Pfizer and BioNTech received CHMP positive opinion for their COVID-19 vaccine
On Dec. 21, 2020, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP)…
Pfizer and BioNTech received authorization in the European Union for COVID-19 vaccine
On Dec. 21, 2020, Pfizer and BioNTech announced that the European Commission (EC) had granted a conditional marketing…
CDC’s ACIP announced interim recommendation for use of Moderna COVID-19 Vaccine
On Dec. 19, 2020, after a transparent, evidence-based review of available data, the Advisory Committee on Immunization Practices…
Pfizer and BioNTech to supply the European Union with 100 million additional doses of COMIRNATY
On Dec. 19, 2020, Pfizer and BioNTech announced they supplying an additional 100 million doses of COMIRNATY the…
National Research Council of Canada supported development of 4 COVID-19 therapeutic candidates
On Dec. 18, 2020, the National Research Council of Canada (NRC) announced it was providing advisory services and…
COVAX announced additional access promising COVID-19 vaccine candidates with global rollout starting 2021
On Dec. 18, 2020, the World Health Organization (WHO) announced that it had arrangements in place to access…
FDA issued Emergency Use Authorization for second COVID-19 vaccine
On Dec. 18, 2020, the FDA issued an emergency use authorization (EUA) for the second vaccine for the…
Lilly began pragmatic study of neutralizing antibody bamlanivimab (LY-CoV555) for COVID-19 in New Mexico
On Dec. 18, 2020, Eli Lilly announced plans to begin a new pragmatic study of bamlanivimab (LY-CoV555) in…
EC exercised option for additional 80 million doses of Moderna’s COVID-19 vaccine candidate
On Dec. 18, 2020, Moderna announced that the European Commission (EC) had exercised its option to purchase an…
Moderna announced FDA authorization of Moderna COVID-19 vaccine in U.S.
On Dec. 18, 2020, Moderna announced that the U.S. Food and Drug Administration (FDA) had authorized the emergency…
Johnson & Johnson announced agreement with Gavi to supply COVID-19 vaccine candidate to lower-income countries in 2021
On Dec. 18, 2020, Johnson & Johnson announced that its subsidiary Janssen Pharma, will provide up to 500…
CDC Advisory Committee on Immunization Practices recommended vaccination with Moderna’s COVID-19 vaccine
On Dec. 18, 2020, Moderna announced that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on…
Investigational COVID-19 therapeutics evaluated in large clinical trials
On Dec. 17, 2020, NIAID announced that two randomized, controlled Phase 3 clinical trials had begun evaluating investigational…
XPhyto completed successful SARS-COV-2 RT-PCR diagnostic testk kit validation
On Dec. 17, 2020, XPhyto Therapeutics and 3a-diagnostics announced the successful validation of their point-of-care SARS-CoV-2 (COVID-19) RT-PCR…
COVID-19 the leading cause of death in the United States
On Dec. 17, 2020, JAMA reported that the daily U.S. mortality rate for COVID-19 deaths was equivalent to…
Biotechnology | COVID-19 | FDA | Life Science News | Vaccine
Moderna received FDA Advisory Committee vote supporting EUA for vaccine against COVID-19 in the U.S.
On Dec. 17, 2020, Moderna confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological…
Quest Diagnostics and The Commons Project delivered access to lab data through the CommonHealth App
On Dec. 17, 2020, Quest Diagnostics and The Commons Project, a non-profit public trust dedicated to building and…
PRA Health Sciences collaborated with PWNHealth and Fulgent Genetics provided at-home COVID-19 test
On Dec. 17, 2020, PRA Health Sciences announced the enhancement of its COVID-19 Monitoring Program with the addition…
Johnson & Johnson announced Its first phase 3 COVID-19 vaccine trial ENSEMBLE was fully enrolled
On Dec. 17, 2020, Johnson & Johnson announced that the large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) of…
NEJM published positive initial Regeneron antibody cocktail results in non-hospitalized patients with COVID-19
On Dec. 17, 2020, Regeneron announced that the New England Journal of Medicine (NEJM) had published initial clinical…
Abbott’s BinaxNOW COVID-19 rapid rest received FDA Emergency Use Authorization for at-home rapid test
On Dec. 16, 2020, Abbott announced that the FDA had issued Emergency Use Authorization (EUA) for virtually guided…
FDA issued new authorization for the BinaxNOW COVID-19 Ag Card Home Test
On Dec. 16, 2020, the U.S. Food and Drug Administration issued a new emergency use authorization (EUA) for…
Novavax announced agreement with government of New Zealand for 107 million doses of COVID-19 vaccine
On Dec. 16, 2020, Novavax announced an Advance Purchase Agreement with the government of New Zealand for the…
Heat Biologics announced completion of ZVX-60 vaccine cell line for COVID-19
On Dec. 16, 2020, Heat Biologics announced it had completed its gp96-based COVID-19 vaccine cell line, which is…
SARS-CoV-2 viral genome sequencing data reported from research using Pacific Biosciences Technology
On Dec. 16, 2020, Pacific Biosciences announced initial findings from the companyﾒs research collaboration with Labcorp that was…
BD surpassed 1 billion injection device orders in support of COVID-19 vaccination efforts around the world
On Dec. 16, 2020, BD (Becton, Dickinson) announced that it had received pandemic orders for needles and syringes…
BioNTech and Fosun Pharma to supply China with mRNA-based COVID-19 vaccine
On Dec. 16, 2020, BioNTech and Shanghai Fosun Pharmaceutical announced an agreement to supply Mainland China with an…
RedHill’s phase 2/3 COVID-19 candidate opaganib reduced ARDS-related blood clotting in preclinical model
On Dec. 15, 2020, a months long study to determine the number of Houstonians carrying COVID-19 antibodies revealed…
Abbott received CE Mark for its COVID-19 IgG quantitative antibody blood test
On Dec. 15, 2020, Abbott announced it received had CE Mark for its new quantitative SARS-CoV-2 IgG (Immunoglobulin…
FDA authorized antigen test as first over-the-counter fully at-home diagnostic test for COVID-19
On Dec. 15, 2020, the FDA granted emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home…