Incremental potency assay development encouraged by FDA. Approach taken in recent guidance for cellular and gene therapy products makes sense for traditional drug products as well, FDA says. Three assay methods recommended. Early start encouraged. Industry comments generally supportive. Challenges developing potency assays for biopharmaceuticals and pros and cons of cell-based vs. binding assays discussed at conference. One key to better assays seen as knowing the mode of action.
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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.
