcturus, Arrowhead, Carisma, CSL, Effector, Ethris, Novavax, Orexo, Sernova, Springworks.
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In the clinic for Nov. 29, 2023

Nov. 29, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alpha Tau, Ambrx, Argenx, Erasca, Escient, Exonate, Geneuro, Immunovant, Index, Merck, Nanoviricides, Rallybio, Remegen, Roivant, Skye, Tectonic, Tolremo.
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