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June 16, 2025
by Jason Scott

Recon: Lilly to sell highest doses of Zepbound on its website; Supernus to acquire Sage for $795M

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

In Focus: US
  • Senators Propose Ban on Drug Advertising to Consumers (The Wall Street Journal)
  • Sarepta reports second patient death after treatment with Duchenne gene therapy (STAT)
  • RFK Jr.’s new vaccine panel raises questions of how Kennedy defines conflicts of interest (STAT)
  • Kennedy allows US Senator Cassidy a pick in revamped CDC vaccine panel (Reuters)
  • Lilly to offer highest doses of weight-loss drug Zepbound on website (Reuters)
  • Lilly posts encouraging early-stage weight loss data on amylin candidate (Endpoints)
  • Another round of consolidation is coming, FDA commissioner tells staff (Endpoints)
  • Big Pharma's 10 highest-paid CEOs of 2024 (Fierce Pharma)
  • Purdue Pharma $7.4 billion opioid settlement wins broad support from US states (Reuters)
In Focus: International                                                                                                       
  • NextCure inks ADC deal with Shanghai drugmaker (Endpoints)
  • US pharma bets big on China to snap up potential blockbuster drugs (Reuters)
  • China Joins US in Brain Implant Race With Clinical Trial (Bloomberg)
  • UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage (Pink Sheet)
  • GSK applies to EU regulator for expanded use of RSV vaccine (Reuters)
Pharma & Biotech
  • Supernus enters depression drug market with up to $795 million Sage deal (Reuters) (Endpoints)
  • Gilead, Arcellx continue to spotlight safety of multiple myeloma cell therapy (Endpoints)
  • Former CEO Anne Wojcicki wins bid for 23andMe (Endpoints)
  • KalVista says FDA delayed decision on HAE drug, citing ‘heavy workload’ (Endpoints)
  • FDA's oncology adcomm to review GSK's Blenrep relaunch plans (Endpoints)
  • AbbVie says blood cancer drug fails late-stage trial (Reuters)
  • Sixth Street-backed Caris lifts IPO price range, eyes $5.7 billion valuation (Reuters)
  • AZ touts Ultomiris results in post-transplant complication trial (Fierce Pharma)
  • Biogen leads Cannes Lions Pharma shortlist, with BMS, Novartis cracking Health & Wellness category (Fierce Pharma)
Medtech
  • Body Scan Makers Are Trying to Cash in on Obesity Drug Boom (Bloomberg)
  • Centerline recalls guidewire over risk of coating being left in patients (MedTech Dive)
  • Joint Commission, CHAI partner to develop guidance on health AI (MedTech Dive)
  • Quest partners with MD Anderson to develop cancer risk blood test (MedTech Dive)
  • Prix Galien Spotlights Mental Health ‘Renaissance’ But Systemic Hurdles Persist (MedTech Insight)
  • Increasing Safety Concerns Spur Scrutiny of Device Plastics Use (MedTech Insight)
  • Ellipsis Raises $45M To Expand AI Care Manager Across Health Systems (MedTech Insight)
Food & Nutrition Government, Regulatory & Legal
  • I’m a fertility doctor, and I think IVF needs more regulation (STAT)
  • Hospitals would be hit hardest by Medicaid cuts in GOP tax bill, report finds (STAT)
  • Don’t cut NIH and NSF budgets — let the government invest like a venture capitalist (STAT)
  • With LDT Rule DOA, Could FDA Shift Focus To RUOs? (MedTech Insight)
  • US FDA Teases Disclosure Program, But Industry Has Seen This Before (Pink Sheet)
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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