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…
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…
HHS and the FDA have expanded the list of states where GlaxoSmithKline’s and Vir Biotechnology’s COVID-19 monoclonal antibody, sotrovimab, may not be used due to concerns about the treatment’s efficacy…
A trial in West Virginia before Judge Derek Swope got under way yesterday against Johnson & Johnson (J&J), Teva Pharmaceuticals and AbbVie for their alleged role in facilitating the state’s…
The FDA has approved Kite’s Yescarta (axicabtagene ciloleucel) drug for a new indication — initial treatment for patients with relapsed or refractory large B-cell lymphoma (LBCL), which its parents company…
The International Council for Harmonization (ICH) has issued two draft guidelines to help drugmakers improve analytical testing used to assess product quality. Source: Drug Industry Daily
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…
Cerevance’s new phase 2 data suggests that its investigational Parkinson’s drug improves function without directly stimulating dopaminergic pathways. Source: Drug Industry Daily
German device manufacturer Fresenius Kabi is acquiring a majority stake in mAbxience, the biosimilars division of Madrid, Spain-based Insud Pharma, for $547 million. Source: Drug Industry Daily
The FDA has placed a partial clinical hold on CytoDyn’s human immunodeficiency virus (HIV) program and a full clinical hold on its COVID-19 program in the U.S. Source: Drug Industry…