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January 27, 2026
by Jason Scott

Recon: China suspends sale of Sun dementia drug; Intellia cleared to resume gene therapy trial after FDA hold

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • In major test for longevity field, FDA greenlights study on a 'near total reset' of cells (STAT)
  • IRA drug pricing petitions pile up at the Supreme Court (STAT)
  • Insurance CEOs In The Hot Seat: House Hearings Emphasize Rx Access, Not Prices (Pink Sheet)
  • Pfizer retains top spot in vaccine rankings as Sanofi slides (Fierce Pharma)
In Focus: International
  • China halts sale of Sun Pharma drug used to treat dementia (Reuters) (Fierce Pharma)
  • Boehringer Ingelheim gets an IBD bispecific from Shanghai-based Simcere (Endpoints)
  • UK and US biotech investor Epidarex raises $145M for fourth fund (Endpoints)
  • Swiss CDMO Siegfried gains 3 sites through M&A, including 2 in US (Fierce Pharma)
  • Catalent plans to close Belgium cell therapy site that employs 150 workers (Endpoints)
  • Indian diagnostic services chain Orange Health eyes profitability in early 2028 (Reuters)
  • EU-India trade pact to largely cull 11% tariff on European drugs (Fierce Pharma)
  • Servier revenue growth hits 16% as group eyes €10B 2030 goal (Fierce Pharma)
  • No Nipah virus cases detected in China, state media says (Reuters)
Pharma & Biotech
  • Roche moves obesity drug to pivotal trials after mid-stage success (STAT) (Reuters)
  • Virtual women’s health company Wisp buys TBD Health (Endpoints)
  • TRexBio gets another $50M to bring more Treg candidates into the clinic (Endpoints)
  • Ex-CytoDyn CEO sentenced to 30 months for pump-and-dump scheme (Endpoints)
  • Intellia gets FDA nod to resume gene therapy trial after safety pause (Reuters)
  • Andreessen Horowitz Invests Early in Swedish AI Startup Dentio (Bloomberg)
  • Teva taps Will Forte to join Huntington’s disease awareness push (Fierce Pharma)
Medtech
  • Former executives of device maker Zynex Medical indicted for fraud (STAT)
  • 5 robotic surgery trends to watch in 2026 (MedTech Dive)
  • FDA guidance eases wearables oversight. But experts have questions about what’s next. (MedTech Dive)
  • Medtronic targets ASCs with extended Mindray collaboration (MedTech Dive)
Food & Nutrition
  • Food and beverage brands adopt new non-ultraprocessed label (Food Dive)
  • Small and local food brands stand out at grocery stores (Food Dive)
Government, Regulatory & Legal
  • 9 influencers shaping health information online, for better or worse (STAT)
  • Hospital group wants Trump administration to block a new Lilly policy on 340B claims data (STAT)
  • Sidelining Black women in clinical trials is not just a moral failure. It’s bad science (STAT)
  • Trump administration proposes tiny pay raise to 2027 Medicare Advantage plans (STAT)
  • UnitedHealth tumbles as Medicare insurer payment rates, 2026 revenue forecast disappoint (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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