Less than 10% of people in the U.S. had detectable SARS-CoV-2 antibodies as of September 2020
On Nov. 24, 2020, JAMA reported that fewer than 10% of people in tye U.S. as of September…
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Todos Medical completed installation of lab automation equipment at Wisconsin lab for COVID-19 PCR testing
On Nov. 24, 2020, Todos Medical announced that it has completed the installation of Tecan’ laboratory automated equipment…
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Mayo Clinic research confirmed critical role of masks in preventing COVID-19 infection
On Nov. 24, 2020, published data from researchers at Mayo Clinic found that physical separation reduced the exposure…
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Baxter announced $50 million investment to expand sterile fill/finish manufacturing site in Bloomington, Ind
On Nov. 24, 2020, Baxter announced a $50 million expansion of its sterile fill/finish manufacturing facilities located in…
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Disease | FDA | Rare Disease
FDA approved first drug to treat rare metabolic disorder
On Nov. 23, 2020, the U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’s Oxlumo (lumasiran) as the…
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Oxford University reported breakthrough on global COVID-19 vaccine
On Nov. 23, 2020, the University of Oxford, in collaboration with AstraZeneca, announced interim trial data from its…
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Viatris announced FDA tentative approval of pediatric formulation of Dolutegravir under PEPFAR
On Nov. 23, 2020, Viatris announced tentative approval from the FDA for a New Drug Application for pediatric…
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CytoDyn reached enrollment target of 293 patients for 2nd DSMC interim analysis of phase 3 COVID-19 trial
On Nov. 23, 2020, CytoDyn announced it had reached enrollment of 293 patients in its Phase 3 trial…
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Bellerophon announced results of interim analysis of phase 3 COViNOX study of INOpulseﾮ for COVID-19
On Nov. 23, 2020, Bellerophon Therapeutics announced that the independent Data Monitoring Committee (DMC) had completed its pre-specified…
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FDA expanded approval of influenza treatment to post-exposure prevention
On Nov. 23, 2020, the U.S. Food and Drug Administration (FDA) expanded the approved indication for Genentech’s Xofluza…
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AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19
On Nov. 23, 2020, AstraZeneca announced positive high-level results from an interim analysis of clinical trials of AZD1222…
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National Resilience launched as the worldﾒs most advanced biopharmaceutical manufacturing ecosystem
On Nov. 23, 2020, National Resilience, founded by ARCH Venture Partnersﾒ Robert Nelsen, launched as the worldﾒs most…
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Merck submited applications for licensure of V114, 15-valent pneumococcal conjugate vaccine, for use in adults
On Nov. 23, 2020, Merck, known as MSD outside the U.S. and Canada, announced the company had submitted…
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FDA authorized monoclonal antibodies for treatment of COVID-19
On Nov. 21, 2020, the FDA issued an emergency use authorization (EUA) for Regeneron Pharmaceuticals’ casirivimab and imdevimab…
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Regeneron’s REGEN-COV2 ntibody cocktail for COVID-19 received FDA Emergency Use Authorization
On Nov. 21, 2020, Regeneron announced that the antibody cocktail casirivimab and imdevimab administered together (also known as…
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Avian influenza virus spread rapidly in Europe
On Nov. 20, 2020, the ‘European Food Safety Authority reported that within the past month more than 300…
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Broad Institute rapid COVID-19 test delivered accurate results with minimal equipment
On Nov. 20, 2020, researchers at the Broad Institute of MIT and Harvard announced they had developed a…
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Lilly’s neutralizing antibody bamlanivimab received interim authorization from Health Canada as treatment for COVID-19
On Nov. 20, 2020, Eli Lilly announced that Health Canada had granted authorization under the Interim Order Respecting…
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Aptima HIV-1 Quant Dx assay receivds additional FDA approval for use as aAid in diagnosis of HIV infection
On Nov. 30, 2020, Hologic announced that the FDA had approved a diagnostic claim for its HIV-1 (human…
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Pfizer and BioNTech to submit Emergency Use Authorization Request to the FDA for COVID-19 vaccine
On Nov. 20, 2020, Pfizer and BioNTech announced they submitted a request to the Food and Drug Administration…
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Prior COVID-19 infection offered protection from re-infection for at least six months
On Nov. 20, 2020, the University of Oxford announced a study suggested that individuals who have previously had…
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NIH expanded research to improve COVID-19 testing among underserved and vulnerable populations
On Nov. 20, 2020, the National Institutes of Health (NIH) awarded nearly $45 million to expand the research…
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Study of ‘exceptional responders’ yields clues to cancer and potential treatments
On Nov. 19, 2020, in a comprehensive analysis of patients with cancer who had exceptional responses to therapy,…
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Novartis secured exclusive rights for potential acute respiratory distress syndrome cell therapy
On Nov. 19, 2020, Novartis announced that it had entered into an exclusive worldwide license and collaboration agreement…
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Biotechnology | COVID-19 | Diagnostics | HIV
Viruses shown to evolve as a result of different immune responses in different ethnic populations
On Nov. 19, 2020, University of Oxford researchers announced that research into the HIV-1 virus had shed light…
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Medigen Vaccines announced publication of positive results from preclinical studies of COVID-19 vaccine candidate
On Nov. 19, 2020, Medigen Vaccine Biologics announced that preclinical results of their COVID-19 vaccine candidate had been…
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ApiJect approved for $590 million loan from US International DFC to build drug manufacturing facility in North Carolina
On Nov. 19, 2020, ApiJect Systems, a public benefit corporatio, announced that it had been approved by the…
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Biotechnology | COVID-19 | FDA | Therapeutics
Baricitinib received Emergency Use Authorization from FDA for treatment of hospitalized patients with COVID-19
On Nov. 19, 2020, Eli Lilly and Incyte announced that the FDA had issued an Emergency Use Authorization…
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Artificial Intelligence | Biotechnology | COVID-19 | Diagnostics | Infectious Disease | Medical Device | Therapeutics
Texas A&M System, Worlds Inc. collaborated on COVID-19 breathalyzer
On Nov. 19, 2020, Dallas-based company, Worlds Inc., the U.S. Air Force and Texas A&M University announced a…
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Oxford Coronavirus vaccine produced strong immune response in older adults
On Nov. 19, 2020, the University of Oxford announced that the ChAdOx1 nCov-2019 coronavirus vaccine had been shown…
