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…
TGen identified gene that could explain disparity in COVID-19 effects
On Dec. 15, 2020, TGen, an affiliate of City of Hope announced that it had identified a specific…
Aurinia and Lonza announced exclusive agreement for dedicated Voclosporin manufacturing capacity
On Dec. 15, 2020, Aurinia Pharmaceuticals announced the funding and initiation of an open-label exploratory trial evaluating the…
AXIM Biotechnologies completed successful Covid-19 live virus test and filed amended EUA
On Dec. 15, 2020, AXIM Biotechnologies announced the development and patent filing for an enzyme-linked immunosorbent assay (ELISA)-based…
INOVIO to develop DNA-encoded monoclonal antibody (dMAb) candidates to treat COVID-19
On Dec. 15, 2020, Inovio Pharma announced the company and a team of scientists from The Wistar Institute,…
FDA approved first-of-its-kind Intentional genomic alteration in Line of domestic pigs for human food, potential therapeutic uses
On Dec. 14, 2020, the U.S. Food and Drug Administration (FDA) approved the a first-of-its-kind intentional genomic alteration…
CureVac commenced global pivotal phase 2b/3 trial for COVID-19 vaccine candidate, CVnCoV
On Dec. 14, 2020, CureVac announced that it had enrolled the first participant in the pivotal Phase 2b/3…
Novartis updated on RUXCOVID study of ruxolitinib for hospitalized patients with COVID-19
On Dec. 14, 2020, Novartis announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard…
No association found between COVID-19 and Guillain-Barre syndrome
On Dec.14, 2020, neuroscientists at University College London (UCL) announced they had found no significant association between COVID-19…
U.S. Dept of Veterans Affairs began COVID-19 vaccinations
On Dec. 14, 2020, the U.S. Dept. of Veterans Affairs (VA) announced that the New Orleans and Bedford,…
Codagenix and Serum Institute commenced first-in-human trial of COVI-VAC single dose, intranasal COVID-19 vaccine
On Dec. 14, 2020, Codagenix and the Serum Institute of India announced that a Phase 1 clinical trial…
Anixa Biosciences Covid-19 therapy demonstrated comparable potency to remdesivir in pre-clinical testing
On Dec. 14, 2020, Anixa Biosciences announced that it and partner OntoChem GmbH had verified that one of…
Biotechnology | CRISPR | FDA | Therapeutics
CIRM-funded project targeting sickle cell disease received green light for clinical trial
On Dec.14, 2020, the US Food and Drug Administration (FDA) announced they had granted Investigational New Drug (IND)…
Incyte announced results of phase 3 study of Ruxolitinib (Jakafi) as treatment for patients with COVID-19 associated cytokine storm
On Dec. 14, 2020, Incyte announced that the Phase 3 RUXCOVID study evaluating the safety and efficacy of…
Moderna confirmed supply agreement to supply Singapore with mRNA vaccine against COVID-19
On Dec. 14, 2020, Moderna confirmed that the Company had concluded an agreement with the Ministry of Health…
Data from phase 1/2 study further characterized immune response with lead COVID-19 vaccine candidate
On Dec. 14, 2020, Pfizer and BioNTech announced additional data on neutralizing antibody and T cell responses from…
Antibody study suggested COVID-19 infections underestimated
On Dec. 14, 2020, a months long study to determine the number of Houstonians carrying COVID-19 antibodies revealed…
FDA approved first intentional genomic alteration in domestic pigs for both human food, potential therapeutic uses
On Dec. 14, 2020, the U.S. Food and Drug Administration approved a first-of-its-kind intentional genomic alteration (IGA) in…
AstraZeneca acquired Alexion Corp for $39 billion
On Dec. 12, 2020, AstraZeneca and Alexion Pharmaceuticals announced an agreement for AstraZeneca to acquire Alexion. Alexion shareholders…
CDC’s ACIP issued interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine in persons aged =16 years for prevention of COVID-19.
On Dec. 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of…
Amarin reported encouraging efficacy and safety results from VASCEPA pilot study treating COVID-19 infected outpatients
On Dec. 12, 2020, Amarin announced clinical results from the CardioLink-9 Trial, the first results of a study…
CDC recommended vaccination with Pfizer and BioNTech COVID-19 vaccine for ages 16 years and older
On Dec. 12, 2020, Pfizer and BioNTech announced that the CDC’s Advisory Committee on Immunization Practices (ACIP) voted…
US FDA issued Emergency Use Authorization for first COVID-19 vaccine
On Dec. 11, 2020, the FDA issued the first emergency use authorization (EUA) for a vaccine for the…
Baricitinib plus remdesivir showed promise for treating COVID-19
On Dec. 11, 2020, the combination of baricitinib, an anti-inflammatory drug, and remdesivir, an antiviral, reduced time to…
AI test ruled out a COVID-19 diagnosis within one hour in Emergency Departments
On Dev. 11, 2020, the University of Oxford reported that an Artificial Intelligence test had been shown to…
UK COVID-19 infections survey revealed changes to pandemic over time
On Dev. 11, 2020, the University of Oxford reported that data from the National COVID-19 Infection Survey, done…
COVID-19 | FDA | Therapeutics
Data from ACTT-2 trial of Baricitinib in hospitalized COVID-19 patients supportive of the EUA published in NEJM
On Dec. 11, 2020, Eli Lilly and Incyte announced The New England Journal of Medicine had published the…
USDA confirmed COVID-19 in a snow leopard at a Kentucky zoo
On Dec. 11, 2020, the USDA’s National Veterinary Services Laboratories announced the first confirmed case of SARS-CoV-2 (the…
U.S. Government exercised 1st option for additional 100 million doses of Moderna’s COVID-19 vaccine
On Dec. 11, 2020, Moderna announced that the U.S. government has exercised its option to purchase an additional…