Two companies explain why they believe the European Medicines Agency was wrong to say that they do not have sufficient study data to prove that their products should be approved for sale in the EU.
Emmaus Life Sciences and Mitsubishi Tanabe Pharma have both challenged the European Medicines Agency’s view that they do not have enough proof to show that their respective drugs for sickle cell disease and amyotrophic lateral sclerosis (ALS) are fit for sale in the EU.
The EMA said yesterday that it was recommending against the approval of Emmaus’s Xyndari (glutamine), and that Mitsubishi Tanabe had...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
