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July 14, 2025
by Jason Scott

Recon: Zimmer to acquire robotics firm Monogram for $177M; WHO adds Gilead’s biannual HIV shot to PrEP guidelines

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

In Focus: US
  • Zimmer to acquire Monogram Technologies for $177 million, boosting robotics portfolio (Reuters)
  • Trump's spending bill will likely boost costs for insurers, shrink Medicaid coverage (Reuters)
  • Federal Hiring Shake-Up (Again): What the Latest Executive Action and Supreme Court Decision Mean for Industry (FDA Law Blog)
  • Trump Says 200% Pharma Tariffs Are Coming. Wall Street Shrugs (The Wall Street Journal)
  • The growing influence of vaccine skeptics inside HHS (STAT)
  • The FDA commissioner is a gifted talker — but the job is about more than that (STAT)
  • Trump’s First Drug Negotiation Move Sparks Combo Medicine Fight (Bloomberg Law)
  • GSK seeks FDA nod for expanded use of RSV vaccine in adults (Reuters)
In Focus: International                                                                                                       
  • WHO adds Gilead's twice-yearly injection to global PrEP guidelines (Endpoints)
  • European MedTech Keeps Calm Despite US Threats Of 30% Tariffs (MedTech Insight)
  • Medtech Will Benefit From Boost To EU’s Quantum Technology Initiative (MedTech Insight)
  • US plans 30% tariffs on EU, Mexico (MedTech Dive)
  • US plans 35% tariffs on Canada imports (MedTech Dive)
Pharma & Biotech
  • Ozempic for addiction: How an elite rehab center is using GLP-1s to ‘obliterate’ all kinds of cravings (STAT)
  • AstraZeneca posts a pivotal trial win for blood pressure pill behind $1.3B deal (Endpoints)
  • FDA declines to approve Ultragenyx's Sanfilippo gene therapy, citing manufacturing issues (Endpoints)
  • Takeda’s first-in-class narcolepsy drug succeeds in two registrational studies (Endpoints)
  • Merck sends new monthly oral PrEP to Phase 3 after earlier islatravir setback (Endpoints)
  • GSK's ViiV expands licensing pact to include long-acting HIV treatment (Endpoints)
  • Sun launches alopecia med Leqselvi after Incyte settlement (Fierce Pharma)
  • Formulation specialist Azurity to lay off 75 amid plans to sunset Massachusetts plant (Fierce Pharma)
Medtech
  • 11 lessons for health tech startups from one of UpToDate’s creators (STAT)
  • Bionic knee developed by MIT researchers gives amputees a new world of motion (STAT)
  • Medtronic, Philips Cement New Pact To Embed Next-Gen Tech In Monitoring Platforms (MedTech Insight)
  • Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions (MedTech Insight)
  • Bivacor Rotary Heart Could Upend The Artificial Heart Market, If It Reaches Its Destination (MedTech Insight)
Food & Nutrition Government, Regulatory & Legal
  • Reports of young children accidentally eating nicotine pouches rose 763% in three years: Study (STAT)
  • U.S. drops charges against doctor accused of throwing away Covid shots, selling fake vaccine cards (STAT)
  • 25 years ago, I reported on horrifying hospital errors. Here’s what’s changed since then — and what hasn’t (STAT)
  • US judge stands by move to block cutting off of Planned Parenthood's Medicaid funding (Reuters)
  • CMS proposes covering renal denervation for hypertension (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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