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July 16, 2024
by Jason Scott

Recon: J&J, BMS and AstraZeneca appeal IRA court losses; Swiss biotech Asceneuron raises $100M to develop Alzheimer’s drug

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

In Focus: US
  • What to know about Trump VP pick J.D. Vance’s health care views and investments (STAT)
  • Vertex sues U.S. government over access to fertility support services for Casgevy patients (STAT)
  • Pharma's 340B Legal Disputes Over Contract Pharmacies May Get A Boost With Chevron Ruling (Pink Sheet)
  • Fatty Liver Disease Drug Approval Opens New Patient Population In Imaging Market (Pink Sheet)
  • J&J, BMS and AstraZeneca strike back in appeals after IRA litigation losses (Fierce Pharma)
  • Umpteenth time’s a charm? Lawmakers try to block DTC drug ad tax deductions yet again (Fierce Pharma)
In Focus: International
  • Novo owner backs Swiss biotech Asceneuron in $100 million round (Reuters) (Endpoints)
  • U.K. pharma increasingly violates voluntary industry marketing codes, and probes are taking longer (STAT)
  • German biotech CatalYm raises $150M to repurpose obesity target for cancer (Endpoints)
  • Japan Makes Renewed Policy Efforts To Fill 'Drug Gap' (Pink Sheet)
  • Eleven New Drugs Filed In EU; Sipavibart & Dorocubicel Win Fast-Track Status (Pink Sheet)
  • EMA Tightens Clock-Stop Rules To Address Impact On Drug Approval Timelines (Pink Sheet)
  • Pilot Shows EU Needs A ‘Robust’ Shortage Signaling System for ‘Critical’ Drugs (Pink Sheet)
  • China Market For Medtech: Opportunity Or Headache? (MedTech Insight)
  • UK Government Accentuates Role Of Medtech As It Orders Review Of NHS (MedTech Insight)
  • Second malaria vaccine launched in Ivory Coast in new milestone (Reuters)
Pharma & Biotech
  • Roche looks to have a competitive GLP-1 drug (STAT)
  • A teenager faced constant seizures. Could a drug developed just for him stop them? (Endpoints)
  • Scorpion raises $150M with sights on the next wave of targeted therapies (Endpoints)
  • Bain-backed Cardurion raises $260M to fund ex-Imara drug, buy more cardio assets (Endpoints)
  • After last year's ImmunoGen pact, Vertex finds another conditioning agent partner in Orum (Endpoints)
  • SOTIO, Biocytogen to jointly develop antibodies; Pliant's mid-stage liver disease data (Endpoints)
  • Exclusive: Kins raises $7M to expand in-home and virtual physical therapy (Endpoints)
Medtech
  • FDA creates communication ‘super office’ at CDRH (MedTech Dive)
  • J&J, Abbott and Intuitive start medtech earnings season (MedTech Dive)
  • Device Center Announces Organizational Changes, Including New Marketing Division (MedTech Insight)
  • AI Act Is Officially Published: Implementation Challenges Ahead For Medtech (MedTech Insight)
Government, Regulatory & Legal
  • Sanford Health aims to shake off a run of failed deals by snapping up a $3 billion Wisconsin health system (STAT)
  • A cancer care startup is making a new bet with payers and providers: only pay if it works (STAT)
  • Q&A: Jefferies analyst Brian Tanquilut talks Walgreens’ retreat from primary care and what’s sinking retailers’ healthcare bets (Endpoints)
  • Slimmed-Down Obesity Drug Coverage In Medicare: First Step Or False Start? (Endpoints
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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