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BioWorld - Friday, January 9, 2026
Home » Topics » Infection » Coronavirus

Coronavirus
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Regulatory actions for Nov. 23, 2020

Nov. 23, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anixa, Arca, Ascentage, Biontech, Brainever, Eiger, Genentech, Hillstream, Innovent, Kiniksa, Lilly, Merck, Neurelis, Onconova, Pfizer, Regeneron, Rigel, Sanofi, Theralase, VBI.
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Other news to note for Nov. 23, 2020

Nov. 23, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3Sbio, Actimed, Amgen, Aquestive, Argenx, Artelo, Bintai Kinden, Biogen, BMS, Connectyx, Curevac, Cytokinetics Selecta, Fairjourney, Generex, Halozyme, Hifibio, Horizon, Immunitybio, Iontas, Immunoprecise, Ligand, Minaris, Mustang, Nantkwest, Novellus, Pandion, Persephone, Pharmsynthez, Pierre Fabre, Poseida, SID Immunotech, Schrödinger, Sotira, Tempus, Teneobio, Tracon, Twist, Wacker, Y-biologics.
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In the clinic for Nov. 23, 2020

Nov. 23, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 3Sbio, Algernon, Arcutis, Astrazeneca, Bellerophon, Bioshin, Cytodyn, Dnatrix, Eisai, Faron, Gemvax & Kael, Idorsia, IGC, Immunocore, Imugene, Innovent, Inovio, Karyopharm, Maplight, Molecular Partners, Neurana, Pfizer, PMV, Silicon Therapeutics, Saniona, Selecta, Syndevrx.
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Astrazeneca’s COVID-19 vaccine shows 70% efficacy on average, 90% with prime-boost regimen

Nov. 23, 2020
By Nuala Moran
LONDON – A third COVID-19 vaccine has turned in positive results in the phase III interim analysis, with Astrazeneca plc/Oxford University reporting an average of 70.4% efficacy across two dose regimens for AZD-1222.
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One step at a time: FDA issues EUA for Lilly’s COVID-19 therapy

Nov. 20, 2020
By Lee Landenberger
In what the FDA calls “an incremental step” in treating hospitalized COVID-19 patients, the agency has issued an emergency use authorization (EUA) for Eli Lilly and Co.’s baricitinib in combination with remdesivir.
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Other news to note for Nov. 20, 2020

Nov. 20, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aspira Women’s Health, Butterfly Network, Crh Medical, Dermtech, GE Healthcare, Ganymed Robotics, Healthverity, Interpace Biosciences, Intraop Medical, Invitae, Kaiser Permanente, Longview, Medidata, Neurodigitx, Ortho Clinical Diagnostics, Pathofinder, Prismatic Sensors, Progenity, Proscia, Spacelabs Healthcare, Vivos.
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Remdesivir vial and syringe

WHO recommends against use of Gilead's Veklury for COVID-19

Nov. 20, 2020
By Michael Fitzhugh
Citing a lack of evidence that it improves survival, the need for ventilation or time to clinical improvement, the World Health Organization (WHO) has advised doctors against using Gilead Sciences Inc.’s antiviral Veklury (remdesivir) to treat COVID-19.
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Scientist injecting vaccine into Earth
How well will they work?

Confidence in ‘spectacular’ COVID-19 vaccine trial wins resonant among experts

Nov. 20, 2020
By Michael Fitzhugh
In a world more familiar with the 30% to 70% efficacy rates of seasonal flu vaccines, news of 95% efficacy rates for two of the major late-stage COVID-19 vaccines in development seems thrilling. But do such robust-sounding numbers, the product of relatively early analyses, really merit the enthusiasm they’ve garnered?
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Regulatory front

Former Mimedx CEO, COO convicted on fraud, conspiracy charges

Nov. 20, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory actions for Nov. 20, 2020

Nov. 20, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, Alexion, Amgen, Astrazeneca, Beigene, Biontech, Eli Lilly, Gilead, Immupharma, Pfizer.
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