UK – Merck’s Keytruda recommended by NICE to reduce risk of lung cancer recurrence
The anti-PD-1 therapy has been specifically recommended for use in combination with platinum-based chemotherapy as a neoadjuvant treatment before surgery and then as a...
UK – Roche’s Alecensa receives NICE recommendation to treat ALK-positive lung cancer
The drug has been specifically recommended by the health technology assessment agency as an adjuvant treatment for adults with stage 1B to 3A ALK-positive...
Europe – Règlement d’exécution (UE) 2024/2699 de la Commission du 18 octobre 2024
LA COMMISSION EUROPÉENNE,
vu le traité sur le fonctionnement de l’Union européenne,
vu le règlement (UE) 2021/2282 du Parlement européen et du Conseil du 15 décembre 2021 concernant...
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...
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The final draft guidance applies to RRMM patients in England and Wales who have received at least three lines of therapy, including an immunomodulatory...
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...
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....
UK – NICE Board says new method allowing greater weight to be given to...
The new modifier was introduced in 2022 to allow extra weight to be given to medicines that address severe diseases. It replaced a previous modifier...
