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Clinical Trials

Injectable opioid dependence treatment succeeds in clinical trial

November 15, 2016 By Sarah Faulkner

Camurus, Braeburn Pharmaceuticals

Camarus AB (STO:CAMX) and Braeburn Pharmaceuticals said this week that a late-stage trial of its injectable opioid dependence treatment was successful. CMAX shares surged 16% at the beginning of the week following the announcement. The injectable buprenorphine therapy could be another treatment used to combat the growing opioid epidemic in the United States, which claimed the lives […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Implants, Pharmaceuticals Tagged With: Braeburn Pharmaceuticals, Camarus AB

Clearside Biomedical launches trial for Zuprata

November 15, 2016 By Sarah Faulkner

Clearside Biomedical

Clearside Biomedical (NSDQ:CLSD) said today that it enrolled the 1st patient in clinical trial of its suspension formulation of corticosteroid triamcinolone acetonide, Zuprata, for the treatment of diabetic macular edema. The Alpharetta, Ga.-based company’s Hulk Phase I/II trial is an open-label, multi-center study designed to evaluate the safety and efficacy Zuprata administered in the suprachoroidal space […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Optical/Ophthalmic Tagged With: Clearside Biomedical

Zimmer Biomet touts preliminary data for stem cell therapy

November 15, 2016 By Sarah Faulkner

Zimmer Biomet (NYSE:ZBH) touted data today from an investigational device exemption trial evaluating the use of autologous concentrated bone marrow aspirate for the treatment of critical limb ischemia. The stem cell study is the 1st pivotal trial of its kind to complete enrollment and a 1-year follow-up in a patient population that is ineligible for revascularization, […]

Filed Under: Clinical Trials, Featured, Regulatory/Compliance, Stem Cells Tagged With: Zimmer Biomet

OCUL’s Dextenza meets endpoints in pivotal study

November 14, 2016 By Sarah Faulkner

Ocular Therapeutix

Ocular Therapeutix (NSDQ:OCUL) said today that its post-surgical ocular pain reliever, Dextenza, met both primary endpoints in a pivotal trial for the treatment of post-surgical ocular inflammation and pain. The product is a bioresorbable intracanalicular insert, designed for drug release to the ocular surface for up to 30 days. The randomized, double-masked study enrolled 438 patients who were […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic Tagged With: Ocular Therapeutix

Stanford uses CRISPR to correct sickle cell, human trials planned

November 8, 2016 By Sarah Faulkner

Stanford Medicine

Researchers from the Stanford University School of Medicine have reportedly used CRISPR, a gene-editing tool, to repair the gene that causes sickle cell disease. The team is planning the 1st human clinical trial using this technique to correct cells with sickle cell disease, according to Reuters.  “What we’ve finally shown is that we can do it. It’s […]

Filed Under: Clinical Trials, Featured, Research & Development, Stem Cells Tagged With: Broad Institute, Stanford University, University of California Berkeley

SanBio touts 1-year data on stem cell transplant for stroke

November 4, 2016 By Sarah Faulkner

SanBio touts 1-year data on stem cell transplant for stroke

SanBio Inc. (TYO:4592) released 1-year interim data from the phase 1/2a, open-label, single-arm dose escalation study of its intracerebral stem cell implant designed for stroke patients. The Mountain View, Calif.-based company touted the results, which indicated that itsSB623 stem cell treatment was generally safe, well-tolerated and associated with improved motor functions in patients  suffering with chronic impairment following […]

Filed Under: Clinical Trials, Featured, Neurological, Research & Development, Stem Cells Tagged With: SanBio Inc

Mast Therapeutics touts interim data from pulmonary hypertension study

November 4, 2016 By Sarah Faulkner

Mast Therapeutics subsidiary launches trial for inhaled sodium nitrite solution

Mast Therapeutics (NYSE:MSTX) touted interim data from a Phase II study of its AIR001 candidate in patients with pulmonary hypertension (PH) and PH associated with heart failure with preserved ejection fraction. Positive interim results from the ongoing trial were published in the Journal of Clinical Investigation. The San Diego-based company enrolled 50 patients to study its nebulized […]

Filed Under: Cardiovascular, Clinical Trials, Featured Tagged With: Mast Therapeutics

Stellarex drug-coated balloon from Spectranetics bests PTA at 1 year

November 2, 2016 By Sarah Faulkner

Spectranetics

The Stellarex drug-coated balloon made by Spectranetics (NSDQ:SPNC) beat out percutaneous transluminal angioplasty in the 300-patient Illumenate pivotal study reported today at the 2016 Transcatheter Cardiovascular Therapeutics Symposium. The study followed a complex group of patients over 12 months to evaluate the low-dose balloon’s efficacy and safety. Nearly 50% of the patient population had diabetes, […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured Tagged With: Spectranetics, TCT 2016

NanoViricides inks deal for shingles study

November 1, 2016 By Sarah Faulkner

Nanoviricides inks deal for shingles study

NanoViricides, Inc. (NYSE:NNVC) said today that it inked a deal with SUNY Upstate Medical University for the evaluation of its nanovirivides drug candidates against varicella zoster virus, also called the shingles virus. The goal of these in vitro, ex vivo, and in vivo studies will be to help select a clinical drug development candidate for toxicology and safety evaluation […]

Filed Under: Business/Financial News, Clinical Trials, Featured, Nanoparticles Tagged With: NanoViricides Inc

FDA OKs stem cell-gene therapy trial for ALS

October 28, 2016 By Sarah Faulkner

FDA OKs stem cell, gene therapy trial for ALS

The FDA approved a combination stem cell-gene therapy clinical trial to test the treatment’s ability to slow the progression of amyotrophic lateral sclerosis. It’s the 1st clinical trial to use neural stem cells to deliver a particular protein in the hopes of slowing ALS progression, according to researchers at the ALS clinic at Cedars-Sinai Medical […]

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Stem Cells Tagged With: ALS Association, Cedars-Sinai Medical Center

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