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BioWorld - Thursday, February 5, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for March 11, 2021

March 11, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Berlin Heart, Canam Scientific, Clordisys Solutions, Sd Biosensor, Zymo Research.
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Other news to note for March 11, 2021

March 11, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Alafair Biosciences, Barm Advanced Communications, Bioventus, Certara, Ibex Medical Analytics, Integrated DNA Technologies, Iridex, Ligolab, Merit Medical Systems, Mevion Medical Systems, Microbix Biosystems, Mission Bio, MVP Health Care, Nemaura Medical, Perflow Medical, Persephone Biosciences, Proscia, Rhinostics, Roche, Shanghai Focus Healthcare, Swift Biosciences, Teleflex.
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GM-CSF

Immune response research shows GM-CSF plays role in COVID-19 severity

March 11, 2021
By Nuala Moran
LONDON – The largest study of its kind to date has identified new biomarkers of inflammation that are both indicators of severe COVID-19 infection and distinguish it from severe influenza.
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Coronavirus and antibodies

‘Profound efficacy’ for the Vir-GSK COVID-19 antibody prompts EUA talk as Roche-Gilead fails

March 11, 2021
By Lee Landenberger
Positive COVID-19 efficacy numbers from Vir Biotechnology Inc. and Glaxosmithkline plc (GSK) has prompted them to immediately seek an emergency use authorization (EUA) with the FDA and similar authorizations in other countries for their monoclonal antibody, VIR-7831. Meanwhile, the phase III Remdacta study of Actemra/RoActemra (tocilizumab) plus Veklury (remdesivir) vs. placebo plus Veklury, from Roche Holding AG and Gilead Sciences Inc., missed its primary endpoint in treating hospitalized patients with severe COVID-19 pneumonia receiving standard of care.
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Regulatory actions for March 11, 2021

March 11, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Astellas, Aveo, Biocryst, Biohaven, Bioxcel, Denali, Eli Lilly, J&J, Kadmon, Longeveron, Marius, Nouscom, Nuvation, RDIF, Spectrum.
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Other news to note for March 11, 2021

March 11, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aeterna Zentaris, Annovis, Betterlife, Biontech, Biovectra, Blanver, Certara, Farmacore, Formosa, Glaxosmithkline, Hoth, Interna, Neonmind, Orgenesis, PDS, Phasebio, Pfizer, Reprocell, Sosei Heptares, Vistagen.
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In the clinic for March 11, 2021

March 11, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aelix, Algernon, Biohaven, Bioventus, Entera, Evgen, Formosa, Genentech, Gilead, GSK, Kintor, Marinomed, Moderna, Novartis, Renibus, Rigel, Roche, Sosei, Sun, Transgene, Vicore, Vir.
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Smartwatch on wrist next to smartphone with Empatica Care app on screen

Empatica wins CE mark for wearable-based early symptoms detection of COVID-19

March 10, 2021
By Meg Bryant
MIT Media Labs spinoff Empatica Inc. secured the CE mark for its Aura system, a wearable solution for the monitoring and early alert of respiratory infections, including COVID-19. For use with people 14 and older, Aura is commercially available in Europe and the U.K., and for pilot purposes in the U.S. – pending FDA authorization. Aura’s algorithm analyzes vital signs from Empatica smartwatches, comparing data against the wearer’s historical baselines. In validation studies, Aura was able to detect patients with possible H1N1 influenza, rhinovirus or SARS-CoV-2 infection with 0.94 sensitivity. Detection occurred on average two days after infection.
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Regulatory actions for March 10, 2021

March 10, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akesis, Breath Direct, Clew, Datar Cancer Genetics.
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Other news to note for March 10, 2021

March 10, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abingdon Health, Agena Bioscience, Alliance Global, Amazon, Biosure UK, Brainlab, Cobius Healthcare Solutions, Corrona, Embody, Emitbio, Empowerdx, Empower Clinics, Eurofins, Flowmetric, Innova Medical Group, Konica Minolta, Liveperson, Medx Health, Mint Medical, Mro, Nanox, Nowrx, Onduo, Opendoctor, Philips, Revbio, Seqonce Biosciences, Spectrum Health, Sterigenics, Thermo Fisher Scientific, Tytocare, Uromedica.
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