AI Access Brief Podcast

Carl Haakon
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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. 

  1. 21h ago

    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 inhibitor baxdrostat while ISPOR signals a shift toward evidence judgment over generation. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

    5 min

  2. 1d ago

    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 surge and EU clinical trial acceleration shows early progress toward 2030 targets. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

    5 min

  3. 2d ago

    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. They clash over emergency regulatory collaboration priorities and disagree on JCA capacity constraints for specialty medicines. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

    5 min

  4. 3d ago

    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 highlights HEOR's expanding role in policy and value frameworks amid accelerating orphan designation trends. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

    5 min

  5. 4d ago

    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 signals the shift from data production to evidence judgment as the new evaluation criterion. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

    6 min

  6. 5d ago

    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 annual report reveals optimization of medicines assessments and HTA regulation coordination progress. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

    5 min

  7. 6d ago

    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 AI tops ISPOR's 2026 trends report. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast

    5 min

  8. Jun 1

    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 simplifications strengthen or weaken evidence standards. Hosted by Marcus and Sara. Access Brief — Daily briefings on HEOR, HTA strategy and the evidence access landscape. Full transcript and sources at outcomes-analytica.no/podcast  GS1M3fTk8J53NF2ecagc

    5 min
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About

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. 

Information

  • Creator
    Carl Haakon
  • Years Active
    2K
  • Episodes
    31
  • Rating
    Clean
  • Copyright
    © 2026 AI Access Brief Podcast
  • Show Website
    AI Access Brief Podcast