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...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2024
EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole
Product information to be updated to raise awareness of known risk of...
UK – MSD’s Welireg recommended by NICE to treat rare von Hippel-Lindau disease
The take-at-home tablet will be available on the NHS in England and Wales to treat von Hippel-Lindau (VHL) disease in adults who require therapy...
UK – Theramex’s Eladynos recommended by NICE for post-menopausal bone disease
Theramex’s Eladynos (abaloparatide) has been recommended by the National Institute for Health Care and Research (NICE) for treating bone disease after menopause.
More than 14,000...
