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Home » SARS-CoV-2

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

Other news to note for May 26, 2020

May 26, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Activstyle, Adapthealth, Astrazeneca, Bio-Techne, Cerus, Echelon Diagnostics, Emed Technologies, Genscript Biotech Europe, Histoindex, IBM Watson Health, Koru Medical Systems, Leica Biosystems, Mauna Kea Technologies, Mesa Labs, Repro Med Systems, Seti, Siemens Healthineers, Skywater Solara Medical Supplies, St Robotics, Velano Vascular, Vizient.
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Gloved hand holding COVID-19 vaccine vial, syringe

Merck bets on viral vector vaccine platforms, plus oral antiviral, in three-way COVID-19 push

May 26, 2020
By Cormac Sheridan
DUBLIN – Merck & Co. Inc. is placing two separate bets on recombinant viral vector technology in a broad effort to tackle COVID-19, in which it is also in-licensing a small-molecule antiviral drug. Kenilworth, N.J.-based Merck is acquiring Austrian vaccine developer Themis Bioscience GmbH in a move that propels the latter firm’s COVID-19 vaccine program to the front ranks of the industry pipeline. It is entering a COVID-19 vaccine development collaboration with the not-for-profit vaccine research organization IAVI.
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U.S. FDA headquarters

FDA says 28 serology tests withdrawn or pulled from availability in the U.S.

May 22, 2020
By Mark McCarty
The U.S. FDA reported that 28 serology tests for antibodies for the SARS-CoV-2 virus either have been withdrawn from the market by the sponsor or delisted by the agency for failure to comply with its notification process for emergency use authorization (EUA). The agency said the list of unavailable tests will be updated over time. For his part, Commissioner Stephen Hahn said the move was undertaken “to ensure that Americans have access to trustworthy tests.”
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Other news to note for May 22, 2020

May 22, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avra, Cls Laserthermia Systems, Infinite Mind, Kahala Biosciences, Orasure, Osang Healthcare, Ra Medical, Rymedi, SG Blocks, Tiziana.
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In the clinic for May 22, 2020

May 22, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott.
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3D illustration of virus with RNA inside

Mammoth Biosciences, GSK team up on CRISPR-based COVID-19 test

May 22, 2020
By Meg Bryant
Mammoth Biosciences Inc., of South San Francisco, and London-based Glaxosmithkline plc (GSK) have joined forces to develop a point-of-care test to detect active COVID-19 infections using Mammoth’s CRISPR-based DETECTR platform. The two companies hope to submit an application to the U.S. FDA for emergency use of the test before the end of the year.
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FDA icons

FDA says pandemic device shortage policy applies to increase in demand even if supply unchanged

May 21, 2020
By Mark McCarty
The pandemic-driven FDA guidance for device shortages addressed a topic that has been discussed for devices for some time despite lack of congressional action, but shortages may be ordinarily interpreted as a consequence of reduced or terminated production that crimps supplies. That interpretation has been expanded for the duration of the COVID-19 pandemic, however, to include circumstances in which demand exceeds supply even when the manufacturer sustains normal production levels, in which case the manufacturer is liable for reporting the shortage to the FDA.
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3D illustration of virus with RNA inside

Mammoth Biosciences, GSK team up on CRISPR-based COVID-19 test

May 21, 2020
By Meg Bryant
Mammoth Biosciences Inc., of South San Francisco, and London-based Glaxosmithkline plc (GSK) have joined forces to develop a point-of-care test to detect active COVID-19 infections using Mammoth’s CRISPR-based DETECTR platform. The two companies hope to submit an application to the U.S. FDA for emergency use of the test before the end of the year.
Read More

Regulatory front for May 21, 2020

May 21, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Cytosorbents.
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Regulatory actions for May 21, 2020

May 21, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomérieux.
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