Procter & Gamble efficacy data on the UVA radiation protection potential of avobenzone in combination with zinc oxide or phenylbenzimidazole sulfonic acid are not adequate to support the combos addition to the sunscreen monograph, FDA tells the company in an April 8 letter. The agency gives the firm 30 days to provide additional data, after which it will make a decision based on extant information.
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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.
