Blog
RSS FeedPosted by Michael Wonder on 12 Apr 2025
Public Summary Documents – December 2024 PBAC meeting
11 April 2025 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the December 2024 PBAC ...
Posted by Michael Wonder on 10 Apr 2025
Hundreds of people in England to benefit from take-at-home tablet bladder cancer treatment
10 April 2025 - Today, for the first time, we have given the green light to a targeted treatment for the ...
Posted by Michael Wonder on 10 Apr 2025
Lorlatinib for the treatment of patients with advanced ALK positive non-small-cell lung cancer (review of TA909)
9 April 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 03 Apr 2025
Real-world evidence to support health technology assessment and payer decision making: is it now or never?
31 March 2025 - The aim of this policy article is twofold: (i) to provide a summary and update of recent ...
Posted by Michael Wonder on 03 Apr 2025
Averoa receives positive opinion from the EMA for Xoancyl, an oral therapy for chronic kidney disease
2 April 2025 - Final European Commission decision expected by June 2025; UK regulatory submission foreseen via MHRA’s international recognition procedure. ...
Posted by Michael Wonder on 02 Apr 2025
Sydnexis announces positive CHMP opinion in Europe for SYD-101 for slowing the progression of paediatric myopia
1 April 2025 - Santen is Sydnexis’ licensing partner to commercialise SYD-101 within the EMEA region upon issuance of a ...
Posted by Michael Wonder on 02 Apr 2025
Efanesoctocog alfa for the treatment and prevention of bleeding episodes in patients with haemophilia A (final guidance)
2 April 2025 - NICE has published final evidence-based recommendations on the use of efanesoctocog alfa (Altuvoct) for the treatment ...
Posted by Michael Wonder on 02 Apr 2025
Agenda for the July 2025 PBAC meeting
2 April 2025 - The agenda for the July 2025 PBAC meeting is now available. ...
Posted by Michael Wonder on 01 Apr 2025
Highlights from the 24-27 March 2025 CHMP meeting
28 March 2025 - The EMA’s CHMP recommended five medicines for approval at its March 2025 meeting. ...
Posted by Michael Wonder on 01 Apr 2025
Pembrolizumab in combination with carboplatin and paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer
24 March 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 01 Apr 2025
Nemolizumab for the treatment of patients with moderate to severe atopic dermatitis
27 March 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 01 Apr 2025
ICER publishes final evidence report on treatment for acute pain
31 March 2025 - Independent appraisal committee vote was split on the net health benefit of suzetrigine compared to non-systemic ...
Posted by Michael Wonder on 31 Mar 2025
Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for first-line mantle cell lymphoma
31 March 2025 - Recommendation based on ECHO Phase 3 trial results which demonstrated over 16 months of progression-free survival ...
Posted by Michael Wonder on 31 Mar 2025
Lilly’s statement about the CHMP opinion issued for donanemab
28 March 2025 - The EMA's CHMP issued an opinion that does not recommend Eli Lilly's donanemab be granted marketing ...
Posted by Michael Wonder on 30 Mar 2025
Bristol Myers Squibb receives positive CHMP opinion for peri-operative regimen of neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo for resectable non-small cell lung cancer in patients with tumour cell PD-L1 expression ≥1%
28 March 2025 - Recommendation based on Phase 3 CheckMate -77T trial showing significant event-free survival improvement when compared to neoadjuvant ...