Current COVID-19 vaccine Phase 3 trials are not designed to show whether they will save lives or reduce transmission: with trials instead based on events with mild symptoms, according to a feature published in The BMJ.
The National Institute for Biological Standards and Control (NIBSC) in the UK, and Q2 Solutions in the US, have joined CEPI’s COVID-19 vaccine assessment network.
The UK is set to begin COVID-19 human challenge trials in January: aiming to increase understanding of coronavirus and speed up development of vaccine candidates.
Ori Biotech Ltd (Ori), a London and New Jersey based innovator in the cell and gene therapy (CGT) manufacturing sphere, last week announced the successful close of a US$30m Series A financing round, bringing the company’s total funding to date to US$41m.
UNICEF, the world’s largest single buyer of vaccines, is laying the groundwork for quick and efficient delivery of COVID-19 vaccines by purchasing and distributing more than half a billion single-dose syringes and other critical equipment in countries...
US company, Dyno Therapeutics, has inked a deal with Roche to develop next-generation AAV gene therapy vectors for central nervous system (CNS) diseases and liver-directed therapies.
Edesa Biotech, Inc. has received clearance from the U.S. Food and Drug Administration (FDA) to begin the Phase 2 portion of its Phase 2/3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients.
Pfizer’s CEO says the company will apply for Emergency Use Authorisation (EUA) for its COVID-19 vaccine candidate ‘soon after’ a safety milestone is reached in the third week of November.
The U.S. Food and Drug Administration (FDA) has approved Regeneron’s Inmazeb for treatment of Ebola. The antibody cocktail was developed using the same ‘rapid response’ technologies as Regeneron’s investigational COVID-19 antibody combination.
Potential vaccines for COVID-19 should not be affected by changes in SARS-CoV-2 seen to date, nor are they likely to need to be redeveloped seasonally, according to Australian scientists.
Enrollment is temporarily on hold in the ACTIV-3 clinical trial, which is evaluating Lilly's investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients. The pause was recommended by the study's...
Roche plans to launch its high-volume Elecsys SARS-CoV-2 Antigen test at the end of 2020 in markets accepting the CE mark; while the company will file for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA).
