FDA declined Humanigenï¾’s Emergency Use Authorization request for lenzilumab in hospitalized COVID-19 patients
On Sept. 9, 2021, Humanigen announced the U.S. FDA had declined its request for emergency use authorization of…
T2 Biosystems T2SARS-CoV-2 panel proved capable of detecting Mu B.1.621 and Iota B.1.526 variants of SARS-CoV-2 virus
On Sept. 9, 2021, T2 Biosystems announced that its T2SARS-CoV-2 Panel – a molecular diagnostic test that detected…
AIM ImmunoTech submitted pre-IND application to FDA for phase 2 clinical study of Ampligen for post-COVID-19 cognitive dysfunction
On Sept. 8, 2021, AIM ImmunoTech announced that is had submitted a Pre-Investigational New Drug application (Pre-IND) to…
Novavax initiated phase 1/2 clinical trial of combination vaccine for COVID-19 and seasonal influenza
On Sept. 8, 2021, Novavax announced enrollment of the first participants in a Phase 1/2 study to evaluate…
Bio-Techne and Carterra initiateed clinical research collaboration for COVID-19 variant analysis
On Sept. 8, 2021, Bio-Techne and Carterra announced a clinical research collaboration studying COVID-19 variants. To assess immune…
Resilience to manufacture mRNA for Moderna’s COVID-19 vaccine
On Sept. 8, 2021, National Resilience announced an agreement to manufacture mRNA for the Moderna COVID-19 vaccine. Under…
Pfizer and BioNTech submitted a variation to EMA with data in support of a booster dose of COMIRNATY
On Sept. 6, 2021, Pfizer and BioNTech announced that they had submitted a variation to the European Medicines…
Moderna announced submission of data to EMA for its COVID-19 vaccine booster
On Sept. 3, 2021, Moderna announced that it had submitted for a conditional marketing approval (CMA) with the…
CDC announced more than $300 million in funding to support community health workers
On Sept. 3, 2021, the Centers for Disease Control and Prevention (CDC) awarded more than $116 million in…
Thermo Fisher awarded $192.5 million U.S. government contract to expand domestic pipette tip manufacturing
On Sept. 2, 2021, Thermo Fisher Scientific announced a $192.5 million contract award from the U.S. Department of…
Data from phase 2 trial of Fostamatinib in hospitalized COVID-19 patients published in Clinical Infectious Diseases
On Sept. 1, 2021, Rigel Pharma announced the publication of results from a Phase 2 clinical trial evaluating…
Moderna announced submission of initial data to U.S. FDA for Its COVID-19 vaccine booster
On Sept. 1, 2021, Moderna announced it had initiated its submission to the U.S. Food and Drug Administration…
Quidel announced QuickVueï¾® at-home OTC COVID-19 tests to CVS Pharmacy
On Sept. 1, 2021, Quidel announced it will make Quidelï¾’s non-prescription QuickVueï¾® At-Home OTC COVID-19 Test available to…
SK bioscience and GSK started Phase 3 trial of adjuvanted COVID-19 vaccine candidate
On Aug. 31, 2021, SK bioscience and GlaxoSmithKline announced the initiation of a Phase 3 clinical study of…
U.S. Department of Defense announced $194.5 million in industrial base expansion contract awards
On Aug. 31, 2021, the U.S. Department of Defense in coordination with the Department of Health and Human…
CureVac’s CVnCoV phase 2b/3 study data published in The Lancet
On Aug. 30, 2021, CureVac announced the publication of its pivotal Phase 2b/3 (HERALD study) primary data of…
AAXIMï¾® Biotechnologiesï¾’ manufacturing partner filed amended EUA for papid COVID-19 neutralizing antibody test
On Aug. 30, 2021, AXIMï¾® Biotechnologies announced that the Companyï¾’s manufacturing partner Empowered Diagnostics had filed an amended…
Biotechnology | COVID-19 | Infectious Disease | Life Science News | Non-Profit Research | Therapeutics
Monoclonal antibody treatment combo reduced hospitalization among high-risk patients with COVID-19
On Aug. 30, 2021, the Mayo Clinic reported that in an observational study the combination of casirivimab and…
OPKO Health completed enrollment in phase 2 trial evaluating RAYALDEE as treatment forsymptomatic COVID-19 outpatients
On Aug. 30, 2021, OPKO announced completion of enrollment in its Phase 2 trial with RAYALDEEï¾® as a…
USDA confirmed COVID-19 in deer in Ohio
On Aug. 27, 2021, the USDA’s National Veterinary Services Laboratories announced confirmation of SARS-CoV-2 (the virus that causes…
NIH launched study of extra COVID-19 vaccine dose in people with autoimmune disease
On Aug. 27, 2021, The National Institutes of Health announced that it had begun a clinical trial to…
US Department of Defense awarded $6.5 million contract to U.S. Cotton to increase domestic production of polyester-tipped swabs
On Aug. 27, 2021, the U.S. Department of Defense in coordination with the Department of Health and Human…
Pfizer and BioNTech announced collaboration with Brazil’s Eurofarma to manufacture COVID-19 vaccine doses
On Aug. 26, 2021, Pfizer and BioNTech announced the signing of a letter of intent with Eurofarma Laboratorios,…
INOVIO received authorization to conduct phase 3 efficacy trial of COVID-19 DNA vaccine candidate, INO-4800 in Brazil
On Aug. 26, 2021, Inovio Pharma announced that it had received regulatory authorization from Brazil’s ANVISA (Agencia Nacional…
University of Nebraska Medical Center team confirmed COVID-19’s airborne transmission in leading scientific journal
On Aug. 26, 2021, the University of Nebraska Medical Center (UNMC) announced findings on airborne transmission have passed…
Anixa Biosciences’ Covid-19 compounds expected to be effective against the Delta variant
On Aug. 25, 2021, Anixa Biosciences announced that a genomic variant analysis indicateed that its potential compounds may…
Moderna completed submission of BLA to the Food and Drug Administration for its COVID-19 vaccine
On Aug. 25, 2021, Moderna announced it had completed the rolling submission process for its Biologics License Application…
BD received EUA for first at-home COVID-19 test to use smartphone to interpret, deliver results
On Aug. 25, 2021, BD (Becton, Dickinson) announced the U.S. Food and Drug Administration (FDA) had issued an…
Johnson & Johnson announced data to support boosting its single-shot COVID-19 vaccine
On Aug. 25, 2021, Johnson & Johnson announced data supporting the use of its COVID-19 vaccine as a…
Pfizer and BioNTech initiated rolling submission of SBLA to U.S. FDA for booster dose of COMIRNATY in individuals 16 and Older
On Aug. 25, 2021, Pfizer and BioNTech announced the initiation of a supplemental Biologics License Application (sBLA) to…