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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.

Cipher Pharmaceuticals Announces Successful Completion of Second Phase III for Ozenoxacin

Posted yesterday in Clinical Trials

MISSISSAUGA, ON, July 30, 2015 /CNW/ - Cipher Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) ("Cipher" or "the Company") today announced that Ferrer International SA ("Ferrer") successfully completed the second phase III clinical trial for Ozenoxacin, a topical treatment for adult and paediatric patients with impetigo, a highly contagious bacterial skin infection. Cipher acquired the Canadian commercialization rights...

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Vaccine Candidate Potentially Effective Against Ebola in Large Trial in Guinea

Posted 3 days ago in Clinical Trials

AMES, Iowa, July 31, 2015 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (NASDAQ:NLNK) today announced that the international partnership studying the VSV-ZEBOV (Ebola) vaccine candidate in Guinea has released interim data suggesting that it is effective against Ebola in a large clinical trial. According to the announcement, the interim results suggest that the vaccine candidate demonstrates efficacy within about...

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KaloBios Announces FDA Clearance of Investigational New Drug Application for KB003 in Patients with Chronic Myelomonocytic Leukemia

Posted 5 days ago in Clinical Trials

SOUTH SAN FRANCISCO, July 29, 2015 /PRNewswire/ -- KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO), a monoclonal antibody company focused on developing innovative therapies to benefit patients with diseases of unmet medical need, with a focus on oncology, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company's investigational new drug (IND) application for KB003, an anti-GM-CSF...

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Sanofi Announces That First LixiLan Phase III Study Met Primary Endpoint

Posted 5 days ago in Clinical Trials

PARIS, July 29, 2015 /PRNewswire/ -- Sanofi announced today that the LixiLan-O Phase III clinical trial met its primary objective in patients with type 2 diabetes treated with metformin. The fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide, a GLP-1 RA, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with lixisenatide and...

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Ignyta Announces FDA Clearance of IND for RXDX-107

Posted 5 days ago in Clinical Trials

SAN DIEGO, July 29, 2015 --(BUSINESS WIRE)-- Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for Ignyta's new chemical entity RXDX-107, a next-generation alkyl ester of bendamustine encapsulated in human serum albumin (HSA) to form nanoparticles. Under this IND, the...

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Lilly Provides Update On Evacetrapib Phase 3 Trial

Posted 7 days ago in Clinical Trials

INDIANAPOLIS, July 27, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has accepted the recommendation of the ACCELERATE study data monitoring committee to continue the Phase 3 trial of the investigational medicine evacetrapib, based on data from an interim futility analysis. Last patient visit in ACCELERATE – which is evaluating evacetrapib in approximately 12,000 patients with high-risk atherosclerotic...

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Sunesis Pharmaceuticals Announces Regulatory Update for Qinprezo (vosaroxin)

Posted 11 days ago in Clinical Trials

SOUTH SAN FRANCISCO, Calif., July 23, 2015 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced regulatory updates from its interactions with the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) regarding a potential path toward marketing authorization for vosaroxin as a treatment for acute myeloid leukemia (AML) in Europe and the United States. With respect...

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AstraZeneca Provides Update on Selumetinib in Uveal Melanoma

Posted 12 days ago in Clinical Trials

Wednesday, 22 July 2015 -- AstraZeneca today announced that the Phase III SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A...

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Data Using New Delayed-Start Methodology Suggested Benefit Of Early Treatment With Solanezumab In Patients With Mild Alzheimer's Disease

Posted 12 days ago in Clinical Trials

INDIANAPOLIS, July 22, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced results suggesting the treatment effect of solanezumab was preserved within a pre-specified amount in patients with mild Alzheimer's disease who received solanezumab earlier in the disease compared to patients who began treatment at a later point. These results were from a pre-specified secondary analysis of the Phase 3...

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BMS Receives FDA Breakthrough Therapy Designation for Investigational HIV-1 Attachment Inhibitor

Posted 13 days ago in Clinical Trials

PRINCETON, N.J., July 21, 2015 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational compound BMS-663068 when used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral...

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Cytokinetics Announces Start of Phase 3 Clinical Trial of Tirasemtiv in Patients with ALS

Posted 2 weeks ago in Clinical Trials

South San Francisco, CA - July 14, 2015 -- Cytokinetics, Inc. (Nasdaq: CYTK), a leading muscle biology company, today announced the start of VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS), a Phase 3 clinical trial designed to assess the effects of tirasemtiv versus placebo on slow vital capacity (SVC) and other measures of respiratory...

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Corbus Pharmaceuticals Announces Dosing of First Patient in Phase 2 Clinical Trial of Resunab for the Treatment of Dermatomyositis

Posted 2 weeks ago in Clinical Trials

NORWOOD, MA -- (Marketwired) -- 07/13/15 -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic, and serious inflammatory and fibrotic diseases, announced today that patient dosing has commenced in a Phase 2 clinical study of its investigational drug Resunab for the treatment of skin-predominant dermatomyositis. The...

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In a Pivotal Study, Genentech’s Investigational Immunotherapy Atezolizumab Shrank Tumors in People With a Specific Type of Bladder Cancer

Posted 3 weeks ago in Clinical Trials

South San Francisco, CA -- July 12, 2015 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that in the IMvigor 210 study, the investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL1) shrank tumors (objective response rate; ORR; the primary end point of this Phase II study) in people with locally advanced or metastatic urothelial bladder cancer (UBC) who had...

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Novo Nordisk Successfully Completes First Phase 3a Trial with Semaglutide in People with Type 2 Diabetes

Posted 3 weeks ago in Clinical Trials

Bagsværd, Denmark, 10 July 2015 - Novo Nordisk today announced the headline results from SUSTAIN1, the first phase 3a trial for semaglutide, a new GLP-1 analogue administered once-weekly. The trial investigated the efficacy and safety of 0.5 mg and 1.0 mg semaglutide as monotherapy during 30 weeks of treatment compared with placebo in 388 people with type 2 diabetes previously on diet and exercise. The trial...

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Phase 2B Findings Published In The NEJM Demonstrate Significant Efficacy Of Guselkumab In Treatment Of Moderate To Severe Plaque Psoriasis

Posted 3 weeks ago in Clinical Trials

Spring House, Pa., July 9, 2015 ― Results published today in The New England Journal of Medicine from a Janssen Research & Development, LLC (Janssen)-sponsored Phase 2b trial showed up to 86 percent of patients with moderate to severe plaque psoriasis receiving guselkumab (CNTO 1959) achieved a Physician’s Global Assessment (PGA) score of cleared psoriasis or minimal psoriasis at week 16, the study’s primary...

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Lilly Statement On FDA Advisory Committee Review Of Necitumumab

Posted 3 weeks ago in Clinical Trials

INDIANAPOLIS, July 9, 2015 /PRNewswire/ -- The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) met today to discuss the data supporting Eli Lilly and Company's (NYSE: LLY) necitumumab in combination with gemcitabine and cisplatin for use in first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC). Squamous NSCLC is a devastating and...

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Cempra Completes Patient Enrollment of Solitaire-IV Phase 3 Clinical Trial

Posted 3 weeks ago in Clinical Trials

CHAPEL HILL, N.C., July 7, 2015 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced the completion of enrollment for the global Solitaire-IV Phase 3 trial of solithromycin in adult patients with moderate to moderately severe community-acquired...

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Pfizer Begins Phase 2b Study Of Its Investigational Multi-antigen Staphylococcus aureus Vaccine In Adults Undergoing Elective Spinal Fusion Surgery

Posted 3 weeks ago in Clinical Trials

Tuesday, July 7, 2015 - Pfizer Inc. (NYSE: PFE) announced today enrollment of the first patient in a Phase 2b clinical trial of its investigational Staphylococcus aureus (S. aureus) multi-antigen vaccine (PF-06290510) in adults undergoing elective spinal fusion surgery. The purpose of the study, named STRIVE (STaphylococcus aureus SuRgical Inpatient Vaccine Efficacy), is to evaluate the safety and efficacy of the...

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Study Shows Novel HIV Vaccine Regimen Provides Robust Protection in Non-Human Primates

Posted 4 weeks ago in Clinical Trials

BOSTON, July 5, 2015 -– A new study led by scientists at Beth Israel Deaconess Medical Center (BIDMC) demonstrates that a heterologous prime-boost HIV-1 vaccine regimen protected 50 percent of vaccinated non-human primates (NHPs) against challenges with the simian immunodeficiency virus (SIV), a virus similar to HIV that infects NHPs. Published today in the online edition of Science, these findings provide a new...

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MediciNova Announces the Completion of Enrollment in Clinical Trial of MN-166 (ibudilast) in Alcohol Dependence

Posted 4 weeks ago in Clinical Trials

LA JOLLA, Calif., June 30, 2015 (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 the clinical trial of MN-166 (ibudilast) in alcohol dependence has completed enrollment of 24 subjects. Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of...

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