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September 24, 2024
by Jason Scott

Recon: Japan approves Lilly’s Alzheimer’s drug; MHRA seeks applicants for AI Airlock

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

In Focus: US
  • Sanders says PBMs won’t penalize Novo for cutting Ozempic, Wegovy prices (STAT) (Reuters)
  • The U.S. has relied on cheap, effective generic drugs for 40 years. Now that promise is under threat (STAT)
  • As Medicare spending on remote patient monitoring jumps, HHS watchdog warns of fraud, misuse (STAT)
  • Updated: Gene therapy maker bluebird bio cuts costs again, lays off staff (Endpoints)
  • House passes reauthorization of rare pediatric voucher program (Endpoints)
  • J&J talc opponents decry bankruptcy as "deja vu all over again" (Reuters)
In Focus: International                                                                                                       
  • Eli Lilly's Alzheimer's drug approved in Japan (Reuters)
  • Sanofi gets two bids valuing its consumer health unit at about $17 billion, Bloomberg News reports (Reuters)
  • US to donate 1 million mpox vaccine doses to halt outbreak in Africa (Reuters)
  • Child in UK 'defies odds' to survive withdrawal of life-sustaining treatment (Reuters)
  • Angiodynamics Initiates Thrombectomy Trial In Europe After Showing Positive Trial Results in US (MedTech Insight)
  • EU HTA Regulation: Some Member States Could Be ‘Deselected’ From Joint Assessments (Pink Sheet)
  • Tech Vs Trialists: The Struggle For Integrated Decentralized Clinical Trial Platforms (Pink Sheet)
  • MHRA opens applications from AI developers to join the AI Airlock regulatory sandbox (MHRA)
Pharma & Biotech
  • Amid push to redefine itself, Sanofi names new chief scientific officer (STAT)
  • Biogen-UCB's lupus drug meets main goal of late-stage trial (Reuters)
  • Metsera’s GLP-1 drug has potential for monthly dosing, new data show (STAT)
  • Regeneron’s Eylea biosimilar fight heats up (STAT)
  • Wave rides new Phase 2 DMD data as it sets sights on accelerated approval (Endpoints)
  • Drug delivery CDMO earmarks $356M to expand injectable device capacity (Endpoints)
  • Samsara adds three venture partners to help steer and advise portfolio companies (Endpoints)
  • Health plan startup Centivo raises $75M (Endpoints)
  • Capricor to begin filing DMD drug with FDA next month; Surrozen’s $10M milestone (Endpoints)
  • Zevra Therapeutics prices rare genetic disorder drug at up to $106,000 per month (Reuters)
Medtech
  • Most cardiovascular devices with serious safety recalls aren’t tested in patients (STAT)
  • Electronic health records giant Epic Systems sued over alleged monopolistic practices (STAT)
  • Route 92 Medical raises $50M to fund global sales of stroke devices (MedTech Dive)
  • UK Medtechs Rue Low Cap Of Rules-Based Innovation Adoption Plan, Note AI Airlock Progress (MedTech Insight)
  • J&J MedTech Keeps Up Cardiovascular Momentum With Shockwave E8 Launch In US (MedTech Insight)
  • ‘Glass Cockpit Project’ Model For Home-Use Devices, Califf Says (MedTech Insight)
Government, Regulatory & Legal
  • Millions of people are missing from U.S. disability data (STAT)
  • Will prescription drugs get prior authorization reform? (STAT)
  • Lawmakers push to let telehealth providers keep prescribing stimulants and addiction treatment (STAT)
  • KKR, GIC hire banks to sell stakes in $3.2 bln Metro Pacific Health, sources say (Reuters)
  • Amneal asks court to block Colorado's free allergy pen program (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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