Meridian Bioscience received FDA Emergency Use Authorization for Revogeneﾮ SARS-CoV-2 molecular assay
On Nov. 10, 2021, Meridian Bioscience announced that their Revogeneﾮ SARS-CoV-2 assay was granted Emergency Use Authorization by…
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Moderna filed to expand the conditional Marketing Authorization for COVID-19 vaccine in the EU to include children ages 6-11 years
On Nov. 9, 2021, Moderna announced that it has submitted for a variation to the conditional marketing authorization…
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Cocrystal Pharma’s SARS-CoV-2 protease inhibitors ddemonstrated pan-viral activity against human common Coronaviruses, Noroviruses, Rhinoviruses and Enteroviruses
On Nov. 8, 2021, Cocrystal Pharma announced that its SARS-CoV-2 main protease inhibitors showed potent in vitro pan-viral…
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Ronapreve approved for additional indication as preventive treatment of symptomatic COVID-19 in Japan
On Nov. 5, 2021, Chugai Pharmaceutical, announced that it had obtained approval from the Ministry of Health, Labour…
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Biotechnology | COVID-19 | Diagnostics | Infectious Disease | Therapeutics | USDA | Vaccine | Veterinary
The USDA confirmed COVID-19 in Hyenas at a Colorado Zoo
On Nov. 5, 2021, the USDA’s (USDA) National Veterinary Services Laboratories announced confirmation of SARS-CoV-2 in two spotted…
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NIH scientists identifed mechanism that may influence infectivity of SARS-CoV-2 variants
On Nov. 5, 2021, scientists at the National Institutes of Health announced they had found that a process…
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Pfizer’s COVID-19 oral antiviral treatment candidate reduced risk of hospitalization or death by 89% in interim analysis
On Nov. 5, 2021, Pfizer announced it was investigational novel COVID-19 oral antiviral candidate, PAXLOVID, significantly reduced hospitalization…
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WHO issued emergency use listing for eighth COVID-19 vaccine
On Nov. 3, 2021, the World Health Organization (WHO) issued an emergency use listing (EUL) for COVAXINﾮ (developed…
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NIH announced study of long-term effects of COVID-19 in pregnancy
On Nov. 2, 2021, the National Institutes of Health announced support for a four-year follow-up study on the…
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FDA cleared the first 510(k) for a COVID-19 test, the BioFire COVID-19 Test 2
On Nov. 1, 2021, the U.S. Food and Drug Administration (FDA) cleared the first 510(k) for a COVID-19…
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Hologic’s Multiplex COVID-19/Flu Test became commercially available in North America and Europe
On Oct. 27, 2021, Hologic announced that its Aptima SARS-CoV-2/Flu Assay was available for the simultaneous detection and…
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Relief Therapeutics reported positive interim data from trial of novel nasal spray Sentinox in SARS-CoV-2 infected patients
On Oct. 27, 2021, RELIEF THERAPEUTICS announced that its wholly owned subsidiary, APR Applied Pharma Research, reported positive…
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COVID-19 booster increased antibody responses, was protective in rhesus macaques
On Oct. 21, 2021, the National Institutes of Health announced that a booster dose of the mRNA-1273 COVID-19…
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Moderna announced FDA authorization of booster dose of COVID-19 vaccine in the U.S.
On Oct. 20, 2021, Moderna announced that the U.S. Food and Drug Administration (FDA) had authorized for emergency…
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Study found that for the unvaccinated, reinfection by COVID-19 was likely
On Oct. 19, 2021, National Science Foundation funded scientists at the Yale School of Public Health and the…
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Pfizer and BioNTech submitted data to EMA for vaccination of children 5 to <12 years of age with COMIRNATY
On Oct. 15, 2021, Pfizer and BioNTech announced they had submitted data supporting the vaccination of children 5…
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NIH RADx initiative expanded COVID-19 testing innovation for additional types of rapid tests
On Oct. 14, 2021, The NIH Rapid Acceleration of Diagnostics (RADx) initiative announced that it has issued contract…
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Cepheid received CE Mark for Xpert Xpress CoV-2/Flu/RSV plus
On Oct. 14, 2021, Cepheid announced it had received the CE mark for Xpert Xpress CoV-2/Flu/RSV plus, a…
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USDA confirmed COVID-19 infection in a Coatimundi at an Illinois Zoo
On Oct. 14, 2021, the U.S. Department of Agriculture’s Agriculture Research Service (ARS) announced confirmation of SARS-CoV-2 (the…
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PerkinElmer received FDA Emergency Use Authorization for respiratory SARS-CoV-2 panel
On Oct. 7, 2021, PerkinElmer announced that the U.S. Food and Drug Administration (FDA) had issued Emergency Use…
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Duke University-led study showed Vaxart’s oral COVID-19 vaccine candidate reduced transmission of SARS-CoV-2 infection
On Oct. 7, 2021, Vaxart announced that a Duke University-led study published in bioRxiv showed that Vaxart’s (investigational…
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USDA confirmed COVID-19 infection in a Binturong and a Fishing Cat at an Illinois Zoo
On Oct. 6, 2021, the U.S. Department of Agriculture’s Agriculture Research Service (ARS) announced confirmation of SARS-CoV-2 (the…
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COVID-19 | Diagnostics | FDA
EUROIMMUN anti-SARS-CoV-2 S1 curve ELISA received FDA Emergency Use Authorization
On Oct. 5, 2021, PerkinElmer announced that the U.S. Food and Drug Administration had provided Emergency Use Authorization…
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Trevena announced results of TRV027 proof-of-concept study in COVID-19 patients
On Sept. 30, 2021, Trevena announced data from 30 patients enrolled in the proof-of-concept study of TRV027, the…
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Cepheid received Emergency Use Authorization For SARS-CoV-2, Flu A, Flu B and RSV combination test
On Sept. 29, 2021, Cepheid announced it had received Emergency Use Authorization from the U.S. Food & Drug…
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VBI Vaccines announced preclinical data and Initiation of VBI-2905 clinical trial targeting broadened immunity against COVID-19
On Sept. 29, 2021, VBI Vaccines announced positive results from multiple preclinical studies against several COVID-19 variants of…
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NIAID issued new awards to fund ‘pan-coronavirus’ vaccines
On Sept. 28, 2021, the National Institute of Allergy and Infectious Diseases announced it had awarded approximately $36.3…
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AIM ImmunoTech submitted pre-IND application to FDA for phase 2 clinical studies of Ampligen as potential therapeutic for COVID-19
On Sept. 28, 2021, AIM ImmunoTech announced that is had submitted a Pre-Investigational New Drug application (Pre-IND) to…
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Soligenix announced publication demonstrating efficacy and broad neutralizing activity of its COVID-19 Vaccine
On Sept. 28, 2021, Soligenix announced publication of pre-clinical immunogenicity studies for CiVax (heat stable COVID-19 vaccine program)…
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Pfizer started global phase 2/3 EPIC-PEP study of novel COVID-19 oral antiviral candidate for post-exposure prophylaxis in adults
On Sept. 27, 2021, Pfizer announced the start of the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for…
