As the coronavirus continues its global spread, the global CEPI partnership is broadening its investment in programs that it hope will result in the rapid development and licensing of new vaccines.
The international Coalition for Epidemic Preparedness Innovations has increased its COVID-19 vaccine candidate portfolio from four to six after it signed partnership deals worth a total of US$4.4m with Novavax and the University of Oxford in the UK.
However, CEPI is running low on money and has launched an appeal for an additional $2bn in funding for coronavirus...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
