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RFK Jr looks to alter rare disease regulation by fast-tracking drug approvals

Pharmaceutical Technology

The approval process for cell and gene therapy candidates is tricky, however, given their high-cost and oft-debated benefit-risk ratio. RFK Jr did not question their importance, and acknowledged panellists’ calls for faster regulatory processes. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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DoH and Children’s National Hospital link for cell and gene therapy

Pharmaceutical Technology

This alliance seeks to bolster clinical trial capabilities through improved regulatory processes and data governance. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. How will RFK Jr’s American dream for vaccines play out? Don’t let policy changes catch you off guard.

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Ultragenyx receives complete response letter for UX111 BLA

Pharmaceutical Technology

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma Formulate Faster. The company is confident that these concerns, which pertain to facilities and processes rather than product quality, can be promptly addressed.

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JCR Pharma and Alexion partner on JUST-AAV gene therapy platform

Pharmaceutical Technology

IZCARGO is the first drug developed with this technology and approved in Japan for treating a lysosomal storage disorder. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. How will RFK Jr’s American dream for vaccines play out? Topic sponsors are not involved in the creation of editorial content.

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AbbVie buys $2.1bn Capstan, adding new in vivo CAR-T to pipeline

Pharmaceutical Technology

AbbVie’s purchase comes just a few days after the US Food and Drug Administration (FDA) removed an access barrier for currently approved CAR-T therapies, regarded as a boost to the sector’s outlook. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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FDA removes safety programme for CAR-T therapies to boost uptake

Pharmaceutical Technology

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. How will RFK Jr’s American dream for vaccines play out? This update also suggests we may not see REMS requirements for CD19 and BCMA autologous CAR-T cell therapies in the future,” the research note added.

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GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients

Pharmaceutical Technology

Sectors Sections Clinical Trials Drug Manufacturers Therapy Area Pricing and Market Access Latest EC approves BeOne’s Tevimbra for nasopharyngeal carcinoma Formulate Faster. How will RFK Jr’s American dream for vaccines play out? MAXSHOT.PL via Shutterstock. Give your business an edge with our leading industry insights.