Weekly Policy Blog: FDA Guidances on 510(k) Submissions; Actuarial Review of Biomarker Testing Coverage Bill 

FDA Issues Three Guidances on Premarket Notification [510(k)] Program  On September 7, 2023, the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) issu...

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Weekly Policy Blog: CMS Announces Drugs Subject to Price Controls Under the IRA 

On August 29, 2023, the Centers for Medicare and Medicaid Services (CMS) announced the first ten prescription drugs that will be subject to price controls in Medicare under the Inflation Reduction Act...

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Weekly Policy Blog: CBSA and Partners Provide Recommendations to Improve CMS’ Transitional Coverage for Emerging Technologies (TCET) Proposal 

CBSA advocates for policies that improve patient access to life-saving novel technologies. This week, CBSA signed on to a letter responding to the long-awaited proposed Transitional Coverage for Emerg...

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Fitzsimons Innovation Community and Aimco Deepen Co-Commitment to Campus Vision

Fitzsimons Innovation Community and Aimco Deepen Co-Commitment to Campus Vision New Partnership Will Accelerate Delivery of Lab Space to Market AURORA, Colo. (August 24, 2023) – Fitzsimons Innovation...

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Growing Colorado’s Promising Startups: Innosphere Ventures

Fort-Collins-based Innosphere Ventures began making an impact for Colorado’s early-stage companies a quarter-century ago. The organization’s focus is to support the business development of early-stage...

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Weekly Policy Blog: PDAB Releases Stakeholder Engagement Guide on Affordability Review Process

As the Colorado Prescription Drug Affordability Board (PDAB) begins affordability reviews of the five prescription drugs selected earlier this month, it is reaching out to stakeholders to request thei...

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Weekly Policy Blog: PDAB Selects Drugs for Affordability Reviews

On Friday, August 4, the Colorado Prescription Drug Affordability Board (PDAB) selected five drugs for affordability reviews: Enbrel, Genvoya, Cosentyx, Stelara, and Trikafta. PDAB staff plan to begin...

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A Pioneering Spirit: Female Leaders Advancing Innovation

Making Colorado a leading location for health innovation requires visionaries, risk takers, problem solvers, and program builders. Women hold these pivotal roles in our state, guiding major institutio...

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Forging the Life Sciences Frontier

Colorado has one of the best talent pools in the United States, top-tier research institutions, a major international airport, a favorable tax climate, a mountain-enhanced quality of life, and support...

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Weekly Policy Blog: Congressional Activity Before August Recess

Congress moved forward with its efforts to address drug shortages, drug pricing, pharmacy benefit managers (PBMs), and transparency ahead of the August recess. This policy post covers the discussion d...

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