An opinion on whether bluebird bio’s transfusion-dependent β-thalassemia gene therapy, LentiGlobin, should be granted an EU marketing authorization is due this week as the EMA’s key scientific committee, the CHMP, meets for the first time in Amsterdam.
Bluebird bio’s LentiGlobin gene therapy for transfusion-dependent β-thalassemia (TDT) is the only product up for an opinion on potential EU marketing authorization at this month’s meeting of the European Medicines Agency’s key drug evaluation committee, the CHMP, which is taking place for the first time in Amsterdam.
The CHMP usually discusses and delivers opinions on several initial marketing authorization applications (MAAs) at each of its monthly plenary...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
