Advicenne withdrew its orphan drug designation application for Sibnayal over concerns that a key study was not designed to compare the product with the standard of care.
The European Commission has approved Advicenne’s Sibnayal for the orphan disease distal renal tubular acidosis (dRTA). The approval came after the company voluntarily withdrew the orphan drug designation (ODD) it had received in June 2017 during its development of the drug after the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) requested more data.
The company told the Pink Sheet that withdrawing the ODD would enable it to make Sibnayal, also known as ADV7103,...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
