Weekly Policy Blog: FDA Guidances on 510(k) Submissions; Actuarial Review of Biomarker Testing Coverage Bill
By: Colorado BioScience Association Date: 09/11/2023
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...
Learn MoreWeekly Policy Blog: CMS Announces Drugs Subject to Price Controls Under the IRA
By: Colorado BioScience Association Date: 09/05/2023
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...
Learn MoreWeekly Policy Blog: CBSA and Partners Provide Recommendations to Improve CMS’ Transitional Coverage for Emerging Technologies (TCET) Proposal
By: Colorado BioScience Association Date: 08/28/2023
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...
Learn MoreFitzsimons Innovation Community and Aimco Deepen Co-Commitment to Campus Vision
By: Colorado BioScience Association Date: 08/28/2023
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...
Learn MoreGrowing Colorado’s Promising Startups: Innosphere Ventures
By: Colorado BioScience Association Date: 08/18/2023
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...
Learn MoreWeekly Policy Blog: PDAB Releases Stakeholder Engagement Guide on Affordability Review Process
By: Colorado BioScience Association Date: 08/14/2023
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...
Learn MoreWeekly Policy Blog: PDAB Selects Drugs for Affordability Reviews
By: Colorado BioScience Association Date: 08/07/2023
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...
Learn MoreA Pioneering Spirit: Female Leaders Advancing Innovation
By: Colorado BioScience Association Date: 08/04/2023
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...
Learn MoreForging the Life Sciences Frontier
By: Colorado BioScience Association Date: 08/04/2023
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...
Learn MoreWeekly Policy Blog: Congressional Activity Before August Recess
By: Colorado BioScience Association Date: 07/31/2023
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...
Learn More