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Newron Pharmaceuticals S.p.A.

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Latest From Newron Pharmaceuticals S.p.A.

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.

Advisory Committees Drug Review

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

Cell Therapy Developers Dominate China VC/PE Funding In October

Six Chinese biotechs raise a combined $141m in major financing deals backed by venture capital and private equity firms.

China Financing

Keeping Track: Enhertu Brings Anti-HER2 Therapy To Lung Cancer; Novaliq Platform Supports Two Dry Eye NDAs

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.

US FDA Performance Tracker Approvals
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