All Clinical trial articles
-
EditorialFrom trials to approval: Regulatory strategies in early drug development
This issue focuses on the acceleration of early drug development, the opportunities and challenges that this brings and strategic guidance for regulatory professionals.
-
ContentsRegulatory Rapporteur October 2025 – Contents
The October issue of Regulatory Rapporteur focuses on early drug development.
-
EditorialAdvanced therapies: A maturing regulatory framework
This issue looks at CMC requirements, recent therapeutic innovations in the oncology field, and the complex interconnection between ATMPs and in vitro diagnostic medical devices.
-
-
-
-
Industry newsGSK Blenrep trial shows ‘significant overall survival benefit’of myeloma treatment
According to a report by GSK, a recent clinical trial has revealed that Blenrep can reduce the risk of death by 42% in multiple myeloma after relapse.
-
Industry newsGene therapy restores hearing in five children
Five children with hereditary deafness have had their hearing restored in both ears through gene therapy in a clinical trial.
-
-
Industry newsWHO endorses use of R21/Matrix-M malaria vaccine in children
The World Health Organization (WHO) has recommended widespread use of the R21/Matrix-M malaria vaccine in children.
-
Industry newsEMA proposes novel method to assess CKD therapy efficacy
Glomerular filtration rate slope can be used as a surragate end point to assess clinical benefit for treatments in CKD in some trial settings.
-
JournalDecentralised clinical trials –
A European Union recommendation paperDecentralised clinical trials (DCTs) have undergone a rapid development over the last three years. This article focuses on the recently published European Union (EU) recommendation paper which provides consolidated guidance for sponsors planning DCTs irrespective of any health-related crisis, as part of the Accelerating Clinical Trials in the European Union ...
-
Industry newsGene therapy gives hope to patients with ‘butterfly skin’
FDA approves first gene therapy to treat dystrophic epidermolysis
bullosa patients – a condition sometimes called ‘butterfly skin’.