Novartis is among a number of companies that this week moved closer to marketing new products across the EU. D&A Pharma has again failed to convince the European Medicines Agency that its alcohol dependence treatment should be approved.
The European Medicines Agency has recommended marketing authorizations for eight new drugs, including one that is set to become the first EU-approved triple combination therapy for asthma – Novartis’s Enerzair breezhaler ((indacaterol acetate/glycopyrronium bromide/mometasone furoate) (IND/GLY/MF)).
Other products that the EMA this week said should be approved include two orphan drugs – Bristol-Myers Squibb and...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
