Sanofi wants the European Medicines Agency to re-examine its opinion that the company’s drug for Pompe disease does not qualify as a new active substance.
The European Medicines Agency has acknowledged a request by Sanofi Genzyme to re-examine its refusal to qualify as a new active substance (NAS) Nexviadyme (avalglucosidase alfa), the company’s drug for Pompe disease that was recommended for pan-EU marketing approval last month.
The notification of re-examination is listed on the agenda of the latest monthly meeting of the EMA’s human medicines...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
