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.
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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.
Big Pharma May 2017: Product Developments Shift Stock
In a new monthly column, Scrip rounds up events on the stock market, noting trends and exceptional performance both good and bad. This month, the focus is on 30 biopharma companies with market caps above $10bn. Between them, these 30 companies account for approximately 75% of the asset value in the pharmaceutical industry.