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)
- 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)
- 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)
- 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)
- 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)
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