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...
Europe – EMA advises about risks of using weight loss medicine Mysimba with opioids
Following a routine review of the safety of the weight loss medicine Mysimba (naltrexone/bupropion), EMA recommends strengthening existing advice to minimise the risks from...
UK – Boehringer Ingelheim’s Metalyse recommended by NICE to treat stroke in adults
The decision could help save the NHS millions of pounds due to Metalyse costing less than the current standard for treating this type of...
International – VIH : un médicament préventif efficace, avec deux injections par an seulement,...
C’est un « moment historique » s’est réjoui, mercredi 24 juillet, le professeur Yazdan Yazdanpanah, directeur de l’Agence nationale de recherche sur le sida-maladies infectieuses émergentes. Mais...
USA – Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers
This guidance provides answers to commonly asked questions from applicants and other interested parties (collectively referred to as applicants throughout this guidance) regarding postapproval...
UK – J&J’s Tecvayli recommended by NICE to treat relapsed and refractory multiple myeloma
The final draft guidance specifically applies to patients who have received at least three prior treatments, have progressed on their last treatment, and would...
France – Définition des conditions méthodologiques requises pour la prise d’un pari lors d’une...
Le bilan des procédures accélérées aux Etats-Unis, qui s’appuie sur plus de 30 ans d’expérience de la FDA, a montré que les études confirmatoires...
Europe – Development and manufacture of oligonucleotides – Scientific guideline
This guideline addresses specific aspects regarding the manufacturing process, characterisation, specifications and analytical control for synthetic oligonucleotides which are not covered in the Guideline...
UK – NICE recommends Accord’s oral hormone therapy Orgovyx for advanced prostate cancer
The androgen deprivation therapy (ADT), which has been specifically recommended for those with hormone-sensitive cases of the disease, is now the first oral treatment...
Europe – EMA confirms its recommendation to update the antigenic composition of authorised COVID-19...
In April 2024, the European Medicines Agency (EMA) issued a recommendation to change the antigenic composition of authorised COVID-19 vaccines for use during the...
