The National Institutes of Health has formed the Trans-NIH Pediatric Research Consortium to coordinate pediatric research programs across its institutes and centers. Nearly all of the 27 NIH institutes and centers fund some aspects of child health research. In fiscal year 2017, this support totaled more than $4 billion. The new consortium aims to harmonize […]

by Angus Liu Patients who go off opioid painkillers face excruciating withdrawal symptoms such as anxiety, nausea, vomiting, insomnia, muscle aches and more. Now, thanks to an FDA approval for US WorldMeds’ Lucemyra, they’ll have the first drug designed to fight those symptoms. Lucemyra won its FDA nod on Wednesday based on two trials showing that the drug reduced […]

2018 Bio International Convention | Lynda Graham, MBA Let’s meet at Bio! Learn about the FDA & EMA Pediatric Guidelines that may impact your Drug Development Process. Our seasoned team brings expertise and insight to pharmaceutical companies of all sizes to effectively navigate the complex pediatric regulatory environments in the US and Europe. Our “Pediatric Center […]

Spark Therapeutics agreed to sell its priority review voucher, good for four months off an FDA decision date for any product, to Jazz Pharmaceuticals for $110 million—providing Spark a nice bonus on top of its recent approval for the world’s most expensive drug. Despite the size of the investment, a Jazz spokesperson said the company has […]

By: Alice Melao, Muscular Dystrophy News Today An advisory committee of the European Medicines Agency (EMA) has issued another negative recommendation after re-examining a request to extend Raxone (idebenone) for use in treating Duchenne muscular dystrophy (DMD). The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued its first negative opinion of the request in September 2017. The therapy’s manufacturer, Santhera Pharmaceuticals, had […]