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BridgeBio Pharma, Inc.

http://bridgebio.com/

Latest From BridgeBio Pharma, Inc.

EU Filing For Infigratinib Pulled After Commercial Deal Crumbles

BridgeBio’s partner Helsinn terminated its agreement to commercialize infigratinib, which was approved in the US last year for treating the rare bile duct cancer, cholangiocarcinoma.

Europe Approvals

Accelerated Approval For Gene Therapies: FDA’s Wilson Bryan Offers A ‘Framework’

Bryan, who oversees reviews of gene and cell therapies in US FDA’s biologics center, cautioned against falling in love with a biomarker when it is showing no ‘clinical effect.’

Gene Therapy Review Pathway

Trials In Focus: Walmart Joins Growing List Of Retailers Entering Clinical Research

SIGA provides an update on its monkeypox program, while Massive Bio announces progress on its AI platform for connecting cancer patients to trials, with additional updates from BridgeBio, the Oncology Institute, and CROs Caidya, Charles River Labs, Syneos Health and PPD parent Thermo Fisher Scientific.

Clinical Trials Companies

Sponsors Want Answers On Consequences Of Missing US FDA Trial Diversity Goals

No negative actions have been taken in the US FDA’s oncology review divisions, but vague diversity guidance continues to raise concerns.

Diversity & Inclusion Clinical Trials
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