This month’s meeting of the European Medicines Agency’s CHMP appears to have been eventful. One marketing authorization application was rejected, one was pulled, and an earlier negative opinion was upheld. Four MAAs were recommended for approval, including a new treatment from Univar for Wilson’s disease.
It was approved in the US in 2017 but EU regulators say Emmaus Life Sciences’ sickle cell disease therapy, Xyndari (oral glutamine), should not be allowed on the market in Europe.
Xyndari was one of six new medicines that were up for an opinion this week from the European Medicines Agency's...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
