Proposed methods for conducting EU-level joint clinical assessments could result in such a broad range of comparator therapies that companies are unable to fulfill scoping requirements, according to a report commissioned by industry federation EFPIA.
Guidelines for implementing forthcoming EU-level joint clinical assessments (JCAs) “do not offer the required flexibility and pragmatism” to address the challenges posed by “highly dynamic” disease areas such as oncology, warns the R&D-based pharmaceutical industry body EFPIA.
In a study commissioned by EFPIA, the methodology for JCAs proposed by EUnetHTA21 were applied to three anonymized oncology...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
