BioNTech and Pfizer initiated a rolling submission to EMA for SARS-CoV-2 vaccine candidate BNT162b2
On Oct. 6, 2020, Pfizer and BioNTech announced initiation of a rolling submission to the European Medicines Agency…
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COVID-19 vaccine AZD1222 clinical trial resumed in Japan, follows restart of trials in the UK, Brazil, South Africa and India
On Oct. 2, 2020, AstraZeneca announced the phase I/II clinical trial for the COVID-19 vaccine AZD1222 had resumed…
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Hydroxychloroquine showed no benefit in COVID-19 prevention
On Sept. 30, 2020, researchers from the Perelman School of Medicine at the University of Pennsylvania reported results…
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Windtree announced FDA acceptance of IND application for phase 2 clinical trial studying KL4 Surfactant in acute lung injury in adults with COVID-19
On Sept. 29, 2020, Windtree Therapeutics announced that FDA had accepted its Investigational New Drug application for a…
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Tonix Pharma completed the purchase of a facility to house advanced development center for vaccine programs
On Sept. 28, 2020, Tonix Pharmaceuticals announced that it had completed the purchase a 40,000 square foot facility…
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Fourth large-scale COVID-19 vaccine trial began in the United States
On Sept. 23, 2020, a fourth Phase 3 clinical trial evaluating an investigational vaccine for coronavirus disease 2019…
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Sinovacﾒs Coronavacﾙ, SARS-CoV-2 vaccine, inactivated, announced approval for phase I/II clinical trial in adolescents and children
On Sept. 23, 2020, Sinovac Biotech announced that the inactivated COVID-19 vaccine candidate developed by Sinovac Life Sciences,…
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NIH expanded clinical trials to test convalescent plasma against COVID-19
On Sept. 22, 2020, the NIH annunced that two randomized, placebo-controlled clinical trials expanded enrollment to further evaluate…
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Sinovac commenced phase III clinical trials for COVID-19 vaccine candidate in Turkey
On Sept. 22, 2020, Sinovac Biotech announced that it had recently commenced phase III clinical trials for its…
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Serum Institute initiated manufacturing of Codagenix’s intranasal live-attenuated COVID-19 vaccine candidate
On Sept. 22, 2020, Codagenix announced that the Serum Institute of India has begun manufacturing CDX-005, the company’s…
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Lilly announced proof of concept data for neutralizing antibody LY-CoV555 in the COVID-19 outpatient setting
On Sept. 16, 2020, Eli Lilly announced proof of concept data from an interim analysis of the BLAZE-1…
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NanoViricides nominated a novel candidate for advancing Into clinical trials for treatment of COVID-19
On Sept. 16, 2020, NanoViricides announced that it had nominated a clinical drug candidate for the treatment of…
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New anti-infective drugs had a 14% speed advantage vs other drugs from 2000-2019
On Sept. 15, 2020, the Tufts Center for the Study of Drug Development reported that new anti-infective drugs…
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Vaxart announced FDA clearance of IND application for oral COVID-19 vaccine
On Sept. 14, 2020, Vaxart announced that the FDA had completed its review of the Companyﾒs Investigational New…
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Mateon global study for Artemisinin intervention against COVID-19 cleared for patient enrollment in India
On Sept. 14, 2020, Mateon Therapeutics announced that its global study based on its ARTI-19 protocol for Artemisinin…
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RECOVERY COVID-19 phase 3 trial evaluated Regeneron’s REGN-COV2 investigational antibody cocktail in the UK
On Sept. 14, 2020, Regeneron and the University of Oxford announced that RECOVERY (Randomised Evaluation of COVid-19 thERapY),…
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MediciNova announced intranasal RS virus vaccine vuccessfully induced neutralizing antibodies against RS virus in mice
On Sept. 11, 2020, MediciNova announced development progress on its intranasal SARS-CoV-2 vaccine for COVID-19 utilizing BC-PIV, a…
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NIH ACTIV initiative launched adaptive clinical trials of blood-clotting treatments for COVID-19
On Sept. 10, 2020, the NIH launched two of three adaptive Phase 3 clinical trials evaluating the safety…
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AstraZeneca Oxford SARS-CoV-2 vaccine, AZD1222, COVID-19 vaccine trials temporary paused
On Sept. 9, 2020, as part of the ongoing randomised, controlled clinical trials of the AstraZeneca Oxford coronavirus…
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BioNTech and Pfizer receive regulatory approval to commence global phase 2/3 trial for COVID-19 vaccine candidate
On Sept. 7, 2020, Pfizer and BioNTech announced that the German regulatory authority, the Paul-Ehrlich-Institut, had approved the…
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Johnson & Johnson announced COVID-19 investigational vaccine candidate prevents severe clinical disease in hamsters
On Sept. 3, 2020, as part of the ongoing randomised, controlled clinical trials of the AstraZeneca Oxford coronavirus…
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Sanofi and GSK initiated Phase 1/2 clinical trial of COVID-19 adjuvanted recombinant protein-based vaccine candidate
On Sept. 3, 2020, Sanofi and GSK announced the start of the Phase 1/2 clinical trial for their…
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US Army uniquely poised to battle global pandemic
On Sept. 2, 2020, the U.S. Army Medical Materiel Development Activity reported it was working to develop a…
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Novavax announced publication of phase 1 data for COVID-19 vaccine candidate in The New England Journal of Medicine
On Sept. 2, 2020, Novavax announced the publication in The New England Journal of Medicine of Phase 1…
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MediciNova announced development progress on intranasal formulation of SARS-CoV-2 vaccine for COVID-19
On Sept. 1, 2020, MediciNova announced development progress on its intranasal SARS-CoV-2 vaccine for COVID-19 utilizing BC-PIV, a…
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COVID-19 | Disease | FDA | Therapeutics
City of Hope doctors lead novel clinical trial to treat cancer patients with COVID-19
On Sept. 1, 2020, City of Hope announced that it was investigating an innovative treatment for cancer patients…
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Phase 3 clinical testing in the US of AstraZeneca COVID-19 vaccine candidate began
On Aug. 31, 2020, a multi-site, Phase 3 clinical trial evaluating an investigational COVID-19 vaccine known as AZD1222…
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Development of COVID-19 vaccine AZD1222 expanded into U.S. Phase III clinical trial across all adult age groups
On Aug. 31, 2020, AstraZeneca announced that the COVID-19 vaccine AZD1222 expanded into U.S. Phase III clinical trial…
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The US Dept of Veterans Affairs anounced new clinical trial for Veterans with COVID-19
On Aug. 28, 2020, the U.S. Dept. of Veterans Affairs (VA) announced a new clinical trial to study…
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COVID-19 drug candidate Brilacidin achieved a selectivity index among the highest reported
On Aug. 24, 2020, Innovation Pharma reported receiving additional data from a U.S. Regional Biocontainment Laboratory (RBL) based…
