NRx Pharma filed Breakthrough Therapy Designation request for ZYESAMIﾮ (aviptadil) in patients at risk of COVID-19 death
On Dec. 29, 2021, NRx Pharmaceuticals announced that it hds filed a new Breakthrough Therapy Designation (BTD) request…
Development of WRAI’s pan-coronavirus vaccine showed promise
On Dec. 28, 2021, researchers at the Walter Reed Army Institute of Research in Silver Spring, Maryland announced…
COVID-19 vaccine developed by Biological E using Dynavax’s CpG 1018 adjuvant received India DCGI approval for emergency use
On Dec. 28, 2021, Dynavax announced that Biological E had reported that CORBEVAXﾙ, their COVID-19 vaccine which contains…
Biotechnology | COVID-19 | Disease | Genomics
PacBio’s HiFiViral Surveillance Kit Performance not impacted by Omicron mutations
On Dec. 28, 2021, Pacific Biosciences announced that its new HiFiViral SARS-CoV-2 solution had successfully sequenced and captured…
Novavax and Serum Institute of India received Emergency Use Authorization for COVID-19 vaccine in India
On Dec. 28, 2021, Novavax and Serum Institute of India announced that the Drugs Controller General of India…
Sorrento announced COVISTIX COVID-19 virus rapid antigen detection test detected the Omicron variant
On Dec. 27, 2021, Sorrento Therapeutics announced that initial testing of COVISTIX on recombinant N proteins demonstrated its…
FDA authorized COVID-19 Over-the-Counter test based on data from NIH Independent Test Assessment Program
On Dec. 27, 2021, the U.S. Food and Drug Administration authorized an over-the-counter (OTC) COVID-19 antigen test, the…
Moderna announced Switzerland exercised option to purchase seven million additional doses of COVID-19 booster vaccine
On Dec. 27, 2021, Moderna announced that the Swiss Federal Government had exercised its option to purchase an…
Moderna announced supply agreement with South Korea for additional 20 million doses of COVID-19 vaccine
On Dec. 27, 2021, Moderna announced a revised supply agreement with the government of South Korea for 20…
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COVID-19 heroes & Remembrance
Our Heroes and Remembrance illustration has Maurice Ralph Hilleman and John Enders, pioneering developers of common vaccines, and…
Merck and Ridgeback’s molnupiravir, an investigational oral antiviral COVID-19 treatment, received special approval for emergency in Japan
On Dec. 24, 2021, Merck and Ridgeback Biotherapeutics announced that Japanﾒs Ministry of Health, Labor and Welfare had…
Roche COVID-19 at-home test granted FDA Emergency Use Authorization to expand access to rapid self-testing solutions in the United States
On Dec. 24, 2021, Roche announced that the U.S. Food and Drug Administration had granted Emergency Use Authorization…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
USDA confirmed COVID-19 in a Canada lynx at a Pennsylvania zoo
On Dec. 21, 2021, the United States Department of Agricultureﾒs National Veterinary Services Laboratories announced confirmation of SARS-CoV-2…
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…
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…
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)…
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…