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...
Europe – Alzheimer : l’Europe dit non au lecanemab… l’Amérique dit oui
18 mois après son autorisation aux Etats-Unis, le médicament anti-béta amyloïde s’est vu refuser une autorisation de mise sur le marché par le gendarme...
Europe – EMA addendum addresses vaccine development for immunocompromised people
The European Medicines Agency (EMA) has published a draft addendum to a guideline on vaccine development that encourages collecting clinical trial data on immunocompromised...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its July 2024 meeting.
The CHMP recommended granting a marketing authorisation for Anzupgo (delgocitinib), a medicine...
