02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
13:15 , Mar 9, 2017 |  BC Week In Review  |  Clinical News

Episalvan: Ph III EASE start

This month, Amryt will begin the double-blind, placebo-controlled, international Phase III EASE trial to evaluate topical Episalvan for 90 days in about 164 patients. Episalvan is approved in the EU to treat partial-thickness wounds. Amryt...
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...