Reducol cholesterol-lowering phytosterol licensed to functional food marketers in U.S. and Australia. Novartis, the exclusive licensee of the Phytrol-containing ingredient developed by Vancouver, B.C.-based Forbes Medi-Science, strikes deal with Pacific Foods of Oregon for Heart Health soy-based beverages and with the Australian marketer of Uncle Tobys Logicol cereal bars. Forbes Medi-Science projects U.S. revenues of $10 mil.-$12 mil. for FY 2001. Novartis submitted a 75-day premarket notification for the new dietary ingredient June 19, but is awaiting FDA's response before itself marketing products containing Reducol
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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.’
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.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
