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

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Regulatory actions for Sept. 16, 2020

Sep. 16, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AVM, Cura, Mateon, Mediwound, Orphazyme.
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Other news to note for Sept. 16, 2020

Sep. 16, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 4TEEN4, 7 Hills, About, Accustem, Allist, Bioclonetics, Cantabio, Dr. Reddy’s, Enzolytics, Greenlight, Havn, Histogen, Hookipa, Inflammasome, Inmune, Janone, Nanoviricides, Octimet, Oncbiomune, Pfizer, Poseida, Revive, Revolution, Seqirus, Springworks, Synaffix, Tiziana, Transcenta, Yufan.
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In the clinic for Sept. 16, 2020

Sep. 16, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adrenomed, Aim Immunotech, Algernon, Arcutis, Arena, Arrowhead, Aveo, Eli Lilly, Exicure, Galera, Genelux, Heron, Horizon, Immune-Onc, Knopp, Menarini, Ryvu, Springworks, Verastem, Verona.
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SARS-CoV-2, neutralizing antibody diagram

Siemens Healthineers leads effort to define COVID-19 immunity with CDC, JRC

Sep. 15, 2020
By Annette Boyle
Siemens Healthineers AG snagged a key role in the mystery playing out across the world's pandemic stage – what do antibody test results mean in terms of immunity to SARS-CoV-2 and how do different tests assessing different proteins compare? The U.S. CDC and the Joint Research Centre (JRC) of the European Commission tapped the Erlanger, Germany-based company to take the lead in developing a process to standardize antibody assays.
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Regulatory actions for Sept. 15, 2020

Sep. 15, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerapedics, Controlrad, Eurobio Scientific, Fibralign, GE Healthcare, Genmark Diagnostics.
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Other news to note for Sept. 15, 2020

Sep. 15, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anpac Bio-Medical Science, Apple, Bostongene, Cardiacsense, Chest Foundation, Concept Medical, Controlrad, Fujifilm Sonosite, Genetic Technologies, Global Plasma Solutions, Illumina, Movendo, Nihon Kohden, Palisade, Polyganics, Sherlock Biosciences, Ursa Health, Visage, Welldoc.
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U.S. vaccine illustration

U.S. vaccine plan can’t be just about COVID-19

Sep. 15, 2020
By Mari Serebrov
What’s the plan? The U.S. CDC is being asked that question a lot these days – not just about COVID-19, but also about preparing for what could be a tough influenza season as flu bugs circulate with the coronavirus.
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Regulatory front

FDA releases guidance on COVID-19, geriatric labeling, EoE

Sep. 15, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: NIH adds funding to Latino Alzheimer’s research; Sprout warned for Addyi promotion; Scripps to pay $10M over use of NIH grants.
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Regulatory actions for Sept. 15, 2020

Sep. 15, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerie, Amryt, Apellis, Ardelyx, Astrazeneca, BMS, Boehringer, Epimab, Equillium, Gensight, Gilead, Kiniksa, Lilly, Mateon, Matinas, Novartis, Plus, Takeda, Zynerba.
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Other news to note for Sept. 15, 2020

Sep. 15, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adicet, Alimera, Anelixis, Applied Stemcell, Axovant, Bayer, Biontech, BMS, Bostongene, C3.ai, Cell and Gene Therapy Catapult, Cellinta, Combigene, Corino, Cullinan, Cue, ERS Genomics, Exelixis, Fosun, Genexine, Humanigen, Iconic, Innovation Pharma, Kiadis, Mabion, Medis, Melior, Mindset, Miragen, Momenta, Mylan, Novavax, Novus, Obsidian, Oligomerix, Pfizer, Protokinetix, Restorbio, Serum Institute of India, Soligenix, Systems Oncology, Teva, Tonix, Vaxine.
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