The European Medicines Agency's human medicines committee has recommended the suspension of marketing authorizations for around 100 generics after identifying “irregularities” in how bioequivalence studies were conducted by Synchron Research Services.
Around 100 generic drugs are expected to see their European marketing authorizations suspended after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) identified irregularities in bioequivalence studies carried out by contract research organization (CRO) Synchron Research Services.
A list of the concerned medicines has been published by the EMA, including products from leading generics players such...
<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.
