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China Biotech Podcast: BIOSECURE Act Updates ASCO Highlights

US-based Citeline writer Sarah Karlin-Smith joins Brian Yang and Dexter Yan in China to discuss the US BIOSECURE Act and the recent BIO meeting in San Diego, while Dexter Yan discusses China-related ASCO highlights, in this mixed Chinese- and English-language episode.

Legislation ASCO

Finance Watch: Lilly’s Gateway Labs, Deerfield’s Cure Offer Biotechs Space To Grow

Private Company Edition: Scrip spoke with the leaders of Gateway Labs and Cure at the BIO International Convention about their mini ecosystems. Also, radiopharmaceutical firm ITM raised €188m ($201.9m), Santa Ana Bio emerged with $168m and Alzheon’s series E totaled $100m.

BIO Financing

US FDA’s Cell-Gene Therapy Office Head Wants Sponsors To Seek Out Meetings

Companies should talk to FDA staff in between formal meetings if they need clarity on agency advice that is several years old or development programs hit a snag, Office of Therapeutic Products Director Nicole Verdun says.

Gene Therapy Clinical Trials

AI Assurance Lab Concept Leaves Potential Regulatory Gap

In an interview with Medtech Insight sister publication the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.

Artificial Intelligence Research & Development
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  • Other Names / Subsidiaries
    • AesRX LLC
    • Althin Medical A.B.
    • Chatham Therapeutics
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    • Claris Injectables Limited
    • Fusion Medical Technologies, Inc.
    • Gambro AB
    • Immuno-US
    • Prism Pharmaceuticals, Inc.
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    • Synovis Life Technologies, Inc.
    • Wound Care Technologies, Inc.
    • Baxter Healthcare Corporation
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