RJ Reynolds Tobacco Company's Avoca division and Next Pharmaceuticals have partnered to develop proprietary dietary supplement ingredients, the firms announce March 8. Flagship Nextracts include the COX-2 anti-inflammatory Nexprofen and Relora, a phenolic complex for anxiety and stress. Others are Standardized Echinacea Purpurea Nextract with 4% phenolic compounds and four Standardized Saw Palmetto Nextracts containing 10%, 25%, 30% and 40% total fatty acids, respectively. The January agreement follows 18 months of R&D; the agricultural and extraction facilities are located at Avoca's 2,400-acre North Carolina facility. Next is courting large pharmaceutical and supplement companies as part of the ingredients' "roll-out" phase
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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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While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.