The European Parliament is pushing for more of a say in how Europe’s new emergency response authority, HERA, deals with R&D and procurement of vaccines and therapies in times of health crises. NRx Therapeutics says it will continue to seek US approval of aviptadil for COVID-19.
Valneva SE’s candidate COVID-19 vaccine, VLA2001, is expected to begin a rolling review at the European Medicines Agency “shortly,” says the French company, which has also announced that the European Commission has ordered up to 60 million doses of the vaccine over the next two years.
Under the supply contract with the commission, Valneva is to provide the EU member states with about 27 million doses...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
