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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.

Phase 3 Study Findings Demonstrate Treatment With Baricitinib Results In Significant Improvements For Patients With Rheumatoid Arthritis Who Had Inadequate Response To Biologics

Posted 3 days ago in Clinical Trials

INDIANAPOLIS, March 31, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced that detailed results of RA-BEACON — a pivotal phase 3 global study of baricitinib, a once-daily oral treatment currently under regulatory review for the treatment of moderate-to-severe rheumatoid arthritis (RA) — were published today in the New England Journal of Medicine. The study met i...

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Cellceutix Receives Preliminary Approval for Clinical Trial of Brilacidin for Ulcerative Proctitis

Posted 4 days ago in Clinical Trials

BEVERLY, MA–(Marketwired – March 30, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that the Company has received initial approval for the planned Proof of Concept, Phase 2, clinical trial of Brilacidin for ulcerative proctit...

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Galena Biopharma Phase 3 PRESENT Clinical Trial with NeuVax (nelipepimut-S) Achieves 70th Qualifying Disease Free Survival Event

Posted 5 days ago in Clinical Trials

SAN RAMON, Calif., March 29, 2016 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced that the 70th qualifying disease free survival (DFS) event has been achieved in the NeuVax™ (nelipepimut-S) Phase 3, PRESENT (Prevention of Recurrence in E...

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Aerie Pharmaceuticals Initiates Second Phase 3 Registration Trial of Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%

Posted 6 days ago in Clinical Trials

IRVINE, Calif., March 28, 2016 --(BUSINESS WIRE)--Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (“Aerie” or the “Company”), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today announced that on March 24, dosing commenced of the first patients enrolled in Mercury 2, the Company’s second Phase 3 registration trial of Roclatan (netar...

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FORUM Pharmaceuticals Inc. Provides Update on Encenicline Phase 3 Clinical Trial Program in Cognitive Impairment in Schizophrenia

Posted 10 days ago in Clinical Trials

WALTHAM, Mass. – March 24, 2016 – FORUM Pharmaceuticals Inc. today announced topline results from two Phase 3 clinical trials in patients with cognitive impairment in schizophrenia (CIS). While encenicline (FRM-6124) demonstrated a favorable safety and tolerability profile in both studies, neither study met its co-primary endpoints based on effect on cognitive function and patient function. “These results are not ...

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BioMarin Phase 3 Study of Pegvaliase for Phenylketonuria (PKU) Meets Primary Endpoint of Blood Phenylalanine (Phe) Reduction (p<0.0001)

Posted 11 days ago in Clinical Trials

SAN RAFAEL, Calif., March 21, 2016 (GLOBE NEWSWIRE) -- BioMarin announced today that the pivotal Phase 3 PRISM-2 study (formerly referred to as 165-302) of pegvaliase met the primary endpoint of change in blood Phe compared with placebo (p

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OncoMed Initiates Phase 1b Immuno-Oncology Combination Clinical Trial for Demcizumab and Pembrolizumab (anti-PD1)

Posted 2 weeks ago in Clinical Trials

REDWOOD CITY, Calif., March 17, 2016 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced dosing of the first patient in its Phase 1b clinical trial of OncoMed's investigational agent demcizumab (anti-DLL4, OMP-21M18), with Merck's anti-Programmed Cell Death 1 (PD1) therapy pembrolizumab...

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Raptor Announces Qualified Infectious Disease Product (QIDP) Designation for MP-376, Inhaled Levofloxacin

Posted 2 weeks ago in Clinical Trials

NOVATO, Calif., March 16, 2016 (GLOBE NEWSWIRE) -- Raptor Pharmaceutical Corp. (Nasdaq:RPTP) today announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to MP-376, the company's proprietary inhaled levofloxacin, for three distinct indications: for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa, in patients with...

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Lilly Announces Change To Primary Endpoint Of EXPEDITION3 Study

Posted 2 weeks ago in Clinical Trials

INDIANAPOLIS, March 15, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced a change to the primary endpoint for the EXPEDITION3 clinical trial, a Phase 3 study of solanezumab in people with mild Alzheimer's dementia. The original study design included co-primary endpoints of cognition and function—measured by ADAS-Cog14 (Alzheimer's Disease Assessment Scale-Cognitive subscale) and ADCS-iADL (...

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GW Pharmaceuticals Announces Positive Phase 3 Pivotal Study Results for Epidiolex (cannabidiol)

Posted 2 weeks ago in Clinical Trials

LONDON, March 14, 2016 (GLOBE NEWSWIRE) -- 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 the positive results of the first pivotal Phase 3 study of its investigational medicine Epidiolex® (cannabidiol or CBD) for the ...

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Celator Announces Phase 3 Trial for Vyxeos™ (CPX-351) in Patients with High-Risk Acute Myeloid Leukemia Demonstrates Statistically Significant Improvement in Overall Survival

Posted 2 weeks ago in Clinical Trials

EWING, N.J., March 14, 2016 /PRNewswire/ -- Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today announced positive results from the Phase 3 trial of Vyxeos™ (cytarabine: daunorubicin) Liposome for Injection (also known as CPX-351) in patients with high-risk (secondary) acute myeloid leukemia (AML) compared to the standard of care regimen of cytarabine and daunorubicin known as 7+3. The trial met its primary endpoint d...

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FDA Grants Genentech’s Cancer Immunotherapy Atezolizumab Priority Review for Advanced Bladder Cancer

Posted 2 weeks ago in Clinical Trials

South San Francisco, CA -- March 14, 2016 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease p...

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Sanofi and Regeneron Announce Topline Results of Phase 3 Monotherapy Study Demonstrating Superiority of Sarilumab Vs. Adalimumab in Patients with Active Rheumatoid Arthritis

Posted 3 weeks ago in Clinical Trials

Paris, France and Tarrytown, NY - March 11, 2016 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that a Phase 3 monotherapy study met its primary endpoint demonstrating that sarilumab was superior to adalimumab (marketed by AbbVie as HUMIRA®) in improving signs and symptoms in patients with active rheumatoid arthritis (RA) at Week 24. The study, called SARIL-RA-MONARCH, also met important secondary ...

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AstraZeneca’s potential medicine for neuromyelitis optica receives FDA Orphan Drug Designation

Posted 3 weeks ago in Clinical Trials

09 March 2016 -- AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational anti-CD19 monoclonal antibody, MEDI-551, for the treatment of patients with neuromyelitis optica (NMO) as well as neuromyelitis optica spectrum disorders (NMOSD). Developed by MedImmune, MEDI-551 is...

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Data Safety and Monitoring Board Recommends Celldex's Phase 3 Study of Rintega (rindopepimut) in Newly Diagnosed Glioblastoma be Discontinued as it is Unlikely to Meet Primary Overall Survival Endpoint in Patients with Minimal Residual Disease

Posted 3 weeks ago in Clinical Trials

HAMPTON, N.J., March 07, 2016 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the independent Data Safety and Monitoring Board (DSMB) has determined, based on a preplanned interim analysis, that continuation of the Phase 3 ACT IV study of RINTEGA® (rindopepimut) in patients with newly diagnosed EGFRvIII-positive glioblastoma will not reach statistical significance for overall ...

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InDex Pharmaceuticals Receives FDA Clearance of IND for Cobitolimod (Kappaproct®) Phase IIb Trial

Posted 3 weeks ago in Clinical Trials

March 7, 2016 – InDex Pharmaceuticals AB today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to initiate a phase IIb study with its lead drug candidate cobitolimod (Kappaproct®) in patients with moderate to severe ulcerative colitis (UC). “The clearance of the IND is a major milestone for InDex Pharmaceuticals in our efforts to devel...

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Corbus Pharmaceuticals Expands Clinical Development of Resunab With Phase 2 Trial for the Treatment of Systemic Lupus Erythematosus

Posted 3 weeks ago in Clinical Trials

NORWOOD, MA -- (Marketwired) -- 03/07/16 -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic, and serious inflammatory and fibrotic diseases, announced today that Resunab will be tested for efficacy and safety in a Phase 2 clinical study in systemic lupus erythematosus (SLE). SLE is a prototypic autoimmune disease that...

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Abbvie and Boehringer Ingelheim Announce Global Collaboration on Promising Immunology Compounds

Posted 3 weeks ago in Clinical Trials

NORTH CHICAGO, Ill. and INGELHEIM, Germany, March 7, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Boehringer Ingelheim today announced a global collaboration to develop and commercialize BI 655066, an anti-IL-23 monoclonal biologic antibody in Phase 3 development for psoriasis. AbbVie and Boehringer Ingelheim also are evaluating the potential of this biologic therapy in Crohn's disease, psoriatic arthritis and...

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MedImmune receives fast track designation in the US for MEDI8852 for treatment of patients hospitalised with influenza A

Posted 3 weeks ago in Clinical Trials

07 March 2016 -- AstraZeneca today announced that its global biologics research and development arm, MedImmune, has received Fast Track designation from the US Food and Drug Administration (FDA) for its investigational human monoclonal antibody (mAb), MEDI8852, for the treatment of patients hospitalised with Type A strain influenza. The FDA’s Fast Track programme is designed to expedite the development and review of ...

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Ixekizumab Demonstrates Rapid, Clinically Meaningful Improvements As Early As One Week Among Patients With Moderate-To-Severe Plaque Psoriasis

Posted 4 weeks ago in Clinical Trials

INDIANAPOLIS, March 4, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that treatment for moderate-to-severe plaque psoriasis with ixekizumab resulted in clinically meaningful improvements as early as one week, compared to patients treated with etanercept or placebo. Detailed results of this combined analysis of UNCOVER-2 and UNCOVER-3 were presented during the American Academy of Dermatology...

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