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Preliminary results from Phase 3 AVERROES trial in atrial fibrillation to be presented at cardiology congress 2010

Bristol-Myers Squibb Company and Pfizer report that preliminary results from the Phase 3 AVERROES clinical trial of the investigational drug apixaban compared with acetylsalicylic acid (ASA, or aspirin) in patients with atrial fibrillation expected to be or demonstrated to be unsuitable for warfarin therapy will be presented at the European Society of Cardiology Congress 2010. The results will be presented during the "Hot Line" session on August 31, 2010, in Stockholm, Sweden.

25 Aug 2010

ZymoGenetics completes enrollment in Phase 2b PEG-IFN lambda clinical trial

ZymoGenetics, Inc. today announced enrollment has been completed in the Phase 2b clinical trial with PEG-Interferon lambda and ribavirin in chronic hepatitis C virus (HCV) infection.

25 Aug 2010

Tranzyme Pharma to present ulimorelin Phase 2 data at NGM Meeting

Tranzyme Pharma announced today that John Wo, MD, Professor of Medicine, Director, Clinical Research, Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, KY, will present ulimorelin Phase 2 data at this year's Joint International NGM Meeting on Saturday, August 28, 2010.

25 Aug 2010

Eisai's Phase III trial of Perampanel for epilepsy shows positive results

The double-blind, placebo-controlled, parallel-group study (Study 306) showed that perampanel was well-tolerated and effective in reducing median seizure frequency and increasing responder rates, the primary outcome measures in the United States and European Union, respectively. The findings were highly statistically significant in 4 mg and 8 mg doses compared to placebo.

25 Aug 2010

First patient treated in Synta Pharmaceuticals' clinical trial of STA-9090

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that the first patient has been treated in its clinical trial of STA-9090 in combination with docetaxel for the treatment of advanced solid tumor malignancies.

24 Aug 2010

FDA clears PROLOR Biotech's Phase II clinical trial of hGH-CTP

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial in the U.S. of its longer-acting version of human growth hormone, hGH-CTP.

24 Aug 2010

Pharmasset commences dosing in PSI-7977 Phase 2b study for chronic hepatitis C

Pharmasset, Inc. announced today that dosing has begun in a Phase 2b study of PSI-7977, a nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (HCV). The trial will evaluate PSI-7977 200mg QD and 400mg QD in combination with pegylated interferon alfa 2a and ribavirin, the current standard of care (SOC) in patients with HCV genotype 1 who have not been treated previously.

24 Aug 2010

USPTO grants Taligen patent for TT30 lead product candidate

Taligen Therapeutics, a biotechnology company developing therapies that regulate the complement system to treat inflammatory and immune diseases, announced today that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,759,304, entitled "Targeting Complement Factor H For Treatment of Diseases", covering the composition of matter for its lead product candidate, TT30, a novel fusion protein that selectively binds to complement activated cells to locally regulate the complement system.

24 Aug 2010

Pfizer reports Progression-Free survival in SUN 1087 combination trial of sunitinib with erlotinib for NSCLC

Pfizer Inc. announced today that the SUN 1087 trial of sunitinib in combination with erlotinib versus erlotinib demonstrated a statistically significant improvement in Progression-Free but not in Overall Survival in patients with previously treated advanced non-small cell lung cancer (NSCLC).

24 Aug 2010

FDA OOPD awards Soligenix $1.2M for orBec Phase 3 study in acute gastrointestinal Graft-versus-Host-Disease

Soligenix, Inc., a late-stage biopharmaceutical company, announced today that it has been awarded a three year $1.2 million clinical research grant by the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA) pursuant to its Orphan Products Development (OPD) Program.

24 Aug 2010

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

Genzyme Corporation announced today that the two-year follow-up results from the phase 2 clinical trial of its investigational therapy known as eliglustat tartrate have been accepted for publication in the journal Blood. The results have been pre-published on the journal's website and are available to subscribers.

23 Aug 2010

InSite Vision initiates Phase 1/2 clinical trial of ISV-303

InSite Vision Incorporated, a company developing novel ophthalmic therapeutics, today announced the initiation of a Phase 1/2 clinical trial of ISV-303, a topical anti-inflammatory product intended to reduce the pain and inflammation associated with ocular surgery. ISV-303 combines a low dose of the non-steroidal anti-inflammatory bromfenac with InSite Vision's proprietary DuraSite technology.

23 Aug 2010

Jazz Pharmaceuticals disappointed with FDA Advisory Committee recommendation for JZP-6 in fibromyalgia

Jazz Pharmaceuticals, Inc. announced that the Joint Advisory Committee of the U.S. Food and Drug Administration (FDA), including the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 20-2 that the benefit/risk balance did not support the approval of JZP-6 for the treatment of with the currently proposed Risk Evaluation Mitigation Strategy (REMS).

21 Aug 2010

'Yakult' effective in reducing acute diarrhea in young children: Study

YAKULT HONSHA CO., LTD. announced on August 20 that its collaborative study on the incidence of acute diarrhea with the National Institute of Cholera and Enteric Diseases in Kolkata, India, showed that daily intake of "Yakult" is efficacious in reducing the incidence of diarrhea in young children.

21 Aug 2010

Protalex initiates dosing in multicenter PRTX-100 Phase 1b clinical study in RA

Protalex, Inc., a clinical stage biopharmaceutical company engaged in developing a class of biopharmaceutical drugs for treating autoimmune and inflammatory diseases, today announced the dosing of the first patient in a multicenter Phase 1b clinical study of PRTX-100 in adult patients with active Rheumatoid Arthritis (RA). The study is being conducted in South Africa.

20 Aug 2010

Knopp Neurosciences enters $345 million worldwide licensing agreement with Biogen Idec

A Pittsburgh start-up company that received an early investment from one of Pennsylvania's most dynamic resources has entered into an exclusive licensing agreement to help find the cure for Lou Gehrig's disease, or ALS, Department of Community and Economic Development Secretary Austin Burke announced today.

20 Aug 2010

Trial shows positive results for radioembolisation technique for colorectal cancer liver metastases treatment

Using the innovative technique of radioembolisation to treat patients with inoperable colorectal cancer liver metastases who have failed all standard-of-care chemotherapy options can more than double the time until their disease progresses, according to the final results of a Phase III randomised controlled trial published in the prestigious Journal of Clinical Oncology.

20 Aug 2010

SRI and Taiho collaborate to advance clinical development of TAS-108 breast cancer program

SRI International, an independent nonprofit research and development organization, announced today that it has assumed responsibility for further clinical development of the TAS-108 breast cancer program, in cooperation with Taiho Pharmaceuticals Co., Ltd., a leading Japanese pharmaceutical company. Further clinical development will focus on the lead compound's registration for the treatment of tamoxifen and aromatase inhibitor-resistant breast cancers.

20 Aug 2010

Quark Pharmaceuticals announces option agreement with Novartis for QPI-1002 siRNA drug

Silence Therapeutics plc, a leading international RNAi therapeutics company, is pleased to note that its partner, Quark Pharmaceuticals, Inc., has announced the grant of an option to Novartis to obtain an exclusive worldwide license to develop and commercialise QPI-1002, a p53 temporary inhibitor siRNA drug which incorporates Silence's AtuRNAi technology.

20 Aug 2010

Bioniche provides update on Urocidin clinical development program for non-muscle-invasive bladder cancer

Bioniche Life Sciences Inc., a research-based, technology driven Canadian biopharmaceutical company, today provided an update on the clinical development program for its proprietary product for non-muscle-invasive bladder cancer - Urocidin.

20 Aug 2010

Drug Trial News

Preliminary results from Phase 3 AVERROES trial in atrial fibrillation to be presented at cardiology congress 2010

ZymoGenetics completes enrollment in Phase 2b PEG-IFN lambda clinical trial

Tranzyme Pharma to present ulimorelin Phase 2 data at NGM Meeting

Eisai's Phase III trial of Perampanel for epilepsy shows positive results

First patient treated in Synta Pharmaceuticals' clinical trial of STA-9090

FDA clears PROLOR Biotech's Phase II clinical trial of hGH-CTP

Pharmasset commences dosing in PSI-7977 Phase 2b study for chronic hepatitis C

USPTO grants Taligen patent for TT30 lead product candidate

Pfizer reports Progression-Free survival in SUN 1087 combination trial of sunitinib with erlotinib for NSCLC

FDA OOPD awards Soligenix $1.2M for orBec Phase 3 study in acute gastrointestinal Graft-versus-Host-Disease

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

InSite Vision initiates Phase 1/2 clinical trial of ISV-303

Jazz Pharmaceuticals disappointed with FDA Advisory Committee recommendation for JZP-6 in fibromyalgia

'Yakult' effective in reducing acute diarrhea in young children: Study

Protalex initiates dosing in multicenter PRTX-100 Phase 1b clinical study in RA

Knopp Neurosciences enters $345 million worldwide licensing agreement with Biogen Idec

Trial shows positive results for radioembolisation technique for colorectal cancer liver metastases treatment

SRI and Taiho collaborate to advance clinical development of TAS-108 breast cancer program

Quark Pharmaceuticals announces option agreement with Novartis for QPI-1002 siRNA drug

Bioniche provides update on Urocidin clinical development program for non-muscle-invasive bladder cancer

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