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Quidel’s Lyra Direct SARS-CoV-2 Assay gets FDA EUA status for molecular detection of COVID-19

Quidel’s Lyra Direct SARS-CoV-2 Assay gets FDA EUA status for molecular detection of COVID-19

Quidel has been given emergency use authorization from the US Food and Drug Administration (FDA) for its Lyra Direct SARS-CoV-2 Assay to be used for the molecular detection of COVID-19. According to the diagnostic healthcare products manufacturer, the EUA status enables the Lyra Direct SARS-CoV-2 Assay for carrying out direct sample processing without the extraction […]

Coronavirus vaccine trial results : Moderna mRNA-1273 shows early promise

Moderna said that mRNA-1273, its novel coronavirus vaccine candidate, has delivered positive interim data in a phase 1 clinical trial by eliciting neutralizing antibody titer levels in all eight initial participants across the 25 µg and 100 µg dose cohorts. The early-stage clinical trial in humans was led by the US National Institute of Allergy […]

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Thermo Fisher, WuXi, Mayo Clinic to develop total antibodies Covid-19 test

US life sciences company Thermo Fisher Scientific said that it will collaborate with China-based WuXi Diagnostics and Mayo Clinic to develop a total antibodies Covid-19 test called the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test. The new antibody test development is said to emerge from an ongoing partnership between the three organizations, which includes […]

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Sorrento Therapeutics says STI-1499 fully inhibited SARS-CoV-2 virus

Sorrento Therapeutics said that STI-1499, its anti-SARS-CoV-2 antibody, showed 100% inhibition of SARS-CoV-2 virus infection in an in vitro virus infection experiment at a very low antibody concentration. The US biotech company will look to create an antibody cocktail product that will work as a protective shield against SARS-CoV-2 coronavirus infection and stay effective even […]

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Abbott gets FDA EUA for COVID-19 antibody blood test on Alinity i system

Abbott has been granted emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 IgG lab-based serology blood test, a COVID-19 antibody blood test, on the Alinity i system. The US medical device company will look to ship close to 30 million antibody tests across the world this world across […]

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Bonne Santé Natural Immunology nutraceutical products launched

US nutraceutical company Bonne Santé Group has launched Bonne Santé Natural Immunology, a new range of nutraceutical products designed to boost the immune system functions. Bonne Santé Natural Immunology is made up of three separate products that use proprietary formulas created by Jorge Lamazares, the chief formulator of the company. Included in the Bonne Santé […]

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FDA grants EUA for Gilead’s investigational COVID-19 drug remdesivir

Remdesivir EUA status : The US has officially pushed the use of remdesivir for treating the novel coronavirus with the Food and Drug Administration (FDA) granting emergency use authorization (EUA) to the investigational COVID-19 drug candidate being developed by Gilead Sciences. The EUA lets the antiviral drug candidate to be used for the treatment of […]

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Eiger BioPharmaceuticals doses first patients with Lambda in COVID-19 trial

Eiger BioPharmaceuticals said that it has dosed the first patients in a phase 2 trial of its hepatitis delta virus drug candidate peginterferon lambda (Lambda) in outpatients at the Stanford University School of Medicine having mild COVID-19. The California-based biopharma company said that nearly 120 patients will be randomly grouped in a 1:1 ratio to […]

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CytoAgents, Quotient Sciences to take COVID-19 drug candidate GP1681 into human trials

US biotech company CytoAgents has joined forces with CDMO and CRO services provider Quotient Sciences to accelerate the development of its COVID-19 drug candidate GP1681 into human clinical trials for the treatment of cytokine storm. According to the partners, scientific consensus is building that severe illness resulting from COVID-19 and other infectious diseases is triggered by […]

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Citius seeks FDA nod for evaluating stem cell therapy for ARDS in COVID-19

Citius Pharmaceuticals has made a Pre-IND submission to the US Food and Drug Administration for a novel stem cell therapy for acute respiratory distress syndrome (ARDS) in COVID-19 patients. In this regard, the late-stage specialty pharma company submitted a pre-IND meeting request and supporting briefing documents to the FDA’s Center for Biologics Evaluation and Research […]

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