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tag european-health-data-space

Can gene therapies for haemophilia defend their high price tags?

Pharmaceutical Technology

NOVEMBER 9, 2022

A previous October 2020 report concluded that longer-term safety and efficacy were needed to update health-benefit price benchmarks. In August 2020, the agency had rejected an approval application, suggesting the company complete its Phase III Gener8-1 study and include two-year follow-up safety and efficacy data. million price tag.

Gene Therapy

Gene Therapy Gene FDA Approval Medicine

Grand Rounds June 30, 2023: Decentralized Trials – From Guidance to Reality & What’s Left (Adrian Hernandez, MD, MHS; Pamela Tenaerts, MD, MPH; Craig Lipset, MPH)

Rethinking Clinical Trials

JULY 6, 2023

Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance. Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance.

Trials

Trials Clinical Trials Clinical Trials Licensing

Can gene therapies for haemophilia defend their high price tags?

Grand Rounds June 30, 2023: Decentralized Trials – From Guidance to Reality & What’s Left (Adrian Hernandez, MD, MHS; Pamela Tenaerts, MD, MPH; Craig Lipset, MPH)

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