Novavax and SK bioscience announed expanded manufacturing agreement
On Dec. 23, 2021, Novavax and SK bioscience announced the expansion of the companies’ collaboration and license agreements…
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Biotechnology | COVID-19 | FDA | Medicine | Pharmaceutical | Therapeutics
Merck and Ridgeback’s molnupiravir received U.S. FDA EUA for treatment of high-risk adults with COVID-19
On Dec. 23, 2021, Merck and Ridgeback Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) had…
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OPKO Health announced topline results from phase 2 trial evaluating RAYALDEE to treat symptomatic COVID-19 outpatients
On Dec. 23, 2021, OPKO announced preliminary topline results from its Phase 2 trial with RAYALDEEﾮ to treat…
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Pfizer and BioNTech submit updated longer-term follow-up data of COMIRNATY in adolescents to EMA
On Dec. 23, 2021, Pfizer and BioNTech announced that they had submitted longer-term follow-up data from the companiesﾒ…
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Eight substances added to 15th Report on Carcinogens
On Dec. 23, 2021, eight substances were added to the Report on Carcinogens, bringing the total list to…
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Merck and Ridgeback announced U.K. Government to purchase additional 1.75 million courses of molnupiravir
On Dec. 22, 2021, Merck and Ridgeback Biotherapeutics announced that the United Kingdom Government agreed to purchase an…
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Gilead announced NEJM publication of data demonstrating Veklury (Remdesivir) significantly reduced risk of hospitalization in patients with COVID-19
On Dec. 22, 2021, Gilead Sciences announced full results from a Phase 3 investigational study evaluating the efficacy…
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Cocrystal Pharma’s COVID-19 oral and intranasal/pulmonary protease inhibitors exhibited powerful in vitro potency against the SARS-CoV-2 Omicron variant
On Dec. 22, 2021, Cocrystal Pharma announced that in vitro studies demonstrate its oral and intranasal/pulmonary SARS-CoV-2 main…
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Novavax announced initial Omicron cross-reactivity data from COVID-19 vaccine booster and adolescent studies
On Dec. 22, 2021, Novavax announced initial data evaluating the immune response of its COVID-19 vaccine, NVX-CoV2373, against…
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Pfizer received U.S. FDA Emergency Use Authorization for novel COVID-19 oral antiviral treatment
On Dec. 22, 2021, Pfizer announced that the U.S. Food and Drug Administration (FDA) had authorized the emergency…
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University of Oxford team published blueprint for making millions of doses of a new vaccine within 100-days
On Dec. 22, 2021, the University of Oxfordﾒs vaccine manufacturing research team published a pre-print paper demonstrating the…
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Novavax announced initiation of PREVENT-19 COVID-19 vaccine phase 3 trial booster study
On Dec. 21, 2021, Novavax announced that the first booster doses of NVX-CoV2373, the company’s recombinant nanoparticle protein-based…
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Oxford team published blueprint for making millions of doses of a new vaccine within 100 days
On Dec. 21, 2021, the University of Oxford’s vaccine manufacturing research team published a pre-print paper demonstrating the…
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USDA confirmed COVID-19 in a Canada lynx at a Pennsylvania zoo
On Dec. 21, 2021, the United States Department of Agriculture’s (USDA) National Veterinary Services Laboratories announced confirmation of…
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EC expanded indication for Veklury (Remdesivir) for treatment of adults not on supplemental oxygen and high risk for COVID-19 progression
On Dec. 21, 2021, Gilead Sciences announced that the European Commission (EC) had approved a variation to the…
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World Health Organization granted scond Emergency Use listing for Novavax COVID-19 vaccine
On Dec. 20, 2021, Novavax announced that the World Health Organization (WHO) had granted a second Emergency Use…
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European Commission granted conditional Marketing Authorization for Novavax COVID-19 vaccine
On Dec. 20, 2021, Novavax announced that the European Commission (EC) had granted Novavax conditional marketing authorization (CMA)…
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Pfizer and BioNTech provided EU more than 200 million additional doses of COMIRNATY for vaccine supply
On Dec. 20, 2021, Pfizer and BioNTech announced an agreement had been reached with the European Commission (EC)…
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Moderna announced preliminary booster data and updated strategy to address Omicron variant
On Dec. 20, 2021, Moderna announced preliminary neutralizing antibody data against the Omicron variant following the Company’s booster…
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Oragenics extended collaboration with the National Research Council of Canada (NRC) to develop vaccine against Omicron variant
On Dec. 20, 2021, Oragenics announced it had extended a licensing and collaboration agreement with the National Research…
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Novavax and Serum Institute of India announced WHO Emergency Use listing for NVX-CoV2373 COVID-19 vaccine
On Dec. 17, 2021, Novavax and SK bioscience announced that the World Health Organization (WHO) had granted Emergency…
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NIH scientists urged pursuit of universal coronavirus vaccine
On Dec. 16, 2021, NIH scientists announced that to counter future coronavirus outbreaks, the global scientific and medical…
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Democratic Republic of the Congo declared Ebola outbreak over
On Dec. 16, 2021, the Ebola outbreak that erupted in the Democratic Republic of the Congo’s North Kivu…
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Merck and Ridgeback published phase 3 study of Molnupiravir, investigational oral antiviral COVID-19 treatment, in NEJM
On Dec. 16, 2021, Merck and Ridgeback Biotherapeutics announced the New England Journal of Medicine had published findings…
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Twist Bioscience began shipping synthetic RNA positive controls for Omicron (B.1.1.529/BA.1) SARS-CoV-2 variant for Development of Accurate Diagnostic Tests
On Dec. 15, 2021, Twist Bioscience announced that synthetic RNA positive controls were available for the SARS-CoV-2 Omicron…
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Novavax announced submission of New Drug Application in Japan for approval of COVID-19 vaccine
On Dec. 15, 2021, Novavax announced the submission of a New Drug Application to the Ministry of Health,…
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Johnson & Johnson announced positive CHMP opinion for a booster shot of its COVID-19 vaccine
On Dec. 15, 2021, Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP)…
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Pfizer announced additional phase 2/3 study results confirming robust efficacy of novel COVID-19 oral antiviral treatment candidate
On Dec. 14, 2021, Pfizer announced final results from an analysis of all 2,246 adults enrolled in its…
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NRx Pharma announced new, favorable safety report for ZYESAMIﾮ (aviptadil) in NIH sponsored ACTIV-3b critical care study in patients with COVID-19
On Dec. 14, 2021, NRx Pharmaceuticals provided a new safety update on ZYESAMIﾮ (aviptadil), which was being tested…
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HHS released $9 billion in provider relief fund payments to support health care providers affected by COVID-19 Pandemic
On Dec. 12, 2021, the U.S. Department of Health and Human Services (HHS) announced the distribution of approximately…
