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BioWorld - Sunday, January 18, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for July 20, 2021

July 20, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Almirall, Aquestive, Astrazeneca, Bluerock, Elucida, G1, Kadmon, Kyowa Kirin, Lyndra, Merck & Co., Oblato, Receptor Life Sciences, Sinovac, Xenikos, Yisheng.
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Other news to note for July 20, 2021

July 20, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affinia, Ambiopharm, Creative Medical, CV Sciences, Creative Biolabs, Enzolytics, Everest Medicines, Eyepoint, Genfleet, Imeka, Inmune Bio, Insilico Medicine, Isa, Meditrust Health, Recce, Selva, Xeris.
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In the clinic for July 20, 2021

July 20, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aronora, Bone, Celsion, Compugen, Cytodyn, Cytokinetics, Frontier, Gilead, Nanoscope, Navidea, Nrx, Prometheus, Receptor Life Sciences, Redhill, Roche, Samsung, Valneva, Vertex, Viiv.
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Antibodies block virus from cell

Aditxt adds neutralizing antibody measurement to COVID-19 immune test

July 19, 2021
By Annette Boyle
Aditxt Technologies Inc. enhanced its immune response test for COVID-19 by adding a high-sensitivity neutralizing antibody quantification. With the expansion, the multidimensional test, Aditxtscore, provides a comprehensive measure of the strength of an individual's immune response to the novel coronavirus.
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Business people with hands atop a digital globe

Mologic acquired by philanthropists to become social enterprise

July 19, 2021
By Nuala Moran
LONDON – U.K. rapid diagnostics specialist Mologic Ltd. has been acquired by a group of philanthropists led by George Soros’ Economic Development Fund and the Bill & Melinda Gates Foundation, and will be turned from a for-profit company to a social enterprise. The aim is to use the change in status to expand access to low-cost point-of-care testing for tropical diseases, including dengue, bilharzia and river blindness, as well at COVID-19. The name Mologic will be changed to Global Access Health (GAH), with the philanthropic owners saying they are to invest at least $41 million in the deal.
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Regulatory actions for July 19, 2021

July 19, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astellas, Eli Lilly, Fibrogen, Hutchmed, Kintor.
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Other news to note for July 19, 2021

July 19, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 9 Meters, Aluda, Aridis, Ascentage, Astrazeneca, Biontech, Biovie, Brooklyn, Celltrion, CN, Contrafect, Effector, Eluminex, Factor, Fibrogen, Green Cross, Ibio, Ipsen, Irlab, Lobesity, Lonza, Nasus, Novellus.
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In the clinic for July 19, 2021

July 19, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alexion, BMS, Corvus, GSK, Innovent, Merck, Mesoblast, Orexo.
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FDA website and logo

FDA class I medical device recalls on track to break record in 2021

July 16, 2021
By Ana Mulero
Following the temporary lapse in FDA inspections of manufacturing sites amid the COVID-19 pandemic, this year has already seen more class I medical device recalls issued than in all of 2020. The agency is now working to remediate the interruptions resulting from the pandemic among certain manufacturers of high-risk medical devices in reporting these recalls to the FDA.
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IPO, coins, financial chart

SD Biosensor makes KOSPI debut, aims to expand both portfolio and global presence

July 16, 2021
By Gina Lee
SD Biosensor Inc. made a splash in its KOSPI board debut on July 16, raising a total ₩776.4 billion (US$679.26 million). The company will now use the funds to mass-produce and promote the company’s diagnostic machines for various indications, including COVID-19.
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