BIO Notebook Day 3: ARM Launches Foundation To Educate Public About Gene And Cell Therapies
Executive Summary
Alliance for Regenerative Medicine initiative seeks to explain gene and cell therapy to the general public. Also, EY's Giovannetti says strategic decisions, not tax reform, should drive deal-making; FDA's Woodcock touts benefits of new drug review office overhaul; and Siga Technologies eyes priority review voucher upon approval of Tpoxx for smallpox.
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Siga Ready For Next Phase, New Cash With Smallpox Drug Approval
Siga is entitled to a $41m “hold back” payment under its contract with the Biomedical Advanced Research and Development Authority and potentially a $50m payment related to the US FDA's extended shelf-life determination for stockpiled Tpoxx; company also picks up first priority review voucher awarded for a medical countermeasure, which it likely will monetize.
BIO Notebook Day 2: Levin Scolds Industry For Squandering Proceeds From US Tax Reform
Former Teva and current Ovid CEO Jeremy Levin says pharma should use tax reform gains for business development, not share buybacks. Also, Patient-focused drug development (PFDD) is about more than just getting new drugs approved, an advocate says, while FDA previews coming guidance on PFDD. And, Alnylam’s CEO reflects on what it took financially to get RNAi to the threshold of its first product approval.
Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions
Long-planned OND 'modernization' to better match workflow, allow more time with stakeholders includes proposed restructuring that would boost number of offices overseeing review operations (adding four for a total of nine) and drug review divisions (adding 11 for a total of 30).