08:00 , Dec 7, 2015 |  BC Week In Review  |  Clinical News

Episalvan oleogel-S10 regulatory update

EMA’s CHMP recommended approval of Episalvan from Birken to treat partial thickness wounds in adults. The product is an ointment containing dry extract from birch bark and sunflower oil. Birken AG , Niefern-Oeschelbronn, Germany  ...
08:00 , Nov 10, 2014 |  BC Week In Review  |  Clinical News

Oleogel-S10 regulatory update

Birken said EMA accepted for review an MAA for Oleogel-S10 to accelerate healing in patients with partial thickness wounds. Birken expects a decision around year end 2015, with a potential launch in 1H16. The ointment...
07:00 , Sep 22, 2014 |  BC Week In Review  |  Clinical News

Oleogel-S10: Phase III data

Data from 3 open-label, European Phase III trials in 280 patients total showed that Oleogel-S10 met the primary endpoint in each of the trials of faster wound healing compared to standard of care (SOC) consisting...