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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Chiesi’s orphan drug Raxone has secured an English funding recommendation for the treatment of Leber's hereditary optic neuropathy, a decade after the orphan drug was approved for marketing. Chiesi told the Pink Sheet about its “long, and often challenging” road to reimbursement.
Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.