Bausch & Lomb's Optura (besifloxacin ophthalmic suspension) receives unanimous support Dec. 5 for treatment of bacterial conjunctivitis. Members of FDA's Dermatologic and Ophthalmic Drugs Advisory Committee added no hesitations or qualifications to their 9-0 vote that besifloxacin's benefits outweigh its risks, agreeing with FDA's conclusions that the sponsor conducted three adequate and well-controlled trials supporting the drug's efficacy
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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.
