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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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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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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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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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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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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EC expanded indication for Veklury (Remdesivir) for treatment of adults not on supplemental oxygen and high risk for COVID-19 progression
On Oct. 21, 2021, Gilead Sciences announced that the European Commission (EC) had approved a variation to 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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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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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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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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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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Military Health System marked 1-year anniversary for COVID vaccinations
One year ago, on Dec. 14, 2020, the Military Health System began administering the first COVID-19 vaccine shots….
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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…
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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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Vaccines shown to induce lower levels of neutralising antibodies against Omicron coronavirus variant
On Dec. 13, 2021, researchers from the University of Oxford analysed the impact of the Omicron COVID-19 variant…
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Novavax filed for Emergency Use of COVID-19 vaccine in the United Arab Emirates
On Dec. 13, 2021, Novavax announced that it had submitted a regulatory filing to the Ministry of Health…
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CEPI partnered with Affinivax to develop a novel COVID-19 vaccine to target variants
On Dec. 13, 2021, the Coalition for Epidemic Preparedness Innovations, and Affinivax announced a partnership to advance the…
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Biotechnology | COVID-19 | Vaccine | WHO
World Health Organization announced interim recommendations for use of the Janssen Ad26.COV2.S vaccine
On Dec. 10, 2021, the World Health Organization announced interim recommendations for the use of the Janssen Ad26.COV2.S…
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Moderna announced additional 20 million doses of COVID-19 vaccine to COVAX for supply in 2021 and additional supply for 2022
On Dec. 10, 2021, Moderna announced an amendment to its existing contract with Gavi, the Vaccine Alliance, to…
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Pfizer and BioNTech received U.S. FDA EUA of COVID-19 vaccine booster for individuals 16 years and older
On Dec. 9, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had expanded…
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CytoDyn submited protocol with FDA for phase 3 Registrational trial of leronlimab for critically ill COVID-19 population
On Dec. 9, 2021, CytoDyn announced that it had submitted a Phase 3, randomized, double blind, placebo controlled…
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Moderna launched AI Academy in partnership with Carnegie Mellon University
On Dec. 9, 2021, Moderna announced the launch of its Artificial Intelligence Academy, an innovative initiative that will…
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Pfizer and BioNTech provided update on Omicron variant
On Dec. 8, 2021, Pfizer and BioNTech announced results from an initial laboratory study demonstrating that serum antibodies…
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FDA authorized long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individuals
On Dec. 8, 2021, the U.S. Food and Drug Administration issued an emergency use authorization for AstraZenecaﾒs Evusheld…
