EMA operationalises new PRIME tools and resets evidence-readiness expectations for 2026 submissions. https://www.mattheneus.com/editorial/ema-prime-three-feature-evidence-readiness-playbook-2026-03-18 #HTA #MAIC #RegulatoryAffairs #Pharma
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NICE ended TA1141 after no evidence submission—another reminder that evidence-readiness timing is strategic, not administrative. https://www.mattheneus.com/editorial/nice-ta1141-nivolumab-chemotherapy-urothelial-cancer-terminated-appraisal-2026-03-17 #HTA #EvidenceSynthesis #Pharma
NICE TA1141 terminates nivolumab plus chemotherapy appraisal in urothelial cancer after non-submission
NICE published TA1141 as a terminated appraisal for nivolumab plus chemotherapy in untreated unresectable or metastatic urothelial cancer. The agency states no recommendation can be made because the company did not submit evidence for appraisal.
FDA clears HERNEXEOS efficacy supplement in HER2-mutant metastatic NSCLC with Beamion LUNG-1 evidence.
https://www.mattheneus.com/editorial/fda-hernexeos-her2-mutant-nsclc-efficacy-supplement-beamion-lung1-2026-02-26
#HTA #Pharma #RegulatoryAffairs
https://www.mattheneus.com/editorial/fda-hernexeos-her2-mutant-nsclc-efficacy-supplement-beamion-lung1-2026-02-26
#HTA #Pharma #RegulatoryAffairs
FDA clears HERNEXEOS efficacy supplement in HER2-mutant metastatic NSCLC with Beamion LUNG-1 evidence
FDA approved an efficacy supplement for HERNEXEOS (zongertinib) in unresectable or metastatic non-squamous NSCLC with HER2 tyrosine kinase domain activating mutations. The label cites Beamion LUNG-1 and accelerated-approval reliance on objective response rate and duration of response.
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Cochrane pilots responsible AI tools — abstract screening, full-text review, and NMA — using the RAISE framework for evidence synthesis. A new governance baseline for systematic reviewers and HTA teams. https://www.mattheneus.com/editorial/cochrane-ai-synthesis-march2026 #HTA #NMA #EvidenceSynthesis #RegulatoryAffairs
Cochrane Pilots Responsible AI Tools in Evidence Synthesis
Cochrane has selected AI tools for its evidence synthesis platform study using the Responsible AI Standards in Evidence Synthesis (RAISE) framework, covering abstract screening, full-text screening, and data extraction phases.
MHRA and NICE launch a joint pathway to run licensing and HTA value decisions in parallel from April 2026 — targeting 3–6 months faster access to medicines.
https://www.mattheneus.com/editorial/mhra-nice-aligned-pathway-integrated-scientific-advice-launch-2026-03-17
#HTA #RegulatoryAffairs #HealthEconomics
https://www.mattheneus.com/editorial/mhra-nice-aligned-pathway-integrated-scientific-advice-launch-2026-03-17
#HTA #RegulatoryAffairs #HealthEconomics
MHRA and NICE launch aligned pathway to run licensing and value decisions in parallel from April
MHRA and NICE announced a 1 April 2026 aligned pathway and updated Integrated Scientific Advice service to synchronise licensing and value assessment timelines. The shift increases pressure for earlier endpoint, comparator, and evidence design alignment.
IQWiG A25-157 finds added benefit not proven for iptacopan in complement 3 glomerulopathy
IQWiG A25-157 finds added benefit not proven for iptacopan in complement 3 glomerulopathy
IQWiG published A25-157 on 16 March 2026 and concluded added benefit is not proven for iptacopan in complement 3 glomerulopathy. The assessment identifies APPEAR-C3G as the relevant randomised evidence for add-on use, while reporting no relevant study for monotherapy and no accepted indirect comparison basis in the published decision chain.
Access Consortium generic work-sharing updates are forcing earlier dossier harmonisation across agencies
Access Consortium generic work-sharing updates are forcing earlier dossier harmonisation across agencies
Recent MHRA updates to the Access Generic Medicines Work Sharing Initiative and Integrated Scientific Advice materials signal a tighter operating model for evidence teams: align Modules 2 to 5 early, document country-level deltas explicitly, and treat regulator dialogue as a design step rather than a rescue step.
NICE TA1140 final guidance recommends ruxolitinib cream for non-segmental vitiligo after rapid review https://www.mattheneus.com/editorial/nice-ruxolitinib-cream-ta1140-final-guidance-non-segmental-vitiligo-2026-03-17 #HTA #MAIC #RegulatoryAffairs #HealthEconomics
NICE TA1140 final guidance recommends ruxolitinib cream for non-segmental vitiligo after rapid review
NICE issued TA1140 on 17 March 2026 recommending ruxolitinib cream for non-segmental vitiligo with facial involvement in people aged 12 years and over. The committee relied on pooled phase 3 TRuE-V direct evidence and reviewed a phototherapy indirect comparison that informed pathway positioning but remained too uncertain for robust cost-utility anchoring.
IQWiG finds no proven added benefit for adjuvant cemiplimab in high-risk cutaneous squamous cell carcinoma.
https://www.mattheneus.com/editorial/iqwig-cemiplimab-cscc-adjuvant-no-added-benefit-c-post-follow-up-2026-03-16
#HTA #RegulatoryAffairs #EvidenceSynthesis
https://www.mattheneus.com/editorial/iqwig-cemiplimab-cscc-adjuvant-no-added-benefit-c-post-follow-up-2026-03-16
#HTA #RegulatoryAffairs #EvidenceSynthesis
IQWiG finds no proven added benefit for adjuvant cemiplimab in high-risk cutaneous squamous cell carcinoma
IQWiG dossier assessment A25-155, published on 16 March 2026, concluded that added benefit of adjuvant cemiplimab is not proven in high-risk cutaneous squamous cell carcinoma because available C-POST follow-up is too short for robust recurrence-focused interpretation.