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Lundbeck’s Vyepti (eptinezumab-jjmr), a monoclonal antibody approved for the treatment of migraines, was associated with greater declines in headache frequency and days of acute headache medication use vs. placebo in people dually diagnosed with chronic migraine and medication overuse headache, the company said. Read More
Citius Pharmaceuticals claimed a topline win in its pivotal phase 3 trial of I/Ontak (E7777) in patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). Read More
To expand the field of gene therapy, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), believes that the current clinical development framework is in need of rethinking in terms of trial design, endpoints, communication and other areas. Read More
Bayer’s Kerendia (finerenone) reduced the risk of cardiovascular and kidney disease events in patients with type 2 diabetes and chronic kidney disease, being especially effective in those with atherosclerotic cardiovascular disease (ASCVD). Read More
Ocrevus (ocrelizumab), Roche’s FDA-approved multiple sclerosis (MS) antibody, demonstrated hints of disease modification and cognitive benefit in phase 3b data that will be presented at the annual meeting of the American Academy of Neurology (AAN). Read More
Bristol Myers Squibbs’ (BMS) investigational drug mavacamten, which reduces cardiac muscle contractility, improved both functional and biomarker outcomes in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), a form of progressive heart failure. Read More
Johnson & Johnson’s subsidiary Janssen has announced data from new analyses of its phase 3 clinical trial showing the benefit of the Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with peripheral arterial disease (PAD) after lower-extremity revascularization (LER), a procedure that restores blood flow to the legs. Read More
Cerevance’s new phase 2 data suggests that its investigational Parkinson’s drug improves function without directly stimulating dopaminergic pathways. Read More
Akebia Therapeutics will have to conduct a new clinical trial if it wants to move its kidney disease drug vadadustat forward, the FDA said in a Complete Response Letter (CRL) denying approval for the investigational drug. Read More