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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.

Cytokinetics Completes Enrollment in VITALITY-ALS, Phase 3 Clinical Trial of Tirasemtiv in Patients with ALS

Posted 6 days ago in Clinical Trials

SOUTH SAN FRANCISCO, Calif., Aug. 17, 2016 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq:CYTK) today announced the completion of patient enrollment in VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS), an international Phase 3 clinical trial of tirasemtiv in patients with ALS. VITALITY-ALS is designed to assess the effects of tirasemtiv...

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Lilly Provides Update On MONARCH 2 Phase 3 Trial Of Abemaciclib

Posted 13 days ago in Clinical Trials

INDIANAPOLIS, Aug. 10, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that following a pre-planned interim analysis for MONARCH 2, an independent Data Monitoring Committee (DMC) provided the recommendation to continue the study without modification as the interim efficacy criteria were not met. The MONARCH 2, Phase 3 trial compares abemaciclib plus fulvestrant* versus placebo with fulvestrant...

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AstraZeneca Provides Update on Phase III Trial of Selumetinib in Non-Small Cell Lung Cancer

Posted 2 weeks ago in Clinical Trials

09 August 2016 -- AstraZeneca today announced results from the Phase III SELECT-1 trial of the MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment in patients with KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC). The results showed that the trial did not meet its primary endpoint of progression-free survival (PFS), and...

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Novartis CDK4/6 inhibitor LEE011 (ribociclib) receives FDA Breakthrough Therapy Designation as First-Line Treatment for HR+/HER2- Advanced Breast Cancer

Posted 2 weeks ago in Clinical Trials

Basel, August 3, 2016 - Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to LEE011 (ribociclib), in combination with letrozole, for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. LEE011 is a selective cyclin dependent kinase (CDK4/6) inhibitor. The...

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Inovio Pharmaceuticals Doses First Subject in Zika Vaccine Clinical Trial

Posted 4 weeks ago in Clinical Trials

PLYMOUTH MEETING, Pa., July 26, 2016 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced the dosing of the first subject in its multi-center phase I trial to evaluate Inovio’s Zika DNA vaccine (GLS-5700). In addition to the previously announced US FDA approval for the conduct of the study, Health Canada’s Health Products and Food Branch has also approved this study, which will be conducted a...

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AstraZeneca’s antibiotic Zavicefta met primary endpoints in Phase III trial for treatment of hospital-acquired pneumonia

Posted 4 weeks ago in Clinical Trials

21 July 2016 -- AstraZeneca today announced positive results from the Phase III REPROVE trial for Zavicefta (ceftazidime-avibactam), a new combination antibiotic for the treatment of a broad range of serious Gram-negative bacterial infections in hospitalised patients. Zavicefta has been developed in response to the urgent need for new antibiotics to treat serious infections that are becoming increasingly resistant...

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Spark Therapeutics and Pfizer Announce Receipt of FDA Breakthrough Therapy Designation for SPK-9001 for the Treatment of Hemophilia B

Posted 4 weeks ago in Clinical Trials

PHILADELPHIA and NEW YORK CITY, July 21, 2016 -- Spark Therapeutics (NASDAQ:ONCE) and Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to SPK-9001, the lead investigational candidate in the companies’ SPK-FIX program, in development for the treatment of hemophilia B. SPK-9001, a novel bio-engineered adeno-associated virus (AAV) c...

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Pfizer Announces the Publication of Final Results from Two Pivotal Phase 3 Studies of Crisaborole Topical Ointment in Patients with Mild to Moderate Atopic Dermatitis

Posted 5 weeks ago in Clinical Trials

July 13, 2016 - Pfizer Inc. (NYSE:PFE) announced today the publication of findings from two pivotal Phase 3 studies of investigational crisaborole topical ointment 2% (formerly AN2728) in the online issue of the Journal of the American Academy of Dermatology. “Atopic dermatitis, or eczema, is a chronic, inflammatory skin disease that affects millions of children and adults. There have been no new therapies a...

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Lilly And Boehringer Ingelheim Announce Clinical Trial Collaboration In Metastatic Breast Cancer

Posted 5 weeks ago in Clinical Trials

INDIANAPOLIS, July 13, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim today announced a new collaboration on a Phase 1b study that will evaluate the safety and tolerability of abemaciclib (LY2835219), Lilly's cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in combination with BI 836845, Boehringer Ingelheim's insulin-like growth factor (IGF)-1/IGF-2 ligand neutralizing antibody,...

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AbbVie Receives U.S. FDA Rare Pediatric Disease Designation for Investigational ABT-414 for the Treatment of a Type of Pediatric Brain Tumor known as Diffuse Intrinsic Pontine Glioma (DIPG)

Posted 6 weeks ago in Clinical Trials

NORTH CHICAGO, Ill., July 11, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for ABT-414, an investigational antibody drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine...

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Idalopirdine Granted Fast Track Designation by U.S. Food and Drug Administration

Posted 6 weeks ago in Clinical Trials

Valby, 2016-07-07 15:00 CEST (GLOBE NEWSWIRE) -- H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Development & Commercialization, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the investigational agent idalopirdine for the treatment of mild to moderate Alzheimer's disease. Idalopirdine is a selective 5HT6 receptor antagonist with a different...

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Revive Therapeutics Ltd. Announces US FDA Acceptance of IND of Bucillamine for the Treatment of Cystinuria

Posted 6 weeks ago in Clinical Trials

TORONTO, ONTARIO--(Marketwired - July 6, 2016) - Revive Therapeutics Ltd. ("Revive" or the "Company") (TSX VENTURE:RVV)(OTCQB:RVVTF), a company focused on commercializing treatments for rare diseases such as Cystinuria, Wilson's disease and Rett Syndrome, today announced that the U.S. Food and Drug Administration ("US FDA") has accepted the Company's Investigational New Drug Application ("IND") for a Phase 2...

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Sanofi Genzyme Begins Pivotal Phase 2/3 Trial of Olipudase Alfa for Adult Patients with Acid Sphingomyelinase Deficiency

Posted 6 weeks ago in Clinical Trials

CAMBRIDGE, Mass.--(BUSINESS WIRE) July 6, 2016 --Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that the first adult patient has enrolled and been dosed in a pivotal Phase 2/3 clinical trial named ASCEND for the investigational therapy olipudase alfa. Olipudase alfa is an enzyme replacement therapy being studied for the treatment of nonneurological manifestations of acid...

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Merck KGaA, Darmstadt, Germany, and Pfizer Initiate Phase III Trial to Evaluate Avelumab as First-line Treatment for Ovarian Cancer

Posted 6 weeks ago in Clinical Trials

July 6, 2016 Merck KGaA, Darmstadt, Germany, and Pfizer (NYSE: PFE) today announced the initiation of a Phase III study, JAVELIN Ovarian 100, to evaluate the efficacy and safety of avelumab* in combination with, and/or as follow-on (maintenance) treatment to, platinum-based chemotherapy in patients with locally advanced or metastatic disease (Stage III or Stage IV) with previously untreated epithelial ovarian...

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Novartis PKC412 (midostaurin) pivotal data published in NEJM show 60% response rate in advanced systemic mastocytosis (SM)

Posted 7 weeks ago in Clinical Trials

Basel, June 29, 2016 - Novartis announced today that The New England Journal of Medicine (NEJM) published data for PKC412 (midostaurin) demonstrating an overall response rate, defined as a major or partial response, of 60% (95% confidence interval [CI], 49-70%; P

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Cascadian Therapeutics Receives ONT-380 Fast Track Designation from FDA for the Treatment of Advanced HER2+ Metastatic Breast Cancer

Posted 7 weeks ago in Clinical Trials

SEATTLE, June 29, 2016 (GLOBE NEWSWIRE) -- Cascadian Therapeutics (NASDAQ:CASC), a clinical-stage biopharmaceutical company, today announced that the ONT-380 program in advanced HER2+ metastatic breast cancer has received Fast Track designation from the U.S. Food and Drug Administration ("FDA"). The Company is actively recruiting patients for a randomized, double-blind, placebo-controlled Phase 2 study, known as...

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Shire Announces Positive Topline Results of SHP465 Efficacy and Safety Study in Adults with ADHD

Posted 7 weeks ago in Clinical Trials

Lexington, Mass. – June 29, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) today announced positive topline results from a four-week randomized, double-blind, multicenter, parallel-group, placebo-controlled, forced-dose titration, efficacy and safety study, SHP465-306, in 275 adults aged 18-55 years with Attention-Deficit/Hyperactivity Disorder (ADHD). SHP465 (triple-bead mixed amphetamine salts - MAS) is an inv...

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Two Additional Phase 3 Lipid-Lowering Studies of Bococizumab Deliver Positive Topline Results

Posted 8 weeks ago in Clinical Trials

June 28, 2016 -- Pfizer Inc. announced two additional Phase 3 bococizumab trials, SPIRE-HR (HighRisk) and SPIRE-FH (Familial Hypercholesterolemia), met their primary endpoint, demonstrating a significant reduction in the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at 12 weeks compared to placebo among adults at high and very high risk for cardiovascular events who were receiving a...

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Esperion Therapeutics Provides Clinical Development and Regulatory Update for Bempedoic Acid

Posted 8 weeks ago in Clinical Trials

ANN ARBOR, Mich., June 28, 2016 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), a late-stage pharmaceutical company focused on developing and commercializing first-in-class oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today provided updates on the bempedoic acid (ETC-1002) clinical development program and regulatory plans. The clinical program...

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GW Pharmaceuticals Announces Positive Phase 3 Pivotal Trial Results for Epidiolex (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome

Posted 8 weeks ago in Clinical Trials

London, UK; 27 June 2016: GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: “GWP,” “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces positive results of the first randomized, double-blind, placebo-controlled Phase 3 clinical trial of its investigational medicine Epidiolex (can...

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