Developments

Developments

FDA accepts Aurinia NDA for voclosporin; agrees to priority review

The FDA accepted for priority review Aurinia Pharmaceuticals’ (NASDAQ:AUPH; TSX:AUP) NDA for voclosporin for the treatment of lupus nephritis (LN). The NDA for voclosporin is based on the Phase 3 AURORA and Phase 2 AURA...

July 22, 2020

Developments

9 Meters doses first patients in Phase 1b/2a short bowel syndrome trial

9 Meters Biopharma (NASDAQ:NMTR) dosed the first patients in its Phase 1b/2a clinical trial evaluating NM-002 for the treatment of short bowel syndrome. Short bowel syndrome is a rare, life-threatening disease caused by...

July 21, 2020

Developments

Cerecor enrolls first patient in COVID-19 trial

Cerecor (NASDAQ:CERC) enrolled the first patient in its a proof-of-concept trial evaluating CERC-002 in patients with COVID-19 cytokine storm-induced acute respiratory distress syndrome (ARDS). CERC-002 is a...

July 21, 2020

Developments

Lexicon sotagliflozin meets primary endpoint in four Phase 3 studies

Lexicon Pharmaceuticals (NASDAQ:LXRX) reported topline data from four Phase 3 studies, each of which demonstrated that sotagliflozin significantly reduced A1C levels in patients with Type 2 diabetes (T2D). Sotagliflozin...

July 21, 2020

Developments

BioXcel BXCL501 meets primary and secondary endpoints in two Phase 3 trials

BioXcel Therapeutics’ (NASDAQ:BTAI) BXCL501, a dexmedetomidine sublingual thin film, met its primary and secondary endpoints in two Phase 3 trials in patients with schizophrenia and bipolar disorders. In the SERENITY I...

July 20, 2020

Developments

IntelGenx and Tilray amend exclusivity of cannabis-infused VersaFilm accord

IntelGenx (TSXV:IGX; OTCQB:IGXT) and Tilray (NASDAQ:TLRY) amended the exclusivity terms of their November 2018 license, development and supply agreement to allow for IntelGenx’s co-development and commercialization of...

July 20, 2020

Developments

Denovo Biopharma DB102 gets FDA fast track designation for glioblastoma

Closely-held Denovo Biopharma’s DB102 received FDA fast track designation for the treatment of patients with newly-diagnosed glioblastoma. DB102, or enzastaurin, is a small molecule, serine/threonine kinase inhibitor...

July 17, 2020

Developments

PhaseBio doses first COVID-19 patient in Phase 2 trial

PhaseBio Pharmaceuticals (NASDAQ:PHAS) dosed the first patient in its potentially pivotal Phase 2 trial evaluating PB1046 for the treatment of high-risk, hospitalized COVID-19 patients. PB1046 is a long-acting analog of...

July 17, 2020

Developments

Liminal BioSciences acquires Fairhaven Pharmaceuticals

Liminal BioSciences (NASDAQ, TSX:LMNL) acquired closely-held Fairhaven Pharmaceuticals for $8-million (Canadian) in common shares. Fairhaven’s assets include a preclinical research program of small molecule...

July 17, 2020

Developments

AC Immune initiates second dosing group in Phase 1b/2a Alzheimer’s disease vaccine trial

AC Immune (NASDAQ:ACIU) initiated the second highest dosing group in a Phase 1b/2a clinical trial evaluating its anti-phospho-tau vaccine in patients with early Alzheimer’s disease (AD). The vaccine, called ACI-35...

July 16, 2020

Developments

Imagin Medical to test i/Blue Imaging System on anatomical bladder models

Imagin Medical (CSE:IME; OTCQB:IMEXF; Frankfurt & Stuttgart Symbol:DPD2) will use anatomical bladder models to confirm the i/Blue Imaging System’s simultaneous white and blue light image display. The anatomical...

July 15, 2020

Developments

Rigel Pharma fostamatinib being evaluated in COVID-19 pneumonia trial

Rigel Pharmaceuticals’ (NASDAQ:RIGL) fostamatinib is being evaluated in an investigator-sponsored study for the treatment of COVID-19 pneumonia. Fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, is approved...

July 14, 2020

FDA accepts Aurinia NDA for voclosporin; agrees to priority review

9 Meters doses first patients in Phase 1b/2a short bowel syndrome trial

Cerecor enrolls first patient in COVID-19 trial

Lexicon sotagliflozin meets primary endpoint in four Phase 3 studies

BioXcel BXCL501 meets primary and secondary endpoints in two Phase 3 trials

IntelGenx and Tilray amend exclusivity of cannabis-infused VersaFilm accord

Denovo Biopharma DB102 gets FDA fast track designation for glioblastoma

PhaseBio doses first COVID-19 patient in Phase 2 trial

Liminal BioSciences acquires Fairhaven Pharmaceuticals

AC Immune initiates second dosing group in Phase 1b/2a Alzheimer’s disease vaccine trial

Imagin Medical to test i/Blue Imaging System on anatomical bladder models

Rigel Pharma fostamatinib being evaluated in COVID-19 pneumonia trial

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