Drugs for treating Duchenne muscular dystrophy and amyotrophic lateral sclerosis are among the products that the European cross-country coalition BeNeLuxA thinks would be suitable for a joint health technology evaluation.
Following a review of the results of the 2023-2024 Dutch Horizon Scan, the medicines access coalition BeNeLuxA has identified four medicines that would be appropriate for a joint health technology assessment by at least two of its members countries.
The four drugs are not yet approved for marketing in the EU. They are Astellas Pharma, Inc.’ fezolinetant for...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
