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…
AbbVie’s Allergan subsidiary and Teva Pharmaceuticals have agreed to pay nearly $330 million to settle claims that they played a role in the opioid abuse and overdose crisis in Florida.…
The FDA included detailed recommendations for booster shot studies in a final guidance on Emergency Use Authorizations (EUAs) for COVID-19 vaccines released yesterday. Source: Drug Industry Daily