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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.

Pivotal Study Results Showed Talimogene Laherparepvec Improved Durable Response Rates in Patients With Metastatic Melanoma

Posted 3 days ago in Clinical Trials

THOUSAND OAKS, Calif., May 26, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the publication of primary results from the Phase 3 OPTiM study in the Journal of Clinical Oncology (JCO). The data published in JCO, which were previously presented at the Annual Meetings of the American Society of Clinical Oncology (ASCO) in 2013 and 2014, demonstrated a significantly higher durable response rate (DRR) in...

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Amgen to Terminate Participation in Co-Development and Commercialization of Brodalumab

Posted 6 days ago in Clinical Trials

THOUSAND OAKS, Calif., May 22, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Company has commenced termination of its participation in the co-development and commercialization of brodalumab with AstraZeneca (LON:AZN, STO:AZN and NYSE:AZN). Brodalumab, an investigational IL-17 inhibitor, is in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial...

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Cardiorentis Completes Enrollment in Pivotal Phase III Clinical Trial of Ularitide for Acute Heart Failure

Posted 6 days ago in Clinical Trials

ZUG, Switzerland – May 22, 2015 – Cardiorentis AG, a privately held biopharmaceutical company, today announced that it has completed enrollment in TRUE-AHF, its pivotal Phase III clinical trial for the treatment of acute heart failure (AHF). The TRUE-AHF Phase III trial was initiated in August 2012. Led by principal investigator Milton Packer, M.D., University Texas, Southwestern Medical Center in Dallas,...

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Intellipharmaceutics Intends to Accelerate its Rexista Oxycodone XR Development Program on the Basis of Positive Feedback from the FDA

Posted 7 days ago in Clinical Trials

TORONTO, May 21, 2015 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the United States Food and Drug Administration ("FDA") provided the Company with...

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Sanofi And Regeneron Announce Positive Topline Results From Phase 3 Studies With Sarilumab In Rheumatoid Arthritis

Posted 8 days ago in Clinical Trials

Paris and Tarrytown, New York - May 21, 2015 - Sanofi and Regeneron Pharmaceuticals, Inc. announced today that a Phase 3 study of sarilumab, an investigational, fully-human IL6 receptor antibody, met its co-primary efficacy endpoints of a greater improvement in signs and symptoms of rheumatoid arthritis (RA) at 24 weeks, and physical function at 12 weeks compared to placebo. The study, called SARIL-RA-TARGET,...

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BMS Receives Amended U.S. FDA Breakthrough Therapy Designation for Investigational Daclatasvir-based Hepatitis C Regimen

Posted 9 days ago in Clinical Trials

PRINCETON, N.J., May 20, 2015 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has amended a previously granted Breakthrough Therapy Designation for the investigational daclatasvir and sofosbuvir combination for use in hepatitis C (HCV) patients. The updated Designation reflects recently presented data on HCV genotype 1 patients with advanced...

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Novartis Investigational Dual Bronchodilator QVA149 (indacaterol/glycopyrronium) Significantly Improved Lung Function Compared to Single Bronchodilators in COPD

Posted 9 days ago in Clinical Trials

EAST HANOVER, N.J., May 20, 2015 Today, Novartis announced for the first time detailed results from its phase III EXPEDITION trial program for QVA149 (indacaterol/glycopyrronium) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In the US, QVA149 and glycopyrronium (NVA237) are currently investigational. The findings were presented at the American Thoracic Society (ATS) International...

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Intercept Pharmaceuticals Announces Pivotal Phase 3 Clinical Trial of Obeticholic Acid in NASH

Posted 9 days ago in Clinical Trials

NEW YORK, May 19, 2015 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept) today announced its plans for an international Phase 3 trial of obeticholic acid (OCA), the company's lead FXR agonist, in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. OCA has received breakthrough therapy designation in this patient population from the U.S. Food and Drug...

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Ardelyx Presents Positive Results from Its Phase 2b Clinical Trial Evaluating Tenapanor in IBS-C

Posted 9 days ago in Clinical Trials

FREMONT, Calif., May 19, 2015 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused on cardio-renal, gastrointestinal, and metabolic diseases, today presented Phase 2b clinical trial results that demonstrated statistically significant and clinically meaningful improvement in IBS-C symptoms for tenapanor-treated patients compared to patients receiving placebo. As previously...

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Regeneron and Sanofi Announce Positive Pivotal Phase 2b Dupilumab Data in Asthma

Posted 11 days ago in Clinical Trials

TARRYTOWN, N.Y. and PARIS, May 18, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today shared positive results from an interim analysis of a pivotal Phase 2b study of dupilumab in adult patients with moderateto-severe asthma, who are uncontrolled despite treatment with inhaled corticosteroids and long-acting beta agonists (ICS/LABA). As previously reported, the study met its primary...

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Amgen Presents First Phase 2 Data For AMG 334 In The Prevention Of Episodic Migraine

Posted 13 days ago in Clinical Trials

THOUSAND OAKS, Calif., May 15, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the first results from its global Phase 2, double-blind, placebo-controlled study evaluating the efficacy and safety of AMG 334 for the prevention of episodic migraine. The study met its primary endpoint of reducing monthly mean migraine days compared with placebo. The data were presented at the 17th Congress of the International...

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Genentech’s Investigational Medicine Alectinib Shrank Tumors in Nearly Half of People with Specific Type of Lung Cancer

Posted 2 weeks ago in Clinical Trials

South San Francisco, CA -- May 13, 2015 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from two pivotal studies (NP28673 and NP28761) that showed alectinib, its oral investigational anaplastic lymphoma kinase (ALK) inhibitor, shrank tumors (overall response rate; ORR: 50.0 percent and 47.8 percent, respectively) in people with advanced ALK-positive non-small...

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Tonix Pharmaceuticals Launches Phase 3 Clinical Study of TNX-102 SL in Fibromyalgia

Posted 2 weeks ago in Clinical Trials

NEW YORK, May 13, 2015 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) ("Tonix") announced today that it has begun a Phase 3 clinical study of TNX-102 SL (cyclobenzaprine HCl sublingual tablet, 2.8 mg) in fibromyalgia, having recently randomized the first patient. The study is expected to enroll approximately 500 patients with fibromyalgia at approximately 35 clinical centers in the U.S. The...

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Takeda Announces First Patient Enrolled in Global Phase 3 Study of Ixazomib as Maintenance Therapy for Newly Diagnosed Multiple Myeloma

Posted 2 weeks ago in Clinical Trials

Cambridge, MA, and Osaka, Japan, May 12, 2015 – Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the first patient has been enrolled in the Phase 3 TOURMALINE-MM4 study of investigational oral ixazomib. This is a superiority study designed to demonstrate whether sustained proteasome inhibition, delivered orally, improves the long term clinical outcomes of people living with multiple...

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Takeda Announces Termination of Alisertib Phase 3 Trial in Relapsed or Refractory Peripheral T-cell Lymphoma

Posted 2 weeks ago in Clinical Trials

Cambridge, MA, May 12, 2015 and Osaka, Japan, May 13, 2015 – Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that it has decided to discontinue the Phase 3 trial of alisertib (MLN8237) for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) following the results of a pre-specified interim analysis that indicated the study is unlikely to meet the primary endpoint of superior...

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Zafgen Presents Positive Safety and Efficacy Data From Phase 2 Trial of Beloranib in Severe Obesity

Posted 3 weeks ago in Clinical Trials

PRAGUE, Czech Republic, May 8, 2015 (GLOBE NEWSWIRE) -- Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced positive efficacy and safety data from its ZAF-201 Phase 2 trial of beloranib, a MetAP2 inhibitor, in obese patients. The Company also announced efficacy and...

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SteadyMed Submits Application for Orphan Drug Designation for Trevyent

Posted 3 weeks ago in Clinical Trials

SAN RAMON, Calif., May 7, 2015 (GLOBE NEWSWIRE) -- SteadyMed Ltd. (Nasdaq:STDY) a specialty pharmaceutical company, today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for its lead drug product candidate, Trevyent, for the treatment of pulmonary arterial hypertension (PAH). The FDA has acknowledged receipt of the application and will notify...

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Investigational Medicine Venetoclax Receives Breakthrough Therapy Designation

Posted 3 weeks ago in Clinical Trials

NORTH CHICAGO, Ill., May 6, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy Designation by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with...

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Ardelyx Reports Results from Phase 2a Clinical Trial Evaluating Tenapanor

Posted 3 weeks ago in Clinical Trials

FREMONT, Calif., May 5, 2015 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused on cardio-renal, gastrointestinal, and metabolic diseases, today announced that a 154-patient Phase 2a clinical trial evaluating tenapanor in Stage 3 chronic kidney disease patients with type 2 diabetes mellitus and albuminuria did not meet the primary endpoint of decreasing the urinary...

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Retrophin Receives FDA Orphan Drug Designation for RE-024 for the Treatment of Pantothenate Kinase-Associated Neurodegeneration

Posted 3 weeks ago in Clinical Trials

SAN DIEGO, May 5, 2015--(BUSINESS WIRE)-- Retrophin, Inc. (NASDAQ:RTRX) today announced RE-024, the Company's investigational phosphopantothenate replacement therapy, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pantothenate kinase-associated neurodegeneration (PKAN). PKAN is a rare and lethal autosomal recessive neurodegenerative disorder believed to...

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