Novartis Zometa
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pooled results of two pivotal studies show improved efficacy for patients with tumor-induced hypercalcemia treated with zoledronic acid versus Novartis' Aredia (pamidronate), according to data presented at May's American Society of Clinical Oncology meeting. Complete response was shown in 69.7% of Aredia patients vs. 88.4% of Zometa 4 mg patients (p=0.002) and 86.7% of Zometa 8 mg patients (p=0.015) by day 10. CR was defined as corrected serum calcium levels of £ 10.8 mg/dL (2.7 mmol/L). Zometa also showed superiority in median time to relapse and median duration of complete response. Zometa's NDA is receiving a priority review with a user fee goal in late Jun
You may also be interested in...
Executives On The Move: Changes At The Top At Enzolytics, Dyne Therapeutics And Seres Therapeutics
Recent moves in the industry include new chief financial officers at LENZ Therapeutics and Botanix Pharmaceuticals, plus new chief medical officers at Vigil Neuroscience and Voyager Therapeutics.
Israel's Gamida Cell Survives By Selling To Lender
Having finally secured US approval for Omisirge, Gamida was hoping to bag a strategic partner for the cell therapy. A year on, no suitable partner has been identified and the firm is delisting from the NASDAQ and going private.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.