The need to accelerate clinical trials of products for treating and preventing coronavirus has led the EU authorities to propose a more streamlined process for allowing the release of GMO-containing investigational medicinal products into the environment.
The European Parliament has adopted an EU regulation that would temporarily relax the rules on the release of genetically modified organisms in order to speed up the start of clinical trials with potential COVID-19 vaccines and make them available to patients more quickly.
To ensure that trials with GMO-containing coronavirus vaccines and treatments can start “without delay,” parliament says the regulation, which has...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
