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Home » SARS-CoV-2

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

Coronavirus diagnostic test

Quest wins EUA for four-swab pooling via PCR diagnostic; Hahn says ‘important step forward’

July 20, 2020
By Mark McCarty
The U.S. FDA announced July 18 that it has granted an emergency use authorization (EUA) to Quest Diagnostics Inc. for the company’s real-time, reverse transcriptase polymerase chain reaction test for the SARS-CoV-2 virus in a development that FDA commissioner Stephen Hahn described as “an important step forward.”
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Coronavirus and syringes

Three COVID-19 vaccines generate T-cell responses

July 20, 2020
By Nuala Moran
LONDON – There were encouraging results from trials of three COVID-19 vaccines on July 20, with Astrazeneca plc, Biontech SE/Pfizer Inc. and Cansino Biologics Inc. all reporting T-cell responses in ongoing phase I/II studies of their respective products.
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Patient in hospital bed

Synairgen stock rockets as inhaled interferon-beta shows signs of efficacy in COVID-19

July 20, 2020
By Cormac Sheridan
DUBLIN – Synairgen plc has detected what appear to be promising efficacy signals in a phase II trial of its inhaled formulation of interferon-beta 1a, SNG-001, in hospitalized COVID-19 patients.
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Beyond antibodies: T cells are a critical aspect of long-term COVID-19 immunity

July 19, 2020
By Nuala Moran
LONDON – From the start of the pandemic antibodies have been the main focus of attempts to understand the immune response to SARS-CoV-2 and ascertain what it will take for vaccines to be protective.
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BioWorld MedTech’s Neurology Extra for July 17, 2020

July 17, 2020
By Andrea Applegate
Keeping you up to date on recent developments in neurology, including: Phantom-limb pain reduced through brain-computer interface training; Anxiety, depression in COVID-19 patients with loss of smell and taste; HBOT improves cognitive function of older adults.
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Antibodies fighting coronavirus

FDA will need applications, more data for EUA template for neutralizing antibody tests

July 16, 2020
By Mark McCarty
The next phase of testing for the COVID-19 pandemic will hopefully include the roll-out of tests for neutralizing antibodies for the SARS-CoV-2 virus, but there are some roadblocks. The FDA’s Tim Stenzel said the agency has a limited amount of information to offer regarding emergency use authorizations for these tests, a predicament that might not resolve until several applicants are in and the agency can see some information that will aid in development of performance and validation standards.
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Regulatory actions for July 16, 2020

July 16, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3D Med, 7D Surgical, Abiomed, Invo Bioscience, M.I. Tech, Todos Medical.
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Other news to note for July 16, 2020

July 16, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Age Labs, Ambra Health, Cardiva Medical, CHF Solutions, Daxor, Elektron Eye Technology, Elligo, Expesicor, Halberd, Imagin Medical, Invenio Imaging, Perimeter Medical Imaging AI, Orpheus Medica, Perspectum, Qiagen, R.R. Donnelley & Sons, Tegra Medical, Therma Bright, Thermo Fisher Scientific, Topcon Healthcare Solutions, Vystar, Wright Medical Group.
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Adagio leaps into the COVID-19 fray with its monoclonal antibodies

July 16, 2020
By Lee Landenberger
Courtesy of a $50 million series A, Adagio Therapeutics Inc. will join a raft of other companies attempting to end the COVID-19 pandemic with antibodies.
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COVID-19 cyberattack illustration

U.K., U.S., Canada warn of cyberattacks targeting COVID-19 vaccine developers

July 16, 2020
By Nuala Moran
LONDON – Pharmaceutical companies and academic researchers working on COVID-19 vaccines are being targeted by Russian state-sponsored hackers, according to the U.K. National Cyber Security Centre (NCSC). The U.K. view is endorsed by the U.S. National Security Agency and Canada’s Communications Security Establishment, and the three agencies have issued a joint statement advising companies how to protect against these attacks.
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