BIO Notebook Day 4: Gottlieb Seeks Early Engagement On Gene Therapy; Ireland’s Brexit Opportunities; AMAG’s Bremelanotide Strategy; Alzheimer’s ‘Learnings’
Executive Summary
US FDA to head off cell/gene therapy manufacturing issues with pre-IND meetings; Republic of Ireland will “chase any opportunities” for business partners stemming from Brexit, even while hoping UK reconsiders EU departure; AMAG won’t follow the flibanserin PR approach with newly submitted female sexual dysfunction drug bremelanotide; United Neuroscience CMO Ajay Verma says Alzheimer’s trial setbacks are “learnings,” with progress toward novel therapies moving faster than it has for cancer and HIV.
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