Alternative approaches to animal models, such as improved tests based on human and animal cells, provide opportunities to develop better and more predictive scientific tools, the European Medicines Agency says.
The European Medicines Agency has implemented a new measure to minimize animal testing by making its free-of-charge Innovation Task Force (ITF) available to companies for discussions on how to replace, reduce and refine animal use during the development, manufacturing and testing of human and veterinary medicines.
Alternative approaches to animal models include improved tests based on human and animal cells, organoids, organ-on-chips and in silico modeling....
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
