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March 19, 2024
by Jason Scott

Recon: AstraZeneca to buy Fusion in targeted radiation deal valued at $2B; Seelos ALS treatment fails in mid-stage trial

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

In Focus: US
  • More than 60% of US abortions in 2023 were done by pill, study shows (Reuters)
  • US CDC urges measles vaccinations amid rising cases (Reuters)
  • CDER, CBER Post FY 2023 Employee Gains, But Behind User Fee Hiring Goals (Pink Sheet)
  • Biden expands women's health research, adds $200 million for sexual, reproductive issues (Reuters)
  • The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews (Pink Sheet)
  • Regeneron advances antitrust lawsuit against Novartis with appeals court's backing (Fierce Pharma)
  • US FDA’s Anti-Misinformation Campaigns Look Safer After Supreme Court Oral Arguments (Pink Sheet)
  • She stood between a dangerous drug and a generation of American babies (WTOP)
In Focus: International
  • EU lawmakers vote to extend exclusivity period for new medicines, softening Commission proposal (Reuters)
  • 'Critical' to catch up on measles vaccinations to stem outbreaks, says WHO (Reuters)
  • All Eyes On Pricing Model As EU Crunch Time Nears For First Ophthalmic Bevacizumab (Pink Sheet)
  • Pakistan Explains Updated Risk-Based Criteria For GCP Inspections (Pink Sheet)
  • EMA Presses On With Keenly-Awaited Guidance On How To Use Patient Experience Data (Pink Sheet)
  • EU Pharma Reform Passes Major Hurdle, With Big Changes To Data Protection Proposals (Pink Sheet)
  • Industry To Scrutinize Proposals On Updating Statutory Pricing Agreement (Pink Sheet)
Pharma & Biotech
  • In small study, baby aspirin cuts fat buildup in liver disease patients (STAT)
  • Wegovy and Zepbound get primetime treatment (STAT)
  • Seelos Therapeutics' ALS treatment fails mid-stage study (Reuters)
  • As targeted radiation field heats up, AstraZeneca to acquire Fusion Pharmaceuticals in $2 billion deal (STAT)
  • Madrigal's $600M offering; PureTech to return $100M to shareholders (Endpoints)
  • Highly-awaited PhIII study of Gates-backed tuberculosis vaccine underway (Endpoints)
  • Morgan Health, JP Morgan’s healthcare venture, is looking to cut pharma costs next (Endpoints)
  • Mid-stage neuroscience startup Engrail raises $157M (Endpoints)
  • Crinetics reports second PhIII win for acromegaly drug, eyes 2025 launch (Endpoints)
  • With positive PhIII data in hot flashes, Bayer is a step closer to challenging Astellas’ Veozah (Endpoints)
  • Bayer to seek approval for menopausal relief drug after third trial win (Reuters)
Medtech
  • ‘An AI foundry’: Nvidia’s Jensen Huang pitches biotech on easy AI, with focus on software going beyond chips (Endpoints)
  • Titan Medical to merge with imaging firm Conavi, ending strategic review (MedTech Dive)
  • J&J Medtech, Nvidia partner to bring AI to the operating room (MedTech Dive)
  • Intuitive details launch plan for new da Vinci 5 robot (MedTech Dive)
  • Feeling the Heat (or Cold) – New Draft Guidance Addresses Requirements for Devices that Produce Thermal Effects (FDA Law Blog)
  • Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development (MedTech Insight)
Government, Regulatory & Legal
  • UnitedHealth appears to be upping loan offers to providers, after Change cyberattack (STAT)
  • Supreme Court questions restricting government efforts to limit Covid-19 misinformation (STAT)
  • Novo Nordisk Foundation backs effort to build supercomputer with Nvidia (Endpoints)
  • UnitedHealth says advanced over $2 bln in payments to providers (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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