The European Medicines Agency is reviewing the safety of bluebird bio’s beta thalassaemia gene therapy, which is so far only approved in the EU and has only been used in one patient outside the context of clinical studies.
The European Medicines Agency has paused the renewal procedure for the EU conditional marketing authorization (CMA) for Zynteglo (betibeglogene autotemcel) while it continues to look into concerns over the safety of the lentiviral vector used to manufacture the beta thalassaemia gene therapy from bluebird bio.
The EMA said on 12 March that it had started reviewing Zynteglo’s safety due to concerns over a case of...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
