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335: A deep dive on Makary, Vertex's pain data, & 2025 predictions

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Dec 19, 2024
Lizzy Lawrence, STAT's FDA reporter and expert on key FDA developments, joins the conversation to discuss her profile of Marty Makary, challenging traditional views in medicine. They delve into Vertex's recent pain drug trial results and the hurdles of breaking into the competitive pain management market. The discussion pivots to bold predictions for 2025, highlighting upcoming medication launches and the shifting dynamics within the biotech industry, particularly in gene therapy and obesity treatments.
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INSIGHT

Contrarianism at the FDA

  • Makary's contrarian nature has pros and cons for the FDA.
  • Questioning assumptions is good, but excessive questioning can hinder progress.
INSIGHT

Makary's Focus

  • Drug companies expect Makary won't make radical changes at the FDA.
  • He hasn't scrutinized drug and device companies as much as medical societies.
INSIGHT

Departure from the FDA

  • Numanji Bumpus, FDA's principal deputy commissioner, is leaving.
  • This might not indicate a wave of resignations, but uncertainty remains.
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