COVID-19 | Diagnostics | FDA
EUROIMMUN anti-SARS-CoV-2 S1 curve ELISA received FDA Emergency Use Authorization
On Oct. 5, 2021, PerkinElmer announced that the U.S. Food and Drug Administration had provided Emergency Use Authorization…
Moderna announced EMA authorized third dose of COVID-19 vaccine for immunocompromised individuals aged 12 years and older
On Oct. 5, 2021, Moderna announced that the European Medicines Agency (EMA) had authorized a third dose of…
Johnson & Johnson submitted EUA amendment to FDA to support booster of single-shot COVID-19 vaccine
On Oct. 5, 2021, Johnson & Johnson announced it had submitted data to the U.S. Food and Drug…
Vaccination linked reduction of over a quarter million COVID-19 cases, 100,000 hospitalizations, and 39,000 deaths among seniors
On Oct. 5, 2021, a new report from the U.S. Department of Health and Human Services (HHS) showed…
Pfizer and BioNTech received CHMP positive opinion for COVID-19 vaccine booster in the European Union
On Oct. 4, 2021, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP)…
ACON’s Flowflexﾙ COVID-19 home test received FDA EUA
On Oct. 4, 2021, ACON Laboratories announced that its Flowflexﾙ COVID-19 Antigen Home Test had been authorized for…
Merck and Ridgeback’s oral antiviral reduced risk of hospitalization or death for patients with COVID-19 in positive phase 3 study
On Oct. 1, 2021, Merck and Ridgeback Biotherapeutics announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine,…
Humanigen submitted all planned modules forpotential conditional Marketing Authorization from UKﾒs MHRA
On Oct. 1, 2021, Humanigen announced it had submitted all the planned modules as well as a risk…
Labcorp received EUA for at home collection kit for combined COVID-19 and flu detection
On Oct. 1, 2021, LabCorp announced that it had received Emergency Use Authorization (EUA) from the U.S. Food…
Relief reported that collaboration partner announced a second favorable safety report for ZYESAMI(TM) in Patients with COVID-19
On Sept. 30, 2021, RELIEF THERAPEUTICS reported that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals,…
Fifteen African countries hit 10% COVID-19 vaccination goal
On Sept. 30, 2021, the WHO announced that fifteen African countries – nearly a third of the continent’s…
Trevena announced results of TRV027 proof-of-concept study in COVID-19 patients
On Sept. 30, 2021, Trevena announced data from 30 patients enrolled in the proof-of-concept study of TRV027, the…
Biotechnology | Cartoons - Original | COVID-19 | Diagnostics | Medical Device | Neurology | NIH | Non-Profit Research | Pharmaceutical | Therapeutics | U.S. Congress | Vaccine
COVID-19 vaccinated vs. non-vaccinated
This cartoon illustrates the various issues facing individuals across the U.S. who are vaccinated against COVID-19 verus those…
Pfizer reported positive top-line results of phase 3 study exploring coadministration of Prevnar 20 With seasonal Flu vaccine
On Sept. 29, 2021, Pfizer and BioNTech announced they had submitted data to the U.S. Food and Drug…
NEJM published positive phase 3 trial resulted for REGEN-COV (casirivimab and imdevimab) to treat COVID-19
On Sept. 29, 2021, Regeneron announced that the New England Journal of Medicine (NEJM) published positive detailed results…
VBI Vaccines announced preclinical data and Initiation of VBI-2905 clinical trial targeting broadened immunity against COVID-19
On Sept. 29, 2021, VBI Vaccines announced positive results from multiple preclinical studies against several COVID-19 variants of…
Phase II/III trial showed Ronapreve (casirivimab and imdevimab) significantly reduced viral load in patients hospitalised with COVID-19
On Sept. 29, 2021, Roche confirmed positive data from the phase II/III 2066 study, investigating Ronapreveﾙ (casirivimab and…
2022 Breakthrough Prize in Life Sciences awarded to Penn Medicine mRNA pioneers Drew Weissman and Katalin Karik
On Sept. 29, 2021, the University of Pennsylvania announced that the Breakthrough Prize in Life Sciences was awarded…
Cepheid received Emergency Use Authorization For SARS-CoV-2, Flu A, Flu B and RSV combination test
On Sept. 29, 2021, Cepheid announced it had received Emergency Use Authorization from the U.S. Food & Drug…
Sanofi terminated mRNA COVID-19 vaccine development to focus on recombinant vaccine candidate
On Sept. 28, 2021, Sanofi announced that it had terminated plans for its own mRNA-based COVID-19 vaccine given…
AIM ImmunoTech submitted pre-IND application to FDA for phase 2 clinical studies of Ampligen as potential therapeutic for COVID-19
On Sept. 28, 2021, AIM ImmunoTech announced that is had submitted a Pre-Investigational New Drug application (Pre-IND) to…
University of Missouri researchers identified mutations of Delta, Delta Plus variants
On Sept. 28, 2021, the University of Missouri researcher Kamlendra Singh led a team that analyzed protein sequences…
Soligenix announced publication demonstrating efficacy and broad neutralizing activity of its COVID-19 Vaccine
On Sept. 28, 2021, Soligenix announced publication of pre-clinical immunogenicity studies for CiVax (heat stable COVID-19 vaccine program)…
Pfizer and BioNTech submitted initial data to FDA from pivotal trial of COVID-19 vaccine in children 5 to <12 years of age
On Sept. 28, 2021, Pfizer and BioNTech announced they had submitted data to the U.S. Food and Drug…
Relief reported that collaboration partner announced improved survival in highly comorbid COVID-19 patients treated with ZYESAMITM
On Sept. 27, 2021, RELIEF THERAPEUTICS reported its U.S. collaboration partner, NRx Pharmaceuticals, had announced top line data…
Pfizer started global phase 2/3 EPIC-PEP study of novel COVID-19 oral antiviral candidate for post-exposure prophylaxis in adults
On Sept. 27, 2021, Pfizer announced the start of the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for…
Moderna announced supply agreement with Peru for 20 million doses of Its COVID-19 vaccine
On Sept. 24, 2021, Moderna announced a supply agreement with the government of Peru for 20 million doses…
Agriculture | Biotechnology | COVID-19 | Infectious Disease | USDA | Vaccine | Veterinary
USDA confirmed COVID-19 in Ferret in Florida
On Sept. 24, 2021, the U.S. Department of Agriculture’s (USDA) announced confirmation of SARS-CoV-2 in a ferret in…
Twist Bioscience single domain antibody TB202-3 showed potent binding to multiple strains of SARS-CoV-2
On Sept. 23, 2021, Twist Bioscience reported that its internally-discovered antibody candidate TB202-3 (CoVIC-094), demonstrated potent binding to…
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…