The New England Journal of Medicine study suggests that the 2022 death of a Duchenne muscular dystrophy patient was due to an adverse effect of recombinant AAV used to deliver the gene therapy.
Tag Archive for: patient death
In its briefing documents, the agency said it does not believe there is sufficient evidence to support NurOwn’s clinical benefit, adding there were large amounts of missing data.
The company announced Monday with its second-quarter earnings that the regulator has officially halted the Phase I study after a child with acute myeloid leukemia died following treatment.
The company and partner Seattle Children’s Therapeutics was studying its experimental therapy as a treatment for children with acute myeloid leukemia (AML), a cancer of the blood and bone marrow.
The company is now focused on analyzing the death and “consider potential next steps for development,” CEO Anna Protopapas said in a statement.
The FDA said the silicon foam used in some reworked ventilator models may separate from plastic backing due to adhesive failure and can reduce the air flow as well as cause debris contamination. The issue can lead to patient injury or death.
Magenta Therapeutics is cutting about 84% of its workforce after a patient’s death halted a Phase I/II trial in acute myeloid leukemia.
Following the death of a patient, Magenta Therapeutics placed a hold on Phase I/II dose-escalation trial of its acute myeloid leukemia therapy.
The FDA is working with the World Health Organization and foreign regulatory authorities to support an investigation into the source of contaminated cough syrups that have killed more than 300 children in Africa and Asia.
Datascope, a unit of Getinge, had recalled 4,454 therapeutic devices in December following a death and four serious injuries from their use.
