International – Novartis confirms death of 2 children after gene therapy
Novartis has recorded two deaths after treatment with its spinal muscular atrophy gene therapy Zolgensma, once again bringing gene therapy’s safety into attention.
Two children...
USA – Patients with incurable cancer should be included in trials for new therapies
The US Food and Drug Administration (FDA) has issued final guidance on the inclusion of patients with incurable cancers in clinical trials for investigational...
USA – FDA issues final guidance on ANDA CRL, Orange Book
The US Food and Drug Administration has published a final draft guidance that addresses what’s expected when sponsors get complete response letters (CRL) to...
USA – FDA final guidance targets neonatal pharmacology studies
The US Food and Drug Administration (FDA) issued final guidance this week to assist sponsors in developing clinical pharmacology studies for neonatal populations. The guidance is...
Europe – EMA reviewing data on sabizabulin for COVID-19
EMA’s Emergency Task Force (ETF) has started a review of data on the use of sabizabulin for treating COVID-19.
The review will look at all available...
International – ICH M10 on bioanalytical method validation
This guideline is intended to provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification and their application in the...
