Targeted Genetics clinical hold following patient death
This article was originally published in Pharmaceutical Approvals Monthly
FDA places clinical hold on Targeted Genetics' gene therapy trial with tgAAC94 for the treatment of inflammatory arthritis following the death of a 36-year-old woman, the biotech announces July 24. The biologic uses a recombinant adeno-associated virus (AAV) derived vector to deliver a gene encoding the protein TNFR:fc, a soluble form of the tumor necrosis factor alpha receptor, to reduce inflammation and disease in patients with active inflammatory arthritis. Since the trial began in October 2005, 127 subjects have received an initial dose of active drug or placebo, and an additional 74 subjects received a second dose of active drug, according to Targeted Genetics...
You may also be interested in...
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.
DePuy Synthes expects its Velys robotic-assisted system to be cost-effective, easy-to-use and to be well-suited for use in ambulatory surgery centers.