A new act in Germany does not go far enough to address the deeply unpopular “guardrail” link between Amnog benefit assessment ratings and price negotiations, which can deter companies from launching.
New provisions to introduce confidential drug pricing in Germany are a step in the right direction, but the conditions attached mean that many companies will not qualify while others may not want to, said Alexander Natz, Secretary General of EUCOPE, the organization that represents small and medium-sized pharma and biotech companies in Europe.
The Bundestag, Germany’s federal parliament, passed the wide-ranging Medical Research Act on 4 July. The aim of the act is...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
