The advanced therapies sector is undergoing something of an industrial revolution, but access issues for products coming to market remain, says Miguel Forte, CEO of Bone Therapeutics. However, there are opportunities to create a better environment for the sector, including regulatory change and more harmonization of HTA processes.
The industrial revolution in the advanced therapies space is continuing at a fast pace, but to ensure access to such medicines, it needs to be accompanied by a “payment revolution,” says Miguel Forte, CEO of Bone Therapeutics SA.
In an interview with the Pink Sheet, Forte also outlined some opportunities that regulatory change could bring, including the recent...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
