Syntex will develop Greenwich's Therafectin (amiprilose hydrochloride), which is currently in clinical trials for the treatment of rheumatoid arthritis. Syntex and Greenwich will hold co-exclusive rights to manufacture and market the drug in the U.S., while Syntex will hold exclusive marketing rights in Canada, Mexico, the Bahamas, Australia, New Zealand and Brazil. In addition to making royalty payments, Syntex will fund the remaining clinical trials.
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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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FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.
US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.
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