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January 23, 2025
by Jason Scott

Recon: Purdue, Sacklers ink $7.4B national opioid settlement; RKF Jr. slated for Senate committee hearings next week

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

In Focus: US
  • Purdue Pharma, Sacklers reach $7.4 bln national opioid settlement (Reuters)
  • Trump executive order declaring only ‘two sexes’ gets the biology wrong, scientists say (STAT)
  • Trump administration’s abrupt cancellation of scientific meetings prompts confusion, concern (STAT)
  • RFK Jr. invested in gene-editing biotech, is owed millions for book advances, disclosures show (STAT)
  • Kennedy Would Keep Stake in HPV Vaccine Suit if Confirmed (The New York Times) (Reuters)
  • RFK Jr. to face key Senate committee hearings next week (STAT)
  • Updated: Biogen makes cuts across its research unit, shifting focus to ‘external opportunities’ (Endpoints)
  • FDA warns of serious allergic reactions with some multiple sclerosis drugs (Reuters)
  • J&J beats quarterly sales and profit estimates on cancer drug sales (Reuters)
In Focus: International                                                                                                       
  • Germany’s ITM, a stalwart in radiopharmaceuticals, gets ready to take its own shots (STAT)
  • U.S. WHO exit jeopardizes Africa, says health body (Reuters)
  • EU’s €66.8M Project To ‘Transform Clinical Studies’ By Boosting Diversity (Pink Sheet)
  • England’s NICE Leads Global Effort On Surrogate Endpoints For Cost-Effectiveness (Pink Sheet)
  • Japan In 2025: Policy Give, Pricing Take Set To Continue (Pink Sheet)
  • India's Mankind Pharma misses Q3 profit view as expenses jump (Reuters)
Pharma & Biotech
  • Tris Pharma, looking to compete with Vertex, reports acute pain trial success (STAT)
  • What to watch on Akero’s MASH-cirrhosis study results next month (STAT)
  • BioMarin turns to ex-Roche dealmaker James Sabry to build ‘next version’ of 27-year-old company (Endpoints)
  • Merck KGaA says high asset prices call for prudent M&A approach (Reuters)
  • AbbVie partners with Neomorph in latest molecular glue deal (Endpoints)
  • With $275M in fresh funding, Innovaccer's looking to make more health tech deals (Endpoints)
  • FDA delays decision on Stealth’s Barth syndrome drug; TargetRx raises $50M (Endpoints)
  • Anthos' detailed mid-stage data back its anticoagulant, but can the drug succeed where Bayer's failed? (Endpoints)
  • Teva’s MS drug and generics to add black box warning for anaphylaxis (Endpoints)
  • AstraZeneca exec stresses Calquence's patent life ahead of next Medicare negotiations (Endpoints)
  • Exclusive: Health navigator Quantum Health cuts 4% of workforce (Endpoints)
  • Abbott banks on glucose monitors, new launches to ride out China, currency hit (Reuters)
  • US FDA Urges Generics To Stay Engaged On Metered Dose Inhalers (Pink Sheet)
Medtech
  • What health tech wants from a Trump administration (Endpoints)
  • Masimo taps Becton Dickinson executive Katie Szyman as CEO (Reuters)
  • AI in medtech is taking off. Here are 4 trends to watch in 2025 (MedTech Dive)
  • Intuitive inks deals to sell robots in Italy, Spain and Portugal (MedTech Dive)
  • Abbott expects to launch first PFA device outside of the US this year (MedTech Dive)
  • J&J coordinating with FDA on US pause of Varipulse due to safety risks (MedTech Dive)
Government, Regulatory & Legal
  • ‘Rationing by inconvenience’: Health insurers count on customers not appealing denials (STAT)
  • RFK Jr., an investor in a CRISPR biotech, has raised alarms about the technology (STAT)
  • Better Luck Next Year: US FDA CRLs May Be Rising, But Are Not The End Of The Story (Pink Sheet)
  • Trump eyes 10% China tariff hike by Feb. 1 (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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