Positive phase 1/2 results reported for Valneva’s inactivated COVID-19 vaccine candidate using CpG 1018ﾙ adjuvant
On Apr. 5, 2021, Dynavax Technologies announced that Valneva had reported positive initial results for Part A of…
Innovation Pharma announced increased dosing in phase 2 clinical trial of Brilacidin in COVID-19 patients
On Apr. 5, 2021, Innovation Pharmaceuticals announced that an independent Data Monitoring Committee (DMC) completed its scheduled review…
Novavax initiated COVID-19 vaccine clinical trial crossover
On Apr. 5, 2021, Novavax announced the initiation of crossover arms in two ongoing clinical trials of NVX-CoV2373,…
Emergent announced support of manufacturing capacity expansion for Johnson & Johnson’s COVID-19 vaccine
On Apr. 4, 2021, Emergent BioSolutions announced it had received a contract modification to increase the original task…
Emergent announced topline data from NIAID phase 3 ITAC Trial evaluating immunoglobulins as treatment for patients with COVID-19
On Apr. 2, 2021, Emergent BioSolutions announced that topline data from the ITAC trial had demonstrated that the…
Moderna provided storage update and FDA authorization for 15-doses per vial of COVID-19 vaccine
On Apr. 1, 2021, Moderna announced that based on submitted stability data, the U.S. Food and Drug Administration…
Pfizer and BioNTech confirmed high efficacy and no serious safety concerns in updated COVID-19 vaccine study
On Apr. 1, 2021, Pfizer and BioNTech announced updated topline results from analysis of 927 confirmed symptomatic cases…
Arbutus Biopharma, X-Chem and Proteros biostructures entered into pan-coronavirus discovery research and license agreement
On Apr. 1, 2021, Arbutus Biopharma, X-Chem and Proteros Biostructures announced hat they had entered into a discovery…
FDA revised Moderna COVID-19 vaccine EUA to increase the number of vaccine doses available
On Apr. 1, 2021, the U.S. Food and Drug Administration (FDA) announced two revisions regarding the number of…
Biotechnology | COVID-19 | FDA
Quidel’s QuickVue At-Home OTC COVID-19 Test received EUA for screening use with serial testing
On Mar. 31, 2021, Quidel announced that it had received an Emergency Use Authorization (EUA) from the FDA,…
Pfizer-BioNTech announced positive topline results of pivotal COVID-19 vaccine study in adolescents
On Mar. 31, 2021, Pfizer and BioNTech announced that, in a Phase 3 trial in adolescents 12 to…
T cells recognize recent SARS-CoV-2 variants
On Mar. 30, 2021, the National Institute of Allergy and Infectious Diseases (NIAID) announced that researchers had analyzed…
Celonic and CureVac announced agreement to manufacture over 100 million doses of CureVacﾒs COVID-19 vaccine CVnCoV
On Mar. 30, 2021, CureVac and Celonic Group announced their partnership for the production of CureVacﾒs mRNA-based COVID-19…
OraSure Technologies submitted COVID-19 rapid antigen prescription home self-test to FDA for EUA
On Mar. 30, 2021, OraSure Technologies announced that it had submitted an application to the U.S. Food and…
Qx Therapeutics received FDA authorization with IND for QXT-101 in phase 2 trial for patients with COVID-19 infection.
On Mar. 30, 2021, Qx Therapeutics announced that the FDA had cleared the companyﾒs Investigational New Drug application…
CytoDyn’s leronlimab decreased mortality at 14 days by 82% amongst critically Ill COVID-19 patients
On Mar. 30, 2021, CytoDyn announced further results from its CD12 trial of severe-to-critically ill patients with COVID-19….
Oxford University researchers released cheap, quick COVID-19 antibody test
On Mar. 29, 2021, an international research team led by Oxford University scientists announced they had developed a…
Humanigen reported positive phase 3 results demonstrating Lenzilumabﾙ improved survival without mechanical ventilation with COVID-19
On Mar. 29, 2021, Humanigen announced positive topline results from its Phase 3 clinical trial evaluating the efficacy…
Moderna announced shipment of 100 millionth dose of its COVID-19 vaccine to the U.S. Government
On Mar. 29, 2021, Moderna announced that the Company has shipped the 100-millionth dose of its COVID-19 vaccine…
GSK to manufacture Novavax’ COVID-19 vaccine
On Mar. 29, 2021, Novavax, GSK and the UK Government Vaccines Taskforce announced an agreement in principle to…
Johnson & Johnson announced agreement with African Vaccine Acquisition Trust for COVID-19 vaccine candidate
On Mar. 29, 2021, Janssen Pharmaceutica announced that it had entered into an agreement with the African Vaccine…
Philippines FDA approved the use of leronlimab to treat a COVID-19 patient
On Mar. 29, 2021, CytoDyn announced that the Republic of the Philippines, Department of Health, Food and Drug…
BioNTech updated on vaccine production status at Marburg manufacturing site
On Mar. 26, 2021, BioNTech announced that the European Medicines Agency (EMA) approved the manufacturing of the COVID-19…
Scientists found evidence that novel coronavirus infects the mouth’s cells
On Mar. 25, 2021, an international team of scientists announced they had found evidence that SARS-CoV-2 infects cells…
Clover Biopharma and Dynavax announcd first participants dosed in phase 2/3 trial for COVID-19 vaccine candidate
On Mar. 24, 2021, Clover Biopharmaceuticals and Dynavax Technologies announced the first participants have were dosed in Clover’s…
COVID-19 | Diagnostics | FDA
AXIM Biotechnologies’ partner Empowered filed EUA with FDA for use of rapid COVID-19 neutralizing antibody test
On Mar. 24, 2021, AXIM Biotechnologies announced that partner Empowered Diagnostics, had filed an Emergency Use Authorization or…
CureVacﾒs COVID-19 vaccine candidate demonstrated protection against SARS-CoV-2 B1351 variant
On Mar. 23, 2021, CureVac announced publication of preclinical data demonstrating that their COVID-19 vaccine candidate, CVnCoV, protected…
Phase III data showed investigational antibody cocktail reduced hospitalisation or death in patients with COVID-19
On Mar. 23, 2021, Roche confirmed positive topline results from the largest trial to date assessing a COVID-19…
FDA issued an EUA to the Twist Bioscience for their SARS-CoV-2 NGS assay.
On Mar. 26, 2021, the FDA issued an emergency use authorization (EUA) to the Twist Bioscience for their…
Pfizer initiated phase 1 study of movel oral antiviral therapeutic agent against SARS-CoV-2
On Mar. 23, 2021, Pfizer announced that it was progressing to multiple ascending doses after completing the dosing…