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Regulatory & Policy Updates

Regeneron and Scholar Rock Reroute Fill/Finish as Novo's Indiana Plant Faces FDA Heat

Submitted by fairsonline_team on
Regeneron and Scholar Rock Reroute Fill/Finish as Novo’s Indiana Plant Faces FDA Heat

SHERIDAN, WYOMING - December 2, 2025 - A series of FDA findings at Novo Nordisk's Bloomington, Indiana, fill/finish facility is forcing biotechs to rethink their commercial manufacturing strategies, with Regeneron and Scholar Rock now accelerating alternative capacity plans to break regulatory logjams linked to the ex-Catalent site.

FDA scrutiny at Novo's Bloomington site triggers CRLs

The Bloomington plant, one of three former Catalent sites Novo acquired for $11 billion to support surging GLP-1 demand, has become a bottleneck rather than a release valve for some of its biopharma customers. As a CDMO hub, the facility provided fill/finish services for a range of partners, but repeated quality issues have resulted in an Official Action Indicated (OAI) classification and multiple complete response letters (CRLs) from the FDA.

U.S. Biotech at Risk: How Federal Budget Cuts Undermine Innovation Leadership

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U.S. Biotech at Risk: How Federal Budget Cuts Undermine Innovation Leadership

SHERIDAN, WYOMING - December 2, 2025 - As the United States grapples with record-setting government shutdowns and budget fights, the country's biotech and research ecosystem is confronting a deeper structural problem: federal science funding is increasingly unstable, putting early-stage innovation, talent pipelines and long-term competitiveness at risk. For an industry built on long horizons and high-risk discovery, interruptions to programs such as NIH grants and Small Business Innovation Research (SBIR) contracts are more than a temporary setback-they threaten the foundations of America's leadership in biopharma innovation.

Federal science funding as the backbone of U.S. biopharma

Philips gains FDA 510(k) clearance for cloud-based Cardiovascular Workspace to accelerate AI in U.S. cardiology

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Philips gains FDA 510(k) clearance for cloud-based Cardiovascular Workspace to accelerate AI in U.S. cardiology

SHERIDAN, WYOMING - November 25, 2025 - Philips has received U.S. FDA 510(k) clearance for the latest release of its Cardiovascular Workspace (IntelliSpace Cardiovascular, ISCV), enabling U.S. health systems to deploy the cardiovascular imaging and information management platform as a cloud-hosted, SaaS solution on Philips HealthSuite. The move positions hospitals and cardiology networks to modernize IT, scale integrated diagnostics, and accelerate real-world adoption of AI-enabled cardiovascular workflows.

Cloud-based cardiovascular informatics for U.S. health systems