Dynavax and Serum Institute announced first participant dosed in trial evaluating Tdap vaccine adjuvanted with CpG 1018
On Feb. 3, 2021, Dynavax Technologies and Serum Institute of India announced that the first participant has been…
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First-in-human clinical trial confirmed novel HIV vaccine approach
On Feb. 3, 2021, IAVI and Scripps Research announced a phase 1 clinical trial testing a novel vaccine…
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NeuroRx initiated phase 2/3 study of inhaled ZYESAMI for severe COVID-19 with UCI Health
On Feb. 3, 2021, RELIEF THERAPEUTICS affirmed that its collaboration partner NeuroRx had initiated a phase 2/3 clinical…
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Innovation Pharmaﾒs phase 2 clinical trial of Brilacidin for treating COVID-19 began
On Jan. 29, 2021, Innovation Pharmaceuticals announced that the companyﾒs Phase 2 clinical trial of Brilacidin for treating…
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Single-shot Janssen COVID-19 vaccine candidate met primary endpoints in interim analysis of phase 3 ENSEMBLE trial
On Jan. 29, 2021, Johnson & Johnson announced topline efficacy and safety data from the Phase 3 ENSEMBLE…
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Rigel awarded $165 Million from US DOD for phase 3 clinical trial of Fostamatinib in COVID-19 patients
On Jan. 29, 2021, Rigel Pharma announced it has been awarded $16.5 million by the U.S. Department of…
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Novavax COVID-19 vaccine demonstrated 89.3% efficacy in UK phase 3 trial
On Jan. 28, 2021, Novavax announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, had met the primary endpoint,…
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OncoSec announced first subjects dosed in phase 1 trial of CORVax12, COVID-19 vaccine candidate
On Jan. 27, 2021, OncoSec Medical announced that it had dosed several subjects in its Phase 1 clinical…
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Antibody infusions prevented acquisition of some HIV strains, NIH studies found
On Jan. 26, 2021, NIH researchers announced that an investigational anti-HIV antibody delivered intravenously once every eight weeks…
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Regeneron reported positive data with REGEN-COV antibody cocktail as passive vaccine to prevent COVID-19
On Jan. 26, 2021, Regeneron announced positive initial results from an ongoing Phase 3 clinical trial evaluating REGEN-COV…
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Medigen’s COVID-19 vaccine announced first participant dosed in phase 2 clinical trial in Taiwan
On Jan. 25, 2021, Medigen Vaccine Biologics and Dynavax Technologies announced that the first participant had been dosed…
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Low-dose aspirin may improve pregnancy chances for women with one or two prior miscarriages
On Jan. 25, 2021, the National Institutes of Health (NIH) announced that in large clinical trial conducted worldwide,…
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Full-dose blood thinners decreased need for life support and improved outcome in COVID-19 patients
On Jan. 22, 2021, the NIH announced that in large clinical trial conducted worldwide, full dose anti-coagulation (blood…
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Moderna announced first participant dosed in phase 1/2 study of COVID-19 vaccine in Japan led by Takeda
On Jan. 21, 2021, Moderna announced that the first participant has been dosed in the Phase 1/2 study…
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ImmunityBio announced phase I trial of COVID-19 vaccine candidate in South Africa as new variants spread
On Jan. 19, 2021, ImmunityBio announced it had received authorization from the South Africa Health Products Regulatory Authority…
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RECOVERY trial closed recruitment to convalescent plasma treatment for patients hospitalised with COVID-19
On Jan. 15, 2021, Oxford University announced that on advice of the independent Data Monitoring Committee (DMC), recruitment…
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Mateon announced positive interim results from its ARTI-19 clinical trial evaluating ARTIVeda against COVID-19
On Jan. 13, 2021, Mateon Therapeutics reported positive interim results from its ARTI-19 clinical trial evaluating ARTIVedaTM against…
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Rising protocol design complexity reported driving rapid growth in clinical trial data volume
On Jan. 12, 2021, the Tufts Center for the Study of Drug Development (Tufts CSDD) reported that ever…
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Biotechnology | CRISPR | FDA | Therapeutics
FDA cleared initiation of the Editas Medicine’s EDIT-301 clinical trial using CRISPR/Cas12a gene editing
On Jan. 11, 2021, Editas Medicine announced the U.S. Food and Drug Administration (FDA) had cleared the initiation…
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Large clinical trial tested combination monoclonal antibody therapy for mild/moderate COVID-19
On Jan. 5, 2021, the National Institute of Allergy and Infectious Diseases (NIAID) announed that a phase 2/3…
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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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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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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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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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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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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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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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Resverlogix announced apabetalone treatment prior to SARS-CoV-2 exposure reduced viral infection
On Dec. 22, 2020, Resverlogix announced published findings in the Proceedings of the National Academy of Sciences (PNAS),…
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NIH ACTIV Trial of blood thinners paused enrollment of critically ill COVID-19 patients
On Dec. 22, 2020, the NIH researchers announced that three clinical trial platforms working together to test the…
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Abivax’s Covid-19 phase 2b/3 miR-AGE trial with ABX464 declared National Priority by French government
On Dec. 22, 2020, Abivax announced that the Companyﾒs ongoing ABX464 phase 2b/3 trial in high-risk Covid-19 patients…
