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Clinical Trial News

This section provides information about recently completed clinical trials. If you cannot find information about a particular clinical trial, you should note that results may not be available even after the trial ends. Some trials end before completion and results are never published.

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Ultragenyx Granted Orphan Drug Designation for Triheptanoin for Glucose Transporter Type-1 Deficiency Syndrome

Posted 2 days ago in Clinical Trials

NOVATO, CA – October 27, 2014 – Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that the FDA Office of Orphan Products Development has granted orphan drug designation for triheptanoin (UX007) for the treatment of glucose transporter type-1 deficiency syndrome (Glut1 DS). Glut1 DS, also known as De...

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Synergy Pharmaceuticals Presents Positive Phase 2b Study Results for Plecanatide in IBS with Constipation

Posted 8 days ago in Clinical Trials

NEW YORK--October 21, 2014 -- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced the presentation of results from a phase 2b dose-ranging study assessing plecanatide’s safety and efficacy in 424 adult patients (mITT population= 423) with irritable bowel syndrome with constipation (IBS-C). Data presented at ACG demonstrate that plecanatide, once-daily oral tablet, significantly improved complete spontaneous...

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CytRx Announces Publication of Phase 1b/2 Aldoxorubicin Clinical Data

Posted 9 days ago in Clinical Trials

LOS ANGELES, Oct. 20, 2014 /PRNewswire/ -- CytRx Corporation (CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that a paper, titled "A Phase 1b/2 Study of Aldoxorubicin in Patients With Soft Tissue Sarcoma," has been published online in Cancer, the prestigious, peer-reviewed journal of the American Cancer Society. The paper discusses results from CytRx's...

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Sanofi And Regeneron Announce Start Of Phase 3 Study Of Dupilumab in Patients With Atopic Dermatitis

Posted 9 days ago in Clinical Trials

TARRYTOWN, N.Y. and PARIS, October 20, 2014 – Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis (AD) that is not adequately controlled with topical AD medications. LIBERTY AD CHRONOS, the first trial in the...

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US FDA Accepts for Review a BLA for Merck and Sanofi Pasteur’s Investigational Pediatric Hexavalent Vaccine

Posted 9 days ago in Clinical Trials

WHITEHOUSE STATION, N.J. & SWIFTWATER, Pa.--(BUSINESS WIRE) October 20, 2014 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT:SAN and NYSE:SNY), announced today that the Biologics License Application (BLA) filed for the companies’ investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB1, has been accepted for review by...

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Bristol-Myers Squibb Statement about Asunaprevir in the U.S

Posted 3 weeks ago in Clinical Trials

PRINCETON, N.J., October 7, 2014 --(BUSINESS WIRE)--Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb (NYSE:BMY) has decided that it will not pursue U.S. Food and Drug Administration (FDA) approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application...

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Zafgen Announces Initiation of Phase 3 Trial of Beloranib in Prader-Willi Syndrome

Posted 4 weeks ago in Clinical Trials

BOSTON, Oct. 1, 2014 (GLOBE NEWSWIRE) -- Zafgen, Inc., a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that the Company has initiated the first Phase 3 clinical trial, in the United States, with its lead product candidate, beloranib, in the treatment of Prader-Willi syndrome (PWS). PWS is a...

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Ardelyx Reports Positive Results from I ts Phase 2b Clinical Trial Evaluating Tenapanor

Posted 4 weeks ago in Clinical Trials

Fremont , CA, October 1, 2014 – Ardelyx , Inc., a clinical-stage biopharmaceutical company focused on cardio-renal, gastrointestinal and metabolic diseases, today announced positive results from its 371 patient Phase 2b clinical trial evaluating tenapanor in patients with constipation-predominant irritable bowel syndrome (IBS-C). Results from this study demonstrated statistically...

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XOMA Initiates Clinical Trial of Gevokizumab in Patients With Behcet's Disease Uveitis

Posted 4 weeks ago in Clinical Trials

BERKELEY, Calif., Sept. 30, 2014 (GLOBE NEWSWIRE) -- XOMA Corporation, a leader in the discovery and development of therapeutic antibodies, today announced that its EYEGUARD-US supplemental clinical study is open for enrollment to patients at study sites located in the United States. The objective of this trial is to assess the efficacy and safety of gevokizumab in treating Behçet's disease uveitis. "To ensure...

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Sanofi and Regeneron Announce Positive Phase 2 Top-line Dupilumab Results in Patients with Chronic Sinusitis with Nasal Polyps

Posted 4 weeks ago in Clinical Trials

Paris and Tarrytown, N.Y. – September 30, 2014 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that a Phase 2a proof-of-concept study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, met all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps (CSwNP) who did not respond to intranasal corticosteroids. “These data...

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Hemispherx Biopharma Expands Research on Potential Ebola Treatments to Five Independent Experts/Institutional Collaborators

Posted 4 weeks ago in Clinical Trials

Philadelphia, PA, Monday, September 29, 2014: Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the “Company” or “Hemispherx”), announced today a widened set of research collaborations designed to develop therapeutic cocktails against Ebola which may potentially overcome the emergence of drug resistance due to Ebola virus mutation. The rapid acquisition of Ebola virus (EBOV) sequence variation has been recently...

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Catalyst Pharmaceuticals Announces Positive Top-Line Phase 3 Data From Pivotal Firdapse Clinical Trial

Posted 4 weeks ago in Clinical Trials

CORAL GABLES, Fla., Sept. 29, 2014 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc., (Catalyst Pharmaceuticals), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced positive top-line results from the pivotal Phase 3 clinical trial of Firdapse™ (amifampridine phosphate tablets equivalent to 10 mg...

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FDA Approves NeuroGenetic Pharmaceuticals Application To Begin Clinical Trials for NGP 555

Posted 4 weeks ago in Clinical Trials

SAN DIEGO, Sept. 29, 2014 – The U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application from NeuroGenetic Pharmaceuticals, Inc. (NGP) to begin clinical trials on its NGP 555 compound to treat and prevent Alzheimer’s disease (AD). The approval follows successful completion of all preclinical phases under a fast-track grant from the National Institute of Neurologic...

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Gilead’s Investigational Tenofovir Alafenamide (TAF)-Based Single Tablet HIV Regimen Meets 48-Week Primary Objective in Two Phase 3 Studies

Posted 5 weeks ago in Clinical Trials

FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 24, 2014-- Gilead Sciences, Inc. today announced that two Phase 3 clinical trials (Studies 104 and 111) evaluating an investigational once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults met their primary objectives. The studies demonstrated that the single tablet regimen comprising...

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MediciNova Provides Update on Phase 2b Trial of MN-166 (ibudilast) in Progressive MS

Posted 5 weeks ago in Clinical Trials

LA JOLLA, Calif., Sept. 23, 2014 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that, as of September 15, 2014, the ongoing Phase 2b trial of MN-166 (ibudilast) in progressive multiple sclerosis (MS) had enrolled 150 of the 250 subjects planned to be enrolled. ...

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Acceleron Provides Update on Clinical Trial of Dalantercept Monotherapy in Ovarian Cancer

Posted 5 weeks ago in Clinical Trials

CAMBRIDGE, Mass.- September 23, 2014 -- Acceleron Pharma Inc., a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases, today announced results from an interim report for a two-part clinical study sponsored by the Gynecology Oncology Group evaluating dalantercept as monotherapy in patients with recurrent or...

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Minerva Neurosciences Announces Completion of FDA Review of Investigational NDA for MIN-202

Posted 5 weeks ago in Clinical Trials

CAMBRIDGE, Mass., Sept. 22, 2014 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc., a leader in the development of new therapies to treat neuropsychiatric diseases and disorders, today announced that the U.S. Food and Drug Administration has completed its review of the Investigational New Drug Application for MIN-202, the Company's selective antagonist for the orexin-2 receptor in development for the treatment of...

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Gilead Announces Data From Phase 2 Study of Simtuzumab for Previously Untreated Pancreatic Cancer

Posted 6 weeks ago in Clinical Trials

FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 17, 2014-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced results from a Phase 2 study evaluating simtuzumab, an investigational inhibitor of lysyl oxidase-like-2 (LOXL2), in combination with gemcitabine for patients with previously untreated advanced pancreatic cancer. In the study, the addition of simtuzumab (200 mg or 700 mg) to gemcitabine did not significantly...

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Achaogen Announces First Patient Enrollment in a Phase 3 Clinical Trial of Plazomicin

Posted 6 weeks ago in Clinical Trials

SOUTH SAN FRANCISCO, Calif., Sept. 17, 2014 -- Achaogen, Inc., a clinical-stage biopharmaceutical company developing novel antibacterials to treat multi-drug resistant (MDR) gram-negative infections, announced today that the first patient has been enrolled in a Phase 3 clinical trial of plazomicin to treat infections caused by carbapenem-resistant Enterobacteriaceae (CRE). The Phase 3 clinical trial is designed to...

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TG Therapeutics Announces SPA Agreement With FDA for Phase 3 Clinical Trial of TG-1101 (ublituximab) with Imbruvica

Posted 6 weeks ago in Clinical Trials

NEW YORK, Sept. 15, 2014 -- TG Therapeutics, Inc. announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design, endpoints and statistical analysis approach of a Phase 3 clinical trial for TG-1101 (ublituximab), its glycoengineered anti-CD20 monoclonal antibody, in combination with Imbruvica® (ibrutinib) for the...

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