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Plus deals involving Dong-A/Polifarma, Intas/Syna, Kissei/Synmosa, Ono/Memo, Takeda/Shionogi, Fosun/Lilly and JW Therapeutics/2seventy bio.
In near unanimous votes, advisory committee rejects budesonide/albuterol sulfate fixed-dose combination for young children but favors approval for adults; the vote in adolescents was more divided, with some panelists believing extrapolation of adult efficacy data were appropriate for this population.
US FDA is asking an advisory committee whether extrapolation of adult data is appropriate to bridge uncertainties in efficacy for asthma patients under age 18 years; metered-dose inhaler would be the first combination product approved in the US containing an inhaled corticosteroid and a short-acting beta2-adrenergic agonist.
Despite all of the buzz around adoption of digital health tools and whopping VC investments in consumer-facing digital health firms, pharma has yet to articulate a business model for co-development or integration of behavior-modifying digital therapeutics into their portfolios.