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BioWorld - Sunday, May 17, 2026
Home » Topics » Infection » Coronavirus

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Regulatory front for Jan. 28, 2021

Jan. 28, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Krishnamoorthi eyes ventilator contract; TGA fines company for failure to provide masks; U.S. PPE hoarder indicted; CAP supports Defense Production Act; South African variant in U.S.; GAO: More needs to be done to respond to COVID-19; Biden orders review of scientific-integrity policies.
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Regulatory actions for Jan. 28, 2021

Jan. 28, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Medtech, DNA Genotekm, Global Instrumentation, Perspectum.
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Other news to note for Jan. 28, 2021

Jan. 28, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adeptrix, Ancora Heart, Avacta Group, Biovaxys Technology, Bruker, Co-Diagnostics, DNA Script, Eurofins, Global Wholehealth Partners, Imaginab, Konica Minolta, Livongo, Medovate, Moda Health, Neurolief, Neuvogen, Nirmidas, Olympus, Omniseq, Omnixon, Precipio, Quest Photonic Devices, Reliq Health Technologies, Sawai, Seqonce Biosciences, Spt Labtech, Teladoc, Thermo Fisher Scientific, Vital.
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Shionogi grants U.S., U.K. and European rights for COVID-19 treatment to Bioage

Jan. 28, 2021
By David Ho and Gina Lee
HONG KONG – Osaka, Japan-based Shionogi & Co. Ltd. has inked a license agreement with Bioage Labs Inc. that sets the stage for the Richmond, Calif.-based startup to test asapiprant, originally developed for allergic rhinitis, for the treatment of COVID-19 and age-related declines in immune function.
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Regulatory front

GAO: More needs to be done to respond to COVID-19

Jan. 28, 2021
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: Biden orders review of scientific-integrity policies; Canada to build rare disease drug strategy; South African variant in U.S..
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Regulatory actions for Jan. 28, 2021

Jan. 28, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Bio-Thera, Harbour, Immunoforge, Kintor, M6P, Opko, Passage, Pfizer.
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Other news to note for Jan. 28, 2021

Jan. 28, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aeterna Zentaris, Applied Genetic Technologies, Asahi, Askbio, Betterlife, Brain Neuropathy Bio, Cosmo, Cybrexa, Eli Lilly, Genocea, Hoth, Imaginab, Laboratoires Thea, Liminal, Mydecine, Neuvogen, Nevakar, Provention, Redhill, Scisparc, Therapix, Valneva.
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In the clinic for Jan. 28, 2021

Jan. 28, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alkahest, Amgen, Appili, Ayala, Azurrx, Beigene, Bioinvent, Catalym, Dimerix, Evotec, Eyepoint, Follicum, Hemostemix, Immunitybio, Kura, Medicure, Omniseq, Phasebio, Prilenia, Takeda, United, Valneva, Zymeworks.
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Other news to note for Jan. 27, 2021

Jan. 28, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Artio Medical, CDx Diagnostics, Dexcom, Electrocore, Everside Health, Freedom Fries, Gatc Health, Heartflow, Infinitt Healthcare, Invo Bioscience, Janssen, Liquid Biosciences, Lunit, Medsential, Microbot Medical, Mymedleads, Nextech Systems, One Codex, Osteopore International, Philips, Ra Medical Systems, Soterix Medical, Spectrum, Theralink, Transnetyx, Triple Ring Technologies, Valcare Medical, Verana Health.
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Coronavirus vs U.S. wrecking balls

Potential for loss of sensitivity a key issue for FDA for testing for SARS variants

Jan. 27, 2021
By Mark McCarty
The SARS-CoV-2 virus has now had ample time to mutate, as reports of the proliferation of multiple variants make clear, and the U.S. FDA’s Tim Stenzel said the agency is now focused on three variants, including one recently reported from Israel. Stenzel said on the latest COVID-19 testing town hall that one of the key concerns regarding existing authorized tests is the potential for loss of sensitivity, a problem the agency hopes to overcome without the use of live virus.
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