Fluvirin FDA Manufacturing Inspections Expected By July
• By Lee Kalowski
Positive outcome of FDA inspections this summer would be final barrier to re-introducing Fluvirin to the U.S. market. Earlier suspension by U.K. health authorities will not dampen demand for vaccine, Chiron says; the company expects to manufacture 25 mil.-30 mil. doses for 2005/2006 flu season.
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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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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.