Novavax and Serum Institute announced submission to WHO for Emergency Use Listing of COVID-19 vaccine
On Sept. 23, 2021, Novavax with its partner, Serum Institute of India announced a regulatory submission to the…
Results from Novavax NanoFlu influenza vaccine phase 3 clinical trial Published in The Lancet Infectious Diseases
On Sept. 23, 2021, Novavax announced publication of complete results from a pivotal Phase 3 clinical trial of…
Tonix Pharmaceuticals expanded research collaboration to develop precision medicine techniques for COVID-19 vaccines and therapeutics
On Sept. 23, 2021, Tonix Pharmaceuticals announced it had expanded its research collaboration with Columbia University. The research…
Clover Biopharmaceuticals’s vaccine using Dynavax’s CpG 1018 adjuvant met primary and secondary efficacy endpoints
On Sept. 22, 2021, Dynavax Technologies announced that Clover Biopharmaceuticals reported positive data for their protein-based COVID-19 vaccine…
Pfizer and BioNTech expanded U.S. collaboration to provide 500 million additional COVID-19 vaccine doses to poorest countries
On Sept. 22, 2021, Pfizer and BioNTech announced plans to expand their agreement with the U.S. government by…
INOVIO received regulatory authorization to conduct phase 3 efficacy trial of COVID-19 DNA vaccine candidate in Mexico
On Sept. 22, 2021, Inovio Pharmaceuticals announced that it had received authorization from COFEPRIS, the national health regulatory…
Biotechnology | COVID-19 | Genomics | HIV | Vaccine
Winners of 2022 Breakthrough Prizes In Life Sciences announced
On Sept. 22, 2021, the Breakthrough Prize Foundation and its founding sponsors announced the 2022 winners of the…
Pfizer and BioNTech announced positive topline results from pivotal trial of COVID-19 vaccine in children 5 to 11 years
On Sept. 20, 2021, Pfizer and BioNTech announced results from a Phase 2/3 trial showing a favorable safety…
Zoo Atlanta reported nine western lowland gorillas tested positive for COVID-19
On Sept. 17, 2021, Zoo Atlanta reported that of the 20 gorillas at the Zoo, 18 showed clinical…
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…
Celsion and Hainan Poly Pharm signed agreement to manufacture Celsionﾒs DNA-based vaccine
On Sept. 16, 2021, Celsion and Hainan Poly Pharm announced an amendment to their existing contract manufacturing agreement…
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…
World global health leaders made urgent call to accelerate vaccination globally
On Sept. 14, 2021, the WHO Director General Dr Tedros Adhanom Ghebreyesus and a group of global health…
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…
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…
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…
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…
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…
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…
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…
Biotechnology | COVID-19 | NIH | Therapeutics | Vaccine
Oragenics SARS-CoV-2 spike protein produced neutralizing antibodies with Intramuscular and intranasal adjuvants
On Aug. 30, 2021, Oragenics announced that the stabilized pre-fusion spike protein trimer produced by its Canadian collaborator…
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…
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…