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MFN Monitor: Europe’s Drug Launch Model Is Becoming a U.S. Pricing Risk
Traditional Global Launch Strategies Are Now Under Pressure For decades, the commercial path for innovative therapeutics followed a relatively predictable pathway. Secure FDA-approval, establish strategic pricing and a robust commercial footprint in US, and expand into Europe shortly thereafter. That framework has now come under attack due to the uncertainty related to the pricing policy debate between biopharma and the current US administration. The growing political and regulatory scrutiny surrounding Most Favored Nation (MFN) drug…
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FDA Raises the Evidence Bar for Rare Disease Biotechs: Jan 2025 to Apr 2026 Analysis
Key Takeaways An FDA In Chaos, But the Dust May Be Settling Starting mid 2025, a great deal of biopharma media attention has centered on FDA rejections of rare disease medicines as the administration’s new leaders have replaced the once predictable, career scientist-driven agency. Vinay Prasad announced his plan to depart the Center for Biologics (CBER) in March 2026 (for the second time), and despite the search for his replacement nearing its end, uncertainty remains…
