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BioWorld - Friday, February 27, 2026
Home » Topics » Infection » Coronavirus

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Regulatory front for Sept. 8, 2020

Sep. 8, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Abbvie, Allergan, Astrazeneca, Calvin Scott, Gedeon Richter, HRA Pharma, Nestle.
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Regulatory actions for Sept. 4, 2020

Sep. 4, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Roche.
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Other news to note for Sept. 4, 2020

Sep. 4, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 54gene, Ascyrus Medical, Cryolife, Ehave, Feinstein Institute, Illumina, Infosys, Kaleidoscope Innovation, Novacyt, Ocular Therapeutix, Organovo, Orthopaedic Innovation Centre, Precipio, T2 Biosystems.
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In the clinic for Sept. 4, 2020

Sep. 4, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Gelesis, Medmira.
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Sputnik V COVID-19 vaccine vials

Early clinical data illuminate Russia’s Sputnik V COVID-19 vaccine

Sep. 4, 2020
By Nuala Moran
LONDON – Results from two non-randomized phase I/II trials of the Russian COVID-19 vaccine Sputnik V that recently received conditional regulatory approval show both a frozen and a freeze-dried formulation of the two-shot vaccine had a good safety profile and induced antibody responses in all 76 participants within 21 days.
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Other news to note for Sept. 4, 2020

Sep. 4, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arcturus, Bioaegis, Curevac, Nanoviricides, Organovo.
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In the clinic for Sept. 4, 2020

Sep. 4, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alligator, Amag, Ampio, Biontech, Blade, Crinetics, Hutchison China Meditech, Lexicon, Mesoblast, Oncopeptides, Relay, Savara.
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Mobiledetect Bio BCC19 test kit

Detectachem wins EUA for rapid COVID-19 test kit

Sep. 3, 2020
By Mary Ellen Schneider
Detectachem Inc. has scored an emergency use authorization (EUA) from the U.S. FDA to market a new molecular RNA test kit for SARS-CoV-2 that provides color-coded results in about 30 minutes.
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Plasma bag

Dueling plasma guidelines a sign of the times

Sep. 3, 2020
By Mari Serebrov
While the emergency use authorization (EUA) the FDA granted Aug. 23 for convalescent plasma remains a political talking point, the agency moved ahead Sept. 2, issuing an updated, immediately effective guidance on the use of convalescent plasma to treat COVID-19 patients in ongoing clinical trials, on an expanded access basis or under the EUA.
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BioWorld MedTech’s Diagnostics Extra for Sept. 3, 2020

Sep. 3, 2020
By Meg Bryant
Keeping you up to date on recent developments in diagnostics, including: A simple point-of-care COVID-19 test; A deep-learning method to predict AMD risk; AP-1 and antidepressant action; Orasure collection device included in Miradx EUA.
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