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)
- 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)
- 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)
- 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)
- ‘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)
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