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...
USA – FDA drafts guidance on drug interaction labeling
The US Food and Drug Administration (FDA) has released a new draft guidance describing what should and should not be included in the Drug...
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...
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The final draft guidance applies to RRMM patients in England and Wales who have received at least three lines of therapy, including an immunomodulatory...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...