The European Medicines Agency is re-examining the benefits and risks of hydroxyprogesterone medicines for gynecologic and obstetrical conditions at the request of the French regulator ANSM.
The European Medicines Agency has commenced an EU-wide review of medicines containing hydroxyprogesterone after two recent studies raised concerns about their safety and effectiveness.
These medicines, available as hydroxyprogesterone caproate, are given as injections to prevent pregnancy loss or premature birth in pregnant women....
<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.
