3M Aldara submission
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
3M submits sNDA for use of its topical immune response modifier Aldara (imiquimod cream, 5%) for superficial basal cell carcinoma. The submission is based on two six-week, double-blind, placebo-controlled studies in 724 patients. The studies found dosing five times a week to be the optimal regimen, with a histological clearance rate of 82% vs. 3% for placebo. Aldara could also be cleared for another indication in 2004; 3M submitted an sNDA May 5 for actinic keratosis (1Pharmaceutical Approvals Monthly June 1, 2003, p. 15)...
You may also be interested in...
3M Submits Aldara For Actinic Keratosis, Plans Carcinoma Filing Mid-Year
3M could gain two new indications for its topical immune response modifier Aldara in 2004, with a recent submission for actinic keratosis and a filing for basal cell carcinoma planned for this summer.
At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use
At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy.
Simplified Clinical Trial Transparency Rules To Go Live In The EU In June
A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules.