BridgeBio’s partner Helsinn terminated its agreement to commercialize infigratinib, which was approved in the US last year for treating the rare bile duct cancer, cholangiocarcinoma.
The EU marketing application for BridgeBio Pharma’s infigratinib, for treating cholangiocarcinoma (CCA), has been withdrawn by the company’s partner Helsinn, which recently terminated its agreement to commercialize the drug because of “commercial considerations.”
Infigratinib, an orphan drug, was approved in the US for metastatic cholangiocarcinoma in May 2021 under the brand name Truseltiq....
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
