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

Pharmaceutical Technology

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. 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. Editorial content is independently produced and follows the highest standards of journalistic integrity.

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Harbour BioMed partners Otsuka on new T-cell therapy

Pharmaceutical Technology

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. In 2024, Otsuka announced the acquisition of US-based Jnana Therapeutics in a deal worth up to $1.1bn. Editorial content is independently produced and follows the highest standards of journalistic integrity.

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SpliceBio secures $135m for gene therapy development

Pharmaceutical Technology

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. In 2023, SpliceBio signed a licensing agreement with Spark Therapeutics, allowing the latter to use its protein splicing platform and develop a gene therapy for an undisclosed inherited renal disease.

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How early planning leads to successful market access and drug launch in Europe

Pharmaceutical Technology

Launching a new drug can be a risky business, with regulatory approval no guarantee that private, commercial, and government-funded insurers will reimburse it. Meanwhile, in Germany, the AMNOG process is conducted twelve months after the drug is launched, thus giving freedom to the company to set the drug’s price during this period.

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NSW government invests $13.39m in life-changing therapies

Pharmaceutical Technology

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Give your business an edge with our leading industry insights.

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Porton Advanced and EVA Pharma collaborate for CAR T-cell therapies

Pharmaceutical Technology

Porton Advanced will apply its knowledge in viral vector technology and CAR-T cell therapy process development to enhance EVA Pharma’s mission to provide safe, effective, and scalable cancer treatments. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.