BioSpace News Archive

Stack of coins balancing on seesaw over a bottle of pills.

Drug pricing

CMS Finalizes Stronger Protections for Orphan Drugs Against IRA Price Negotiations

Expanded exemptions for orphan drugs could mean prolonged protections for top-selling drugs like Merck’s Keytruda, which was initially approved under this designation in 2014.

October 3, 2025

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2 min read

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Tristan Manalac

Cardiovascular disease

Amgen Builds Case for Repatha To Prevent Heart Disease With Late-Stage Data

Findings from the Phase III VESALIUS-CV study reinforce the cholesterol-lowering benefit of Repatha in high-risk patients without prior cardiovascular disease, for which the drug was approved in August 2024.

October 3, 2025

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1 min read

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Tristan Manalac

NIAID Director Dr. Jeanne Marrazzo addresses staff. She is wearing a black and white shirt, black pants, and round glasses.

Regulatory

Fired NIAID Director Claims Ouster Was Payback for Whistleblower Report

Jeanne Marrazzo, former director of the National Institutes of Allergy and Infectious Disease, was formally terminated Thursday after months on administrative leave, after filing a whistleblower report.

October 3, 2025

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2 min read

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Tristan Manalac

A man and a wolf stand on a cliff overlooking a surreal floating island with a circular path and a glowing orb in the distance, digital art style, illustration painting

Cell and Gene Therapy

FDA’s New Cell and Gene Therapy Guidances Finally Go a ‘Click Further’ to ‘Game Changing’

Following up on previous, dimly received issuances, a new set of ideas published by the FDA to streamline regulatory pathways for cell and gene therapies ‘for small populations’ is receiving a warmer welcome—but experts warn it will take more to turn the tide for the fraught therapeutic space.

October 3, 2025

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5 min read

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Dan Samorodnitsky