UK – AstraZeneca and Amgen’s Tezspire recommended by NICE for severe asthma
The final draft guidance from the National Institute for Health and Care Excellence (NICE) specifically applies to patients who are inadequately controlled with high...
USA – FDA Approves First Over-the-Counter Naloxone Nasal Spray
Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first...
USA – QMSR: Start now to be ready for final rule, slated for December
The US Food and Drug Administration (FDA) asserts that it is on track to release a final rule this December that harmonizes the agency’s decades-old Quality...
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The US Food and Drug Administration (FDA) issued draft guidance on the design of oncology trials for accelerated approval, calling randomized controlled trials (RCTs)...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The head of the National Cancer Institute’s (NCI) investigational drug research branch said that recent draft guidance from the US Food and Administration (FDA)...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The US Food and Drug Administration (FDA) has issued draft guidance to clarify which pharmacogenomic study findings and data should be included in regulatory...
