Biotechnology | COVID-19 | FDA
Quidel’s QuickVue At-Home OTC COVID-19 Test received EUA for screening use with serial testing
On Mar. 31, 2021, Quidel announced that it had received an Emergency Use Authorization (EUA) from the FDA,…
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Pfizer-BioNTech announced positive topline results of pivotal COVID-19 vaccine study in adolescents
On Mar. 31, 2021, Pfizer and BioNTech announced that, in a Phase 3 trial in adolescents 12 to…
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T cells recognize recent SARS-CoV-2 variants
On Mar. 30, 2021, the National Institute of Allergy and Infectious Diseases (NIAID) announced that researchers had analyzed…
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OraSure Technologies submitted COVID-19 rapid antigen prescription home self-test to FDA for EUA
On Mar. 30, 2021, OraSure Technologies announced that it had submitted an application to the U.S. Food and…
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Qx Therapeutics received FDA authorization with IND for QXT-101 in phase 2 trial for patients with COVID-19 infection.
On Mar. 30, 2021, Qx Therapeutics announced that the FDA had cleared the companyﾒs Investigational New Drug application…
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CytoDyn’s leronlimab decreased mortality at 14 days by 82% amongst critically Ill COVID-19 patients
On Mar. 30, 2021, CytoDyn announced further results from its CD12 trial of severe-to-critically ill patients with COVID-19….
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Oxford University researchers released cheap, quick COVID-19 antibody test
On Mar. 29, 2021, an international research team led by Oxford University scientists announced they had developed a…
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Humanigen reported positive phase 3 results demonstrating Lenzilumabﾙ improved survival without mechanical ventilation with COVID-19
On Mar. 29, 2021, Humanigen announced positive topline results from its Phase 3 clinical trial evaluating the efficacy…
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Moderna announced shipment of 100 millionth dose of its COVID-19 vaccine to the U.S. Government
On Mar. 29, 2021, Moderna announced that the Company has shipped the 100-millionth dose of its COVID-19 vaccine…
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GSK to manufacture Novavax’ COVID-19 vaccine
On Mar. 29, 2021, Novavax, GSK and the UK Government Vaccines Taskforce announced an agreement in principle to…
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Johnson & Johnson announced agreement with African Vaccine Acquisition Trust for COVID-19 vaccine candidate
On Mar. 29, 2021, Janssen Pharmaceutica announced that it had entered into an agreement with the African Vaccine…
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Philippines FDA approved the use of leronlimab to treat a COVID-19 patient
On Mar. 29, 2021, CytoDyn announced that the Republic of the Philippines, Department of Health, Food and Drug…
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BioNTech updated on vaccine production status at Marburg manufacturing site
On Mar. 26, 2021, BioNTech announced that the European Medicines Agency (EMA) approved the manufacturing of the COVID-19…
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Scientists found evidence that novel coronavirus infects the mouth’s cells
On Mar. 25, 2021, an international team of scientists announced they had found evidence that SARS-CoV-2 infects cells…
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Clover Biopharma and Dynavax announcd first participants dosed in phase 2/3 trial for COVID-19 vaccine candidate
On Mar. 24, 2021, Clover Biopharmaceuticals and Dynavax Technologies announced the first participants have were dosed in Clover’s…
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COVID-19 | Diagnostics | FDA
AXIM Biotechnologies’ partner Empowered filed EUA with FDA for use of rapid COVID-19 neutralizing antibody test
On Mar. 24, 2021, AXIM Biotechnologies announced that partner Empowered Diagnostics, had filed an Emergency Use Authorization or…
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Phase III data showed investigational antibody cocktail reduced hospitalisation or death in patients with COVID-19
On Mar. 23, 2021, Roche confirmed positive topline results from the largest trial to date assessing a COVID-19…
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FDA issued an EUA to the Twist Bioscience for their SARS-CoV-2 NGS assay.
On Mar. 26, 2021, the FDA issued an emergency use authorization (EUA) to the Twist Bioscience for their…
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Pfizer initiated phase 1 study of movel oral antiviral therapeutic agent against SARS-CoV-2
On Mar. 23, 2021, Pfizer announced that it was progressing to multiple ascending doses after completing the dosing…
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Positive leronlimab treatment in critically Ill COVID-19 patient published
On Mar. 23, 2021, CytoDyn announced the publication in the Journal of Translational Autoimmunity ‘Case study of a…
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Omeros and Quantum Leap announced first patients dosed with Narsoplimab in the I-SPY COVID-19 trial
On Mar. 23, 2021, Omeros and Quantum Leap Healthcare Collaborative announced that dosing of patients with narsoplimab in…
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Investigational AstraZeneca vaccine prevented COVID-19
On Mar. 22, 2021, the NIH announced that results from a large clinical trial in the U.S. and…
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US, Chile and Peru interim trial data showed Oxford-AstraZeneca vaccine was safe and highly effective
On Mar. 22, 2021, Oxford University announced that a Phase III study of the Oxford-AstraZeneca coronavirus vaccine conducted…
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AIM ImmunoTech announced addition of single-agent Ampligen arm to Cancer Center’s study in cancer patients with COVID-19
On Mar. 22, 2021, AIM ImmunoTech announced that the Institutional Review Board (IRB) of Roswell Park Comprehensive Cancer…
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Moderna announced supply agreement with the Philippines for 7 million additional doses of COVID-19 Vaccine Moderna
On Mar. 22, 2021, Moderna announced that the Philippines had secured 7 million additional doses of COVID-19 Vaccine…
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Cepheid received Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test
On Mar. 21, 2021, Cepheid announced it had received Emergency Use Authorization from the U.S. Food & Drug…
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FDA authorized first machine learning-based screening device to identify COVID-19 infection biomarkers
On Mar. 19, 2021, the FDA issued an emergency use authorization to Tiger Tech Solutions for the first…
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UK and EU regulatory agencies confirmed COVID-19 Vaccine AstraZeneca was safe and effective
On Mar. 18, 2021, AstraZeneca announced that the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines…
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XPhyto announces European approval for 25 minute COVID-19 PCR test
On Mar. 18, 2021, XPhyto and 3a-diagnostics announced the European approval of its point-of-care SARS-CoV-2 (COVID-19) RT-PCR test…
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Incyte announced results from phase 3 DEVENT study evaluating Jakafi as treatment for patients with COVID-19
On Mar. 18, 2021, Incyte announced results from the Phase 3 DEVENT study evaluating the efficacy and safety…
