In the second in a series of articles on amendments to the EU pharmaceutical reform proposals, the Pink Sheet looks at changes made by the European Parliament to the “transferable exclusivity voucher” and its ideas for a milestone payment and subscription-model scheme.
Among the numerous amendments introduced by the European Parliament to the European Commission’s pharmaceutical legislative reform is a dilution of the additional regulatory data protection (RDP) available when a company is awarded a “transferable exclusivity voucher” (TEV) for the development of a “priority” antimicrobial drug.
The parliament, which adopted its amendments at a plenary session last month, has also proposed a new milestone payment scheme...
<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.
