SmithKline Beecham launching a $10 mil. direct-to-consumer campaign for its Rx topical cold sore cream (penciclovir 1%). The campaign will include 45- and 60-second TV spots during early morning, daytime network and cable programming as well as print ads in late July and August issues of People, Health and Cosmopolitan. Print ads will carry the tagline, "No face should have to face another cold sore alone," while the TV spots feature people hiding their faces with playing cards, newspapers and turtlenecks due to cold sore "embarrassment." Grey Advertising (New York City) developed the DTC campaign. In December, FDA's NDAC and Antiviral Drugs Advisory Committees voted against the switch of Denavir due to viral resistance concerns (1"The Tan Sheet" Dec. 7, 1998, pp. 3-8). The company received a "not approvable" letter from FDA this year, but said at the time it was still pursuing the switch (2"The Tan Sheet" May 3, p. 6)
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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 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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