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July 8, 2024
by Jason Scott

Recon: Eli Lilly to buy Morphic for $3.2 billion; White House appeals patent decision on HIV preventives

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

In Focus: US
  • Eli Lilly to acquire Morphic for $3.2 billion (STAT)
  • Biden administration appeals jury finding in battle over patents for HIV prevention pills (STAT)
  • News We’re Watching: FDA Issues Monkeypox EUAs, IMDRF Publishes AI Principes, Quest Buys LifeLabs (MedTech Insight)
  • J&J's tuberculosis med Sirturo lands full US, EU approvals after more than a decade on the market (Fierce Pharma)
  • Roche scores FDA nod for prefilled syringe version of Vabysmo, easing its administration (Fierce Pharma)
  • US FDA Advisory Committee Open Public Hearing Changes Urged (Pink Sheet)
  • Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight (FDA Law Blog)
 
In Focus: International
  • U.K. pharma increasingly violates voluntary industry marketing codes, and probes are taking longer (STAT)
  • Novo Nordisk reprimanded in UK for failure to disclose payments to healthcare sector (Reuters)
  • BD to close Ireland facility, putting 170 jobs at risk (MedTech Dive)
  • UK Regulation: In A System Of Regulatory Reliance, PMS Assumes A Central Role (MedTech Insight)
  • MDCG 2021-5 Rev. 1: EU’s Standardization Guidance Brought Up To Date (MedTech Insight)
  • EU Regulators Call For More Registrations To Help Unlock Real-World Data Potential (Pink Sheet)
  • Novartis’ Gene Therapy Luxturna Gets Routine Funding In Scotland (Pink Sheet)
 
Pharma & Biotech
  • The maddening saga of how an Alzheimer’s ‘cabal’ thwarted progress toward a cure for decades (STAT)
  • Infections are major cause of non-relapse deaths after CAR-T cell therapy, study shows (Endpoints)
  • Exclusive: Gene insertion startup launches with new integrase technology from University of Hawaii (Endpoints)
  • HilleVax's stock tumbles after Phase 2b norovirus vaccine fails in infants (Endpoints)
  • Vanqua raises $45M; Aerovate to look for strategic alternatives (Endpoints)
  • Ideaya showcases proof-of-concept data in a boost to synthetic lethality play (Endpoints)
  • Masimo receives offer of up to $950 mln for consumer business (Reuters)
  • Novo's Ozempic, Wegovy linked to potential eye problem? Not so fast, analysts say (Fierce Pharma)
 
Medtech
  • AI leads the way as health tech funding inches toward a post-pandemic stability (STAT)
  • Digital health deals rallied in the first half of 2024, though funding still trails last year (Endpoints)
  • Carlyle in Advanced Talks to Acquire Baxter’s Vantive (WSJ)
  • Quest to buy Lifelabs for $985M (MedTech Dive)
  • Deals Shaping The Medtech And Diagnostics Industries, June 2024 (MedTech Insight)
 
Government, Regulatory & Legal
  • Steward Health Care spent millions on surveillance of its critics — even amid financial crisis (STAT)
  • EcoHealth Alliance: Covid’s anti-science mob extracting its pound of flesh (STAT)
  • J&J, Arcutis back educational video series about how skin conditions affect people of color (Fierce Pharma)
 
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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