Clinical Intelligence

CTI Clinical Trial and Consulting Services, Galectin Therapeutics collaborate

Thursday, June 13, 2013 02:03 PM

CTI Clinical Trial and Consulting Services (CTI), an international drug and device development organization, will collaborate with Galectin Therapeutics on a first-in-man phase I clinical trial  of GR-MD-02 for treatment of non-alcoholic steatohepatitis (NASH) with advanced fibrosis.

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Abbott initiates trial to evaluate Absorb BVS

Thursday, June 13, 2013 12:00 PM

Abbott has announced the initiation of the Absorb Japan randomized, controlled clinical trial to evaluate the Absorb Bioresorbable Vascular Scaffold (BVS) in patients with coronary artery disease (CAD), the most common form of heart disease. The results of this trial will support regulatory filings with the Japanese Pharmaceutical and Medical Devices Agency (PMDA) for approval of Absorb BVS in Japan.

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Viatronix V3D-Colon software used in trial

Wednesday, June 12, 2013 02:44 PM

Viatronix, a maker of non-invasive 2D/3D medical imaging and diagnostic software, said its dedicated CT Colonography (CTC) software, V3D-Colon, was exclusively used in a clinical study relating to colorectal cancer screening. The latest CTC study tracked polyp growth in 243 patients over an eight-year period.

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BioAlliance Pharma initiates phase II trial of Validive

Tuesday, June 11, 2013 04:04 PM

BioAlliance Pharma, a developer of orphan oncology products and supportive care products, initiated its phase II clinical trial evaluating the efficacy and safety of Validive (clonidine Lauriad) in the U.S. in patients with chemoradiation therapy-induced oral mucositis with head and neck cancer.

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BDSI to file NDA for Bunavail

Monday, June 10, 2013 11:49 AM

BioDelivery Sciences International (BDSI) had a positive pre-New Drug Application (NDA) meeting with the FDA regarding Bunavail for the maintenance treatment of opioid dependence.

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HemaQuest completes enrollment in phase IIb study

Monday, June 10, 2013 11:48 AM

HemaQuest Pharmaceuticals, a biotechnology company focused on developing small molecule therapeutics to treat hemoglobin disorders, has completed enrollment in a randomized, double-blind, placebo-controlled phase IIb study of HQK-1001 in patients with sickle cell disease.

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Cohera Medical completes enrollment of No-Drain Study

Friday, June 7, 2013 02:09 PM

Cohera Medical, a developer of absorbable surgical adhesives and sealants, has completed enrollment for its U.S. No-Drain Study for its lead product, TissuGlu Surgical Adhesive. The study has enrolled 130 patients at five centers in the U.S. and is investigating the safety and effectiveness of TissuGlu in the reduction of wound drainage, seroma development and other complications in abdominoplasty patients without the use of postoperative drains.

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Boston Scientific, PFDN collaborate on Uterine Prolapse treatment

Friday, June 7, 2013 02:03 PM

Global medical technology company Boston Scientific provided a research and education grant of more than $1 million to the Pelvic Floor Disorders Network (PFDN) for the SUPeR clinical trial.  The SUPeR study will evaluate treatment outcomes of two different surgical options for women with uterine prolapse, a form of pelvic organ prolapse. PFDN is funded by the NIH.

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Sinovac files NDA for EV71 vaccine

Tuesday, June 4, 2013 08:07 AM

Sinovac Biotech’s NDA for its proprietary EV71 vaccine has been accepted by the Beijing Drug Administration, which will conduct an on-site inspection of Sinovac's clinical trials and submit its  opinion along with the application documentations to the Centers for Drug Evaluation (CDE) of the China Food and Drug Administration (CFDA) for further review and evaluation.

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The CenterWatch Monthly, June 2013

Monday, June 3, 2013 09:24 AM

Operating environment spurs out-of-the-box ideas

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