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...
Europe – EMA guidance document on the use of medicinal products for treatment in...
In 2003, at the request of the Directorate General Enterprise of the European Commission, the EMA published a guidance document on the use of...
Europe – Concept paper for the development of a guideline on the demonstration of...
The guideline on the pharmaceutical quality of inhalation and nasal medicinal products
(EMEA/CHMP/QWP/49313/2005 Corr) (which is under revision) covers, as the title indicates, both orally...
UK – BeiGene’s Brukinsa recommended by NICE to treat marginal zone lymphoma
The Bruton’s tyrosine kinase inhibitor, which is the first treatment to be specifically licensed for this form of blood cancer, is now available on...
UK – Merck’s Keytruda combination recommended by NICE for advanced gastric cancer
The anti-PD-1 therapy has been specifically recommended for use alongside platinum- and fluoropyrimidine-based chemotherapy to treat untreated locally advanced unresectable or metastatic human epidermal...
