Pfizer aerosol foam mousse lice treatment designated "approvable" in July 8 letter from FDA. Active ingredients are pyrethrins and piperonyl butoxide. Victoria, Australia-based Soltec Research, developer of a topical mousse delivery system, filed the original new drug application. Mousse formulation would join the Rid lice-control product line, which includes Maximum Strength Shampoo, Lice Control Spray, egg removal comb and Lice Egg Loosener Gel, which began shipping in mid-June (1"The Tan Sheet" June 21, 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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A new pilot aims to take Brazil closer to ‘digital transformation.’
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.
