Amgen Perfectly Positioned To Deal With Prolia Complete Response Letter; Quick Turn-Around Expected
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA handed Amgen a complete response letter for Prolia, but the company has an armamentarium for handling the agency's requests.
You may also be interested in...
Getting Past FDA's HALT: Can Amgen Escape New Trial Requirement For Prolia With Data From SRE Studies?
Amgen will attempt to use data culled from its trials of Prolia (denosumab) in reducing skeletal-related events to resolve FDA's questions about the drug's effects in cancer patients, raised in the agency's "complete response" letter on d-mab's use in treating patients with bone loss due to hormone ablation therapy
Getting Past FDA's HALT: Can Amgen Escape New Trial Requirement For Prolia With Data From SRE Studies?
Amgen will attempt to use data culled from its trials of Prolia (denosumab) in reducing skeletal-related events to resolve FDA's questions about the drug's effects in cancer patients, raised in the agency's "complete response" letter on d-mab's use in treating patients with bone loss due to hormone ablation therapy
Amgen Buries Second FDA Action Letter For Bone Drug in Cancer Indications
HALT! More bad news: Complete Response letter from Agency this week requests new studies in treatment induced bone loss.