FDA approved prosthetic implant for above-the-knee amputations
On Dec. 18, 2020, the FDA approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System,…
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National Research Council of Canada supported development of 4 COVID-19 therapeutic candidates
On Dec. 18, 2020, the National Research Council of Canada (NRC) announced it was providing advisory services and…
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Johnson & Johnson announced agreement with Gavi to supply COVID-19 vaccine candidate to lower-income countries in 2021
On Dec. 18, 2020, Johnson & Johnson announced that its subsidiary Janssen Pharma, will provide up to 500…
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COVAX announced additional access promising COVID-19 vaccine candidates with global rollout starting 2021
On Dec. 18, 2020, the World Health Organization (WHO) announced that it had arrangements in place to access…
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Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics
FDA approved first adjuvant therapy for most common type of lung cancer
On Dec. 18, 2020, the the U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Tagrisso (osimertinib) as the…
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CDC Advisory Committee on Immunization Practices recommended vaccination with Moderna’s COVID-19 vaccine
On Dec. 18, 2020, Moderna announced that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on…
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Lilly began pragmatic study of neutralizing antibody bamlanivimab (LY-CoV555) for COVID-19 in New Mexico
On Dec. 18, 2020, Eli Lilly announced plans to begin a new pragmatic study of bamlanivimab (LY-CoV555) in…
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Moderna announced FDA authorization of Moderna COVID-19 vaccine in U.S.
On Dec. 18, 2020, Moderna announced that the U.S. Food and Drug Administration (FDA) had authorized the emergency…
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PRA Health Sciences collaborated with PWNHealth and Fulgent Genetics provided at-home COVID-19 test
On Dec. 17, 2020, PRA Health Sciences announced the enhancement of its COVID-19 Monitoring Program with the addition…
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XPhyto completed successful SARS-COV-2 RT-PCR diagnostic testk kit validation
On Dec. 17, 2020, XPhyto Therapeutics and 3a-diagnostics announced the successful validation of their point-of-care SARS-CoV-2 (COVID-19) RT-PCR…
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NEJM published positive initial Regeneron antibody cocktail results in non-hospitalized patients with COVID-19
On Dec. 17, 2020, Regeneron announced that the New England Journal of Medicine (NEJM) had published initial clinical…
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COVID-19 the leading cause of death in the United States
On Dec. 17, 2020, JAMA reported that the daily U.S. mortality rate for COVID-19 deaths was equivalent to…
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Johnson & Johnson announced Its first phase 3 COVID-19 vaccine trial ENSEMBLE was fully enrolled
On Dec. 17, 2020, Johnson & Johnson announced that the large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) of…
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NIAID study of Coronavirus infection and multisystem inflammatory syndrome in children began
On Dec. 17, 2020, NIAID announced that an observational study had launched to evaluate the short- and long-term…
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Biotechnology | COVID-19 | FDA | Vaccine
Moderna received FDA Advisory Committee vote supporting EUA for vaccine against COVID-19 in the U.S.
On Dec. 17, 2020, Moderna confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological…
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ACON Laboratories received Emergency Use Authorization for its SARS-COV-2 IgG/IgM rapid test
On Dec. 17, 2020, ACON Laboratories announced that its SARS-COV-2 IgG/IgM Rapid Test has been authorized for emergency…
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Investigational COVID-19 therapeutics evaluated in large clinical trials
On Dec. 17, 2020, NIAID announced that two randomized, controlled Phase 3 clinical trials had begun evaluating investigational…
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Quest Diagnostics and The Commons Project delivered access to lab data through the CommonHealth App
On Dec. 17, 2020, Quest Diagnostics and The Commons Project, a non-profit public trust dedicated to building and…
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Novavax announced agreement with government of New Zealand for 107 million doses of COVID-19 vaccine
On Dec. 16, 2020, Novavax announced an Advance Purchase Agreement with the government of New Zealand for the…
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Heat Biologics announced completion of ZVX-60 vaccine cell line for COVID-19
On Dec. 16, 2020, Heat Biologics announced it had completed its gp96-based COVID-19 vaccine cell line, which is…
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BD surpassed 1 billion injection device orders in support of COVID-19 vaccination efforts around the world
On Dec. 16, 2020, BD (Becton, Dickinson) announced that it had received pandemic orders for needles and syringes…
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SARS-CoV-2 viral genome sequencing data reported from research using Pacific Biosciences Technology
On Dec. 16, 2020, Pacific Biosciences announced initial findings from the companyﾒs research collaboration with Labcorp that was…
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FDA issued new authorization for the BinaxNOW COVID-19 Ag Card Home Test
On Dec. 16, 2020, the U.S. Food and Drug Administration issued a new emergency use authorization (EUA) for…
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Abbott’s BinaxNOW COVID-19 rapid rest received FDA Emergency Use Authorization for at-home rapid test
On Dec. 16, 2020, Abbott announced that the FDA had issued Emergency Use Authorization (EUA) for virtually guided…
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Meridian received NIH award for supporting rapid development of Revogeneﾮ molecular test for SARS-CoV-2
On Dec. 16, 2020, Meridian Bioscience announced that it had been awarded funding in the amount of approximately…
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BioNTech and Fosun Pharma to supply China with mRNA-based COVID-19 vaccine
On Dec. 16, 2020, BioNTech and Shanghai Fosun Pharmaceutical announced an agreement to supply Mainland China with an…
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NIH observational study of coronavirus infection and multisystem inflammatory syndrome in children began
On Dec. 16, 2020, National Institute of Allergy and Infectious Diseases reported that an observational study had launched…
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AXIM Biotechnologies completed successful Covid-19 live virus test and filed amended EUA
On Dec. 15, 2020, AXIM Biotechnologies announced the development and patent filing for an enzyme-linked immunosorbent assay (ELISA)-based…
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INOVIO to develop DNA-encoded monoclonal antibody (dMAb) candidates to treat COVID-19
On Dec. 15, 2020, Inovio Pharma announced the company and a team of scientists from The Wistar Institute,…
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FDA authorized antigen test as first over-the-counter fully at-home diagnostic test for COVID-19
On Dec. 15, 2020, the FDA granted emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home…
