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Lexicon Pharmaceuticals, Inc.

http://www.lexpharma.com/

Latest From Lexicon Pharmaceuticals, Inc.

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

Vanda May Go Another Round With US FDA Over Hetlioz Jet Lag Indication

Agency offers Vanda chance to request a hearing over its plan to refuse to approve its supplemental new drug application. Such a hearing seems unlikely given FDA’s rejection of past requests and Vanda’s track record with the agency.

Complete Response Letters Drug Approval Standards
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