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Over 90 percent of packages at three companies met all of the Drug Supply Chain Security Act (DSCSA) labelling requirements in 2020, despite there being three years until the final deadline.
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.
New research suggests the use of innovative and development of eco-friendly packaging, as well as the COVID-19 pandemic will all drive growth in the pharmaceutical packaging market.
After a positive recommendation from the EMA, the European Commission has granted the single-dose vaccine conditional marketing authorisation.
The conditional marketing authorisation of Retsevmo® (selpercatinib) was based on positive results from the LIBRETTO-001 Phase I/II trial.
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.
![Lines of vials labelled 'COVID-19 Vaccines' [Credit: Dimitris Barletis/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Covid-19-vaccines-2-1-300x278.jpg)
![Lines of vials labelled 'COVID-19 Vaccines' [Credit: Dimitris Barletis/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Covid-19-vaccines-2-1-e1614176959561.jpg)
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 highest doses of the novel maturation inhibitor, GSK3640254, had the greatest antiviral activity and were shown to be safe in 34 treatment-naïve adults with HIV.
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.
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).
