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FDA Raises the Evidence Bar for Rare Disease Biotechs: Jan 2025 to Apr 2026 Analysis
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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…
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J.P. Morgan Healthcare Conference, the “Superbowl of Healthcare” – 2026 Watchlist
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In December 2025, as we prepare for JP Morgan Healthcare on Jan 12-15, 2026, the U S Congress will be refining federal government funding of US Healthcare as influenced by the One Big Beautiful Bill Act (OBBBA). Spending on Medicare Part D drugs and overall Medicaid programs are once again in the cross hairs, and recent drug pricing and reimbursement reforms are likely to intensify in 2026. Prescription Drug Spending and Funding Trends According to…
