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SkyePharma PLC

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Asia Deal Watch: Eisai Advances Portfolio Focus With Divestiture Of Two Products To DKSH

Plus deals involving Dong-A/Polifarma, Intas/Syna, Kissei/Synmosa, Ono/Memo, Takeda/Shionogi, Fosun/Lilly and JW Therapeutics/2seventy bio.

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AstraZeneca/Avillion Asthma Combo Draws Split Decision At FDA Panel; Data Was ‘All Over The Place’

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.

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Avillion/AstraZeneca’s Budesonide/Albuterol Combo For Asthma Has ‘Uncertain’ Pediatric Benefit

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.

Advisory Committees Drug Review

Digital Health And Pharma Still Defining Rules Of Engagement

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.

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