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

Posted yesterday 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 yesterday 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 6 days 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 8 days 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 8 days 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 8 days 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 13 days 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 13 days 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 2 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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Merck Announces Data from Phase 3 Study for Odanacatib for Treatment of Osteoporosis

Posted 2 weeks ago in Clinical Trials

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Monday, September 15, 2014 -- Merck, known as MSD outside the United States and Canada, today announced data from the pivotal Phase 3 fracture outcomes study for odanacatib in postmenopausal women with osteoporosis. Odanacatib is Merck’s investigational once-weekly cathepsin K inhibitor. In the Long-Term Odanacatib Fracture Trial (LOFT), odanacatib met its primary...

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Analysis of Phase III Trials Examines the Impact of Nintedanib on Lung Function Decline

Posted 3 weeks ago in Clinical Trials

Ridgefield, Conn., September 9, 2014 – A pre-specified, pooled subgroup sensitivity analysis from the two identically designed Phase III INPULSIS™ trials, presented today at the European Respiratory Society International Congress (ERS) evaluated the impact of the investigational drug nintedanib on reducing the decline in lung function, as measured by annual rate of decline in forced vital capacity (FVC), in...

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NEJM and ERS publish positive results from GSK phase III studies of mepolizumab

Posted 3 weeks ago in Clinical Trials

London UK ,08 September 2014 -- Results published today in the New England Journal of Medicine (NEJM) and presented at the European Respiratory Society (ERS) congress provide further data from the two pivotal Phase III asthma studies of mepolizumab, an investigational IL-5 antagonist monoclonal antibody: MENSA - MEpolizumab as adjunctive therapy iN patients with Severe Asthma SIRIUS – The SteroId ReductIon with...

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MediciNova Announces New NIDA Grant for MN-166 (ibudilast) in Opioid Dependence

Posted 3 weeks ago in Clinical Trials

LA JOLLA, Calif., Sept. 7, 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 Columbia University and the New York State Psychiatric Institute was awarded new grant funding from the National Institute on Drug Abuse (NIDA) to continue clinical research on...

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Merck’s Beta-lactamase Inhibitor Relebactam Granted QIDP and Fast Track Designations by FDA

Posted 3 weeks ago in Clinical Trials

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Thursday, September 4, 2014 --Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has designated relebactam (previously known as MK-7655), the company’s investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product (QIDP) with designated Fast Track status. The QIDP and Fast Track...

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MEI Pharma Completes Enrollment In Randomized Phase II Clinical Trial Of Pracinostat In Front Line Myelodysplastic Syndrome

Posted 4 weeks ago in Clinical Trials

SAN DIEGO, Sept. 2, 2014 PRNewswire -- MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, announced today that it has completed enrollment in a randomized Phase II clinical trial of its lead investigational drug candidate Pracinostat in combination with azacitidine in patients with previously untreated intermediate-2 or high-risk myelodysplastic...

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MediciNova to Present Data on MN-001 (tipelukast) for the Treatment of Idiopathic Pulmonary Fibrosis

Posted 4 weeks ago in Clinical Trials

LA JOLLA, Calif., Sept. 1, 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 it will present at the 18th International Colloquium on Lung and Airway Fibrosis (ICLAF) to be held this September in Mont Tremblant, Quebec, Canada. In June 2014, MediciNova...

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Sanofi and Regeneron Present Detailed Positive Results from Four Pivotal Alirocumab Trials at ESC Congress 2014

Posted 4 weeks ago in Clinical Trials

Paris and Tarrytown, New York – August 31, 2014 – Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced detailed positive results from four Phase 3 ODYSSEY trials of alirocumab in people with hypercholesterolemia. Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). Results from the four ongoing...

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Novartis' new heart failure medicine LCZ696 cut cardiovascular deaths by 20% vs. ACE-inhibitor in landmark PARADIGM-HF trial

Posted 4 weeks ago in Clinical Trials

Basel, August 30, 2014 - Today at the European Society of Cardiology congress and published simultaneously in the New England Journal of Medicine, Novartis revealed that its investigational heart failure medicine, LCZ696, was superior to ACE-inhibitor enalapril on key endpoints in the largest heart failure study ever done[1],[6]. In PARADIGM-HF patients with heart failure with reduced ejection fraction (HF-REF) who...

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Pfizer’s Investigational Vaccine Candidate for Clostridium difficile Receives FDA Fast Track Designation

Posted 4 weeks ago in Clinical Trials

August 28, 2014 - Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090). Currently in Phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhea and...

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Ebola vaccine trials fast-tracked by international consortium

Posted 4 weeks ago in Clinical Trials

28 August 2014 -- A candidate Ebola vaccine could be given to healthy volunteers in the UK, The Gambia and Mali as early as September, as part of a series of safety trials of potential vaccines aimed at preventing the disease that has killed more than 1,400 people in the current outbreak in west Africa. Human trials of this candidate vaccine, being co-developed by the US National Institutes of Health (NIH) and...

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