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Hep C Nucleoside Scare: FDA Wants Idenix’s CV Safety Data After BMS Event

 
• By Shirley Haley

Idenix announced FDA has placed a partial clinical hold on its hepatitis C candidate IDX184 after Bristol-Myers Squibb was forced to halt a study of its similar drug following a serious cardiovascular event. The news sparked new worries concerning a class effect for nucleoside polymerase inhibitors, though Gilead stood by its candidate GS7977’s clean CV profile and Idenix said no CV toxicities have been associated with ‘184.

Idenix Pharmaceuticals Inc. will not enroll patients in additional clinical trials of its nucleoside polymerase inhibitor IDX184 while the company does additional cardiac testing of patients in an ongoing Phase IIb trial and FDA reviews the data.

Idenix, in Cambridge, Mass., got news of the partial clinical hold on its investigational “nuc” in a phone call from...

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More from United States

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The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

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The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.

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A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

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• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.

More from North America

Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
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Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.