Schering AG/Berlex Angeliq second try
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Schering AG/Berlex expect a six-month review for Angeliq (drospirenone/estradiol) with the late March filing of a "complete response" for the hormone replacement therapy. Angeliq received a "not approvable" letter Oct. 17, 2002 in the wake of the Women's Health Initiative study results (1Pharmaceutical Approvals Monthly Nov. 1, 2002, In Brief). The firm is touting a potential anti-hypertensive effect with Angeliq...
You may also be interested in...
Berlex HRT agents "not approvable"
Schering AG U.S. subsidiary Berlex receives "not approvable" letter for hormone replacement therapy Angeliq (drosperinone) Oct. 17 and is seeking "active dialogue" to learn more about FDA's concerns. Schering AG is pointing to concerns about HRT raised in Women's Health Initiative study. The firm's estradiol/ levonorgestrel patch (formerly Climara) was deemed "not approvable" Oct. 8. FDA cited technical aspects of one of the clinical studies in the NDA, Berlex indicated. The patch received an earlier "not approvable" letter June 27, 200
Financing Quarterly Statistics, Q1 2024
During Q1, biopharmas brought in an aggregate $30.1bn in financing and device company fundraising totaled $2.8bn; while in vitro diagnostic firms and research tools players raised $724m.
Helping Organizations Deliver On KPIs And Giving Staff A Voice
ImproveWell has won awards for its software technology that allows health care staff at the sharp end of patient care to report on problems as they happen. The outcome is a real-time learning process that contributes to improved operational efficiencies for health systems, says In Vivo Rising Leader Lara Mott.