NRx Pharmaceuticals has again filed for a US emergency use authorization for aviptadil, this time for critically ill patients with no other options. The UK has said that there is currently no need to give a second booster vaccine.
The European Medicines Agency has begun assessing a conditional marketing authorization application (MAA) from Pfizer for its oral antiviral, Paxlovid (PF-07321332 plus ritonavir), for treating mild-to-moderate COVID-19 in adult and adolescent patients who are at high risk of progressing to severe disease.
An opinion on the product from the agency’s human drugs committee, the CHMP, is expected “within weeks” as the committee...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
