European Medicines Agency began rolling review of Moderna’s mRNA vaccine candidate against COVID-19
On Nov. 16, 2020, Moderna announced that the European Medicines Agency (EMA) human medicines committee (CHMP) had started…
Johnson & Johnson Initiated second global phase 3 clinical trial of Janssen COVID-19 vaccine candidate
On Nov. 15, 2020, Johnson & Johnson announced that it continued to enroll and vaccinate study participants for…
Moderna’s COVID-19 vaccine candidate met primary endpoint in first interim analysis of phase 3 COVE study
On Nov. 15, 2020, an independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of…
COVID-19 patients treated with fluvoxamine had lower likelihood of clinical deterioration over 15 days
On Nov. 14, 2020, JAMA reported that in a preliminary study, adult outpatients with symptomatic COVID-19 treated with…
Biotechnology | COVID-19 | FDA | Therapeutics
NeuroRx and Relief Therapeutics announce enrollment of 150 patients in phase 2b/3 trial of RLF-100™ for Critical COVID-19 with Respiratory Failure
On Nov. 13, 2020, NeuroRx and Relief Therapeutics announced that to-date, 150 patients (out of a targeted enrollment…
Swissmedic began rolling review of Moderna’s mRNA vaccine against COVID-19
On Nov. 13, 2020, Moderna announced that Swissmedic had started a rolling review of mRNA-1273, the Company’s vaccine…
Respiratory failure in COVID-19 usually not driven by cytokine storm
On Nov. 13, 2020, a study from Washington University School of Medicine in St. Louis and St. Jude…
CALAVI did not meet the primary endpoint in patients hospitalised with respiratory symptoms of COVID-19
On Nov. 12, 2020, AstraZeneca announced that the CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised…
CureVac’s COVID-19 vaccine candidate, CVnCoV, suitable for standard fridge temperature logistics
On Nov. 12, 2020, CureVac announced that its mRNA-based COVID-19 vaccine candidate, CVnCoV, remained stable and within defined…
Gates Foundation announced funds to develop COVID-19 vaccines and increase access in low-income countries
On Nov. 12, 2020, the Bill & Melinda Gates Foundation announced new commitments totaling $70 million to global…
Biotechnology | COVID-19 | Diagnostics | FDA
Wren Laboratories launched saliva-based PCR COVID-19 test
On Nov. 12, 2020, Wren Laboratories announced that it had been granted an emergency use authorization by the…
Early mutation in SARS-CoV-2 virus in Europe led to its domination world wide
On Nov. 12, 2020, a study published in Science by a team of researchers in the U.S. and…
Sorrento announced IND filing for COVI-DROPS against SARS-CoV-2
On Nov. 11, 2020, Sorrento Therapeutics announced that it was filing an investigational new drug application (IND) for…
Treatments for people with early COVID-19 infection urgent research focus
On Nov. 11, 2020, National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony S. Fauci, M.D., and…
DSMB analysis recommended continuance of P3 COVID-19 ARDS trial
On Nov. 11, 2020, Mesoblast announced that the randomized controlled Phase 3 trial of remestemcel-L in patients with…
Mateon and Windlas Biotech announced agreement to commercialize ARTIVEDA against COVID-19
On Nov. 11, 2020, Mateon Therapeutics announced an agreement with Windlas Biotech of India to commercialize ARTIVeda. ARTIVeda…
Moderna completed case accrual for first planned interim analysis of mRNA vaccine against COVID-19
On Nov. 11, 2020, Moderna announced that it had completed case accrual for the first interim analysis of…
Cardinal Health partnered with CDC to support vaccine access for pharmacies
On Nov. 11, 2020, Cardinal Health announced it had reached an agreement with the Centers for Disease Control…
Data showed SARS-CoV-2 reactive T Cells are associated with protection from COVID-19 was published
On Nov. 10, 2020, Oxford Immunotec announced the release of data from a prospective cohort study in keyworkers…
Medigen Vaccines and BlueWillow Biologics partnered to Develop intranasal vaccine for SARS-COV-2
On Nov. 19, 2020, Medigen Vaccine Biologics and BlueWillow Biologics announced a partnership to develop S-2P-NE-01, a nasal…
ImmunityBio, NantKwest announced positive interim phase 1 safety data of hAd5 COVID-19 vaccine dose study
On Nov. 10, 2020, ImmunityBio and NantKwest, a clinical-stage, natural killer cell-based therapeutics company, announced they had administered…
Altimmune added Lonza as manufacturing partner for supply of AdCOVIDﾙ vaccine candidate for COVID-19
On Nov. 10, 2020, Altimmune announced an agreement with Lonza for the manufacturing of AdCOVIDﾙ, Altimmuneﾒs next-generation, single-dose…
TB Quat Disinfectant Ready-to-Use Cleaner from 3M approved by EPA for use against SARS-CoV-2
On Nov. 10, 2020, 3M announced that its TB Quat Disinfectant Ready-to-Use Cleaner had been approved by the…
BD announced Canadian Government order of 76 million portable, rapid point-of-care antigen tests to detect SARS-CoV-2
On Nov. 10, 2020, BD (Becton, Dickinson) announced its rapid, point-of-care, SARS-CoV-2 antigen test for use on the…
Hydroxychloroquine does not benefit adults hospitalized with COVID-19
On Nov. 9, 2020, a National Institutes of Health (NIH) clinical trial evaluating the safety and effectiveness of…
Effect of hydroxychloroquine on clinical status at 14 days in hospitalized patients with COVID-19
On Nov. 9, 2020, a study published in JAMA reported the effect of hydroxychloroquine on clinical status at…
Lilly’s neutralizing antibody bamlanivimab received FDA emergency use authorization for treatment of recently diagnosed COVID-19
On Nov. 9, 2020, the FDA granted Emergency Use Authorization (EUA) for Eli Lilly’s investigational neutralizing antibody bamlanivimab…
Pfizer and BioNTech announced vaccine candidate against COVID-19 achieved success in interim analysis from phase 3 study
On Nov. 9, 2020, Pfizer and BioNTech announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 had demonstrated evidence…
Corvus completed enrollment in phase 1 study of CPI-006 for patients with COVID-19
On Nov. 9, 2020, Corvus Pharmaceuticals announced that it had completed patient enrollment in its Phase 1 study…
Fred Hutch began experimental COVID-19 vaccine efficacy trial
On Nov. 9, 2020, the Fred Hutchinson Cancer Research Center announced the start of volunteer enrollment for a…