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Lexicon Pharmaceuticals, Inc.

http://www.lexpharma.com/

Latest From Lexicon Pharmaceuticals, Inc.

Bountiful Approvals May Be Ahead As FDA Starts 2023 With Almost 60 Novel Agents Under Review

The upcoming year could see a rebound approvals if the bigger-than-usual queue of novel agents with 2023 user fee goal dates pans out.

Pink Sheet Perspectives US FDA Performance Tracker

Lexicon Stresses Path Forward In Neuropathic Pain Despite Phase II PHN Disappointment

The US firm’s AAK1 inhibitor asset missed the mark in a Phase II shingles-related pain trial but it appears unfazed as an earlier success in diabetes-related pain has a secured a path forward in the neuropathy space.

Clinical Trials Neurology

Korean Bioventure Financing Continues Downward Spiral In Q3

VC Investment in South Korea’s biopharma sector drops again as investors continue to shy away amid higher interest rates and reduced out-licensing deals.

South Korea Financing

Vanda Objects To FDA’s ‘Highly Prejudicial’ Hearing Process And ‘Extra-Regulatory’ Requirements

Vanda says FDA improperly requires it to disprove all alleged deficiencies in its Hetlioz application for jet lag. Contentious approach to notice of opportunity for hearing contrasts with that of Intarcia and Lexicon, which also seek hearings over FDA’s proposal to refuse their applications.

Drug Review Drug Approval Standards
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