Pharmacia & Upjohn's Estring: Estradiol vaginal ring for treatment of local symptoms of urogenital atrophy is approved April 26. Estring had been "approvable" at FDA since Sept. 29. The product is an elastomer ring containing 2 mg of 17-beta estradiol that is inserted into the upper vagina, where it releases 50%-60% of the estradiol over a period of three months. Estring is the only product that treats both vaginal and urogenital symptoms of urogenital atrophy. The company plans to introduce Estring sometime this autumn...
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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.
