AstraZeneca and the European Commission have both claimed victory in the Vaxzevria supply case brought against the company by the commission. The Moderna coronavirus vaccine is now under review by the European Medicines Agency for use in younger people.
It is too early to say whether the 47% efficacy shown in interim results of the Phase IIb/III HERALD study of CureVac NV’s COVID-19 vaccine candidate will be sufficient to recommend it for EU marketing authorization, according to the European Medicines Agency.
The vaccine is currently undergoing a rolling review in the EU, whereby data are being submitted as they are generated,...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
