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Janssen R&D LLC

Division of Johnson & Johnson
www.janssenrnd.com

Latest From Janssen R&D LLC

Janssen’s Esketamine Gets US FDA Panel Endorsement, But With Pricing, Access And Diversion Concerns

Committee overwhelmingly supports approval for treatment-resistant depression but warns that pricing and combination therapy indication could hinder patient access. Esketamine’s risks of sedation and dissociative effects, and its abuse potential, will necessitate a strict risk management strategy.

Advisory Committees Drug Review

Janssen’s Esketamine Needs Better Defined REMS, US FDA Panel Says

Advisory committee overwhelmingly endorses approval for patients with treatment-resistant depression but says proposed Risk Evaluation and Mitigation Strategy needs refinement, including clarifying the types of facilities where the drug will be administered.

Advisory Committees Drug Review

Janssen’s Esketamine: US FDA Panel To Weigh Efficacy, REMS Restrictions For Treatment-Resistant Depression

FDA proposes requiring that healthcare facilities monitor patients for sedation and dissociative effects for two hours after self-administration; reliance on a randomized withdrawal trial as one of two adequate, well-controlled studies to support approval would be a first in the depression setting.

Advisory Committees Drug Review

Eight For 8: Things You Need To Know About China Biopharma Regulation In 2018

The Pink Sheet's pick of eight major events that captured major regulatory developments in China’s dynamic, highly fluid biopharma scene in 2018.

China Drug Approval Standards
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