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BioWorld - Friday, December 19, 2025
Home » Topics » Infection » Coronavirus

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Regulatory actions for May 1, 2020

May 1, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bio-Rad, Quotient, Scibase.
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Other news to note for May 1, 2020

May 1, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adeptrix, Avacta Group, Babson Diagnostics, Biolife Solutions, Biosig Technologies, Co-Diagnostics, Dermtech, Ipsum Diagnostics, Omega Bio-tek, Quantumdx Group Tandem Diabetes Care, Trinetx, Viewray.
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EU flag and pills
Rolling with remdesivir

EMA begins remdesivir review, as CHMP recommends eight new meds for approval

May 1, 2020
By Michael Fitzhugh
The EMA's Committee for Medicinal Products for Human Use said Friday it has started a rolling review of Gilead Sciences Inc.'s antiviral, remdesivir, for the potential treatment of COVID-19. The move put into play one of multiple regulatory tools it has deployed "to speed up the assessment of a promising investigational medicine during a public health emergency."
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Antibodies fighting coronavirus

Bio-Rad receives FDA emergency use go-ahead for COVID-19 total antibody test after submission

May 1, 2020
By Stacy Lawrence
Bio-Rad Laboratories Inc. has launched its SARS-CoV-2 Total Ab test, which is a blood-based assay to identify all the antibodies that are developed by the human body in response to the novel coronavirus SARS-CoV-2. Companies have been racing to offer serological tests that work to detect the antibodies developed during a COVID-19 infection that remain present in the blood after the initial infection clears.
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Regulatory front for May 1, 2020

May 1, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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Other news to note for May 1, 2020

May 1, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ADC, Agex, Aradigm, Bixink, Coimmune, Enzychem, Evergreen, Formula, Gilead, Inovio, Lixte, Lonza, Moderna, Oxford Biodynamics, Puma, Teva, Vivus, Xbiotech.
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In the clinic for May 1, 2020

May 1, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ADC, Akari, Astrazeneca, Athersys, Azurrx, BMS, Calcimedica, Eiger, Flexion, Ipsen, Kubota, Lilly, Merck, Novartis, Synairgen, TG.
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Coronavirus punch

Youth involvement, tech startups and AI at the heart of Pakistan’s coronavirus fight

April 30, 2020
By Khawar Khan
KARACHI, Pakistan – With limited resources, a growing outbreak and a tech savvy population, Pakistan is reaching into a diverse bag of tricks to find ways to battle COVID-19. Part of these efforts include at least one artificial intelligence (AI)-based diagnostic product as well as molecular diagnostic assays.
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Hologic infographic on Panther system integrated testing

Hologic to launch Aptima molecular assay to help in COVID-19 fight

April 30, 2020
By Liz Hollis
Hologic Inc., of Marlborough, Mass., is introducing another tool to help combat COVID-19, revealing the impending launch of a new Aptima molecular assay to detect the SARS-CoV-2 virus that will run on its Panther system. The company expects to be able to provide its lab customers with about 3 million Aptima tests next week. In addition, it anticipates producing about 1 million tests a week starting late next month.
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1QBit-xrAI-Chest-X-ray-Abnormal.png

Health Canada accelerates approval of AI-driven COVID-19 tool

April 30, 2020
By David Godkin
TORONTO – Within a week of completing clinical trials the chest radiography AI tool developed by Vancouver, B.C.-based 1Qbit Inc. has been given the all-clear from Health Canada for deployment across the country. The XrAI was originally developed to better identify patients with respiratory illness including SARS, pneumonia and tuberculosis (TB), but then in February was tested on a publicly available data set of COVID-19 X-ray images.
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