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 the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
