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November 7, 2024
by Jason Scott

Recon: How Trump and RFK Jr. could reshape healthcare; Moderna reports slower RSV vaccine sales but better-than-expected COVID vaccine revenue

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • ‘MAHA’ is moving into Trump’s White House. Here’s who RFK Jr. could bring along for the ride (STAT)
  • D.C. Diagnosis: RFK Jr. targets the F in FDA (STAT)
  • RFK Jr. says ‘entire departments’ at FDA ‘have to go’ (The Hill) (MSNBC interview)
  • Donald Trump returns to the presidency with big ambitions to shake up health care (STAT)
  • Biotech and pharma executives on what Trump and RFK Jr. could mean for the industry (STAT) (MedTech Dive)
  • FDA seeks to pull OTC nasal decongestant ingredient due to lack of efficacy (Endpoints)
  • Moderna reports slow start to RSV sales as Bancel steps back from commercial role (Endpoints)
  • Moderna reports surprise profit on higher-than-expected COVID vaccine sales (Reuters)
In Focus: International                                                                                                       
  • AstraZeneca says China has detained a senior executive (STAT)
  • Coherus restarts biosimilar supply after delays; Novavax ends Covid vaccine deal with UK (Endpoints)
  • Africa health body calls on Trump to honour US vaccine pledges (Reuters)
  • Whirlwind Week As German Medtechs Ponder Trump Effect And Whither Domestic Government (MedTech Insight)
  • UK Diagnostic Services Must Get In Shape To Benefit From AI Opportunities (MedTech Insight)
Pharma & Biotech
  • Sarepta discontinues next-generation Duchenne drugs (STAT)
  • Q&A: Demis Hassabis talks winning the Nobel Prize, building an AI biotech sans lab, and Trump’s potential impact (Endpoints)
  • Denali teases early data for enzyme replacement therapy in rare disease (Endpoints)
  • Xanax maker Viatris beats quarterly estimates on demand for new generic drugs (Reuters)
  • Genmab chops early cancer prospects to prioritize Phase 3 projects (Endpoints)
  • Aurinia cuts nearly half of its workforce in second round of layoffs this year (Endpoints)
  • Geron’s royalty deal; Minghui’s new VEGF bispecific data (Endpoints)
  • Grifols on track to meet 2024 targets as core earnings rise (Reuters)
  • Gilead's CAR-T sales stagnate as Trodelvy takes another impairment hit (Fierce Pharma)
  • AGC Biologics aims to become 'safe harbor' for manufacturing clients as new CEO takes the reins (Fierce Pharma)
  • While Lilly Blames Wholesalers for Slow GLP-1 Sales, Novo’s Rival Medicine Is Flowing (BioSpace)
  • Viracta Therapeutics Cuts 42% of Staff as Part of Resource Reprioritization (BioSpace)
Medtech
  • These 6 companies are using AI to streamline clinical trials for pharma (STAT)
  • How Menlo Ventures thinks AI in health tech is going to be commoditized (Endpoints)
  • US FDA approves Johnson & Johnson's device for heart condition (Reuters)
  • Tempus AI to buy genetic testing company for $600M (MedTech Dive)
  • Masimo, amid leadership transition, targets cost reductions (MedTech Dive)
  • Advamed asks CMS to cover extra imaging of dense breast tissue (MedTech Dive)
  • lucoModicum’s Magnetohydrodynamic CGM Platform Moves Closer To The Clinic (MedTech Insight)
Government, Regulatory & Legal
  • Social media misinformation is scaring women about birth control (STAT)
  • Cover Supplemental Breast Screenings, AdvaMed Urges Medicare (MedTech Insight)
  • While the Orphan Battles Wage, Jazz Takes a Loss (FDA Law Blog)
  • Siemens Healthineers confident it can cope with Trump tariffs (MedTech Dive)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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