Will be the subject of a two-day meeting of FDA's Anesthetic & Life Support Drugs Advisory Committee Jan. 17-18 beginning at 8:30 a.m. Abbott filed an NDA for Sevorane (sevoflurane, NDA 20-478), an inhalation anesthetic licensed from Japanese firm Maruishi, in the early fall ("The Pink Sheet" Oct. 17, p. 13). The anesthetic and life support committee is also scheduled to consider pending INDs and NDAs during a closed session on the afternoon of Jan. 18. The meeting will take place at FDA's Parklawn Building, Conference Rooms D&E
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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.’
In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.
A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.
Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.
