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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.

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

Posted 9 days 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 9 days 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 2 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 2 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 2 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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Revive Therapeutics Ltd. Announces US FDA Acceptance of IND of Bucillamine for the Treatment of Cystinuria

Posted 3 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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Merck KGaA, Darmstadt, Germany, and Pfizer Initiate Phase III Trial to Evaluate Avelumab as First-line Treatment for Ovarian Cancer

Posted 3 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 4 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 4 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 4 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 4 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 4 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 4 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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Gilead Presents Preliminary Data on Bictegravir, an Investigational Integrase Strand Transfer Inhibitor for the Treatment of HIV

Posted 5 weeks ago in Clinical Trials

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 20, 2016-- Gilead Sciences, Inc. today announced data from four pre-clinical and Phase 1 studies evaluating bictegravir (GS-9883), a novel, unboosted, investigational once-daily integrase strand transfer inhibitor (INSTI). The studies, which examined the antiviral potency, resistance profile, pharmacokinetics and safety of bictegravir, were presented this weekend during a...

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Results of Phase 2 Study of Merck’s Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Presented at ASM Microbe

Posted 5 weeks ago in Clinical Trials

KENILWORTH, N.J., June 20, 2016 --(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that a Phase 2 study of relebactam, the company’s investigational beta-lactamase inhibitor, in combination with imipenem/cilastatin (an approved carbapenem antibiotic), in patients with complicated urinary tract infections, met its primary endpoint. The addition of relebactam is d...

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Inovio Pharmaceuticals and GeneOne Life Science Receive Approval for First-in-Man Zika Vaccine Clinical Trial

Posted 5 weeks ago in Clinical Trials

PLYMOUTH MEETING, Pa. and SEOUL, South Korea, June 20, 2016 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) and GeneOne Life Science, Inc. (KSE:011000) today announced that they have received approval to initiate a phase I human trial to evaluate Inovio’s Zika DNA vaccine (GLS-5700) to prevent infection from this concerning virus. In preclinical testing this synthetic vaccine induced robust antibody a...

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Epizyme Reports Early Data from Global Phase 2 Trial of Tazemetostat in Non-Hodgkin Lymphoma at ASH Lymphoma Biology Meeting

Posted 5 weeks ago in Clinical Trials

CAMBRIDGE, Mass., June 19, 2016 --(BUSINESS WIRE)-- Epizyme, Inc. (NASDAQ: EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, today reported preliminary data from its ongoing, global Phase 2 clinical trial of orally administered tazemetostat, a first-in-class EZH2 inhibitor, in relapsed or refractory patients with non-Hodgkin lymphoma (NHL). Early data from the Phase 2 trial...

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Aerie Pharmaceuticals Completes Enrollment of Rocket 4 Phase 3 Clinical Trial of Rhopressa (netarsudil ophthalmic solution) 0.02%

Posted 6 weeks ago in Clinical Trials

IRVINE, Calif., June 16, 2016 --(BUSINESS WIRE)-- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today announced the completion of patient enrollment in Rocket 4, the Company's Phase 3 clinical trial for Rhopressa (netarsudil ophthalmic solution) 0.02% intended to satisfy filing...

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Mallinckrodt Submits Investigational New Drug Application for Synacthen Depot

Posted 6 weeks ago in Clinical Trials

CHESTERFIELD, United Kingdom, June 13, 2016 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced it has submitted an Investigational New Drug (IND) application for Synacthen® Depot to the U.S. Food and Drug Administration (FDA). The company will pursue an indication for the drug in treatment of Duchenne muscular dystrophy (DMD). Synacthen Depot is a ...

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Pfizer Announces Final Results from Inotuzumab Ozogamicin Pivotal Phase 3 Study in Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia

Posted 6 weeks ago in Clinical Trials

June 12, 2016 - Pfizer Inc. (NYSE:PFE) today announced the publication of findings from the Phase 3 INO-VATE ALL study in the online issue of The New England Journal of Medicine. The study, also known as Study 1022, is an open-label, randomized, Phase 3 study evaluating the safety and efficacy of inotuzumab ozogamicin as compared with investigator-choice chemotherapy in 326 adult patients with relapsed or refractory...

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