BioNTech and InstaDeep developed and successfully tested early warning system to detect high-risk SARS-CoV-2 variants
On Jan. 11, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration had expanded the…
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First successful transplant of porcine heart into adult human with end-stage heart disease
On Jan. 10, 2022, in a first-of-its-kind surgery, a 57-year-old patient with terminal heart disease received a successful…
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Novartis and Molecular Partners reported positive topline data from Phase 2 study for ensovibep antiviral therapeutic for COVID-19
On Jan. 10, 2022, Novartis Molecular Partners announced that Part A of the EMPATHY clinical trial that compared…
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Biden-Harris administration required insurance and group health plans to cover cost of at-home COVID-19 tests
On Jan. 10, 2022, the Biden-Harris Administration announced it was requiring insurance companies and group health plans to…
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DoD awarded contract to Revival Health to purchase COVID-19 Antigen OTC kits in support of POTUS’ 500 million free at-home COVID-19 rests
On Jan. 7, 2022, the Department of Defense, in coordination with the U.S. Department of Health and Human…
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COVID-19 | FDA | Life Science History | NIH
NRx Pharmac submited EUA Application to US FDA for ZYESAMIﾮ (aviptadil) to treat patients at risk of death from COVID-19
On Jan 5, 2022, NRx Pharmaceuticals announced that it had submitted an application for Emergency Use Authorization (EUA)…
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Hologic added Aptima SARS-CoV-2 assay to its Global Access Initiative in resource-limited countries
On Jan 5, 2022, Hologic the addition of the Aptimaﾮ SARS-CoV-2 assay to its Global Access Initiative, a…
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Revelar Biotherapeutics and Twist Bioscience announced RBT-0813 neutralized SARS-CoV-2 Omicron and Delta variants
On Jan 5, 2022, Revelar Biotherapeutics and Twist Bioscience announced that RBT-0813 binded to and neutralized the Omicron…
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Pfizer and BioNTech received U.S. FDA EUA of COVID-19 vaccine booster for individuals 12 years of age and older
On Jan. 3, 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration had expanded the…
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Amyris and Immunitybio completed joint venture for next generation Covid-19 RNA vaccine
On Jan. 3, 2022, Amyris and ImmunityBio announced the completion of a previously announced joint venture agreement to…
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Johnson & Johnson COVID-19 vaccine demonstrated 85 percent effectiveness against hospitalization in South Africa when Omicron was dominant
On Dec. 30, 2021, Johnson & Johnson announced preliminary results from the South African Phase 3b Sisonke study…
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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…
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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…
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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…
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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…
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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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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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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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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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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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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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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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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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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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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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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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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…
