The World Health Organization has developed a draft addendum to its 2023 guideline on the evaluation of mAbs intended for the prevention or treatment of infectious diseases, focusing on supplementary aspects specific to respiratory syncytial virus disease.
The World Health Organization is inviting stakeholder feedback on the aspects to consider when evaluating the safety and efficacy of monoclonal antibodies (mAbs) directed against respiratory syncytial virus (RSV) antigens and intended primarily for pre-exposure prophylaxis in infants and young children.
The approach is explained by the WHO in a draft document that will serve as an addendum to its...
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.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
