Valneva expects its vaccine candidate to be approved this month. Meanwhile, the core functions of the UK’s Vaccine Taskforce are to be transferred to the UK Health Security Agency and the Office for Life Sciences.
On 15 June, the European Medicines Agency began a rolling review of an adapted version of Pfizer Inc./BioNTech SE’s mRNA COVID-19 vaccine, Comirnaty, which is designed to provide better protection against a specific variant or variants of the SARS-CoV-2 virus.
“The details about the adapted vaccine, for example whether it will specifically target one or more SARS-CoV-2 variants or subvariants,...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
