The Swiss major has finally been granted a positive opinion for Ocrevus but a patient group is concerned that the proposed label will not mean access for many patients with primary progressive multiple sclerosis.
After several attempts, Roche received a recommendation Nov. 10 for EU approval for its multiple sclerosis treatment Ocrevus (ocrelizumab) and the drug, which has enjoyed a stellar launch in the US since its approval there in March, is expected to be on the market in Europe early next year.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for...
<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.
