GlaxoSmithKline's first-of-its kind treatment for multiple myeloma is among 11 new medicines that have won an EU approval nod from the European Medicines Agency this week.
The European Medicines Agency has this week recommended for EU approval a raft of new drugs, including Blenrep (belantamab mafodotin), GlaxoSmithKline’s first-of-a-kind treatment for multiple myeloma that last week overcame ocular toxicity concerns to win a US Food and Drug Administration panel endorsement.
Blenrep, which is now set to become the first BCMA (B-cell maturation antigen)-targeting therapy for multiple myeloma, should be granted...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
