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AI Generated Daily briefings on HEOR, HTA strategy and the evidence access landscape. For pharmaceutical and biotech professionals navigating regulatory-payer alignment, HTA submissions, and evidence strategy.
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Recent Episodes
S1E30 EU JCA Medical Devices Launch, MHRA-NICE First Guidance
Episode 30 — 14 June 2026 The EU JCA framework expands into medical devices this month while MHRA-NICE alignment delivers its first coordinated guidance. Europe's HTA infrastructure shows sustained…
S1E29 MHRA-NICE Aligned Pathway and EU JCA Operationalization
Episode 29 — 13 June 2026 The UK's MHRA-NICE aligned pathway delivers first guidance this month with 27 early adopter companies, while the EU publishes its second JCA report on tovorafenib. These…
S1E28 First JCA Published, CHMP Patterns, Device Expansion
Episode 28 — 12 June 2026 The EU published its first joint clinical assessment report for tovorafenib, marking a milestone in HTA coordination. CHMP approval patterns show a pipeline increasingly…
S1E27 First JCA Report and Oral Semaglutide Approval
Episode 27 — 10 June 2026 The EU published its first Joint Clinical Assessment report for tovorafenib while EMA approved oral semaglutide for weight management. JCA capacity constraints emerge as…
S1E26 CHMP Pipeline Shift and Critical Medicines Act Mandates
Episode 26 — 09 June 2026 CHMP's May approvals reveal a structural shift toward rare disease development while the Critical Medicines Act introduces mandatory supply chain transparency requirements.…
S1E25 Medical Device JCAs Launch and Novel Mechanism Approvals
Episode 25 — 08 June 2026 Medical device Joint Clinical Assessments begin in June 2026 as the EU HTA Regulation expands beyond oncology medicines. FDA approves first-in-class aldosterone synthase…
S1E24 NICE Diabetes Revolution, EU Device JCAs, Clinical Trial Acceleration
Episode 24 — 07 June 2026 NICE's revolutionary diabetes guideline makes SGLT-2 inhibitors first-line therapy while EU HTA regulation expands to high-risk medical devices. FDA accelerated approvals…
S1E23 Orphan Dominance and Oral Semaglutide Market Shifts
Episode 23 — 06 June 2026 Marcus and Sara examine the CHMP's May session showing 42% orphan designation rates and debate whether oral semaglutide represents genuine innovation or market expansion.…
S1E22 DMD Access Breakthrough and CHMP Pipeline Shift
Episode 22 — 05 June 2026 NICE approves third DMD treatment givinostat via Innovative Medicines Fund while CHMP's May output signals structural shift toward rare disease therapies. ISPOR 2026…
S1E21 RNA Breakthroughs, Critical Medicines Act, and Evidence Judgment Era
Episode 21 — 04 June 2026 European Parliament and Council reach provisional agreement on Critical Medicines Act while EMA approves first RNA-based veterinary vaccine. ISPOR's latest trends report…
S1E20 First-in-Class HEOR Challenges and Regulatory Framework Shifts
Episode 20 — 03 June 2026 Multiple first-in-class therapies create new HEOR value demonstration challenges while industry increasingly funds academic research to support policy positions. EMA's…
S1E19 CHMP Approvals Signal Shift, JCA Device Rollout Begins
Episode 19 — 02 June 2026 CHMP's May session approved eight medicines including oral semaglutide, signaling structural changes in European drug development. Medical device JCAs launch in June while…
S1E18 Medical Device JCAs Launch and NICE Methodology Shifts
Episode 18 — 01 June 2026 Medical device JCAs begin this month as NICE refines implementation guidance and biosimilar value assessment approaches. The hosts disagree on whether NICE's procedural…
S1E17 CHMP Rare Disease Pipeline and NICE Threshold Implementation
Episode 17 — 31 May 2026 EMA's CHMP approved eight medicines in May with heavy focus on rare diseases and specialty indications. NICE reveals implementation details for threshold increase while JCA…
S1E16 Device JCAs Launch, NICE Prioritisation, and MFN Reality Check
Episode 16 — 30 May 2026 Medical device JCAs launch in June as NICE implements new prioritisation framework. Trump's MFN commitments clash with reality as pharma raises prices on over 350…
S1E15 Critical Medicines Act, AI Tops HEOR Trends, NICE Advice ROI
Episode 15 — 29 May 2026 The EU Critical Medicines Act positions EMA as central authority for supply chain assessments across 200+ substances. AI jumps to #1 in ISPOR trends while NICE advice cuts…
S1E14 EQ-5D-5L Update Reshapes Cancer Economics
Episode 14 — 28 May 2026 NICE's first QALY valuation update in over a decade shows cancer medicines becoming more cost-effective while quality-of-life therapies face higher ICERs. Meanwhile, JCA…
S1E13 MHRA-NICE Pathway Under Fire, Clinical Trial Targets Hit
Episode 13 — 27 May 2026 LSE expert challenges the new UK aligned drug approval pathway as industry-favoring while EU reports progress on 2030 clinical trial targets. NICE approves first…
S1E11 CHMP Pipeline Surge, NICE Threshold Jump, JCA Device Push
Episode 11 — 27 May 2026 EMA's CHMP recommended eight medicines including first-ever PROS treatment while NICE raised cost-effectiveness thresholds to £25,000-35,000 per QALY. The EU's Joint…
S1E12 Critical Medicines Act and NICE Technology Priorities
Episode 12 — 27 May 2026 The EU Critical Medicines Act's provisional agreement introduces supply chain resilience metrics into HTA frameworks, while NICE advances systematic technology adoption and…
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AI Access Brief Podcast has published 36 episodes since May 2026, covering topics in Business, Management.
AI Access Brief Podcast is currently highly active with new episodes daily. Average episode length is 5m.
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