News Lilly, Regeneron among firms chosen for FDA fast plant pilot Eli Lilly, Regeneron, and five other drugmakers will take part in an FDA pilot designed to make it quicker and easier to set up manufacturing plants.
News Cancer risk scuppers Kyowa Kirin's autoimmune disease drug Kyowa Kirin has terminated all clinical trials of its anti-OX40L antibody rocatinlimab, after cases of cancer were seen in patients taking the drug.
News Kura scores FDA okay for rival to Syndax's leukaemia drug Kura has claimed FDA approval for oral menin inhibitor Komzifti for acute myeloid leukaemia, setting up a battle with Syndax's rival Revuforj.
Patients How pharma is tackling new direct-to-patient programmes At Reuters Pharma USA, executives from AstraZeneca, Gilead, Kyowa Kirin, and EVERSANA discussed the what, why, and how of direct-to-patient models.
News Spain agrees to reimburse Orchard's gene therapy Libmeldy Spain has agreed to reimburse Orchard Therapeutics' ex vivo gene therapy for the rare childhood disease metachromatic leukodystrophy.
News Orchard will help Kyowa Kirin grow in gene therapy Japan’s Kyowa Kirin has reached an agreement to buy Orchard Therapeutics of the UK in a deal valued at up to $478 million, ahead of an FDA decision on the biotech’s lead g
News Lundbeck preps for key bexicaserin data around year-end Lundbeck has completed patient randomisation in a pivotal trial of epilepsy candidate bexicaserin, one of its major growth hopes.
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