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16 October 2025
by Jason Scott

Recon: Roche to market $50 flu pill to US cash buyers; Praxis surges on positive results from shaking disorder trials

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

In Focus: US
  • Roche to sell flu pill for $50 to cash-paying US patients (Reuters)
  • Novo vs. KBP Chapter 3: Fraud or due diligence slipup? (Fierce Pharma)
  • What J&J’s ortho spinoff means for the industry (MedTech Dive)
  • Obesity remains high in the US, but more states are showing progress, a new report finds (The Hill)
  • Successful Diagnostics Alter Clinical Pathways, Says NHS Foundation Trust Leader (MedTech Insight)
In Focus: International                                                                                                       
  • AstraZeneca Gets Rare Sell as Deutsche Bank Has Pipeline Worries (Bloomberg)
  • Dianthus inks licensing deal with Chinese biotech; C4 targets $125M offering (Endpoints)
  • Germany's Merck eyes life science deals, but muted 2026 outlook knocks shares (Reuters)
  • Nordic Capital-led consortium raises takeover price for Bavarian Nordic to $39 per share (Reuters)
  • Fixing The Fractures: New Aspirations For EU Medtech Regulatory Progress (MedTech Insight)
  • J&J faces first UK lawsuits alleging its baby powder caused cancer (Reuters)
Pharma & Biotech
  • Veteran biotech executive Clive Meanwell on drug pricing and the obesity market (STAT)
  • Funding cuts threaten new generation of cancer immunotherapies, researcher says (STAT)
  • This scientist is revealing the immune system in our nasal passages (STAT)
  • Baby KJ’s doctors will ask FDA this winter to OK a clinical trial of pioneering gene editing approach (STAT)
  • Pharmanovia Seeks to Reassure Lenders as Performance Wanes (Bloomberg)
  • Are PD-1xVEGF bispecifics being tested in the wrong kinds of cancer? (Endpoints)
  • Novartis’ Fabhalta gets confirmatory late-stage trial win in kidney disease IgAN (Endpoints)
  • Praxis surges as drug improves daily function for movement disorder patients in trials (Reuters)
  • J&J eyes earlier myeloma treatment with ph. 3 Tecvayli combo win (Fierce Pharma)
  • Diabetes drug soothes brain inflammation in female mice with MS (Fierce Pharma)
Medtech
  • Medical device maker Becton Dickinson's CFO to depart; shares slide (Reuters)
  • Lyra launches ‘clinical-grade’ chatbot amid growing concern about mental health and AI (STAT)
  • Thiel, Bezos Back Startup Treating Tumors With Sound Waves (Bloomberg)
  • How wearable maker Whoop is making its move into healthcare (Endpoints)
  • Town Hall Ventures raises $440M fund as it invests deeper into health tech (Endpoints)
  • BD CFO Chris DelOrefice leaving for new job (MedTech Dive)
  • Abbott CEO: ‘We’re right on time’ to the PFA party (MedTech Dive)
Food & Nutrition
  • In Texas, ex-vegan restaurateurs put MAHA’s vision for farming to the test (STAT)
  • Food recalls are on the rise. What happens to the waste? (Food Dive)
Government, Regulatory & Legal  
  • The Health-Care Debate That’s Driving the Shutdown (Again) (Bloomberg)
  • ‘Doctor Mike,’ the popular YouTube creator, faults AMA communication strategies to counter misinformation (STAT)
  • Democratic governors form a public health alliance in rebuke of Trump administration (STAT)
  • Doctor groups need to ‘step up to the plate’ as CDC guidance becomes harder to trust, former leaders say (STAT)
  • Medicare backs off plan to pause doctor payments amid shutdown (STAT)
  • Idaho First to Pull Back the Curtain on Health Insurance Pain (Bloomberg)
  • Court blocks Cosette's attempt to drop $438 million Mayne deal; shares jump (Reuters
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.