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)
- 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)
- 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)
- 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)
- 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)
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