First-in-human implant of ‘closed-loop’ bioelectronic research system begun for Parkinson’s-like Multiple Systems Atrophy
On Feb. 8, 2022, researchers at Oxford University announced they had implanted a novel closed-loop research platform for…
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Study of Penn patients with decade-long leukemia remissions after CAR T cell therapy revealed new details about persistence of personalized ‘Living Drug’ cells
On Feb. 2, 2022, a new analysis of the first two patients treated in a clinical trial with…
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Novavax submitted request to U.S. FDA for Emergency Use Authorization of COVID-19 vaccine
On Jan. 31, 2022, Novavax announced that it had submitted a request to the U.S Food and Drug…
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Hyperimmune intravenous immunoglobulin does not improve outcomes for adults hospitalized with COVID-19
On Jan. 27, 2022, NIAID announced that a clinical trial found that the combination of remdesivir plus a…
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COVID-19 | FDA | Life Science History | NIH
Mix-and-match trial found additional dose of COVID-19 vaccine safe, immunogenic
On Jan. 26, 2022, the NIH announced that adults who had previously received a full regimen of any…
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Oral immunotherapy induced remission of peanut allergy in some young children
On Jan. 20, 2022, a clinical trial funded by the National Institutes of Health (NIH) found that giving…
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Novartis and Molecular Partners reported positive topline data from Phase 2 study for ensovibep antiviral therapeutic for COVID-19
On Jan. 10, 2022, Novartis Molecular Partners announced that Part A of the EMPATHY clinical trial that compared…
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Revelar Biotherapeutics and Twist Bioscience announced RBT-0813 neutralized SARS-CoV-2 Omicron and Delta variants
On Jan 5, 2022, Revelar Biotherapeutics and Twist Bioscience announced that RBT-0813 binded to and neutralized the Omicron…
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Pfizer and BioNTech submit updated longer-term follow-up data of COMIRNATY in adolescents to EMA
On Dec. 23, 2021, Pfizer and BioNTech announced that they had submitted longer-term follow-up data from the companiesﾒ…
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Novavax announced initiation of PREVENT-19 COVID-19 vaccine phase 3 trial booster study
On Dec. 21, 2021, Novavax announced that the first booster doses of NVX-CoV2373, the company’s recombinant nanoparticle protein-based…
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Novavax filed for Emergency Use of COVID-19 vaccine in the United Arab Emirates
On Dec. 13, 2021, Novavax announced that it had submitted a regulatory filing to the Ministry of Health…
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Novavax filed for interim authorization of COVID-19 vaccine in singapore
On Nov. 24, 2021, Novavax announced its submission to the Singapore Health Sciences Authority for interim authorization of…
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Innovation Pharmaceuticals conducted full data analysis of phase 2 brilacidin COVID-19 trial results to support inclusion in Government-sponsored trials
On Nov. 12, 2021, Innovation Pharma announced the Company was conducting full data analysis of the Phase 2…
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Innovation Pharmaceuticals announced topline results from phase 2 clinical trial of brilacidin for COVID-19
On Nov. 11, 2021, Innovation Pharma reported topline results from the Companyﾒs Phase 2 clinical trial of Brilacidin…
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Database lock completed for Innovation Pharmaceuticalsﾒ phase 2 clinical trial of brilacidin for COVID-19
On Nov. 3, 2021, Innovation Pharma announced that the Company had received confirmation that hard lock of the…
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Vaxart dosed first subject in phase II COVID-19 oral tablet vaccine clinical trial
On Oct. 26, 2021, Vaxart announced that it has dosed the first subject in its Phase II COVID-19…
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Axcella Therapeutics launched clinical program to develop treatment for patients with long COVID
On Oct. 26, 2021, Axcella Therapeutics announced a new clinical program to investigate AXA1125 as a potential treatment…
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Subcutaneous Interferon does not improve outcomes for hospitalized adults with COVID-19
On Oct. 18, 2021, a NIAID sponsored clinical trial found that treatment with the immunomodulator interferon beta-1a plus…
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LogicBio Therapeutics announced early clinical trial results demonstrated first-ever in vivo genome editing in children
On Oct. 18, 2021, LogicBio Therapeutics announced clinical trial results that demonstrated the first-ever in vivo genome editing…
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Vaxartﾠ began recruiting in global phase II COVID-19 oral tablet vaccine clinical trial
On Oct. 6, 2021, Vaxart announced that it had begun recruiting subjects for its Phase II COVID-19 oral…
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Washington University School of Medicine in St. Louis led pediatric COVID-19 vaccine trial launched
On Oct. 6, 2021, Washington University School of Medicine announced the start of a pediatric COVID-19 vaccine clinical…
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Pfizer announced Study of mRNA-based next generation flu vaccine program
On Sept. 27, 2021, Pfizer announced that the first participants have been dosed in a Phase 1 clinical…
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Clover Biopharmaceuticals’s vaccine using Dynavax’s CpG 1018 adjuvant met primary and secondary efficacy endpoints
On Sept. 22, 2021, Clover Biopharmaceuticals, a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates,…
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Novavax included in University of Oxford Com-COV3 study comparing mixed COVID-19 vaccine in adolescents
On Sept. 16, 2021, Novavax announced its participation in a newly expanded Phase 2 clinical trial called Comparing…
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City of Hope trial was first to test an investigational COVID-19 vaccine in immunocompromised bone marrow transplant
On Sept. 14, 2021, City of Hope announced that it had begun enrolling patients in a Phase 2…
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Novavax initiated phase 1/2 clinical trial of combination vaccine for COVID-19 and seasonal influenza
On Sept. 8, 2021, Novavax announced enrollment of the first participants in a Phase 1/2 study to evaluate…
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Data from phase 2 trial of Fostamatinib in hospitalized COVID-19 patients published in Clinical Infectious Diseases
On Sept. 1, 2021, Rigel Pharma announced the publication of results from a Phase 2 clinical trial evaluating…
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NIH launched study of extra COVID-19 vaccine dose in people with autoimmune disease
On Aug. 27, 2021, the National Institutes of Health announced that it had begun a clinical trial to…
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clinical trial tested donated antibodies for effectiveness in fighting infection caused by Coronavirus
On Aug. 19, 2021, Oregon Health & Science University (OHSU) announced that it was part of a randomized,…
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Biotechnology | COVID-19 | FDA | Infectious Disease | NIH | Therapeutics
FDA declined to issue Rigel Pharma EUA for fostamatinib for teatment of COVID-19 in hospitalized adults
On Aug. 13, 2021, Rigel Pharma announced that the U.S. Food and Drug Administration (FDA) had informed the…
