The EU’s backing for a new prophylactic vaginal ring containing dapirivine is being seen as a welcome addition to efforts to tackle the spread of HIV in lower resourced countries, particularly in sub-Saharan Africa. But there are still some hurdles to overcome before it can be made available to those who are in most urgent need.
The non-profit organization, the International Partnership for Microbicides, says it plans to file the first African approval applications later this year for its dapirivine-containing vaginal ring for HIV prophylaxis, following last week’s endorsement of the product by the European Medicines Agency.
It described the EMA’s backing as a “significant step forward” for women in low- and middle-income countries (LMICs) who “urgently...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
