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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.

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Interim Analysis of Clinical Trial Suggests Efficacy of Avigan Tablet 200mg as a Treatment for Ebola Virus Disease

Posted 3 days ago in Clinical Trials

February 24, 2015 -- FUJIFILM Corporation (President: Shigehiro Nakajima) announced that the French National Institute of Health and Medical Research (Inserm) ** released today an interim analysis of the clinical trial suggesting the efficacy of anti-influenza drug Avigan® Tablet 200mg* (Favipiravir), which is being provided to clinical trials in Guinea for patients with Ebola Virus Disease (EVD). For patients...

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BioTime Announces First Patient Treated in Pivotal Clinical Trial of Renevia for HIV-Associated Lipoatrophy

Posted 3 days ago in Clinical Trials

ALAMEDA, Calif.--(BUSINESS WIRE)--Feb. 24, 2015-- BioTime, Inc. (NYSE MKT: BTX) today announced that the first patient was successfully treated in the Company’s pivotal clinical trial in Europe assessing the efficacy of Renevia™ for the treatment of HIV-associated lipoatrophy. HIV-associated lipoatrophy is a disorder characterized by abnormal loss of body fat from under the skin that occurs in almost half of the...

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Flexion Therapeutics Completes Enrollment in Pivotal Phase 2b Confirmatory Clinical Trial With Lead Compound FX006

Posted 3 days ago in Clinical Trials

BURLINGTON, Mass., Feb. 24, 2015 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced today that it has completed enrollment in its pivotal Phase 2b confirmatory clinical trial designed to further evaluate the safety, tolerability and efficacy of FX006 as a treatment for relieving pain associated with OA of the knee. FX006 is Flexion's novel, non-opioid, sustained-release, intra-articular (IA)...

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Lilly Announces Update On Regulatory Submission Timing For Basal Insulin Peglispro

Posted 4 days ago in Clinical Trials

INDIANAPOLIS, Feb. 23, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced a delay in the submission of basal insulin peglispro (BIL) to regulatory agencies beyond the first quarter of 2015. The delay includes filings with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. Lilly will delay submission in order to generate additional clinical data to further understand...

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Baricitinib Superior to Placebo in Reducing Rheumatoid Arthritis Disease Activity in Second Phase 3 Study

Posted 4 days ago in Clinical Trials

INDIANAPOLIS, Feb. 23, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announce that the investigational medicine baricitinib demonstrated a statistically significant improvement compared to placebo in a second consecutive Phase 3 trial in rheumatoid arthritis (RA). The RA-BUILD study included patients with moderately-to-severely active rheumatoid arthritis who had...

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Lilly Provides Update On Evacetrapib Phase 3 Trial

Posted 8 days ago in Clinical Trials

INDIANAPOLIS, Feb. 19, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has accepted the recommendation of the ACCELERATE study academic executive committee, based on emerging science in the cardiovascular field, to extend the Phase 3 trial of the investigational medicine evacetrapib by approximately six months. The decision is not based on any data from ACCELERATE, as both the academic committee and the...

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Takeda Announces Phase 3 MONET-A Study Evaluating Motesanib in Non-Small Cell Lung Cancer Does Not Meet Primary Endpoint

Posted 10 days ago in Clinical Trials

Cambridge, Mass. and Osaka, Japan, February 17, 2015 – Takeda Pharmaceutical Company Limited (TSE:4502) today announced the primary endpoint of progression-free survival (PFS) was not met in the Phase 3 MONET-A study of patients with stage IV non-squamous non-small cell lung cancer (NSCLC) who were randomized to treatment with investigational motesanib in combination with paclitaxel and carboplatin compared to...

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MediciNova Provides Update on Clinical Trial of MN-166 (ibudilast) in ALS

Posted 11 days ago in Clinical Trials

LA JOLLA, Calif., Feb. 16, 2015 (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 the ongoing clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) has enrolled 30 of the 60 subjects planned for participation. The trial is a randomized,...

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Bexion Pharmaceuticals Receives Orphan Drug Designation for Saposin C, the Active Ingredient in BXQ-350 for Glioblastoma Multiforme from FDA

Posted 11 days ago in Clinical Trials

COVINGTON, KY - February 16, 2015 -- Bexion Pharmaceuticals LLC announced today that the U.S. Food and Drug Administration (FDA) has granted the company Orphan Drug designation for Saposin C, active ingredient in its proprietary drug BXQ-350 for the potential treatment of glioblastoma multiforme. The FDA’s Office of Orphan Drug Products Development reviews applications for Orphan Drug status to support...

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Novartis' Heart Failure Medicine LCZ696 Granted FDA Priority Review

Posted 2 weeks ago in Clinical Trials

EAST HANOVER, N.J., Feb. 13, 2015 Novartis announced today that the US Food and Drug Administration (FDA) has granted priority review for LCZ696, an investigational medicine for the treatment of heart failure with reduced ejection fraction (HFrEF). The designation is intended to accelerate the review of therapies that offer a significant improvement in the safety or effectiveness of the treatment, prevention or...

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Novavax Announces Initiation of Ebola Vaccine Phase 1 Clinical Trial Supported by Non-Human Primate Challenge Data and Documented Rapid Manufacturing Capabilities

Posted 2 weeks ago in Clinical Trials

GAITHERSBURG, Md., Feb. 12, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that enrollment has begun in a Phase 1 clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M™ (Ebola GP...

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Amgen Announces FDA Advisory Committees to Review Talimogene Laherparepvec for the Treatment of Patients with Metastatic Melanoma

Posted 2 weeks ago in Clinical Trials

THOUSAND OAKS, Calif., Feb. 11, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today that the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) will jointly review the Company's Biologics License Application (BLA) for talimogene laherparepvec. The FDA is currently reviewing the talimogene laherparepvec...

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Takeda Announces That the First Interim Analysis of the Phase 3 Study of Oral Ixazomib in Patients with Multiple Myeloma Met Primary Endpoint

Posted 2 weeks ago in Clinical Trials

Cambridge, Mass. and Osaka, Japan, February 10, 2015 – Takeda Pharmaceutical Company Limited (TSE:4502) today announced that the randomized, double-blind, placebo-controlled TOURMALINE-MM1 pivotal Phase 3 trial evaluating the safety and efficacy of ixazomib, the first oral proteasome inhibitor, conducted in patients with relapsed or refractory multiple myeloma (MM) achieved its primary endpoint of improving...

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GSK and Theravance Announce Start of Phase III Lung Function Study with ‘Closed’ Triple Combination Treatment FF/UMEC/VI for COPD

Posted 2 weeks ago in Clinical Trials

London UK and South San Francisco, CA - 09 February 2015 -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the start of a second global phase III study to evaluate the effects of the investigational once-daily closed triple combination of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with chronic obstructive pulmonary disease (COPD). Enrolling...

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Helsinn and Zealand Announce the Advance of Elsiglutide into Phase IIB Development for the Prevention of Chemotherapy-Induced Diarrhea

Posted 3 weeks ago in Clinical Trials

Lugano, Switzerland and Copenhagen, Denmark, February 5, 2015 – Helsinn Healthcare S.A. (“Helsinn”) and Zealand Pharma A/S (“Zealand”) (Nasdaq Copenhagen: ZEAL) jointly announce that Helsinn has started a Phase IIB clinical dose-finding trial of elsiglutide for the prevention of chemotherapy-induced diarrhea (CID). The first patients out of a planned total of 600 patients with colorectal cancer treated...

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OncoMed Initiates Dosing in Phase 2 Clinical Trial of Demcizumab for the Treatment of Non-Small Cell Lung Cancer

Posted 3 weeks ago in Clinical Trials

REDWOOD CITY, Calif., Feb. 4, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, announced that patient dosing has begun in the double-blinded, placebo-controlled, randomized Phase 2 clinical trial of demcizumab (anti-DLL4, OMP-21M18) for the treatment of patients with first-line...

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Daiichi Sankyo Announces First Patients in Large-scale, Multi-national Phase 3 Clinical Programs for Mirogabalin

Posted 3 weeks ago in Clinical Trials

Tokyo, Japan – (February 4, 2015) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced enrollment of the first patients in large-scale, multi-national clinical programs evaluating the safety and efficacy of investigational mirogabalin (DS-5565), the first preferentially selective alpha-2 delta ligand. The phase 3 clinical program across Asia includes the REDUCER (An Asian, phase 3,...

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Amgen Announces Positive Top-Line Results From Phase 3 Study Evaluating The Efficacy And Safety Of Biosimilar Candidate ABP 501 Compared With Adalimumab

Posted 3 weeks ago in Clinical Trials

THOUSAND OAKS, Calif., Feb. 3, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared with Humira® (adalimumab) in patients with moderate-to-severe rheumatoid arthritis met its primary and key secondary endpoints. The primary endpoint compared the ACR20 measurements (20 percent or greater improvement in ACR assessment) at...

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Genmab Announces Preliminary Results in Phase II Study of Daratumumab in Double Refractory Multiple Myeloma

Posted 3 weeks ago in Clinical Trials

Copenhagen, Denmark; February 3, 2015 — Genmab A/S (OMX: GEN) announced today preliminary results from the Phase II study of daratumumab in double refractory multiple myeloma conducted by its collaboration partner Janssen Biotech, Inc. (Janssen). The overall response rate (ORR) in the study was 29.2% in the 16 mg/kg dosing group and the median duration of response was 7.4 months as determined by an Independent...

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FDA Grants Breakthrough Therapy Designation for Genentech’s Investigational Cancer Immunotherapy MPDL3280A (anti-PDL1) in Non-Small Cell Lung Cancer

Posted 3 weeks ago in Clinical Trials

South San Francisco, Calif. -- February 1, 2015 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it has received a second Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its investigational cancer immunotherapy MPDL3280A (anti-PDL1). The designation was granted for the treatment of people with PD-L1 (Programmed Death-Ligand 1) positive...

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