Europe – DARWIN EU® has completed its first studies and is calling for new...
DARWIN EU®, the Data Analysis and Real-World Interrogation Network, has accomplished its first year of establishment. Following the set-up of the DARWIN EU® Coordination...
Europe – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from...
This document considers testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. It outlines...
USA – FDA encourages RCTs in accelerated approval guidance for oncology
The US Food and Drug Administration (FDA) issued draft guidance on the design of oncology trials for accelerated approval, calling randomized controlled trials (RCTs)...
UK – NICE sees ‘promise’ in four UTI tests that could help in fight...
AMR develops when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time, making them more resistant to drug treatments. As a...
UK – Recommendation from NICE for PTC Therapeutics gene therapy
Eladocagene exuparvovec, the only gene therapy for children with the ultra-rare genetic disorder, aromatic L-amino acid decarboxylase (AADC) deficiency, has been recommended by the...
USA – NCI official raises concerns about FDA’s cancer drug dose optimization guidance
The head of the National Cancer Institute’s (NCI) investigational drug research branch said that recent draft guidance from the US Food and Administration (FDA)...
USA – FDA issues guidance on submission of pharmacogenomic data
The US Food and Drug Administration (FDA) has issued draft guidance to clarify which pharmacogenomic study findings and data should be included in regulatory...
UK – MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation...
A series of new measures will be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) with support from partners to make it faster...
International – ICH adopts S12 guideline for gene therapies
The International Council for Harmonisation (ICH) last week announced that its S12 guideline on nonclinical biodistribution (BD) considerations for gene therapy products has reached...
UK – MHRA to recognize foreign regulatory approvals for medicines and medical technologies and...
Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high...
