US Department of Defense awarded $3.2 billion in contract modifications for monoclonal antibodies
On Sept. 15, 2021, the U.S. Department of Defense in coordination with the Department of Health and Human…
Misdirected antibodies linked to severe COVID-19
On Sept. 14, 2021, the NIH announced that an international project called the COVID Human Genetic Effort has…
Emergent BioSolutions announced manufacturing agreement with Providence Therapeutics for mRNA COVID-19 vaccine candidate
On Sept. 14, 2021, Emergent BioSolutions announced a five-year contract development and manufacturing (CDMO) services agreement spanning Emergentﾒs…
City of Hope trial was first to test an investigational COVID-19 vaccine in immunocompromised bone marrow transplant
On Sept. 14, 2021, City of Hope announced that it had begun enrolling patients in a Phase 2…
Atlanta Zoo’s western lowland gorillas tested presumptive positive for COVID-19
On Sept. 10, 2021, Zoo Atlanta reported that it had received presumptive positive test results indicating that members…
US Department of Defense awarded $35.8 million contract to Mettler-Toledo Rainin to increase domestic production capacity of pipette tips
On Sept. 10, 2021, the U.S. Department of Defense in coordination with the Department of Health and Human…
FDA declined Humanigenﾒ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…
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…
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…
Biotechnology | COVID-19 | FDA | Pharmaceutical | Therapeutics | Vaccine
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…
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…
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…
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…
Quidel announced QuickVueﾮ at-home OTC COVID-19 tests to CVS Pharmacy
On Sept. 1, 2021, Quidel announced it will make Quidelﾒs non-prescription QuickVueﾮ At-Home OTC COVID-19 Test available to…
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…
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…
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…
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…
AAXIMﾮ Biotechnologiesﾒ manufacturing partner filed amended EUA for papid COVID-19 neutralizing antibody test
On Aug. 30, 2021, AXIMﾮ Biotechnologies announced that the Companyﾒs manufacturing partner Empowered Diagnostics had filed an amended…
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 RAYALDEEﾮ 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…