Biotechnology | COVID-19 | FDA
Quidel received EUA for moderately complex Solana SARS molecular test for COVID-19 diagnosis
On Dec. 23, 2020, Quidel announced that it had received Emergency Use Authorization (EUA) from the FDA to…
Mink at affected Oregon farm negative for SARS-CoV-2, wildlife surveillance continued
On Dec. 23, 2020, recent tests confirmed mink that tested positive for SARS-CoV-2 at an Oregon farm in…
NIH neuroscientists isolated promising mini antibodies against COVID-19 from a llama
On Dec. 22, 2020, the NIH researchers announced they had isolated a set of promising, tiny antibodies, or…
Biotechnology | COVID-19 | FDA | Therapeutics
Sorrento announced it had submitted an EUA application to the FDA for COVI-STIX rapid test for detection of SARS-CoV-2 antigen
On Dec. 22, 2020, Sorrento Therapeutics announced that an Emergency Use Authorization (EUA) Application had been submitted to…
Cocrystal Pharma selected lead compound for further development against Coronaviruses
On Dec. 22, 2020, Cocrystal Pharma announced the selection of CDI-45205 as the lead compound for further development…
Biotechnology | COVID-19 | Diagnostics | Genomics | Vaccine | WHO
New SARS-CoV-2 variant identified through viral genomic sequencing in United Kingdom and Northern Ireland
On Dec. 21, 2020, the WHO reported that authorities of the United Kingdom of Great Britain and Northern…
Quidel received Emergency Use Authorization for QuickVue SARS rapid antigen test for COVID-19 diagnosis
On Dec. 21, 2020, Quidel announced that it had received Emergency Use Authorization from the U.S. Food and…
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…
OraSure updated Its Emergency Use Authorization application for lab-based oral SARS-CoV-2 antibody test
On Dec. 21, 2020, OraSure Technologies disclosed that the FDA had requested additional information as part of its…
NIAID study of Coronavirus infection and multisystem inflammatory syndrome in children began
On Dec. 17, 2020, NIAID announced that an observational study had launched to evaluate the short- and long-term…
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…
ACON Laboratories received Emergency Use Authorization for its SARS-COV-2 IgG/IgM rapid test
On Dec. 17, 2020, ACON Laboratories announced that its SARS-COV-2 IgG/IgM Rapid Test has been authorized for emergency…
NIH observational study of coronavirus infection and multisystem inflammatory syndrome in children began
On Dec. 16, 2020, National Institute of Allergy and Infectious Diseases reported that an observational study had launched…
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…
Meridian received NIH award for supporting rapid development of Revogeneﾮ molecular test for SARS-CoV-2
On Dec. 16, 2020, Meridian Bioscience announced that it had been awarded funding in the amount of approximately…
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,…
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…
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…
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…
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…
Roche partnered with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials
On Dec. 10, 2020, Roche announced a partnership with Moderna to utilise the Elecsys Anti-SARS-CoV-2 S antibody test…
ImmunityBio’s hAd5 T-Cell COVID-19 vaccine candidate showed complete protection of airways
On Dec. 10, 2020, ImmunityBio announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates…
Roche partnered with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials
On Dec. 9, 2020, Roche announced a partnership with Moderna to utilise the Elecsys Anti-SARS-CoV-2 S antibody test…