USA – mRNA technology for universal flu vaccine shows early promise in US study
The World Health Organization cites vaccination as the current principal means of reducing or counteracting influenza mortality and morbidity burden, but the constantly evolving...
International – ICH adopts M7(R2) guideline on mutagenic impurities to limit carcinogenic risk
The International Council for Harmonisation (ICH) earlier this week announced the adoption of its M7(R2) guideline that aims to harmonize the framework for assessing...
UK – MSD and Eisai’s combination therapy recommended by NICE for advanced endometrial cancer
The combination therapy is specifically indicated for adults with advanced or recurrent endometrial cancer whose disease has progressed on or after platinum-based chemotherapy and...
International – WHO releases key regulatory considerations on AI for health
The World Health Organization (WHO) has published new key regulatory considerations on artificial intelligence (AI) for health to emphasise the importance of establishing the...
Europe – EMA seeks feedback on quality, therapeutic equivalence of inhaled drugs
The European Medicines Agency (EMA) has released two draft guidelines for consultation on inhaled medicines. One covers the pharmaceutical quality of inhalation and nasal...
Europe – Regulatory update – EMA encourages companies to submit type I variations for...
The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA and type IAIN variations for 2022 no later than Wednesday, 30 November 2022. This...
UK – Ipsen’s cabozantinib receives NICE approval for advanced hepatocellular carcinoma
Specifically, the recommendation is for adult patients who have had sorafenib – the standard initial treatment for advanced disease – only if they have...
Europe – Data Quality Framework for EU medicines regulation
As acknowledged in the recommendations of the HMA-EMA Joint Big Data Task Force (BDTF) and the workplan of the HMA-EMA Joint Big Data Steering...
USA – FDA issues emergency guidance to spur development of monkeypox tests
The US Food and Drug Administration (FDA) issued an immediately effective guidance and a corresponding FAQ to spur the development of new monkeypox diagnostics...
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...
