ITF Pharma Plans October US Roll-Out Of Liquid Riluzole Formulation For ALS
Early engagement with US payers suggests openness to covering a liquid form of riluzole, because the tablet version is proven, but it's impossible to take for many ALS patients, says Italfarmaco subsidiary ITF Pharma.
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Glutamate modulators could play a role in a range of central nervous system disorders, including social anxiety, amyotrophic lateral sclerosis. Biohaven's first – a reformulation of a generic ALS drug – could be on the market in two years.
With Phase III Failure, Cytokinetics Shelves Tirasemtiv, Pivots To ALS Backup
Partnered with Astellas, the San Francisco-area biotech hopes next-generation CK-107 will succeed in a measure of slow vital capacity due to stronger potency and better tolerability compared to tirasemtiv.
FDA’s Remarkable ALS Drug Approval: Call It The 'Hendeles Standard'
US FDA’s approval of Mitsubishi's Radicava (edaravone) is yet another demonstration of the agency’s flexibility for drugs to treat rare diseases – and pre-emptive action to fend off “Right to Try” laws. It is also a belated endorsement of one of the stranger votes by an FDA advisory committee member almost a decade ago.