Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Ten new medicines recommended for approval
The committee recommended granting a marketing authorisation for Alhemo (concizumab), a medicine for routine prophylaxis of bleeding in patients with...
USA – Guidance : Core Patient-Reported Outcomes in Cancer Clinical Trials
This guidance provides recommendations to sponsors for collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for...
Europe – EMA drafts concept paper for future radiopharmaceuticals guideline
The European Medicines Agency (EMA) last week released a new concept paper for a future guideline on the clinical evaluation of therapeutic radiopharmaceuticals (tRPs)...
UK – Johnson & Johnson receives updated NICE recommendation for Tecvayli in multiple myeloma
The final draft guidance applies to RRMM patients in England and Wales who have received at least three lines of therapy, including an immunomodulatory...
International – Industry stakeholders call for changes to ICH M14 RWD guideline
Pharmaceutical industry stakeholders from both sides of the Atlantic generally supported the International Council for Harmonization’s (ICH) M14 guidance on using real world data...
India – National Regulatory Authority of India meets WHO international standards for vaccine regulations
The Central Drugs Standard Control Organisation (CDSCO), along with the National Regulatory Authority of India (NRA) and affiliated institutions, has been found to meet...
Europe – Seizing opportunities in a changing medicines landscape
EMA and the Heads of Medicines Agencies (HMA) have published their draft joint EU network strategy to 2028 for an eight-week public consultation.
This is a review...
France – Wegovy, le médicament vedette contre l’obésité de Novo Nordisk, est lancé en...
C’est une arrivée qui ne devrait pas passer inaperçue. Le géant pharmaceutique danois, Novo Nordisk, a lancé, mardi 8 octobre, la commercialisation en France de...
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....
