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Kathy Vuksanaj

Beyond the Payload

Cell Therapy Industry

AI summary

A new expert perspective examines how delivery technologies will influence the future of cell and gene therapy. Anthony Blaszczyk, a principal scientist at USP, offers insights on the delivery challenges and opportunities that may shape the field. For professional readers, the commentary underscores that therapeutic payloads alone are not enough and that delivery innovation is central to advancing these therapies.

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Jason Mast

STAT+: In China, a flood of controversial clinical trials slows to a trickle

China has sharply restricted investigator-initiated biotech clinical trials after patient deaths, slowing what had been a surge of controversial studies. The change leaves rare disease families with fewer trial options and creates uncertainty for US investors exposed to China’s biotech sector. It matters because tighter oversight may improve safety but could also delay access and complicate cross-border investment.

Clinical TrialsEthics & SafetyCell Therapy IndustryRead more →
Megan Giboney

Cell therapy weekly: BLA for Huntington’s disease gene therapy accepted for review

The FDA has accepted a biologics license application for a Huntington’s disease gene therapy for review, signaling another regulatory milestone for gene therapy in a difficult-to-treat neurological disease. The weekly update also notes new FDA potency guidance for cell and gene therapy manufacturers and MHRA approval of a Casgevy extension for younger patients. For professionals, these developments matter because potency expectations can affect manufacturing and review, while the label extension broadens access to an approved cell therapy.

Clinical TrialsRegulation & ApprovalRead more →
Katie Palmer

STAT+: As more doctors consult chatbots, health systems can block them — or buy in

Hundreds of thousands of doctors are turning to AI chatbots for help with care decisions, prompting health systems to weigh new risks to patient health data. Organizations now face a choice: block the tools or formally adopt them. The decision matters because it will shape how clinical AI use is governed and how sensitive patient information is protected.

Clinical TrialsRead more →
Stem Cell TreatmentsMore coverage →Photo: Gannu03 · CC BY-SA 4.0

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