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Home » SARS-CoV-2

Articles Tagged with ''SARS-CoV-2''

Gloved hand holding COVID-19 vaccine vial, syringe

BIO Digital: COVID-19 vaccines outlook offers reasons for hope, concern

June 10, 2020
By Michael Fitzhugh
Threads of hope and caution stitched together a wide-ranging appraisal of COVID-19 vaccines at June 9's BIO Digital plenary, "A Way Forward." The good news, delivered by one of the world's most sober participants in the pandemic response, mercifully came first.
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Regulatory actions for June 9, 2020

June 10, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4web Medical, Atomic Blue, Dexcom, Hangzhou Biotest Biotech, Incelldx, Seasun Biomaterials, Sekisui Diagnostics, Vasoptic Medical.
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Digital illustration of U.S., coronavirus

U.S. federal government eyes private sector role in strategic stockpile management

June 9, 2020
By Mark McCarty
Rear Admiral John Polowczyk, vice director of logistics for the Joint Chiefs of Staff, said in a Senate hearing that the one solution to managing pandemic supplies might be to use federal taxpayer dollars to sustain inventories in private-sector warehouses.
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Other news to note for June 9, 2020

June 9, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agios Pharmaceuticals, Applied DNA Sciences, Biosensors International, Blue Sail Medical, Cepheid, Cytosorbents, Endovantage, Gene-IQ, Isoplexis, Makemedical, Mallinckrodt, Naglreiter Consulting, Nvt, RapidAI, Thermo Fisher, Titan Medical, Veracyte, Xoran Technologies.
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Regulatory actions for June 8, 2020

June 8, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chembio Diagnostics, Edwards, Genetron Health, Laminate Medical Technologies, Nuvaira, Surmodics.
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Regulatory front for June 5, 2020

June 5, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory actions for June 5, 2020

June 5, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Medtronic, Opti Medical Systems.
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Hydroxychloroquine prescription bottle
‘Unequivocal evidence’

Study shows no clinical benefit with hydroxychloroquine in hospitalized COVID-19 patients

June 5, 2020
By Nuala Moran
LONDON – After all the controversy and a huge dose of hype, there is no clinical benefit from the use of hydroxychloroquine in patients admitted to the hospital with COVID-19, according to headline data from a large randomized trial of potential drugs for the infection currently running in the U.K.
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FDA’s Stenzel says standards for molecular tests for SARS-CoV-2 a good approximation for NGS testing

June 3, 2020
By Mark McCarty
The latest U.S. FDA town hall for testing for the COVID-19 included a few updates on serological testing, but perhaps the most important take-away was when Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiology, advised attendees that performance expectations regarding next-generation sequence (NGS) testing for the SARS-CoV-2 virus will closely resemble those of conventional molecular testing.
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Woman using Human-on-a-Chip system

Hesperos' Human-on-a-Chip system provides insight on immune response in COVID-19

June 3, 2020
By Annette Boyle
Hesperos Inc.'s Human-on-a-Chip in vitro system demonstrated two types of responses of the immune system in a study conducted with Hoffman-La Roche Pharmaceuticals and the University of Central Florida.
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