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BioWorld - Thursday, July 2, 2026
Home » Topics » Infection » Coronavirus

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Regulatory front

TGA hits company for violative imports

Nov. 23, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Other news to note for Nov. 23, 2020

Nov. 23, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ambu, Aridea Solutions, Beckman Coulter, Becton Dickinson, Compugroup Holding, Emds, Exactech, GE Healthcare, Halozyme Therapeutics, Horizon Therapeutics, Inovytec, Intalere, Lifelabs, Richardson RFPD, Solace Therapeutics, Theralase Technologies, Vitalconnect.
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Antibodies fighting coronavirus

FDA grants EUA to Regeneron's antibody treatment for COVID-19

Nov. 23, 2020
By Michael Fitzhugh
An antibody cocktail developed by Regeneron Pharmaceuticals Inc. has received emergency use authorization (EUA) from the FDA for the treatment of mild to moderate COVID-19. Monoclonal antibodies (Mabs) such as Regeneron's, called casirivimab and imdevimab, "have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load," the company said.
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Merck’s COVID-19 coalition grows with Oncoimmune acquisition

Nov. 23, 2020
By Lee Landenberger
With its acquisition of privately held Oncoimmune Ltd. for an up-front $425 million in cash, Merck & Co. Inc. ups its COVID-19 game with CD24Fc, a recombinant fusion protein targeting the innate immune system that is faring well in treating pandemic patients.
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FDA icons

COVID-19 pandemic delays FDA approvals, causes CRL

Nov. 23, 2020
By Brian Orelli
Multiple companies have had their FDA reviews put on hold because coronavirus-related travel restrictions at the FDA has kept their manufacturing plants from being inspected.
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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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