Evidence generated through an EU public-private funding initiative has resulted in a new biomarker method for measuring the level of Alzheimer’s disease in a person’s brain, which drug developers can use during clinical trials.
The European Medicines Agency has endorsed a new method for quantifying how much amyloid plaque is visible on a patient’s brain scan, which could help researchers developing drugs for Alzheimer’s disease to identify patients for clinical trials and evaluate how well treatments are working.
The technique, known as the Centiloid method, grades the level of Alzheimer’s disease a person has by measuring the amyloid...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
