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BioWorld - Monday, July 6, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for May 4, 2021

May 4, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Carmot, Clarity, Eli Lilly, Hutchmed, Immunomet, Newron, Pfizer, Quercis, R-Pharm Germany, Siga Technologies, Viiv Healthcare.
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Other news to note for May 4, 2021

May 4, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcellera, Abpro, Alligator, Aphios, APR, Aria, Astrazeneca, Aura, Bioarctic, Biocartis, Cartesian, CSL, Edgewise, Effector, Enesi, Esteve, Evotec, Exelixis, Gain, Gamamabs, Gemini, Gensight, Hcmed, Hoth, Hutchmed, Immunicum, J&J, Kowa, Lilly, Logicbio, Moderna, Moonlake, Merck KGaA, Nflection, Novobiome, Ocugen, Plus, Proqr, Recce, Relief, Samsung Bioepis, Sesen, Stoke, Twoxar, Xoma, Yarrow.
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In the clinic for May 4, 2021

May 4, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arch, Biolinerx, Checkmate, Cytokinetics, Cyxone, Genprex, HDT Bio, Ichnos, Immunitybio, Kiniksa, Merus, Obseva, Revolo, Rezolute, Tarsus, Vaxart, Verona.
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Phlebotomist draws blood from patient

Celltrion wins European approval for ELISA COVID-19 test kit

May 3, 2021
By Gina Lee
HONG KONG – Celltrion Inc. has received the European CE mark for Tekitrust, its COVID-19 tests kit developed with Mico Biomed Co. Ltd. “Mico, which is a diagnostic device specialist, partnered with Celltrion to combine both companies’ strengths in the test kit sector,” a Celltrion spokesperson told BioWorld. Mico will manufacture the kits, while Celltrion handles marketing and sales.
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Pfizer-Biontech COVID-19 vaccine vial

Single dose of Pfizer vaccine not strong enough against variants, U.K. study shows

May 3, 2021
By Nuala Moran
LONDON – A single dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine does not promote a strong enough immune response to provide protection against variants of SARS-CoV-2, including the Kent variant B.1.1.7, which as of April 29 had caused 226,635 confirmed infections in the U.K.
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Other news to note for May 3, 2021

May 3, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Canon Medical Systems USA, Closedloop.ai, Cradle Genomics, Echelon Diagnostics, Ocular Therapeutix, Precipio, Raysearch Laboratories.
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Regulatory actions for May 3, 2021

May 3, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advicenne, Amicus, Avrobio, Astrazeneca, Camurus, Chiesi, Clearside, Galmed, Intra-Cellular, Jacobio, Moderna.
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Other news to note for May 3, 2021

May 3, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Actuate, Biovaxys, Cocrystal, Enteris, Esteve, Gain, Gemini, Gensight, Hoth, Immunicum, J&J, Kowa, Lantern, Moderna, Moonlake, Merck KGaA, New Life, Ocugen, Revive, Samsung Bioepis, Sonnet, Tryp, Xoma.
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In the clinic for May 3, 2021

May 3, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Aeglea, AGTC, Alnylam, Biogen, BMS, Eiger, Cabaletta, Denali, Jcyte, Lilly, Lineage, Mallinckrodt, Novan, Novartis, Novavax, Regulus, Repare, Sandoz, Sarepta, Seqirus, Sunovion, Xenothera, Zealand.
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Other news to note for April 30, 2021

April 30, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arup Laboratories, Conventus-Flower, Cynosure, Evon Medics, Genome Medical, Midiagnostics, Myellevate, Patientsafe Solutions, Red One Medical, Specific Diagnostics, Techcyte, Vocera.
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