A bumper crop of products are up for an opinion this week by the European Medicines Agency’s human medicines committee, the CHMP, as to whether they should be approved in the EU.
The European Medicines Agency is this week due to decide whether to recommend pan-EU marketing approval for 15 new products, including talquetamab, Janssen’s investigational bispecific antibody for treating patients with relapsed or refractory multiple myeloma (RRMM).
Pfizer’s respiratory syncytial virus vaccine for older adults, and the company’s ritlecitinib for treating alopecia areata in adults and...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
