Scientific questions from member state experts and a recent court ruling on impartiality in the drug approval process prompted the European Commission to query the EMA’s negative opinion on PTC’s Translarna.
In a very rare move, the European Commission has rejected advice from the European Medicines Agency not to renew the conditional marketing authorization (CMA) for PTC Therapeutics’ rare disease treatment Translarna (ataluren), the first ever treatment approved for Duchenne muscular dystrophy.
The commission has asked the EMA to review its scientific assessment of the drug following scientific questions from EU member...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
