DOD participated in COVID-19 antibody treatment trial
On Feb. 11, 2021, the the Military Health System (MHS) announced partcipation in the AstraZeneca phase III clinical…
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Clinical trial in hospitalized COVID-19 patients evaluate long-acting antibody therapy
On Feb. 8, 2021, the NIH announced that an international randomized, controlled Phase 3 clinical trial had begun…
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NanoViricides’s antiviral drug candidate for treatment of COVID-19 infections well tolerated in animal safety studies
On Feb. 8, 2021, NanoViricides announced that its broad-spectrum anti-coronavirus drug candidate for the treatment of COVID-19 infections…
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Corvus Pharmaceuticals initiated phase 3 clinical trial of CPI-006 for patients with COVID-19
On Feb. 4, 2021, Corvus Pharmaceuticals announced that it had initiated a Phase 3 clinical trial of CPI-006…
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Johnson & Johnson announced submission of application to FDA for EUA of its single-shot COVID-19 vaccine candidate
On Feb. 4, 2021, Johnson & Johnson announced that subsidiary Janssen Biotech, had submitted an application to the…
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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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Humanigen and Avid Bioservices entered Into cGMP manufacturing agreement for COVID-19 therapeutic
On Feb. 3, 2021, Avid Bioservices and Humanigen announced that they had entered into a manufacturing services agreement…
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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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AXIM Biotechnologies began clinical trials of ImmunoPass rapid diagnostic test with vaccine recipients
On Feb. 3, 2021, AXIM Biotechnologies announced initiation of clinical trials for ImmunoPass, the Companyﾒs rapid point-of-care test…
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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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Humanigen completed enrollment in phase 3 study of lenzilumab in hospitalized patients with COVID-19
On Jan. 29, 2021, Humanigen announced it had completed enrollment for its pivotal phase 3 study of lenzilumab…
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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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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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Ajinomoto Bio-Pharma and Humanigen expanded agreement to support fill finish for COVID-19 therapeutic
On Jan. 27, 2021, Ajinomoto Bio-Pharma Services and Humanigen announced the companies will be expanding their manufacturing agreement…
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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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Humanigen and Emergent BioSolutions announced CDMA for phase 3 COVID-19 therapeutic candidate Lenzilumabﾙ
On Jan. 25, 2021, Emergent BioSolutions and Humanigen announced a contract development and manufacturing (CDMO) services agreement to…
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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…
