21:18 , Jan 3, 2017 |  BC Week In Review  |  Clinical News

XaraColl regulatory update

FDA issued a refusal to file letter for an NDA from Innocoll for XaraColl bupivacaine collagen-matrix implants to treat postsurgical pain. According to the company, FDA said the NDA was “not sufficiently complete to permit...
00:40 , Nov 22, 2016 |  BC Week In Review  |  Clinical News

XaraColl regulatory update

Innocoll submitted an NDA to FDA for XaraColl bupivacaine collagen-matrix implants to treat post-surgical pain. The company hopes to launch the biodegradable and bioresorbable collagen/bupivacaine matrix developed using CollaRx sponge membrane technology in 2017. Innocoll Holdings...
21:47 , Nov 14, 2016 |  BC Week In Review  |  Clinical News

XaraColl regulatory update

Innocoll submitted an NDA to FDA for XaraColl bupivacaine collagen-matrix implants to treat postsurgical pain. The NDA is based on data from the Phase III MATRIX-1 and MATRIX-2 trials (see BioCentury, May 30). XaraColl is...
07:00 , Oct 3, 2016 |  BioCentury  |  Finance

ASH and others

Cancer and hematology companies are likely to garner the most headlines in 4Q16 thanks to ESMO in October and ASH in December, but some investors also are branching out to events that typically receive less...
07:00 , Jul 11, 2016 |  BioCentury  |  Finance

Rethinking risk

Steve Edelson, Senior Editor   The second half does not contain the high-impact, sector-moving milestones seen in the first six months of the year, but investors still have at least 90 late-stage milestones from which to...
23:28 , Jun 17, 2016 |  BC Extra  |  Financial News

Innocoll raises $40.1M follow-on

Innocoll Holdings plc (NASDAQ:INNL) raised $40.1 million through the sale of 5.7 million shares at $7 in a follow-on underwritten by Morgan Stanley, Piper Jaffray, Stifel, FBR and Janney Montgomery Scott. Innocoll proposed to raise...
07:00 , May 30, 2016 |  BC Week In Review  |  Clinical News

Bupivacaine collagen sponge: Phase III data

Top-line data from the identical, double-blind, U.S. Phase III MATRIX-1 and MATRIX-2 trials each in over 300 patients with unilateral inguinal hernia undergoing open hernioplasty showed that 3 XaraColl implants each containing 100 mg bupivacaine...
00:08 , May 26, 2016 |  BC Extra  |  Clinical News

Innocoll jumps on Phase III data for analgesic implant

Innocoll AG (NASDAQ:INNL) gained $3.40 (48%) to $10.51 after its XaraColl bupivacaine collagen sponge met the primary endpoint in the Phase III MATRIX-1 and MATRIX-2 studies to treat postoperative pain. The company plans to submit...
07:00 , Sep 28, 2015 |  BC Week In Review  |  Clinical News

Bupivacaine collagen sponge: Phase III started

Innocoll began the double-blind, placebo-controlled, U.S. MATRIX-2 trial to evaluate 3 XaraColl implants each containing 100 mg bupivacaine in about 300 patients with a unilateral inguinal hernia undergoing open hernioplasty. Innocoll began the identical MATRIX-1...
07:00 , Apr 13, 2015 |  BC Week In Review  |  Clinical News

Bupivacaine collagen sponge: Clinical trial data

Top-line data from a double-blind, U.S. clinical trial in 62 patients undergoing open laparotomy hernioplasty showed that 200 and 300 mg doses of XaraColl led to peak serum concentrations (Cmax) that were below levels that...