Fujifilm to launch rapid antigen COVID-19 test in Europe
Having received the CE certificate, Fujifilm can now launch its highly-sensitive, rapid antigen test kit for SARS-CoV-2 in Europe.
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Having received the CE certificate, Fujifilm can now launch its highly-sensitive, rapid antigen test kit for SARS-CoV-2 in Europe.
In this article, Dr Ronan Brown, IQVIA’s SVP and Head of Integrated Global Compliance, explores the long-term impact of COVID-19 on regulatory practices in three key areas: clinical trial study design, clinical trial study development and post-clinical trial regulatory submissions.
The Janssen COVID-19 Vaccine is the first single-dose vaccine regimen to ever be granted WHO emergency use listing and is now eligible for distribution via COVAX.
After a positive recommendation from the EMA, the European Commission has granted the single-dose vaccine conditional marketing authorisation.
New trial data shows Novavax’s COVID-19 vaccine, NVX–CoV2373, is effective against both the B.1.1.7 UK and the B1.351 South African variants.
Several countries have temporarily stopped the use of the vaccine while reports of blood clots are investigated by the EMA’s pharmacovigilance committee and other authorities.
New research shows a second COVID-19 vaccine dose may be unnecessary in individuals previously infected with SARS-CoV-2 and needlessly exposes individuals to higher rates of adverse effects.
In a Phase III trial, Proxalutamide reduced mortality and expedited recovery of hospitalised COVID-19 patients in Brazil.
Moderna has begun testing two new mRNA COVID-19 vaccines, one specifically targeting the B.1.351 variant and the other a multivalent candidate.
In a high-risk patient cohort, treatment with the combination of bamlanivimab and etesevimab reduces COVID-19 related hospitalisation and death by 87 percent.
The collaborators hope to make mRNA COVID-19 vaccines accessible to all by creating a shelf-stable, reconstitutable powder formulation.
The spin-out from the Universities of Helsinki and Eastern Finland will leverage years of research to test and bring to market a nasal spray vaccine against COVID-19.
Kirsten Axelsen and Rajini Jayasuriya of Charles River Associates explore a framework for ethical COVID-19 vaccine allocation in the US.
The PCR based Alinity™ m Resp-4-Plex molecular assay can detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV).
In clinical testing, the T-SPOT.COVID test was found to agree with PCR test results in over 96 percent of samples taken within first 60 days of infection.