EMA clears use of COVID-19 Vaccine AstraZeneca
The EMA’s drug safety committee concluded that the vaccine is not associated with an increased risk of thromboembolic events and that its benefits still outweigh its risks.
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The EMA’s drug safety committee concluded that the vaccine is not associated with an increased risk of thromboembolic events and that its benefits still outweigh its risks.
European Pharmaceutical Review’s Hannah Balfour outlines the findings of market research reports exploring the challenges and drivers for the pharmaceutical packaging equipment market between 2020 and 2025.
In a new study, low dose aspirin reduced risk of mechanical ventilation, ICU admission and in-hospital mortality by over 40 percent each.
The Phase II/III trial will assess the safety and efficacy of the COVID-19 Vaccine Moderna in children aged six months to less than 12 years.
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.