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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Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab

Posted 2 days ago in Clinical Trials

THOUSAND OAKS, Calif. and LONDON, Nov. 25, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and AstraZeneca (NYSE: AZN) today announced that AMAGINE-2TM, a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara® (ustekinumab) and placebo at week 12. Brodalumab 210 mg given every two...

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Avaxia Biologics Receives FDA Orphan Drug Designation for AVX-470 for Pediatric Ulcerative Colitis

Posted 3 days ago in Clinical Trials

LEXINGTON, Mass. – November 21, 2014 – Avaxia Biologics, Inc., a clinical stage biopharmaceutical company developing gut-targeted antibody therapeutics for gastrointestinal diseases, announced today that the US Food and Drug Administration (FDA) granted Orphan Drug Designation to AVX-470 for the treatment of pediatric ulcerative colitis. AVX-470 is a gut-targeted anti-TNF antibody, which earlier this year...

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Amgen Announces Termination Of All Amgen-Sponsored Clinical Studies Of Rilotumumab In Advanced Gastric Cancer

Posted 3 days ago in Clinical Trials

THOUSAND OAKS, Calif., Nov. 24, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the termination of all Amgen-sponsored clinical studies of rilotumumab in advanced gastric cancer, including the Phase 3 RILOMET-1 and RILOMET-2 studies. Amgen's decision is based on a planned safety review by the RILOMET-1 independent data monitoring committee that found an increase in the number of deaths in the rilotumumab...

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Merck and NewLink Genetics Enter Into Licensing and Collaboration Agreement for Investigational Ebola Vaccine

Posted 3 days ago in Clinical Trials

WHITEHOUSE STATION, N.J. & AMES, IA, November 24, 2014 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, and NewLink Genetics Corporation (NASDAQ:NLNK), announced today that they have entered into an exclusive worldwide license agreement to research, develop, manufacture, and distribute NewLink’s investigational rVSV-EBOV (Ebola) vaccine candidate. The vaccine candidate, originally...

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OncoMed Presents New Clinical and Biomarker Data From Its Tarextumab and Demcizumab Clinical Trials

Posted 7 days ago in Clinical Trials

BARCELONA, Spain and REDWOOD CITY, Calif., Nov. 21, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, presented data in two posters highlighting the company's translational research and biomarker efforts for its tarextumab (anti-Notch2/3, OMP-59R5) and demcizumab (anti-DLL4,...

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Results from Phase III Trials Show That Alirocumab Significantly Reduced LDL Cholesterol

Posted 9 days ago in Clinical Trials

Paris and Tarrytown, New York - November 19, 2014 - Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new detailed positive results from six Phase 3 ODYSSEY trials that showed alirocumab significantly reduced low-density lipoprotein cholesterol (LDL-C, or “bad” cholesterol). Alirocumab is an investigational fully human monoclonal antibody targeting the protein PCSK9 (proprotein convertase...

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CytRx Announces Partial Clinical Hold Affecting Aldoxorubicin Clinical Trials

Posted 9 days ago in Clinical Trials

LOS ANGELES, Nov. 18, 2014 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that the Company has received notice from the United States Food and Drug Administration (FDA) that its clinical trials for aldoxorubicin have been placed on partial clinical hold. All currently enrolled patients can continue receiving...

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New Data Show Idarucizumab Restores Wound-Site Formation of Fibrin in Healthy Volunteers Given Pradaxa

Posted 10 days ago in Clinical Trials

Ridgefield, CT, November 18, 2014 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced phase I study sub-analyses showing that its investigational antidote idarucizumab reverses the effects of dabigatran, the active ingredient in Pradaxa (dabigatran etexilate mesylate), on fibrin formation in healthy volunteers. The results showed idarucizumab, a humanized antibody fragment (Fab), restores wound-site...

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Statistically Significant Results from the First Part of the Phase 3 ANNEXA™-A Studies of Investigational Andexanet Alfa

Posted 10 days ago in Clinical Trials

November 17, 2014, Portola Pharmaceuticals (NASDAQ: PTLA), Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced results from the first part of the Phase 3 ANNEXA™-A (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXA Inhibitors – Apixaban) studies. Andexanet alfa produced rapid and nearly complete reversal (by approximately 94 percent, p value

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Nine New Analyses Show Novartis' LCZ696 Could Change Course of Heart Failure for Patients

Posted 10 days ago in Clinical Trials

EAST HANOVER, N.J., Nov. 17, 2014 New data on Novartis' investigational medicine, LCZ696, for patients with heart failure with reduced ejection fraction (HFrEF) shows it has the potential to change the course of the disease for patients.1,2 In August 2014, Novartis presented topline results from the landmark PARADIGM-HF study showing LCZ696 was superior to ACE inhibitor enalapril on key endpoints, including...

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AstraZeneca Presents Data from Phase III Studies of Lesinurad in Combination with Allopurinol for Gout

Posted 11 days ago in Clinical Trials

Sunday, 16 November 2014 -- AstraZeneca (NYSE: AZN) today presented top-line results of two pivotal Phase III trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor (SURI), when used in combination with xanthine oxidase (XO) inhibitor allopurinol. The results show that approximately twice as many patients met the primary endpoint with a statistically significant higher...

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Sotatercept Data from the Phase 2a Clinical Trial in Hemodialysis Patients Presented

Posted 2 weeks ago in Clinical Trials

CAMBRIDGE, Mass., November 13, 2014 --(BUSINESS WIRE)-- 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 reported that investigators on the sotatercept program presented interim clinical data demonstrating encouraging effects of sotatercept on vascular calcification, bone...

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Amgen And AstraZeneca Announce Positive Results From Second Pivotal Phase 3 Study Of Brodalumab

Posted 2 weeks ago in Clinical Trials

THOUSAND OAKS, Calif. and LONDON, November 11, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and AstraZeneca (NYSE: AZN) today announced that AMAGINE-3TM, a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara® (ustekinumab) and placebo at week 12. Brodalumab was shown to be...

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Sanofi And Regeneron Announce Positive Results From Phase 2b Study of Dupilumab

Posted 2 weeks ago in Clinical Trials

Paris and Tarrytown, NY – November 11, 2014 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced positive results from the interim analysis of a dose-ranging Phase 2b study of dupilumab in adult patients with uncontrolled moderate-to-severe asthma. Dupilumab is an investigational therapy blocking IL-4 and IL-13, two cytokines required for the Th2 immune response. “Many have thought that targeting the...

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Pioneering study combining the diabetes vaccine Diamyd® with GABA in children with type 1 diabetes approved by the US FDA

Posted 2 weeks ago in Clinical Trials

STOCKHOLM - November 11 2014 -- Diamyd Medical informs that an investigator initiated study combining the diabetes vaccine Diamyd® and GABA in children with new onset type 1 diabetes has been approved by the US Food and Drug Administration. Diamyd Medical and University of Alabama at Birmingham has entered a Clinical Trial Agreement regarding the study, which will be conducted at Children’s of Alabama in...

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Sage Therapeutics Reports Positive Top-Line Phase 2 Data of SAGE-547 in Patients With Super-Refractory Status Epilepticus

Posted 2 weeks ago in Clinical Trials

CAMBRIDGE, Mass., Nov. 10, 2014 (GLOBE NEWSWIRE) -- SAGE Therapeutics today announced that in a Phase 1/2 clinical trial of SAGE-547, an allosteric modulator of both synaptic and extra-synaptic GABAA receptors, all primary and secondary endpoint targets were achieved in patients with super-refractory status epilepticus (SRSE), a critical condition in which the brain is in a state of persistent seizure. In 73 percent...

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Boehringer Ingelheim Initiates U.S. Sites in Phase III Trial of Investigational Antidote in Patients Taking Pradaxa

Posted 2 weeks ago in Clinical Trials

Ridgefield, CT, November 10, 2014 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced the initiation of U.S. sites of the RE-VERSE AD™ trial (NCT02104947), a phase III global study investigating idarucizumab* in actual clinical settings where Pradaxa (dabigatran etexilate mesylate) patients may require emergency intervention or experience an uncontrolled or life-threatening bleeding event. Idarucizumab...

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Interim Data from Proof-of-Concept Study of Merck’s Investigational Hepatitis C Treatment Grazoprevir/Elbasvir Presented

Posted 2 weeks ago in Clinical Trials

BOSTON, November 9, 2014 --(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of interim data from the C-SWIFT study exploring the potential of a candidate triple-therapy regimen consisting of the fixed-dose combination of grazoprevir/elbasvir (MK-5172/MK-8742, MK-5172A), the company’s investigational NS3/4A protease inhibitor and NS5A inhibitor,...

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ALLY Trial Demonstrates High Cure Rates for Investigational Daclatasvir and Sofosbuvir Combination among Genotype 3 Hepatitis C Patients

Posted 2 weeks ago in Clinical Trials

PRINCETON, N.J., November 8, 2014 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced late-breaking data from the landmark ALLY Trial investigating a ribavirin-free 12-week regimen of daclatasvir (DCV) in combination with sofosbuvir (SOF) in genotype 3 hepatitis C (HCV) patients, a patient population that has emerged as one of the most difficult to treat. The results of the study, which showed...

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Phase 3 UNITY Trials Demonstrate High Cure Rates for Investigational, All-Oral Daclatasvir TRIO Fixed-Dose Combination in Genotype 1 Hepatitis C Patients

Posted 2 weeks ago in Clinical Trials

PRINCETON, N.J., November 8, 2014 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced late-breaking data from the UNITY Trial program investigating a 12-week regimen of its all-oral daclatasvir (DCV) TRIO regimen – a fixed-dose combination of daclatasvir with asunaprevir (ASV) and beclabuvir (BCV) – in a broad range of patients with genotype 1 hepatitis C virus (HCV). The data will be...

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