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…
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…
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 National Institutes of Health (NIH) announced that the investigational vaccine known as mRNA-1273…
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…
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…
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…
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…
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),…
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…
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…
COVID-19 targeted treatment trial launched in Vienna
On Dec. 22, 2020, a phase II clinical trial of a treatment for COVID-19 patients was started at…
FDA granted IND approval for phase 2 clinical trial of Innovation Pharmasﾒ Brilacidin for treating COVID-19
On Dec. 21, 2020, Innovation Pharma announced that the FDA had approved the Companyﾒs Investigational New Drug (IND)…
FDA granted IND approval for phase 2 clinical trial of Innovation Pharma’s Brilacidin for treating COVID-19
On Dec. 21, 2020, Innovation Pharmaceuticals announced that the FDA had approved the Companyﾒs Investigational New Drug (IND)…
Investigational COVID-19 therapeutics evaluated in large clinical trials
On Dec. 17, 2020, NIAID announced that two randomized, controlled Phase 3 clinical trials had begun evaluating investigational…
Heat Biologics announced completion of ZVX-60 vaccine cell line for COVID-19
On Dec. 16, 2020, Heat Biologics announced it had completed its gp96-based COVID-19 vaccine cell line, which is…
INOVIO to develop DNA-encoded monoclonal antibody (dMAb) candidates to treat COVID-19
On Dec. 15, 2020, Inovio Pharma announced the company and a team of scientists from The Wistar Institute,…
Codagenix and Serum Institute commenced first-in-human trial of COVI-VAC single dose, intranasal COVID-19 vaccine
On Dec. 14, 2020, Codagenix and the Serum Institute of India announced that a Phase 1 clinical trial…
Biotechnology | CRISPR | FDA | Therapeutics
CIRM-funded project targeting sickle cell disease received green light for clinical trial
On Dec.14, 2020, the US Food and Drug Administration (FDA) announced they had granted Investigational New Drug (IND)…
Baricitinib plus remdesivir showed promise for treating COVID-19
On Dec. 11, 2020, the combination of baricitinib, an anti-inflammatory drug, and remdesivir, an antiviral, reduced time to…
INOVIO dosed first subject in phase 2 segment of INNOVATE phase 2/3 trial for INO-4800 to prevent COVID-19
On Dec. 7, 2020, Inovio Pharmaceuticals announced it had dosed its first subject in a Phase 2 clinical…
Peanut allergy treatment significantly lowered risk of life-threatening reactions in preschoolers
On Dec. 3, 2020, a new study by researchers at the University of British Columbia and BC Children’s…
NIH announced restructured HIV clinical trials networks
On Nov. 30, 2020, The National Institute of Allergy and Infectious Diseases (NIAID) announced the clinical investigators and…
City of Hope coronavirus vaccine produced strong immunity in preclinical research
On Nov. 30, 2020, the City of Hope reported that its investigational vaccine produced strong protective immunity against…
BioNTech and Fosun Pharma announced start of phase 2 clinical trial of mRNA COVID-19 vaccine in China
On Nov. 25, 2020, BioNTech and Shanghai Fosun Pharmaceutica jointly announced that their lead mRNA COVID-19 vaccine candidate…
Biotechnology | COVID-19 | Disease | Therapeutics | Vaccine
NeuroRx and Relief announced successful results from expanded use of RLF-100 in patients with COVID-19
On Nov. 24, 2020, RELIEF THERAPEUTICS announced that more than 175 patients with Critical COVID-19 and Respiratory Failure…
MediciNova announced initiation of master virus seed stock production for intranasal COVID-19 vaccine
On Nov. 24, 2020, MediciNova announced development progress on its intranasal SARS-CoV-2 vaccine for COVID-19 utilizing BC-PIV, a…
AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19
On Nov. 23, 2020, AstraZeneca announced positive high-level results from an interim analysis of clinical trials of AZD1222…