GlaxoSmithKline's UK launch of smoking cessation lozenges backed by £10 mil. (approximately $14.2 mil.) marketing campaign including £5 mil. ad campaign beginning in December, firm says. Mint-flavored lozenges contain either 2 mg or 4 mg nicotine polacrilex and launched in UK pharmacies in October. A one-week supply costs roughly $24.80. Launch could pave the way for eventual product introduction in U.S. Study finding lozenges lead to higher success rate than other nicotine-replacement therapies slated for publication in March Archives of Internal Medicine...
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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.