At global level, Médecins Sans Frontières has called for all countries to support a revised version of the IP waiver for COVID-19 vaccines, singling out the recalcitrant European Commission for special attention.
The European Medicines Agency says its human drugs committee, the CHMP, is to hold an extraordinary virtual meeting on 28 May to evaluate an application to extend the use of Pfizer/BioNTech’s COVID-19 vaccine, Comirnaty, to include children aged 12 to 15.
The committee began assessing whether the vaccine should be administered to young people in this age group around the beginning...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
