Moderna confirmed 40 million COVID-19 vaccine dose supply agreement with Republic of Korea
On Dec. 31, 2020, Moderna confirmed it had entered into a supply agreement with the government of the…
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CytoDyn research on critically Ill COVID-19 patients published in Journal of Translational Autoimmunity
On Dec. 31, 2020, CytoDyn announced a research manuscript submitted by Nicholas J. Agresti, M.D. had been accepted…
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Biotechnology | COVID-19 | Vaccine | WHO
WHO issued its first EUV for a COVID-19 vaccine and emphasized need for equitable global access
On Dec. 31, 2020, the World Health Organization (WHO) listed the Comirnaty COVID-19 mRNA vaccine for emergency use,…
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Biotechnology | COVID-19 | FDA | NIH | Therapeutics
Medigen Vaccines obtained TFDA phase 2 IND approval for COVID19 vaccine
On Dec. 30, 2020, Medigen Vaccine Biologics announced that it had obtained TFDA Phase 2 IND approval of…
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Recipharm and Moderna finalized agreement for aseptic drug manufacturing and fill-finish for countries outside the U.S.
On Dec. 30, 2020, Moderna announced that they had reached an agreement to support formulation and fill-finish a…
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Mateon global study for OT-101/ TGF-inhibitor against COVID-19 treated its first patient
On Dec. 30, 2020, Mateon Therapeutics announced that it had enrolled and treated its first sentinel Part 1…
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Peer-reviewed report on Moderna COVID-19 vaccine published
On Dec. 30, 2020, the National Institutes of Health (NIH) announced that the investigational vaccine known as mRNA-1273…
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UK medicines regulator approved Oxford University/AstraZeneca COVID-19 vaccine
On Dec. 30, 2020, the COVID-19 vaccine developed by Oxford University/AstraZeneca was given regulatory approval by the UK…
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COVID-19 | Neurology | NIH | Therapeutics
NIH study uncovered blood vessel damage and inflammation in COVID-19 patients’ brains but no infection
On Dec. 30, 2020, the NIH researchers announced that an in-depth study of how COVID-19 affects a patient’s…
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Bausch Health’s DEXAVEN received new indication in Poland to treat patients with SARS-CoV-2
On Dec. 30, 2020, Bausch Health announced that the Office for Registration of Medicinal Products, Medical Devices and…
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UNMC participated in COVID-19 vaccine study, planned to enroll 1,000
On Dec. 29, 2020, University of Nebraska Medical Center (UNMC) and Nebraska Medicine announced participation in a clinical…
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Additional DOD locations selected to support COVID-19 vaccine clinical trials
On Dec. 29, 2020, the U.S. Department of Defense (DOD) announced that the Womack Army Medical Center was…
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Regeneron announced encouraging data from COVID-19 antibody cocktail trial in hospitalized patient
On Dec. 29, 2020, Regeneron announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the…
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Moderna confirmed discussions with government of South Korea to supply 40 million doses of COVID-19 vaccine
On Dec. 29, 2020, Moderna confirmed that the Company was engaged in discussions with the government of South…
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Emergent and Mount Sinai Health System announced clinical program to evuate COVID-HIG product candidate
On Dec. 29, 2020, Emergent BioSolutions and Mount Sinai Health System announced initiation of the clinical program to…
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Biotechnology | Disease | FDA | Therapeutics
FDA approved first generic of drug used to treat severe hypoglycemia
On Dec. 28, 2020, the U.S. Food and Drug Administration approved the first generic of glucagon for injection…
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Soligenix announced $15 million NIH SBIR award advancing COVID-19 vaccine development
On Dec. 28, 2020, Soligenix announced that the National Institute of Allergy and Infectious Diseases (NIAID), had awarded…
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The Serum Institute of India launched India’s first indigenously developed pneumococcal vaccine
On Dec. 28, 2020, Serum Institute of India announced the launch of India’s first indigenously developed pneumococcal vaccine…
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Novavax initiated PREVENT-19 pivotal phase 3 efficacy trial of COVID-19 vaccine in the U.S. and Mexico
On Dec. 28, 2020, Novavax announced initiation of PREVENT-19, its pivotal Phase 3 study in the U.S. and…
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AIM ImmunoTech announced availability of ME/CFS clinical trial of drug Ampligen for enrollment to COVID-19 ‘Long Haulers’
On Dec. 24, 2020, AIM ImmunoTech announced that the post-COVID-19 ‘Long Hauler’ portion of the active AMP-511 Expanded…
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INOVIO announced publication of phase 1 data from COVID-19 DNA vaccine candidate in The Lancet
On Dec. 24, 2020, Inovio Pharmaceuticals announced publication of peer-reviewed Phase 1 clinical data from the first cohort…
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Merck announced agreement with US Government for doses of Investigational biological therapy for COVID-19 patients
On Dec. 23, 2020, Merck announced an agreement with the U.S. Government to support the development, manufacture and…
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Tonix Pharmaceuticals announced commercial scale vaccine manufacturing facility in Hamilton, Montana
On Dec. 23, 2020, Tonix Pharmaceuticals announced that it had completed the purchase of an approximately 44-acre site…
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Health Canada authorized Moderna COVID-19 vaccine in Canada
On Dec. 23, 2020, Moderna announced that Health Canada had authorized its vaccine against COVID-19 for the immunization…
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Serum Institute of India and Dynavax announced first participants dosed in phase 1/2 clinical trial for COVID-19 vaccine
On Dec. 23, 2020, Serum Institute of India and Dynavax jointly announced that the first participants had been…
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Pfizer and BioNTech to supply the US with 100 million additional doses of COVID-19 vaccine
On Dec. 23, 2020, Pfizer and BioNTech announced a second agreement with the U.S. government to supply an…
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VBI Vaccines announced EMA acceptance of MAA for 3-Antigen prophylactic Hepatitis B vaccine
On Dec. 23, 2020, VBI Vaccines announced that the European Medicines Agency (EMA) has accepted the filing of…
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Biotechnology | COVID-19 | FDA
Quidel received EUA for moderately complex Solana SARS molecular test for COVID-19 diagnosis
On Dec. 23, 2020, Quidel announced that it had received Emergency Use Authorization (EUA) from the FDA to…
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Mink at affected Oregon farm negative for SARS-CoV-2, wildlife surveillance continued
On Dec. 23, 2020, recent tests confirmed mink that tested positive for SARS-CoV-2 at an Oregon farm in…
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Altimmune provided an update on investigational New Drug Application for phase 1 AdCOVIDﾙ clinical trial
On Dec. 23, 2020, Altimmune announced that the FDA had issued a clinical hold on the Companyﾒs Investigational…
