Updated information about PHARMAC’s priority lists as at 15 December 2025

15 December 2025 - PHARMAC’s Prioritisation Update provides the latest information about applications for medicines, vaccines, and related products that ...

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Highlights from the 8-11 December 2025 CHMP meeting

12 December 2025 - The EMA’s CHMP recommended seven medicines for approval at its December 2025 meeting. ...

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Aflibercept 8 mg recommended for EU approval for third retinal indication

12 December 2025 - Positive opinion of the CHMP is based on the outcomes from the clinical Phase 3 trial QUASAR ...

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PBAC weight loss drug decision imminent

12 December 2025 - Patients are spending as much as $5,000/year on private market GLP-1 therapies – an incoming PBAC recommendation ...

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More efficacious dose of Wegovy recommended by the EMA can help people with obesity achieve an average of 20.7% weight loss

12 December 2025 - In the STEP UP programme, people with obesity taking Wegovy 7.2 mg lost an average of ...

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Depemokimab receives positive CHMP opinion for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps

12 December 2025 - Positive opinion based on four Phase 3 trials with statistically significant and clinically meaningful primary endpoints across ...

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Nucala (mepolizumab) receives positive CHMP opinion for treatment of chronic obstructive pulmonary disease

12 December 2025 - Positive opinion based on MATINEE Phase 3 trial showing significant reduction in COPD exacerbations versus placebo in ...

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GSK’s RSV vaccine, Arexvy, receives positive CHMP opinion for all adults 18 years and older

12 December 2025 - GSK today announced that the EMA's CHMP has recommended expanding the indication of its adjuvanted recombinant respiratory ...

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Cytokinetics announces positive CHMP opinion of Myqorzo (aficamten) for the treatment of obstructive hypertrophic cardiomyopathy

12 December 2025 - Cytokinetics today announced that the CHMP of the EMA has adopted a positive opinion recommending marketing authorisation ...

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ICER publishes evidence report on medication for smoking cessation

11 December 2025 - Cytisinicline is effective for smoking cessation; a 12 week course of cytisinicline would be cost effective ...

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ICER releases draft evidence report on therapies for IgA nephropathy

10 December 2025 - Public comment period now open until 14 January 2026; Requests to make oral comment during public ...

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EMA publishes agenda for 8-11 December 2025 CHMP meeting

8 December 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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New resource: understanding Canada’s drug approval and reimbursement pathway

3 December 2025 - Understanding how new oncology and non-oncology drugs move through Canada’s regulatory and drug access pathways can ...

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Agenda for the December 2025 PBAC meeting

5 December 2025 - The agenda for the December 2025 PBAC meeting is now available. ...

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Lecanemab in early Alzheimer's disease: previously unpublished data show no additional benefit

1 December 2025 - Based on previously unpublished data, the IQWiG concludes that lecanemab offers no proven advantage over the existing ...

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