Optimer released positive data Feb. 4 from its second pivotal Phase III trial of fidaxomicin, raising hopes that hospitals will soon have a new weapon for fighting new deadly strains of Clostridium difficile, a bacterium that occurs naturally in the gut and is ordinarily benign. Problems arise, however, when antibiotics used to treat hospital-acquired infections eliminate other resident flora, allowing novel and toxic strains of C. diff to proliferate. Outbreaks of the disease, typified by diarrhea, nausea and in severe cases, colitis, sepsis and death, have made headlines in the United Kingdom and Canada.
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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.
