regulatory

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J&J is hoping the AMPLITUDE study results will make Akeega the first drug in the PARP inhibitor class for castration-sensitive prostate cancer.

Market Access

The MHRA, will be running five pilot dialogues as part of its first year exploring a real-world evidence scientific dialogue programme.

Market Access

AI technologies can enable companies to program, rather than write, submissions to health authorities.

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The UK has revealed a new 'innovator passport' designed to accelerate the rollout of proven medtech in the NHS.

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Reports suggest a new framework for medicine reviews and a push to reduce NHS reliance on overseas-trained staff will feature in the 10-year plan.

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There is enough experience with the first wave of autologous CAR-T therapies to allow strict rules ensuring their safe use to be relaxed, says FDA.