21:50 , Apr 20, 2017 |  BC Week In Review  |  Clinical News

Xiaflex: Ph I started

BioSpecifics Technologies began an open-label, dose-escalation, sham-controlled, U.S. Phase I trial to evaluate single doses of 0.05, 0.1, 0.2 and 1.16 mg Xiaflex injected directly into the fibroid prior to hysterectomy in about 15 patients....
11:39 , Dec 1, 2016 |  BC Week In Review  |  Clinical News

Xiaflex: Ph IIa data

A double-blind, U.S. and Australian Phase IIa trial in 75 patients with Dupuytren’s disease and ≥1 palmar nodule showed that a single injection of Xiaflex significantly reduced mean nodule surface area, consistency score and hardness...
08:00 , Feb 22, 2016 |  BC Week In Review  |  Clinical News

Xiaflex: Phase IIb started

Endo began a placebo-controlled, U.S. Phase IIb trial to evaluate 0.84 mg collagenase clostridium histolyticum per session for up to 3 sessions about 21 days apart in about 350 women ages >=18. Patients will receive...
08:00 , Nov 23, 2015 |  BC Week In Review  |  Clinical News

Xiaflex regulatory update

The European Commission approved a label expansion for Xiapex collagenase clostridium histolyticum from Swedish Orphan to treat 2 palpable cords concurrently in adults with Dupuytren’s contracture, which affects joints in the hand. The injectable form...
08:00 , Nov 23, 2015 |  BioCentury  |  Analyst Picks & Changes

Analyst picks & changes

Analyst picks & changes Analyst picks & changes Company Bank Analyst Coverage Opinion Wk chg 11/20 cls Clovis Oncology Inc. (NASDAQ:CLVS) Mizuho Eric Criscuolo Downgrade Neutral (from buy) -73% $26.41 Criscuolo also lowered his target...
07:00 , Oct 5, 2015 |  BC Week In Review  |  Company News

BioSpecifics, Endo, Swedish Orphan Biovitrum sales and marketing update

NICE issued final draft guidance recommending against Xiapex collagenase clostridium histolyticum from Swedish Orphan to treat Dupuytren’s contracture in adult patients with a palpable cord. The agency said it recommends the injectable form of collagenase...
07:00 , Jul 27, 2015 |  BC Week In Review  |  Clinical News

Xiaflex regulatory update

BioSpecifics said Japan approved Xiaflex collagenase clostridium histolyticum to treat Dupuytren’s contracture. BioSpecifics is eligible for a milestone payment upon launch of Xiaflex in Japan, where Asahi Kasei has exclusive rights to develop and commercial...
07:00 , Mar 23, 2015 |  BC Week In Review  |  Clinical News

Xiaflex collagenase clostridium histolyticum regulatory update

The U.K.’s NICE issued a final appraisal determination (FAD) recommended against Xiapex collagenase clostridium histolyticum from Swedish Orphan to treat Dupuytren’s contracture in adult patients with a palpable cord only in the context of research....
08:00 , Feb 9, 2015 |  BC Week In Review  |  Clinical News

Xiaflex collagenase clostridium histolyticum regulatory update

The European Commission approved Xiapex collagenase clostridium histolyticum from Swedish Orphan to treat Peyronie’s disease with a palpable plaque and curvature deformity of 30 degrees. The injectable form of collagenase is also approved in the...
08:00 , Jan 19, 2015 |  BC Week In Review  |  Clinical News

Xiaflex collagenase clostridium histolyticum regulatory update

EMA’s CHMP recommended expanding the label of Xiapex collagenase clostridium histolyticum from Swedish Orphan to include the treatment of Peyronie’s disease with a palpable plaque and curvature deformity of >=30 degrees. The injectable form of...