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April 2, 2024
by Jason Scott

Recon: FDA approves Abbott’s TriClip heart valve repair device; Teva, Viatris revive patent challenge against J&J schizophrenia drug

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

In Focus: US
  • Lawmakers want to add more Chinese biotechs to defense list (STAT)
  • Watch: Medicare billing forms are running out of space for growing health care prices (STAT)
  • Conservative groups object to 'naming names' rule from Pfizer diversity decision (Reuters)
  • Teva, Viatris win new chance to challenge J&J schizophrenia drug patent (Reuters)
  • Abbott's heart valve repair device gains US FDA approval (Reuters) (MedTech Dive)
  • Some doses of Lilly's Mounjaro in tight supply through April, US FDA says (Reuters)
In Focus: International
  • Lonza taps Siegfried leader Wolfgang Wienand as new CEO (Endpoints)
  • Australia Cuts Regulatory Burden Of Product Recalls (Pink Sheet)
  • EU Regulators Explain How To Ensure Transitioned Trials Align With CTR (Pink Sheet)
Pharma & Biotech
  • Roivant CEO: New deals could ‘materialize later this year’ (STAT)
  • Roivant autoimmune drug succeeds in eye condition; company to buy back $1.5 billion in stock (STAT)
  • Why researchers think human milk could repair the gut microbiome and reduce infections (STAT)
  • Gritstone Bio says personalized cancer vaccine falls short in key trial (STAT)
  • Verve Therapeutics ‘pauses’ tests of its gene editor for heart disease and prioritizes a backup treatment (STAT)
  • The biotech scoreboard for the second quarter: 32 stock-moving events to watch (STAT)
  • Acorda files for bankruptcy, agrees to sell MS drug and other assets to Merz for $185M (Endpoints)
  • Zymeworks removes CFO; Gilead extends Nurix deal (Endpoints)
  • Pharma is betting big on connecting potential patients to its medications. It's just the beginning (Endpoints)
  • Ipsen boards ADC train in $900M pact with Sutro (Endpoints)
  • Contineum says it will seek $136M in IPO to back its mid-stage neuro drug (Endpoints)
  • Providence spinout Praia Health raises $20M (Endpoints)
  • Carlyle’s Abingworth will help fund Teva’s Phase 3 asthma rescue inhaler (Endpoints)
Medtech
  • Q&A: Insitro CEO Daphne Koller on ‘potentially destructive’ AI hype, Nvidia's chips, and biotech's data problem (Endpoints)
  • This AI company scans penis pictures for STIs. Its unproven tech is in an FDA gray zone (STAT)
  • Abbott wins FDA clearance for bedside blood concussion test (MedTech Dive)
  • Infutronix pulls infusion pumps from US after nearly 3,700 complaints (MedTech Dive)
  • Masimo faces another proxy challenge from Politan Capital (MedTech Dive)
  • 3M spins out Solventum (MedTech Dive)
Government, Regulatory & Legal
  • A nation with too few pediatricians could see health care costs soar (STAT)
  • US health insurers slide as final Medicare payment rates fall below expectations (Reuters)
  • Fitch says UnitedHealth unit hack to have no credit impact on not-for-profit hospitals (Reuters)
  • Biden administration US ban on menthol cigarettes delayed (Reuters)
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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