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…
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 Companyï¾’s rapid point-of-care test…
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…
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…
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…
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…
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…
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…
Innovation Pharmaï¾’s phase 2 clinical trial of Brilacidin for treating COVID-19 began
On Jan. 29, 2021, Innovation Pharmaceuticals announced that the companyï¾’s Phase 2 clinical trial of Brilacidin for treating…
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…
Novavax COVID-19 vaccine demonstrated 893% efficacy in UK phase 3 trial
On Jan. 28, 2021, Novavax announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with…
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…
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…
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…
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…
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…
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,…
Humanigen and Emergent BioSolutions announced CDMA for phase 3 COVID-19 therapeutic candidate Lenzilumabï¾™
On Jan. 25, 2021, Emergent BioSolutions and Humanigen announced a contract development and manufacturing (CDMO) services agreement to…
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…
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…
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…
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…
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 reported that ever more complex…
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 FDA had cleared the initiation of the safety phase of…
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…
Peer-reviewed report on Moderna COVID-19 vaccine published
On Dec. 30, 2020, the NIH announced that the investigational vaccine known as mRNA-1273 was 94.1% efficacious in…
Biotechnology | COVID-19 | FDA | Life Science News | 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…
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…
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…
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…