GlaxoSmithKline and Genmab gambled that by submitting a pivotal trial including both chronic lymphocytic leukemia patients refractory to two standard therapies and patients refractory to only one of them, fludarabine, but who also had bulky lymphadenopathy, they could garner a broader indication for Arzerra (ofatumumab), despite advice from FDA that the two groups could not be combined for one indication
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
FDA Commissioner Martin Makary suggested 60 new molecular entities could be approved in 2025, which appears possible, but can the strained staff deliver?
PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.
Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.
