Latest From Alaric DeArment
Yescarta surged ahead of competitors Kymriah and Breyanzi, helping Gilead’s oncology sales exceed $2bn, while the company reported the strongest sales in its HIV-dominated core business since 2015.
The company said the first three cohorts of its Phase II atopic dermatitis study failed, while another trial with a faster-release formulation of EDP1815 continues, along with a Phase III study in psoriasis.
The Loxo@Lilly drug got FDA accelerated approval in mantle cell lymphoma as the first non-covalent BTK inhibitor, enabling its use in post-BTKi disease.
The companies unblinded data from CARTITUDE-4, which met its primary endpoint, but analysts citing KOLs said they continue to face issues with limited manufacturing slots and out-of-spec product.
The diabetic retinopathy candidate failed on its Phase II primary endpoint, but showed efficacy on a key secondary endpoint that the company hopes to use as the Phase III primary outcome measure.
JAMA reports on the COVID-19 Prevention Network’s efforts. Also, Inhibikase said the US FDA lifted a hold on its drug for Parkinson’s disease, while Astellas Pharma said the agency lifted a clinical hold on its gene therapy for Pompe disease. And Trefoil, Theriva Biologics and Nektar initiated new trials.