Africa faced 470 million COVID-19 vaccine shortfall in 2021
On Sept. 16, 2021, the WHO reported that the continent faced almost 500 million doses short of the…
Moderna announces Health Canada approves its COVID-19 vaccine
On Sept. 16, 2021, Moderna announced Health Canada had approved the New Drug Submission (NDS-CV) for SPIKEVAX (elasomeran…
Novavax included in University of Oxford Com-COV3 study comparing mixed COVID-19 vaccine in adolescents
On Sept. 16, 2021, Novavax announced its participation in a newly expanded Phase 2 clinical trial called Comparing…
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…
Biotechnology | COVID-19 | Diagnostics | FDA
InBios received FDA EUA for COVID-19 IgG antibody rapid test
On Sept. 15, 2021, InBios announced that it had received Emergency Use Authorization from the U.S. Food and…
NIH builds large nationwide study population of tens of thousands to support research on long-term effects of COVID-19
On Sept. 15, 2021, the National Institutes of Health (NIH) awarded nearly $470 million to build a national…
Oragenics initiated COVID-19 challenge study evaluating multiple formulations of its SARS-CoV-2 vaccine candidate
On Sept. 15, 2021, Oragenics announced the initiation of a study to evaluate the immunogenicity and viral load…
Moderna reported clinical data on its COVID-19 vaccine
On Sept. 15, 2021, Moderna announced new analysis suggesting that the COVID-19 vaccine was highly effective against circulating…
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…
Regeneron announced U.S. Government agreement to purchase additional REGEN-COV antibody cocktail
On Sept. 14, 2021, Regeneron announced an agreement with the U.S. Department of Health and Human Services and…
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…
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…
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…
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…
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…
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…
Takeda announced manufacture and provision of 150 million doses of Novavax COVID-19 vaccine candidate to the government of Japan
On Sept. 7, 2021, Takeda Pharmaceutical announced the Government of Japan’s Ministry of Health, Labour and Welfare purchase…
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…
Coronavirus Epidemics first hit more than 21,000 years ago
On Sept. 2 , 2021, an Oxford University Study showed that the most recent common ancestor of these…
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…