Top-line results showing that type 1 diabetics treated with the dual SGLT inhibitor sotagliflozin achieved statistically significant reductions in A1C at 24 weeks in a pivotal phase III trial drew fresh enthusiasm for Lexicon Pharmaceuticals Inc. Friday, pushing shares 16.6 percent higher and encouraging partner Sanofi SA.
Two years after an errant statistical analysis derailed Emmaus Life Sciences Inc.'s initial efforts to gain approval for its pharmaceutical-grade L-glutamine, a treatment for adults and children with sickle cell disease, the company is back on track, seeking priority review for its new drug application.
Pipeline growth, clinical development and manufacturing are all slated for a boost from a $474 million equity financing for Moderna Therapeutics Inc., a substantial follow-on to the messenger RNA (mRNA) specialist's monster $450 million series C round in January 2015 – a sum it has yet to even touch, CEO Stéphane Bancel told BioWorld Today.
A long-awaited global phase III study of Cytokinetics Inc.'s chronic heart failure drug omecamtiv mecarbil, funded and run by partner Amgen Inc., is on track to start during the fourth quarter, the companies said.
Some chronic heart failure (HF) patients given an intravenous injection (IV) of specially prepared stem cells during a small phase IIa study saw significant functional and quality of life improvements associated with the treatment, Cardiocell LLC reported during the European Society of Cardiology Congress in Rome.
An internal restructuring at Novartis AG moved the company to unwind its cell and gene therapies unit, established in 2014 to streamline the complex process of combining clinical development, technical operations and manufacturing.
Nearly six months after downsizing, in part to focus on gaining regulatory approvals for its anaplastic lymphoma kinase (ALK) inhibitor brigatinib, Ariad Pharmaceuticals Inc. has completed a rolling submission of a new drug application for the candidate.
Top-line data from CTI Biopharma Corp.'s phase III trial of pacritinib, a JAK2/FLT3 multikinase inhibitor for high-risk patients with advanced myelofibrosis showed the treatment demonstrated statistically significant improvement in spleen volume reduction vs. best available treatment.
Some chronic heart failure (HF) patients given an intravenous injection (IV) of specially prepared stem cells during a small phase IIa study saw significant functional and quality of life improvements associated with the treatment, Cardiocell LLC reported during the European Society of Cardiology Congress in Rome.
Novartis AG's siponimod (BAF312), a second-generation sphingosine 1-phosphate (S1P) receptor modulator designed to be more selective than Gilenya (fingolimod), reduced the risk of disability progression vs. placebo for people with secondary progressive multiple sclerosis (SPMS) during a large phase III study, the company reported. Regulatory filings seeking approval for the therapy are planned for 2019.
