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...
USA – FDA pulls Evusheld authorization as coronavirus evolution quashes another therapy
The evolution of the coronavirus has knocked out another treatment.
The Food and Drug Administration on Thursday withdrew the authorization of Evusheld, the latest antibody therapy to...
USA – Study: Certain cancer drugs saw widespread use before accelerated approval withdrawal
In the period between when three accelerated approval (AA) drugs received approval from the US Food and Drug Administration (FDA) for oncology indications and...
International – ICH guideline Q13 on continuous manufacturing of drug substances and drug products
This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. It is applicable to CM for new...
Europe – ETF statement on the loss of activity of anti-spike protein monoclonal antibodies...
Since the declaration of the COVID-19 public health emergency in early 2020, four monoclonal antibody products have been approved in the European Union for...
