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.’
If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
