Celgene resubmits NDA for ozanimod FDA and EMA accepted submissions from Celgene Corp. (NASDAQ:CELG) for ozanimod to treat multiple sclerosis. The PDUFA date for the selective S1PR1 and S1PR5 modulator is March 25, 2020, and...

Having long been demoted to tool compound status, shRNA is gaining renewed attention as a therapeutic modality by offering a simpler path to creating next-generation cell therapies than gene editing. Celyad has jumped in, using...

Benitec Biopharma Ltd. (ASX:BLT; NASDAQ:BNTC) said an initial analysis of the 12-patient Stage 1 cohort in a Phase II trial to treat recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) showed...

Axovant Sciences Ltd. (NASDAQ:AXON) discontinued development of nelotanserin after the product missed the primary endpoint in a Phase II trial to treat REM sleep behavior disorder in patients with Lewy body dementia. The double-blind trial...

Based on work spearheaded by the Cystic Fibrosis Foundation, Corbus Pharmaceuticals Holdings Inc. will be the first company to attempt to gain approval in CF based on pulmonary exacerbations instead of FEV1. The company is...

Axovant Sciences Ltd. (NASDAQ:AXON) broadened its gene therapy pipeline by obtaining exclusive, worldwide rights from Benitec Biopharma Ltd. (ASX:BLT; NASDAQ:BNTC) to BB-301. Axovant plans to start a placebo-controlled clinical trial next year of the gene...

Axovant Sciences Ltd. (NASDAQ:AXON) broadened its gene therapy pipeline by obtaining exclusive, worldwide rights from Benitec Biopharma Ltd. (ASX:BLT; NASDAQ:BNTC) to BB-301. Axovant plans to start a placebo-controlled clinical trial next year of the gene...

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said enrollment was temporarily stopped in the Phase I/II COMPOSER trial evaluating RG6107 (SKY59) in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH) after two patients who received RG6107...