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

Posted yesterday 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 3 days 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 days 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 days 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 6 days 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 7 days 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 8 days 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 11 days 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 12 days 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 12 days 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 13 days 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 13 days 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 2 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 2 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 2 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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Seattle Genetics Initiates Phase 1 Trial of Antibody-Drug Conjugate SGN-CD70A

Posted 3 weeks ago in Clinical Trials

BOTHELL, Wash.--(BUSINESS WIRE)--Aug. 12, 2014-- Seattle Genetics, Inc. (NASDAQ:SGEN) today announced the initiation of a phase 1 clinical trial evaluating SGN-CD70A for CD70-positive relapsed or refractory non-Hodgkin lymphoma (NHL) and metastatic renal cell carcinoma (RCC). SGN-CD70A is a novel antibody-drug conjugate (ADC) targeted to CD70 utilizing the company’s newest ADC technology. The phase 1 trial is...

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Cempra Initiates Phase 3 Clinical Trial in Patients With Uncomplicated Gonorrhea Infection

Posted 3 weeks ago in Clinical Trials

CHAPEL HILL, N.C., Aug. 12, 2014 (GLOBE NEWSWIRE) -- Cempra, Inc., (Nasdaq:CEMP) today announced the initiation of a Phase 3 clinical trial, called Solitaire-U, of a single 1000 mg dose of oral solithromycin in patients with uncomplicated Neisseria gonorrhea and chlamydia infections. The trial is being conducted in Australia and the U.S. and will enroll approximately 300 patients in a randomized 2-arm study with...

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Cellceutix Prepares for Phase 2 Clinical Trial of Brilacidin-OM for Oral Mucositis

Posted 3 weeks ago in Clinical Trials

August 11, 2014 -- Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to announce that the Company has just received the final toxicology report for Brilacidin-OM. Cellceutix is developing Brilacidin-OM as a new treatment for oral mucositis, a common and often...

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FDA Grants Fast Track Designation to CTI BioPharma's Pacritinib, a Novel JAK2 Inhibitor for the Treatment of Myelofibrosis

Posted 3 weeks ago in Clinical Trials

SEATTLE, Aug. 7, 2014 /PRNewswire/ --CTI BioPharma Corp. (CTI or the Company) (NASDAQ and MTA: CTIC) announced today that pacritinib has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of intermediate and high risk myelofibrosis, including but not limited to patients with disease related thrombocytopenia, patients experiencing treatment emergent thrombocytopenia...

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FDA Modifies Tekmira's TKM-Ebola Clinical Hold to Partial Hold

Posted 3 weeks ago in Clinical Trials

VANCOUVER, British Columbia, Aug. 7, 2014 (GLOBE NEWSWIRE) -- Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today announced that the U.S. Food & Drug Administration (FDA) has verbally confirmed they have modified the full clinical hold placed on the TKM-Ebola Investigational New Drug Application (IND) to a partial clinical hold. This action...

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