Novo Nordisk is seeking EU marketing approval to use its blockbuster obesity drug for reducing the risk of heart attack and stroke and it wants the European Medicines Agency to consider its request for an extra year of market protection.
The European Medicines Agency is discussing whether Novo Nordisk should be granted approval to extend the EU indication of its blockbuster obesity drug Wegovy (semaglutide) to include its use for reducing the risk of major adverse cardiovascular events (MACEs), and also be awarded an extra year of market protection.
The company’s application for approval of the new indication and extended market protection is listed on this week’s draft...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
