Pink Sheet Podcast: Regeneron’s COVID Monoclonal Deal, New FDA Advisor, Project Optimus In Cancer Combos
Pink Sheet reporter and editors discuss the somewhat novel pricing language in Regeneron’s deal with the US government to develop a COVID-19 monoclonal antibody, US FDA Commissioner Robert Califf hiring a new senior advisor, and optimizing dosing in cancer combination therapies.
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In overwhelmingly concluding that efficacy has not been demonstrated for the mesenchymal stromal cell therapy, panelists went beyond just the failed Phase III trial and cited BrainStorm’s ‘statistical magic’ and failure to adequately describe the mechanism of action, as well as safety and product quality concerns.
However, user fee carryover balances will not last forever and service cuts are inevitable if a shutdown lingers for several weeks.
NurOwn Adcomm Is 20 Members Strong Despite US FDA’s ‘Struggle’ To Find Unconflicted Neurology Experts
Seven panelists are regular members of the Cellular, Tissue and Gene Therapies advisory committee, while many of the 13 temporary voting members bring neurology and neuroscience expertise. In a conflict-of-interest waiver, the agency noted a struggle to find experts in clinical neurology and neurodegenerative diseases who lack disqualifying financial interests.