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The European Medicines Agency has recommended approval of Shire’s Intuniv to treat attention deficit hyperactivity disorder — potentially breathing new life into the drug, which is facing new competition from generics in the U.S. Read More
If the FDA were to implement a quality metrics program similar to the collection of the 16 metrics used in ISPE’s Quality Metric Pilot Program, the cost would be about $75,000 annually per company, or $35 million across the industry, ISPE says. Read More
The European Medicines Agency is declaring that six classes of diseases occur in children, forcing drugmakers to conduct pediatric tests prior to approval. Read More
Global health experts are calling for at least $2 billion in seed money to spur vaccine development against diseases including Ebola, MERS, SARS, West Nile virus and Lyme disease. Read More
AstraZeneca’s investigational drug selumetinib has failed to meet its primary endpoint of progression free survival during a Phase 3 trial for a rare eye cancer. Read More