The US FDA has rejected an emergency use authorization application for NRx Pharmaceuticals’ Zyesami (aviptadil) for use in COVID-19 patients with respiratory failure. The UK has revamped its emergency delivery service for drugs that experience shortages as a result of the pandemic and other factors.
The World Health Organization has granted an emergency use listing (EUL) to Indian company Bharat Biotech’s coronavirus vaccine Covaxin, which the WHO said had shown “78% efficacy against COVID-19 of any severity” 14 or more days after the second dose.
Formulated from an inactivated SARS-CoV-2 virus antigen and available in single- and multi-dose vials, Covaxin is “extremely suitable for low-...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
