DTC Advertising "Tone-Down" Could Address FDA Concerns, Schering Says
• By Kate Rawson
Marketers will begin airing more balanced DTC ads as a result of increased scrutiny from FDA about the quality of some ads, Schering CFO Bertolini says. With Levitra, Schering now participates in what may be a high-risk market for DTC ads: erectile dysfunction disorder.
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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 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.