Regulatory milestones

Biofrontera AG (Xetra:B8F) gained €0.01 to €2.10 last week after the EMA accepted for review an MAA for BF-200 ALA to treat actinic keratosis. BF-200 ALA is a photodynamic therapy comprising nanoemulsion BF-200 with 5-aminolevulinic acid (ALA) photosensitizer followed by red light illumination.

Dendreon Corp. (NASDAQ:DNDN) lost $1.97 to $40.61 last week after CMS included several efficacy-related questions in its draft questions posted ahead of a Nov. 17 meeting to discuss the company's Provenge sipuleucel-T prostate cancer therapy. The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) will be asked to rate its confidence that there is adequate evidence of Provenge's efficacy and to provide input on what clinical trials designs would be needed to fill any identified evidence gaps (see Online Links, A35). ...