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The International Council for Harmonization (ICH) has issued two draft guidelines to help drugmakers improve analytical testing used to assess product quality. 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
German device manufacturer Fresenius Kabi is acquiring a majority stake in mAbxience, the biosimilars division of Madrid, Spain-based Insud Pharma, for $547 million. Read More
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. Read More