Immunomedics' CEA assay data to be re-analysed
This article was originally published in Clinica
Although Immunomedics had hoped for a recommendation for approval for its colorectal imaging agent, CEA-Scan (arcitumomab) assay, on October 17th, the company appreciates that the US FDA oncologic drugs advisory panel "was not necessarily the correct advisory group to evaluate a diagnostic imaging agent". The panel requested that review of the agent be reassigned to a medical imaging devices advisory committee (see Clinica No 677, p 15).
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.