Tuomo Pätsi of US biotech firm Seagen discusses plans for the rollout of Tukysa in Europe, how it successfully used a new mechanism for approval in Great Britain, and why the UK will be a go-to market for future innovative drug filings.
Seagen has begun launching its advanced breast cancer drug Tukysa (tucatinib) in its first EU markets – Germany, Austria and France – following its regulatory approval last month in both the EU and the post-Brexit UK.
“This is a big day for us,” Tuomo Pätsi, Seagen’s executive vice president, commercial international, said on 15 March. “In...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
