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BioWorld - Sunday, February 8, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for Sept. 28, 2020

Sep. 28, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic, Masimo, Quotient, Zymo Research.
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Doctor signaling timeout

Stop and go at Inovio: Planned phase II/III of COVID-19 vaccine put on partial hold

Sep. 28, 2020
By Lee Landenberger
With only days left before Inovio Pharmaceuticals Inc. planned to initiate a phase II/III trial of its COVID-19 DNA vaccine candidate, INO-4800, and its accompanying delivery device, the FDA placed a partial clinical hold on the company’s study. This is the study’s second delay as the company originally planned to begin in July or August. November is now the earliest potential start date. Inovio told BioWorld that the company and its partners are continuing to prepare for the phase II/III trial “following resolution of the FDA’s partial clinical hold.”
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Bag of euros

Biopharm America: European money spigot wide open in pandemic

Sep. 28, 2020
By Randy Osborne
Wellington Life Sciences general partner Regina Hodits, during a talk with CBT Advisors CEO Steve Dickman at the recent Biopharm America meeting, said the disaster scenario feared for European investments when COVID-19 struck “turned out very different. We never have a lot of time off in summer, not as much as we would want to, but this year we certainly had no time off,” as portfolio firms found money and Wellington tapped new opportunities.
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Regulatory actions for Sept. 28, 2020

Sep. 28, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aligos, Apollomics, Aquestive, Avrobio, Biomed Valley, Cipla, CSL, FSD, Gilead, Glaxosmithkline, Heron, Huya, Inceptua, Inovio, Khondrion, Orchard, Shionogi, Stemedica, Xcures.
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Other news to note for Sept. 28, 2020

Sep. 28, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abeona, Applied Biology, Aqilion, Fibrogenesis, Genetex, Genfit, Immunscape, Iontas, Kiadis, Oragenics, Patrys, Pfizer, Principia, Sanofi, Sojournix, Sosei, Therapeutics Solutions, Visus.
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In the clinic for Sept. 28, 2020

Sep. 28, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aptinyx, Aurinia, Basilea, Covaxx, Covistat, Eiger, Immunic, Innovent, PTC, Sarepta, Sorrento, Tilray, Tilt, Valirx.
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RNA

Blood-based test IDs viral infection before symptoms appear

Sep. 25, 2020
By Meg Bryant
A team of scientists at Duke Health has identified biomarkers that accurately detect viral infections before a person becomes symptomatic. The findings were published in The Lancet Infectious Diseases.
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Regulatory front for Sept. 25, 2020

Sep. 25, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory actions for Sept. 25, 2020

Sep. 25, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Songbird Life Science, Starfish Medical.
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Other news to note for Sept. 25, 2020

Sep. 25, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Artificial Intelligence Defense Platform, Axonics, Biovica, Bose, Establishment Labs, Lambdavision, Medtronic, Nexstim, Puregraft, Space Tango, Todos Medical.
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