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Home » Topics » Infection » Coronavirus

Coronavirus
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Aerosolsense Sampler in waiting room

Thermo Fisher launches SARS-CoV-2 ambient air surveillance system

March 29, 2021
By Mary Ellen Schneider
Thermo Fisher Scientific Inc. has launched a surveillance system that can detect SARS-CoV-2 in ambient air in indoor spaces, providing a potential complement to individual testing and other COVID-19 safety protocols. The system, called the Aerosolsense Sampler, works by capturing a sample of the ambient air on a cartridge using Thermo Fisher’s collection substrate.
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Antibodies block virus from cell

EU sets guidelines for COVID rapid antibody tests

March 29, 2021
By Nuala Moran
LONDON – Getting a handle on the specificity and sensitivity of rapid COVID-19 antibody tests, how they compare to each other and how they should be applied in population screening to understand who has had the virus and how it has spread, has been a source of difficulty and dispute between manufacturers, clinicians and public health experts.
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Regulatory actions for March 29, 2021

March 29, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Helius Medical Technologies, Medtronic, Qiagen, STS Lab.
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Other news to note for March 29, 2021

March 29, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aurora Spine, Batm, Bracco Diagnostics, Cardionavix, Casamba, Coloplast, Escher Biomedical Diagnostics, Health Logic Interactive, Hitachi, Hoya, Lumendi, Meso Scale Diagnostics, Net Health Systems, Orbita, Philips, Vizient.
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Antibody therapies show new benefits for both high and low-risk COVID-19 patients

March 29, 2021
By Michael Fitzhugh
Shares of Humanigen Inc. (NASDAQ:HGEN) leapt 54.5% to $21.61 March 29 on news that its monoclonal antibody, lenzilumab, improved the relative likelihood of survival without mechanical ventilation in hospitalized patients with COVID-19, setting the company up to submit an application for emergency use authorization (EUA) in the U.S. "as soon as possible," it said. Separately, a combination of two monoclonal antibodies, the Eli Lilly and Co.-Abcellera Biologics Inc.-developed therapy bamlanivimab and the Vir Biotechnology Inc.-Glaxosmithkline plc candidate VIR-7831, demonstrated a 70% relative reduction in persistently high SARS-CoV-2 viral load at day seven compared to placebo for low-risk adult patients with mild to moderate COVID-19, the companies reported.
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Regulatory actions for March 29, 2021

March 29, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amryt, Antibe, Bluebird, Bristol Myers Squibb, Celltrion, Henlius, Mezzion, Merck & Co., Mirum, Myovant, Nymox, Paion, Pfizer, Rocket, Samsung, TG, Union, Xenetic.
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Other news to note for March 29, 2021

March 29, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aevi, Alexion, Alkido, Amarin, Aveo, Biohaven, Cardior, Cerecor, Exagen, Immune, Kyowa Kirin, J&J, Kazia, Lineage, Menarini, Millendo, Mitolytix, Moderna, Nippon Shinyaku, Novartis, Pierre Fabre, Royalty Pharma, Simcere, Tempest, Therapeutic Solutions, Valeo, Y-Biologics.
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In the clinic for March 29, 2021

March 29, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adagene, Adamas, Astrazeneca, Bayer, Biohaven, Celldex, Cohbar, Cynata, Daiichi, Destiny, Eli Lilly, Foresee, Gradalis, Gritstone, GSK, GT, Henlius, Humanigen, Hutchison, Immunitybio, Ionis, Medsenic, Neurorx, Orphazyme, Oryzon, Vir.
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Regulatory front

Canada invests in variant research

March 29, 2021
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: Time needed to develop immunity with Sputnik V; CRS: Rutledge opens door to more PBM reforms.
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SARS-CoV-2 illustration turns from blue to red

FDA grants Twist Bioscience and Biotia EUA for capture-based NGS SARS-CoV-2 assay

March 26, 2021
By Annette Boyle
South San Francsico-based Twist Bioscience Corp. and Biotia Inc., of New York, received the first FDA emergency use authorization (EUA) for a capture-based next-generation sequencing (NGS) assay for the coronavirus that causes COVID-19. The technique reduces the likelihood of misdiagnosing or failing to identify mutations compared to standard sequencing.
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