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RSS FeedPosted by Michael Wonder on 17 Oct 2025
Health Economics Methods Advisory Group releases draft report: asssessing treatment benefits in health technology assessment decision-making
9 October 2025 - Public comment period now open until 30 October 2025. ...
Posted by Michael Wonder on 17 Oct 2025
Highlights from the 13-16 October 2025 CHMP meeting
17 October 2025 - The EMA’s CHMP has recommended two medicines for approval at its October 2025 meeting. ...
Posted by Michael Wonder on 17 Oct 2025
ICER to assess treatment for narcolepsy
17 October 2025 - Report will be subject of Midwest CEPAC meeting in May 2026; draft scoping document open to ...
Posted by Michael Wonder on 17 Oct 2025
Saphnelo subcutaneous self-administration recommended for approval in EU by CHMP for systemic lupus erythematosus
17 October 2025 - Recommendation based on TULIP-SC Phase III trial results showing first in class Saphnelo reduced disease activity ...
Posted by Michael Wonder on 17 Oct 2025
Libtayo (cemiplimab) recommended for EU approval by the CHMP for adjuvant treatment of cutaneous squamous cell carcinoma with a high risk of recurrence after surgery and radiation
17 October 2025 - Positive opinion based on results of Phase 3 C-POST trial that show Libtayo significantly reduced the ...
Posted by Michael Wonder on 17 Oct 2025
Novartis Scemblix receives positive CHMP opinion for the treatment of adults with newly diagnosed CML
17 October 2025 - If approved, Scemblix will be indicated for adults with chronic myeloid leukaemia (CML), both newly diagnosed and ...
Posted by Michael Wonder on 17 Oct 2025
Rare cancer lifeline comes with dual drug discounts
17 October 2025 - Two common immunotherapy drugs will now be subsidised for all advanced or metastatic cancers, providing a ...
Posted by Michael Wonder on 17 Oct 2025
Immunotherapy for patients with advanced cancers
17 October 2025 - More Australians living with advanced cancer could have access to immunotherapy treatment options, thanks to a ...
Posted by Michael Wonder on 17 Oct 2025
First HIV prevention injection for people unable to have daily PrEP recommended
17 October 2025 - A ground-breaking HIV-1 prevention injection has been recommended by NICE, marking a significant advance for a small ...
Posted by Michael Wonder on 17 Oct 2025
Same time decisions on licensing and value - what pharmaceutical companies need to know
10 October 2025 - Learn how NICE and MHRA are launching an aligned pathway to accelerate patient access to medicines and ...
Posted by Michael Wonder on 16 Oct 2025
Recommendations made by the PBAC - September 2025
17 October 2025 - Recommendations made by the PBAC in September 2025 relating to the listing of medicines on the PBS ...
Posted by Michael Wonder on 13 Oct 2025
EMA publishes agenda for 13-16 October 2025 CHMP meeting
13 October 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 11 Oct 2025
MHRA and NICE invite early adopters to trial accelerated aligned pathway – six months ahead of schedule
10 October 2025 - Aligned pathway will streamline decisions on licensing and value for medicines, helping patients to benefit from them ...
Posted by Michael Wonder on 04 Oct 2025
Andexanet alfa for haemorrhage: hope not fulfilled
1 October 2025 - A comparative study conducted at the instigation of the EMA shows only negative effects. ...
Posted by Michael Wonder on 04 Oct 2025
Engaging stakeholders along health technology assessment pathways: a scoping review of international practice
30 September 2025 - Health technology assessment has been characterised as a complex adaptive system that centrally features stakeholder interactions. ...