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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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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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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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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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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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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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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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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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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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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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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FX06 clinical trial for treatment of most severely affected patients with COVID-19 begun in France
On Nov. 19, 2020, F4 Pharma announced the inclusion of the first patient with severe COVID-19 in 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…
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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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BioVersys announced first subjects dosed in phase 1 clinical trial of BV100
On Nov. 18, 2020, BioVersys announced a milestone by entering clinical development with the start of Phase 1…
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Pfizer and BioNTech announced phase 3 study of COVID-19 vaccine candidate met all efficacy endpoints
On Nov. 18, 2020, Pfizer and BioNTech announced that, after conducting the final efficacy analysis in their ongoing…
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Todos Medical announced positive initial clinical proof-of-concept data for rapid SARS-CoV-2 3CL protease detection assay
On Nov. 18, 2020, Todos Medical announced positive clinical proof of concept data from its lab-based rapid SARS-CoV-2…
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NIH to fund research of racial disparities in pregnancy-related complications and deaths
On Nov. 17, 2020, the NIH announced funding of new research examining racial and ethnic disparities in pregnancy-related…
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The US Dept of Veterans Affairs, federal partners plan for COVID-19 vaccination distribution
On Nov. 17, 2020, the U.S. Dept. of Veterans Affairs (VA) announced it was working with the Centers…
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FDA authorized first COVID-19 test for self-testing at home
On Nov. 17, 2020, the FDA issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test…
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Overweight and obese younger people at greater risk for severe COVID-19
On Nov. 17, 2020, UT Southwestern researchers reported that being younger doesnﾒt protect against the dangers of COVID-19…
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BioNTech and Fosun Pharma approved to commence COVID-19 vaccine candidate BNT162b2 trial in China
On Nov. 16, 2020, BioNTech and Shanghai Fosun Pharmaceutica announced that the China National Medical Products Administration had…
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European Medicines Agency began rolling review of Moderna’s mRNA vaccine candidate against COVID-19
On Nov. 16, 2020, Moderna announced that the European Medicines Agency (EMA) human medicines committee (CHMP) had started…
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Bausch Health announced investigational in vitro data indicating inactivation of SARS-CoV-2 with eye drops
On Nov. 16, 2020, Bausch Health announced the results of new investigational in vitro data showing that two…
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Biological E Limited started phase I/II clinical trial of its COVID-19 vaccine candidate
On Nov. 16, 2020, Biological E. Limited (BE), a Hyderabad-based vaccines and pharmaceutical company, Dynavax Technologies, and Baylor…
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Innovation Pharma announced overseas regulatory filing submitted for COVID-19 clinical study
On Nov. 16, 2020, Innovation Pharmaceuticals announced that an overseas Clinical Trial Application (CTA) has been submitted to…
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Johnson & Johnson Initiated second global phase 3 clinical trial of Janssen COVID-19 vaccine candidate
On Nov. 15, 2020, Johnson & Johnson announced that it continued to enroll and vaccinate study participants for…
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Moderna’s COVID-19 vaccine candidate met primary endpoint in first interim analysis of phase 3 COVE study
On Nov. 15, 2020, an independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of…
