A therapy for wet age-related macular degeneration and a new drug for leukemia have become the first two products to be approved by all countries involved in the international Access Consortium.
Roche Holding AG’s Vabysmo (faricimab) and Novartis AG’s Scemblix (asciminib) have now been approved by all five regulators taking part in the Access Consortium, an international work-sharing initiative that is intended to avoid duplication of work and promote regulatory collaboration and alignment.
These are the first two products to receive approvals from all of the regulators involved in the 15-year-old consortium, according...
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
To help sponsors developing candidate mpox vaccines, the World Health Organization will soon be finalizing guidance on the preferred and minimum characteristics these products must satisfy regarding efficacy, dose regimen and other aspects to secure regulatory approval.
The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.
An ongoing collaborative initiative involving global regulators assessing post-approval manufacturing changes has highlighted the need to establish a standardized platform that can facilitate the submission and regulatory evaluation of such changes.
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
