Market exclusivity is the key incentive offered under the EU orphan drug framework, but pricing and regulatory problems are the main challenges for rare disease drugmakers, not the pressure from competitors, a life sciences lawyer says.
The EU is among several jurisdictions to have introduced a specific incentive framework for orphan medicines, but the current offering does not address some of the main hurdles faced by developers, according to Lincoln Tsang, head of law firm Ropes & Gray's European life sciences practice.
“The current regulation does not provide incentives at all stages where they are needed along the orphan product lifecycle. 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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
