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September 17, 2024
by Jason Scott

Recon: Express Scripts sues FTC over PBM report; Neuralink brain implant nabs breakthrough device designation

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

In Focus: US
  • Express Scripts sues FTC over a ‘biased’ report about pharmacy benefit managers (STAT) (Reuters)
  • Philip Morris to sell Vectura for $198 mln after health shift criticism (Reuters)
  • US Senate set to vote again on IVF bill after Trump's pledge of support (Reuters)
  • US FDA approves Eli Lilly's drug for eczema (Reuters)
  • Musk's Neuralink receives FDA's breakthrough device tag for brain implant (Reuters)
  • US Senator Sanders says generic drugmakers could sell Ozempic for less than $100/month (Reuters)
In Focus: International
  • WHO pandemic threat director: Here’s what needs to happen to combat mpox (STAT)
  • After 10 years of game-changing immunotherapies, a cancer conference celebrates — and sees more work to do (STAT)
  • Sun, surprises and new summits at Europe’s biggest cancer conference (Endpoints)
  • How To Transfer Surveillance Oversight For IVDs From One EU Notified Body To Another (MedTech Insight)
  • EU Pharma Calls For Better Metrics On True Impact Of Clinical Trial Disclosure (Pink Sheet)
  • Geopolitics, US BIOSECURE: Pharma Looks To Redistribute CDMO Footprint (Pink Sheet)
  • EU Decision Time For Orphan Drugs Marstacimab, Serplulimab And Mirvetuximab Soravtansine (Pink Sheet)
  • Antibiotic-resistance deaths to surge from 2025-2050, study says (Reuters)
Pharma & Biotech
  • FDA formalizes protocol for international cancer trials (STAT)
  • 11 people shaping psychedelics drug development (STAT)
  • Genentech, a biotech with a storied past, confronts new turbulence in the present (STAT)
  • Emmet Stephenson gives $150M to City of Hope for pancreatic cancer, creating million-dollar research prize (STAT)
  • Bad trip: How culture conflict and a need for cash nearly broke Lykos (Endpoints)
  • Merck and Daiichi’s rejected HER3 ADC clears a Phase 3 in certain lung cancers (Endpoints)
  • Nura Bio raises $68M for clinical tests of SARM1 inhibitor to potentially slow or prevent nerve degeneration (Endpoints)
  • Coherus warns of limited cancer drug supply due to third-party ‘capacity constraints’ (Endpoints)
  • Capricor expands DMD pact with Nippon Shinyaku; AbbVie’s new eye deal (Endpoints)
  • After landing a key win in a common cancer condition, Pfizer faces a big test in Phase 3 (Endpoints)
  • 23andMe heads to ESMO to tout its two clinical-stage drugs after scrapping discovery team (Endpoints)
  • Click’s Digital Therapeutic Shown To Enhance Clinical Benefit Of Migraine Drugs In Pivotal Trial (MedTech Insight)
Medtech
  • Most cardiovascular devices with serious safety recalls aren’t tested in patients (STAT)
  • What pharma companies and insurers think about Medicare’s plan to cover digital treatments (STAT)
  • A documentary film asks: Can health systems improve patient safety by embracing new tech? (STAT)
  • J&J Versus Auris: Robotics Fallout With Big Implications For M&A (MedTech Insight)
  • Exact Sciences Announces Early Results From Colorectal Cancer Blood Test At ESMO 2024 (MedTech Insight)
  • MDIC Head Andy Fish On Driving Positive Change In The Medtech Ecosystem (MedTech Insight)
Government, Regulatory & Legal
  • End the ‘forced swim test’ on mice for antidepressant research (STAT)
  • How insurers are covering Humira and copycat medicines (STAT)
  • J&J gets $260 million talc verdict overturned in Oregon, new trial ordered (Reuters)
  • Drug Pricing And The US Presidential Campaign: A Non-Issue? (Pink Sheet)
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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