Gene Therapy Situation Gets More Awkward With Another Death In Astellas XLMTM Study
Patient Received Lower Dose Of AT132 After Initial Hold Lifted
An expert pointed out that XLMTM patients are already at high risk, but if linked to therapy toxicity, the death could doom the ASPIRO trial.
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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.
Plus deals involving Takeda/Zedira/Dr. Falk, Lupin/Sunovion, Eucure/Syncromune, Hetero/Johnson & Johnson, Nitto Denko/Omega, Harbour BioMed/CSPC and Pregene/Bone Therapeutics.
The main Japanese pharma players report a generally strong fiscal Q1, helped by mainstays including Daiichi Sankyo's Enhertu, Astellas's Xtandi and Padcev and Chugai's Actemra, and in some cases by the weaker yen.