In the latest development in the long-running case pitting Novartis and Roche against the Italian competition authority over a fine imposed in 2014, the Court of Justice of the EU has confirmed that the firms’ arrangement over Avastin and Lucentis could constitute a serious restriction on competition if it involved the dissemination of misleading information. The case now goes back to the Italian court.
The Court of Justice of the EU has ruled that if two companies marketing competing products agree to disseminate misleading information about the safety risks of one of those products in order to discourage its use and increase that of the other, that arrangement could constitute a serious restriction of competition rules.
The court also confirmed that a medicine used off-label for an unapproved indication can be considered a competitor in the...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
