pharma news

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Eli Lilly's fast-growing Jaypirca has won a new FDA approval as an earlier treatment for relapsed/refractory chronic lymphocytic leukaemia.

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FDA mulls reduced fees for programmes with US-based phase 1 trials, and higher fees for those tested overseas, to incentivise US R&D.

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Bayer has started a phase 2a trial of an antibody that it hopes could provide a targeted, potentially disease-modifying therapy for Alport syndrome.

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Tracy Beth Høeg, who has very little regulatory experience, is making the switch from CBER to replace FDA veteran Richard Pazdur.

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A US appeals court has reversed a 2023 decision that ordered Daiichi Sankyo to pay royalties on sales of cancer drug Enhertu to Seagen (now Pfizer).

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VectorY has been cleared by the FDA to start human trials of a drug against a target implicated in up to 97% of amyotrophic lateral sclerosis cases.