An agreement allowing the production and distribution of the US firm’s new protease inhibitor in 95 countries has been welcomed by the Medicines Patent Pool. But some medicines access advocates are not so sure it’s necessarily a good deal for lower-income countries.
In a move intended to maximize access to what has been described as a potential “game-changer” COVID-19 therapy, Pfizer Inc. has signed a deal with the Medicines Patent Pool for the voluntary licensing of its candidate oral antiviral, Paxlovid (PF-007321332, in combination with ritonavir).
The agreement covers 95 countries representing about 53% of the world’s population, including all low- and lower-middle-income countries as well...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
