An interim analysis of the phase III Recovery study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for treating post-traumatic stress disorder (PTSD) compelled Tonix Pharmaceuticals Holding Corp. to halt enrollment in the clinical trial. Read More
Sanofi SA said an investigational Bruton's tyrosine kinase (BTK) inhibitor it licensed from Principia Biopharma Inc. in 2017 significantly reduced disease activity associated with multiple sclerosis (MS) as measured by magnetic resonance imaging, meeting the trial's primary endpoint. Read More
DUBLIN – Shares in PTC Therapeutics Inc. dropped as much as 13% during premarket trading Feb. 6 on eagerly awaited 12-month data for its oral spinal muscular atrophy (SMA) drug risdiplam, which is licensed to Genentech. Although patients with type 2 or type 3 SMA demonstrated statistically significant improvements in motor function, the level of that improvement evidently disappointed some investors. Read More
DUBLIN – Azafaros BV raised €25 million (US$27.5 million) to develop orally available azasugar drugs with potential application to multiple lysosomal storage diseases. Read More
Lineage Cell Therapeutics Inc. CEO Brian Culley told BioWorld that concerns about the pace of the company’s dry age-related macular degeneration (AMD) phase I/IIa trial have been alleviated after an independent data safety monitoring board (DSMB) decreed that the study’s protocol-mandated treatment stagger can be removed. Read More
BEIJING – Share prices of Chinese biotechs that partner with Gilead Science Inc. have surged in China this week, after the U.S. firm’s remdesivir was identified as the most promising drug candidate to treat 2019-nCoV. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arrowhead, Cytodyn, Cytokinetics, Faron, Foamix, Lineage Cell, Novan, PTC, Roche, Sanofi, Scholar Rock, Tonix. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atreca, Aurigene, Chiesi, Curis, Evgen, Foamix, Generex, Genprex, Janone, Jounce, Marinomed, Menlo Therapeutics, Merck, Nanostring, Oncternal, Scholar Rock, Summit. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aquestive, Blueprint, Chiesi, Kleo, Neurosense, Novan, Protalix, Realta, Revance. Read More
