Ligand and CR Double-Crane entered agreement to develop oral COVID-19 therapeutic
On Oct. 21, 2021, Ligand Pharmaceuticals announced the signing of a collaboration agreement granting China Resources Double-Crane Pharmaceutical…
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U.S. CDC Advisory Committee unanimously recommended Johnson & Johnson COVID-19 vaccine as booster for all eligible individuals
On Oct. 21, 2021, Johnson & Johnson announced that the U.S. Centers for Disease Control and Prevention (CDC)…
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Pfizer and BioNTech announced phase 3 trial data showing high efficacy of booster dose of COVID-19 vaccine
On Oct. 21, 2021, Pfizer and BioNTech announced topline results from a Phase 3 randomized, controlled trial evaluating…
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INOVIO announced MOU with Colombia for protecting against COVID-19 and broader health initiatives
On Oct. 21, 2021, Inovio Pharma announced the signing of a non-binding memorandum of understanding with Colombia’s Ministry…
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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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COVID-19 vaccine developed by Valneva using Dynavax’s CpG 1018 adjuvant met co-primary endpoints in phase 3 trial
On Oct. 18, 2021, Valneva, a specialty vaccine company, announced positive topline results from the Phase 3 pivotal…
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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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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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NIH RADx initiative expanded COVID-19 testing innovation for additional types of rapid tests
On Oct. 14, 2021, The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative announced that…
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FDA accepted REGEN-COV (casirivimab and imdevimab) for priority review for treatment and prophylaxis of COVID-19
On Oct. 14, 2021, Regeneron announced that the U.S. Food and Drug Administration (FDA) has accepted for priority…
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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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Washington University School of Medicine reported antiviral compound blocked SARS-CoV-2 from entering cells
On Oct. 11, 2021, scientists at Washington University School of Medicine in St. Louis announced they had developed…
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INOVIO expanded INNOVATE phase 3 for INO-4800 to include Colombia
On Oct. 11, 2021, Inovio Pharmaceuticals announced that it had received authorization from Colombia’s INVIMA, to conduct the…
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Merck and Ridgeback announced Submission of EUA to the FDA for Molnupiravir, an Investigational Oral antiviral medicine, for treatment of COVID-19
On Oct. 11, 2021, Merck and Ridgeback Biotherapeutics announced that Merck had submitted an Emergency Use Authorization (EUA)…
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CDC | COVID-19 | Infectious Disease | Vaccine
U.S. CDC reported more than 140,000 U.S. children lost a primary or secondary caregiver due to COVID-19 pandemic
On Oct. 7, 2021, the Centers for Disease Control and Prevention (CDC) reported that one U.S. child loses…
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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) has 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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WHO, UN set out steps to meet world COVID vaccination targets
On Oct. 7, 2021, the World Health Organization (WHO) launched the Strategy to Achieve Global Covid-19 Vaccination by…
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Vaxartﾠ began recruiting in global phase II COVID-19 oral tablet vaccine clinical trial
On Oct. 6, 2021, Vaxart announced that it had begun recruiting subjects for its Phase II COVID-19 oral…
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AIM ImmunoTech published phase 1 clinical study data supporting the safety of Ampligen as intranasal therapy
On Oct. 6, 2021, AIM ImmunoTech released detailed safety data from a Phase 1 clinical study which supported…
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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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Johnson & Johnson submitted EUA amendment to FDA to support booster of single-shot COVID-19 vaccine
On Oct. 5, 2021, Johnson & Johnson announced it had submitted data to the U.S. Food and Drug…
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Pfizer and BioNTech received CHMP positive opinion for COVID-19 vaccine booster in the European Union
On Oct. 4, 2021, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP)…
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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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NEJM published positive phase 3 trial resulted for REGEN-COV (casirivimab and imdevimab) to treat COVID-19
On Sept. 29, 2021, Regeneron announced that the New England Journal of Medicine (NEJM) published positive detailed results…
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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…
