National press ad, London Underground poster for GSK's NiQuitin CQ smoking cessation lozenge deemed "misleading" by Britain's Advertising Standards Authority in Sept. 11 ruling. Ad watchdog upheld a complaint brought by rival Pharmacia Consumer Healthcare challenging claim NiQuitin CQ can "triple your chances of success." In its defense, GSK maintains claim was based on a study of over 1,800 UK and U.S. smokers, which found 23.6% of participants in active arm achieved cessation, compared with 10.2% of those in control arm. GSK rounded up the odds ratio of 2.76 to give the "triple" claim. However, ASA concludes the inflated ratio "did not justify the claim" and recommends GSK amend the ads with help from the Committee of Advertising Practice Copy Advice...
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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.
