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March 4, 2025
by Jason Scott

Recon: US health agencies make early retirement offer to staff; South Africa probes Novo, Sanofi over insulin practices

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

In Focus: US
  • ‘Wrong,’ ‘misleading,’ and ‘reasonable’: How Jay Bhattacharya became, for some, the least bad option to run NIH (STAT)
  • As RFK Jr. delivers his message on measles, public health experts hear a familiar tune (STAT)
  • Questions about Pfizer’s GenAI ‘Health Answers’ (STAT)
  • Republicans’ new Medicaid arguments: They’re only cutting waste, fraud, and abuse (STAT)
  • Exclusive: US health agency says employees can apply for early retirement (Reuters)
In Focus: International                                                                                                       
  • After Canada required pharma to pay fees, drug agency recommended coverage more often (STAT)
  • Sofinnova Partners raises €1.2B to back another 50 to 60 life sciences startups (Endpoints)
  • Obesity rates soaring globally in 'monumental social failure', study says (Reuters)
  • South Africa's Aspen aims for slice of booming GLP-1 drug market by 2026 (Reuters)
  • South African watchdog probes Novo Nordisk and Sanofi over insulin (Reuters)
  • UN appeals for funds to help contain Uganda Ebola outbreak (Reuters)
  • EU Medtech In Turmoil: Navigating The Impact Of US President Trump’s Orders (MedTech Insight)
Pharma & Biotech
  • Protagonist drug hits goals in pivotal study of rare blood cancer (STAT)
  • Acelyrin rejects buyout offer from Tang’s Concentra, sticks to Alumis merger (Endpoints)
  • Tenaya raises about $53M; BeiGene’s PD-1 gets a first-line approval (Endpoints)
  • Bourla says Pfizer could transfer production to US to sidestep Trump's tariffs (Endpoints)
  • 23andMe rejects CEO's second take-private offer (Endpoints)
  • Cerebral CEO David Mou has stepped down (Endpoints)
  • GSK, Amgen and AstraZeneca tout Phase 3 data in inflammatory nasal condition (Endpoints)
  • Pliant calls it quits on Phase 2b idiopathic pulmonary fibrosis study (Endpoints)
  • Bayer faces investors' impatience ahead of fourth-quarter results (Reuters)
Medtech
  • DOJ probes device maker whose test resulted in lucrative diagnoses for UnitedHealth and other insurers (STAT)
  • Trump hikes tariffs on China by 10% (MedTech Dive)
  • Boston Scientific to buy Sonivie for up to $540M (MedTech Dive)
  • FDA’s Cyber Device Regulations Demand Focus on Security, Webinar Says (MedTech Insight)
  • AvaSure, Oracle And NVIDIA Launch Virtual Care Assistant For Enhanced Clinical Workflow (MedTech Insight)
  • HIMSS 2025: Google Cloud Launches Visual Q&A For Multimodal Search Capabilities (MedTech Insight)
Government, Regulatory & Legal
  • DTC Advertising: Industry Learning To Live With US FDA’s Clear, Conspicuous And Neutral Rule (Pink Sheet)
  • Health plans need to take accountability for a broken system (STAT)
  • NIH terminates ongoing grants for LGBTQ+ research (STAT)
  • Marty Makary, Trump nominee to lead FDA, pledges to avoid conflicts if confirmed (STAT)
  • Sutter Health settles sweeping antitrust case, narrowly avoiding trial (STAT)
  • UnitedHealthcare’s copay-only plan is booming, despite backlash over care denials (Endpoints)
  • NIH-backed research tries to use stem cells to restore the eye’s outer layer (Endpoints)
  • Wild Coast recalling raw cat food on bird flu contamination risk, FDA says (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.
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