GLP-1 drugs Ozempic and Mounjaro close to reimbursement in diabetes care

23 Septemner 2025 - With GLP-1 receptor agonists nearing reimbursement for diabetes treatment, the Government is preparing tighter oversight and ...

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Koselugo recommended for approval in the EU by CHMP for plexiform neurofibromas in adults with neurofibromatosis type 1

22 September 2025 - Recommendation based on KOMET Phase 3 trial results which showed 20% objective response rate in tumour ...

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Tezspire recommended for approval in the EU by CHMP for chronic rhinosinusitis with nasal polyps

22 September 2025 - Recommendation based on WAYPOINT Phase III trial results showing Tezspire reduced nasal polyp severity and nasal ...

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Dupixent (dupilumab) to treat chronic spontaneous urticaria advances in EU with positive CHMP opinion

22 September 2025 - Recommendation for adults and adolescents based on Phase 3 trials showing Dupixent significantly reduced itch and hives ...

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First treatment recommended for rare immunoglobulin-related autoimmune disease

19 September 2025 - Uplizna significantly reduced the number of flares in patients with active immunoglobulin G4-related disease. ...

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Highlights from the 15-18 September 2025 CHMP meeting

19 September 2025 - The EMA’s CHMP has recommended 14 medicines for approval at its September 2025 meeting. ...

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Merck receives two positive EU CHMP opinions for Keytruda (pembrolizumab), for subcutaneous administration and for new indication for earlier-stage head and neck cancer

19 September 2025 - Positive opinion also granted for Keytruda as part of a peri-operative regimen for the treatment of certain ...

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Hundreds of people set to benefit after life-extending lung cancer treatment given green light

16 September 2025 - Targeted immunotherapy found to significantly increase overall survival rates for people with an aggressive form of lung ...

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The use of real world evidence among health care payers: a scoping review

12 September 2025 - Real world evidence is increasingly used to assess and make regulatory decisions on health technologies. However, its ...

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Public Summary Documents (first time decisions not to recommend and deferrals) – May 2025 PBAC meeting

12 September 2025  - The Public Summary Documents (first time decisions not to recommend and deferrals) from the May 2025 PBAC ...

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Methods used in early value assessments for NICE: a scoping review

8 September 2025 - NICE in England introduced early value assessments as an evidence-based method of accelerating access to promising ...

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Review panel backs expanded indications for Keytruda, Dupixent; Imfinzi sent for reconsideration

5 September 2025 - HIRA's Pharmaceutical Reimbursement Evaluation Committee (PREC) has determined that the expanded indications for MSD's immuno-oncology drug ...

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ICER releases draft evidence report on treatments for obesity

9 September 2025 - Public comment period now open until 6 October 2025; requests to make oral comment during public ...

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ICER publishes evidence report on treatment for non-cystic fibrosis bronchiectasis

8 September 2025 - There are significant uncertainties regarding long term efficacy of brensocatib; ICER estimates that treatment would achieve ...

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SMC - September 2025 decisions

8 September 2025 - The SMC has today published advice on two medicines. ...

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