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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Merck Announces Data from Phase 3 Study for Odanacatib for Treatment of Osteoporosis

Posted 4 days 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 10 days 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 11 days 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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Merck’s Beta-lactamase Inhibitor Relebactam Granted QIDP and Fast Track Designations by FDA

Posted 2 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 2 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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Sanofi and Regeneron Present Detailed Positive Results from Four Pivotal Alirocumab Trials at ESC Congress 2014

Posted 2 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 2 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 3 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 3 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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Pfizer and Merck to Collaborate on Study Evaluating Novel Anti-Cancer Combination Regimen

Posted 3 weeks ago in Clinical Trials

WHITEHOUSE STATION, N.J. – August 26, 2014 -- Pfizer Inc. (NYSE:PFE) and Merck & Co. Inc. (NYSE: MRK), known as MSD outside the United States and Canada, through a subsidiary, announced today that they have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s crizotinib (XALKORI®) with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a Phase 1b clinical...

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Alkermes Announces Initiation of Phase 1 Clinical Study of ALKS 7106 for Treatment of Pain

Posted 3 weeks ago in Clinical Trials

DUBLIN--(BUSINESS WIRE)--Aug. 26, 2014-- Alkermes plc (NASDAQ: ALKS) today announced the initiation of a phase 1 clinical study of ALKS 7106, a proprietary, novel, oral, small-molecule drug candidate for the treatment of pain. The randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of ALKS 7106 in approximately 80 healthy, male adults. ALKS 7106 represents a...

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Advaxis and Merck Form Collaboration to Evaluate Investigational Combination of Two Novel Immunotherapy Candidates for Advanced Prostate Cancer

Posted 3 weeks ago in Clinical Trials

PRINCETON, N.J., Aug. 25, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, has entered into a clinical trial collaboration agreement with Merck, known as MSD outside the United States and Canada, through its subsidiaries, to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's investigational anti PD-1...

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Baxter Announces Positive Top-Line Results from Its Phase 3 Study of BAX 855, Extended Half-Life Recombinant FVIII

Posted 4 weeks ago in Clinical Trials

DEERFIELD, Ill., August 21, 2014 - Baxter International Inc. (NYSE:BAX) today announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)], which met its primary endpoint in reducing annualized bleed rates (ABR) in the prophylaxis arm compared to...

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Lilly's Ixekizumab Superior to Etanercept and Placebo in Phase 3 Psoriasis Studies

Posted 4 weeks ago in Clinical Trials

INDIANAPOLIS, Aug. 21, 2014 /PRNewswire/ -- Eli Lilly and Company's (NYSE: LLY) investigational medicine ixekizumab was statistically superior to etanercept and placebo on all skin clearance measures in Phase 3 studies, the company said today in disclosing top-line results from its pivotal UNCOVER studies in moderate-to-severe plaque psoriasis. "These data are important for people suffering from...

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Nuvilex Begins Preclinical Studies With Translational Drug Development to Determine if Cancer Treatment Can Slow Accumulation of Malignant Ascites Fluid

Posted 4 weeks ago in Clinical Trials

SILVER SPRING, Md., Aug. 20, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), a clinical-stage, international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that studies are underway at Translational Drug Development's (TD2) facilities in Scottsdale, Arizona, to determine if Nuvilex's unique cancer treatment can slow the accumulation of fluid, known as...

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Alcobra Announces Enrollment of First Patient in Phase IIb Clinical Trial of MDX in Fragile X Syndrome

Posted 4 weeks ago in Clinical Trials

TEL AVIV, Israel, Aug. 19, 2014 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD), an emerging pharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate Metadoxine Extended Release (MDX), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, announced today that the first patient has been enrolled in a Phase IIb Fragile X study of MDX. The FDA...

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Cellceutix Completes Enrollment in Phase 2b Clinical Trial of Brilacidin for ABSSSI

Posted 4 weeks ago in Clinical Trials

BEVERLY, MA–(Marketwired –August 19,2014)- Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, has announced the completion of enrollment in its Phase 2b trial comparing Brilacidin™ to daptomycin (Cubicin®) in patients with acute bacterial skin and skin structure infections...

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Auspex Pharmaceuticals Completes Enrollment in Phase 3 Registration Clinical Trial of SD-809

Posted 4 weeks ago in Clinical Trials

LA JOLLA, Calif., Aug. 18, 2014 (GLOBE NEWSWIRE) -- Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX), a late clinical stage biopharmaceutical company focused on developing and commercializing novel medicines for the treatment of orphan diseases, today announced that it has completed the enrollment of the planned 90 patients in its Phase 3 registration clinical trial (First-HD) of SD-809 for the potential treatment of...

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FDA Grants Tentative Approval for Lilly and Boehringer Ingelheim's Basaglar (insulin glargine injection)

Posted 4 weeks ago in Clinical Trials

INDIANAPOLIS and RIDGEFIELD, Conn., Aug. 18, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today granted tentative approval for Basaglar™ (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. Basaglar is not recommended for the treatment of...

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Pfizer Announces FDA Acceptance Of And Priority Review Designation For BLA For Investigational Meningococcal B Vaccine

Posted 5 weeks ago in Clinical Trials

Thursday, August 14, 2014 - Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. The FDA has also granted Priority...

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