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BioWorld - Monday, June 15, 2026
Home » Topics » Infection » Coronavirus

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Regulatory front

FDA: COVID-19 shows why diversity needed in trials

Nov. 9, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Other news to note for Nov. 9, 2020

Nov. 9, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akida, Applied UV, Apyx Medical, Cleveland Clinic, Concept Medical, Epic, Orbusneich, P+F, Protec Scientific.
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BioWorld MedTech’s Cardiology Extra for Nov. 9, 2020

Nov. 9, 2020
By Liz Hollis
Keeping you up to date on recent developments in cardiology, including: What is causing COVID-19 blood clots?; Using machine learning to predict survival rates with OHCA; Remote cardiac rehabilitation proves itself.
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Vials on production line

Celltrion shares positive phase I results and plans for anti-COVID-19 antibody CT-P59

Nov. 9, 2020
By Gina Lee
HONG KONG – Incheon, South Korea-based Celltrion Inc. has gleaned positive results in a small early stage trial for its anti-COVID-19 monoclonal antibody CT-P59. The results were presented at the Korean Society of Infectious Diseases’ 2020 fall conference, which took place on Nov. 5.
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Virus and vaccine illustration

Pfizer, Biontech’s top-line gun an elite fighter in COVID-19 vaccines?

Nov. 9, 2020
By Randy Osborne
Enthusiasm stayed high but abated somewhat throughout the day as Wall Street took in the positive interim phase III results from Biontech SE and Pfizer Inc. with the COVID-19 vaccine candidate BNT-162b2.
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Digital illustration of U.S., coronavirus

Biden transition team plans for COVID-19 fight

Nov. 9, 2020
By Mari Serebrov
Preparing for a Biden presidency in which COVID-19 will be a top priority, the Joe Biden-Kamala Harris transition team named a board of scientists and public health experts Nov. 9 to advise the team on how to respond to the surging pandemic in the U.S.
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Regulatory actions for Nov. 9, 2020

Nov. 9, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amo, Astrazeneca, Axovant, Bayer, Beigene, Eusa, Impel, Liminal, Novavax, Orphazyme, Sorrento.
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Other news to note for Nov. 9, 2020

Nov. 9, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apeiron, Applied Therapeutics, Arcturus, Boehringer Ingelheim, Bridge, Cannabics, Capricor Cartox, Cellink, Deciphera, Galmed, GPCR, Homology, Intelgenx, Johnson& Johnson, Lift, Medison, Mybiotics, Nkarta, Ossianix, Oxford Biomedica, Pfizer, Phoremost, Stembiosys, Taigen, Ultragenyx.
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In the clinic for Nov. 9, 2020

Nov. 9, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 9 Meters, American Brivision, Amylyx, Aptevo, Arcturus, Bioarctic, Biomarin, Biontech, BMS, Calliditas, Celltrion, Corvus, Daewoong, EIP, Eisai, Entera Bio, Immunitybio, Inmune, Intellia, Leap, Nevakar, Noxxon, Pfizer, Pierre Fabre, Reata, Regenerx, Synact, Vallon, Viiv.
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Regulatory front

FDA: COVID-19 shows why diversity needed in trials

Nov. 9, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: Final analysis: hydroxychloroquine offers no benefit; FDA finalizes PDUFA VI fee guidance.
Read More
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