A number of new drugs have taken a major step towards being approved for use in the EU after receiving the nod from the European Medicines Agency’s human medicines committee, the CHMP. Meanwhile, the marketing applications for three drugs have been withdrawn.
Omvoh (mirikizumab), Eli Lilly’s treatment for moderately to severely active ulcerative colitis, is among the nine drugs that the European Medicines Agency this week said should be approved for use across the EU.
A humanized IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23, mirikizumab is currently under review by...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
