Sen. Hatch (R-Utah) has asked representatives from the Pharmaceutical Research & Manufacturers of America, the Biotechnology Industry Organization and the Generic Pharmaceutical Industry Association to meet with him Nov. 17 to discuss potential revisions to the Waxman/Hatch patent reform legislation of 1984
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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.