Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 September-3 October...
Review of medicines containing finasteride and dutasteride started
Review assesses data related to suicidal thoughts and behaviours
EMA has started a review of medicines containing finasteride...
Europe – Improving efficiency of approval process for new medicines in the EU
EMA and the European medicines regulatory network are working to further improve efficiency in the assessment and approval processes for new medicines in the European Union....
UK – NICE Board says new method allowing greater weight to be given to...
The new modifier was introduced in 2022 to allow extra weight to be given to medicines that address severe diseases. It replaced a previous modifier...
UK – Roche’s injectable C5 inhibitor PiaSky recommended by NICE for rare blood disorder...
PiaSky (crovalimab), which can be self-administered by patients following adequate training, will be available on the NHS in England and Wales as a monotherapy...
Europe – EMA adopts reflection paper on AI/ML in drug development
The European Medicines Agency (EMA) has adopted a reflection paper (RP) on using artificial intelligence (AI) in drug development after considering feedback from scores...
Europe – EMA recommends suspension of sickle cell disease medicine Oxbryta
EMA’s human medicines committee (CHMP) has recommended suspending the marketing authorisation for the sickle cell disease medicine Oxbryta (voxelotor); this measure is taken as...
Europe – Establishing efficacy based on single-arm trials submitted as pivotal evidence in a...
Following a public consultation, the Methodology Working Party (MWP) has finalised the Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation.
The reflection...
Europe – EMA updates guideline on developing drugs for bipolar disorder
The European Medicines Agency (EMA) on 9 September proposes updating its guideline on developing drugs for treating bipolar disorder (BD) to reflect new medical...
UK – Relugolix for treating hormone-sensitive prostate cancer
The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health...
UK – Emergency kits for people with adrenal insufficiency recommended to avoid hospital admission
The kits would be used help those with primary or secondary adrenal insufficiency to treat and avoid an adrenal crisis and the need to...
