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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A new pilot aims to take Brazil closer to ‘digital transformation.’
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
