BioMarin's Drisapersen 'Compete Response' Shows FDA Flexibility Still Limited
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA wants another clinical trial for Duchenne muscular dystrophy treatment; focus moves to Sarepta's candidate, which gets committee review next week.
You may also be interested in...
The Greatest FDA Advisory Committees Of All Time Part IV: Neurology Lays Claim To The Crown
We look back at another of the greatest FDA advisory committees of the last 20 years. This time: the nearly 12-hour meeting in 2016 on Sarepta’s eteplirsen for Duchenne muscular dystrophy.
Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent
Biogen and Eisai's surprise decision to advance Alzheimer’s antibody despite mixed clinical results could follow a similar path as pioneering neurodegenerative therapies Xenazine and Rilutek, or more recent Parkinson’s drug Nourianz – or could end with suspended development, like Kyndrisa.
Once More Unto The Breach: PTC's Duchenne Drug Translarna Gets Advisory Cmte.
US FDA's Peripheral and Central Nervous System Drugs Advisory Committee to consider application, which PTC Therapeutics filed over protest.