The Australian Therapeutic Goods Administration recommends raising the minimum age for OTC pediatric cough and cold products to 6 years - the same age 1U.K. regulators recommend and two years older than in the 2U.S. TGA bases the recommendation on an external safety review of data summarized in Australia's 3review of cough and cold medicines in children. It also wants the 4National Drugs and Poisons Schedule Committee to make cough and cold products for 6- to 12-year-olds available only from a pharmacist, and wants manufacturers to package all cough and cold products in child-resistant containers by July 2010
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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.
