ROCHE GAINING SOLE RIGHTS TO OTC ALEVE AND FEMSTAT 3 under an agreement with Procter & Gamble announced by the companies June 27. Roche Holding Ltd. will acquire P&G's 50% interest in the company's U.S. Rx-to-OTC switch joint venture with Syntex. P&G, which has dedicated considerable marketing resources to the two switch products -- over $100 mil. to launch Aleve -- reports that it will see a "$120 mil. after-tax gain" in the fourth quarter as a result of the sale. However, P&G says the sale of its stake in the joint venture will provide a greater return than would continued marketing of the products.
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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.
