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2nd January 2025
by Jason Scott

Recon: Drugmakers ring in 2025 with new round of pricing hikes; FDA approved 50 new drugs, 11 biologics in 2024

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

In Focus: US
  • Latest updates to hospital price transparency rules aim to make the data more useful (STAT)
  • The biggest medical advances of 2024 (STAT)
  • 3 key issues to watch at the FDA as Trump takes office (STAT)
  • A look at biotech's year of the megaround (Endpoints)
  • Podium Finish: US FDA’s 61 Novel Approvals In 2024 Fall Short Of 2023 Peak But Exceed Average (Pink Sheet)
  • Hidden Figures: Medicare Price Negotiation Post-Mortem Offers Few New Insights (Pink Sheet)
  • 2024 drug approvals: Small companies loom large with several key FDA nods (Fierce Pharma)
  • Pfizer, BMS and more ring in 2025 with fresh round of drug price increases: report (Fierce Pharma)
In Focus: International                                                                                                       
  • Roche circles back to China biotech with $80M deal for lung cancer ADC (Endpoints)
  • China Health Commission to narrow gaps in mental health services (Reuters)
  • Merck wins UK approval for lung disease drug acquired in $11 billion deal (Reuters)
  • China defends COVID-19 data-sharing as WHO seeks more access (Reuters)
  • France reports bird flu on two farms, losing disease-free status (Reuters)
  • Indian drugmaker Anthem Biosciences files for $397 mln IPO (Reuters)
  • Boosting Reliability: EMA Backs AI Tool For MASH Trials (Pink Sheet)
  • Why the Obesity Drug Revolution Is a Work in Progress (Bloomberg)
  • Swiss Move To Prioritize Ambulatory Care In Healthcare Reform (MedTech Insight)
Pharma & Biotech
  • Neumora’s antidepressant stumbles in first Phase 3 trial readout (STAT)
  • Pfizer kills hemophilia gene therapy deal, imperiling Sangamo (STAT)
  • Hutchmed’s divestiture; Xgene reports Phase 2b win for non-opioid pain drug (Endpoints)
  • Flagship biotech Valo Health ends 2024 with mid-stage fail (Endpoints)
  • Despite mixed data in Alzheimer's agitation, Axsome will still seek FDA approval (Endpoints)
  • After delay with FDA, Novartis touts pivotal trial win for intrathecal Zolgensma in older SMA patients (Fierce Pharma)
  • Lilly’s Zepbound expected to surpass Novo’s Wegovy to ‘dominate’ obesity market: GlobalData (Fierce Pharma)
  • After phase 3 setbacks, troubled Marinus inks $151M sale to Immedica Pharma (Fierce Pharma)
  • Bristol Myers celebrates 10 years of Opdivo with FDA approval for subcutaneous version (Fierce Pharma)
Medtech
  • Fixing pulse oximeters requires federal might and possible legal action, researchers say (STAT)
  • Four digital health unicorns on what they expect in 2025 (STAT)
  • Top 10 medtech deals of 2024 (MedTech Dive)
  • Few medical devices are designed for children. An FDA-Children’s National collaboration aims to change that. (MedTech Dive)
  • Abbott, Dexcom settle glucose monitor patent lawsuits (MedTech Dive)
Government, Regulatory & Legal
  • Aletha Maybank to step down as AMA’s chief health equity officer (STAT)
  • Save the Food and Drug Administration by breaking it up (STAT)
  • Rx Enforcement In 2025: Shift Away From Opioid Makers But Tougher Approach On Ad/Promo (Pink Sheet)
  • Saving the Skinny Label Through the Skinny Label, Big Savings Act (FDA Law Blog)
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.