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FDA accepts DBV Technologies' IND for clinical study of VIASKIN for desensitization to peanut allergy

DBV Technologies (DBV), a biotech company specializing in food allergy with innovative products for diagnosis and treatment, announced today the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application. DBV Technologies will begin clinical investigation of its lead food allergy desensitization candidate, VIASKIN® PEANUT, for the desensitization to peanut allergy. The Company expects to commence recruitment of peanut allergy patients at several medical centers in the U.S. this month.

7 Jul 2010

Phase Ia clinical trial of SYL040012 for treating elevated intraocular pressure, glaucoma completed

Sylentis, a biopharmaceutical subsidiary of Grupo Zeltia and a pioneer in the research and development of new drugs based on gene silencing (interference RNA, RNAi), has completed Phase Ia of its first clinical trial with SYL040012 in the form of ophthalmic drops to treat elevated intraocular pressure and glaucoma.

7 Jul 2010

Crux Biomedical commences enrollment in Retrieve 2 pivotal U.S. IDE trial of new Vena Cava Filter

Crux Biomedical®Inc. announced today that it has successfully enrolled the first patient in its Retrieve 2 pivotal U.S. IDE trial. The trial will evaluate the safety and efficacy of Crux's new Vena Cava Filter (VCF). The Crux VCF is a retrievable, implantable filter which is designed to trap blood clots that can lead to a potentially fatal pulmonary embolism (PE). It is the first VCF to be developed that is bidirectional and thus permits insertion or retrieval from either the femoral or jugular veins.

7 Jul 2010

PuraMed BioScience completes clinical study of LipiGesic M for treating acute migraine

PuraMed BioScience, announced today that a clinical study of LipiGesic M has been completed. The study design was a double blind, placebo controlled, multi-site study measuring the effectiveness of LipiGesic™ M for the treatment of acute migraine attacks. The next steps include completion of the manuscript, submission for publication in a peer-reviewed medical journal and actual publication. In an effort to maximize the potential for publication, an embargo has been placed on the disclosure of any of the results of this study.

7 Jul 2010

FDA grants Angion Biomedica's BB3 therapeutic Fast Track and Orphan Drug product designations

Angion Biomedica Corp., a biopharmaceutical company dedicated to the discovery and development of novel therapeutics that enhance quality of life, eradicate disease and save lives by modulating the body's protective, reparative and regenerative systems, announced today that its lead therapeutic BB3 was accepted into the Fast Track program of the U.S. Food and Drug Administration (FDA) and has also been designated an Orphan Drug product by FDA.

7 Jul 2010

Adeona completes $1 million equity financing and provides update on Zinthionein ZC clinical study

Adeona Pharmaceuticals, Inc., announced today that on July 6, 2010, it completed an equity financing of $1 million with a single institutional investor, Seaside 88, L.P. The financing involved the sale of 1,212,121 registered shares of common stock and no warrants. Enclave Capital served as placement agent and will receive a 7% cash commission and 5-year warrants to acquire 60,606 shares of Adeona at $1.32 per share. The use of proceeds is intended for general corporate purposes.

6 Jul 2010

$CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL$

CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL

Cell Therapeutics, Inc. announced today that it has submitted an expanded Pediatric Investigation Plan to the European Medicines Agency, as part of the process for its submission for a Marketing Authorization Application for pixantrone in the E.U. for the treatment of relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL).

6 Jul 2010

Nottingham researchers undertake new clinical trial on hearing loss

Researchers at The University of Nottingham are embarking on a clinical trial that will help them to further understand the debilitating condition of hearing loss.

6 Jul 2010

EC approves change in posology of Circadin from 3 weeks to 3 months of treatment

Neurim Pharmaceuticals confirmed today that the European Commission (EC) has approved a change in treatment duration with Circadin from 3 to 13 weeks (3 months). Circadin is indicated for the treatment of primary insomnia in patients who are aged 55 or over.

6 Jul 2010

Study: ONGLYZA and metformin improve HbA1c levels for adult patients with type 2 diabetes at 76-weeks

Bristol-Myers Squibb Company and AstraZeneca today announced results up to 76-weeks from a Phase 3 study of ONGLYZA(TM) (saxagliptin) as initial combination therapy with metformin, which produced long-term glycemic improvement (as measured by glycosylated hemoglobin level (HbA1c)) in treatment-naive adults with type 2 diabetes mellitus inadequately controlled on diet and exercise compared to treatment with an investigational 10 mg dose of saxagliptin or metformin alone.

2 Jul 2010

Shire presents positive data from TKT-025 EXT Phase I/II study for VPRIV in type 1 Gaucher disease patients

Shire plc, the global specialty biopharmaceutical company, today announced positive data from its long-term extension to its open label Phase I/II study (TKT-025 EXT) for VPRIV® (velaglucerase alfa), the company's enzyme replacement therapy for patients with type 1 Gaucher disease. The data were presented at the 9th Annual European Working Group on Gaucher Disease (EWGGD) in Cologne, Germany, and add to the growing body of clinical evidence which supports the safety and sustained efficacy of VPRIV.

2 Jul 2010

Chelsea reports positive outcome from DMC review of droxidopa Phase II trial in fibromyalgia

Chelsea Therapeutics International, Ltd. announced the completion and favorable outcome of an independent Data Monitoring Committee (DMC) review of the safety and efficacy data from approximately half the target enrollment in Chelsea's Phase II trial of droxidopa in fibromyalgia.

2 Jul 2010

QR Pharma to present clinical data from mechanism of action study in MCI patients at ICAD 2010

QR Pharma, Inc., a developer of novel drugs to treat Alzheimer's disease (AD), announced today that it has been accepted to present a poster on clinical data from its recent mechanism of action study in mild cognitive impaired (MCI) patients at the International Congress on Alzheimer's Disease (ICAD 2010).

2 Jul 2010

Compugen's CGEN-15001 recombinant fusion protein abolishes spontaneous relapses in animal model of MS

Compugen Ltd. announced today that administration of CGEN-15001 in an animal model of multiple sclerosis (MS) has been shown to completely abolish spontaneous relapses. In addition, administration of this novel molecule prior to disease onset demonstrated a pronounced delay of disease onset and a significant decrease in disease symptoms.

2 Jul 2010

Genentech's second Phase III ICON7 study of Avastin in ovarian cancer meets primary endpoint

Genentech, a member of the Roche Group, announced today that a second large, Phase III, international study showed that the combination of Avastin® (bevacizumab) and chemotherapy, followed by the continued use of Avastin alone, increased the time women with previously untreated ovarian cancer lived without the disease worsening (progression-free survival or PFS, the primary endpoint), compared to chemotherapy alone.

2 Jul 2010

ThromboGenics to present microplasmin Phase III trial data at 28th ASRS and 10th EURETINA Congress

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, announces that data from the second Phase III trial of microplasmin (TG-MV-007) for the non-surgical treatment of vitreomacular adhesion (VMA), are to be presented at the 28th Annual Meeting of the American Society of Retina Specialists (ASRS) and the 10th EURETINA Congress.

1 Jul 2010

Studies on VIAject and Vialog presented at 70th American Diabetes Association sessions

Studies of a more-rapid-acting injectable human insulin formulation (VIAject®) in the treatment of type 1 and type 2 diabetes and of a novel insulin analog formulation (Vialog™) in an animal model of diabetes were reported this week in three poster presentations at the 70th Scientific Sessions of the American Diabetes Association in Orlando, Florida. The findings are based upon results from recent clinical and preclinical studies sponsored by Biodel Inc..

1 Jul 2010

Oxycyte PFCE decreases mortality after onset of decompression sickness in porcine model study

Oxygen Biotherapeutics, Inc. today announced that results from U.S. Navy studies demonstrated decreased mortality in porcine animal models that were given an intravenous dose of Oxycyte® perfluorocarbon emulsion (PFCE) after the onset of decompression sickness (DCS). These results showed a statistically significant decrease in mortality compared with the control group that did not receive Oxycyte PFCE. This data was published in the June issue of Aviation Space and Environmental Medicine.

1 Jul 2010

Study results of triple combination therapy in patients with diabetes and hypertension presented at ADA 2010

Preliminary results of a pre-specified subgroup study analysis of patients with diabetes and hypertension demonstrated that the investigational triple combination therapy of olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg) resulted in a statistically significant greater Least Squares mean reduction in blood pressure from baseline at week 12 (37.9/22.0 mm Hg versus 26.4-28.0/14.7-17.6 mm Hg, P less than or equal to 0.0013) as compared to corresponding dual combination therapy [olmesartan medoxomil (40 mg) / amlodipine (10 mg); olmesartan medoxomil (40 mg) / hydrochlorothiazide (25 mg); or amlodipine (10 mg) and hydrochlorothiazide (25 mg)].

1 Jul 2010

Afinitor more than doubles progression-free survival in advanced pancreatic NET: Study

Novartis Pharmaceuticals Corporation announced today that results of a Phase III study show Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival, or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET). The study, RADIANT-3, was presented at the 12th World Congress on Gastrointestinal Cancer and is part of the largest clinical trial program in patients with advanced NET.

1 Jul 2010

Drug Trial News

FDA accepts DBV Technologies' IND for clinical study of VIASKIN for desensitization to peanut allergy

Phase Ia clinical trial of SYL040012 for treating elevated intraocular pressure, glaucoma completed

Crux Biomedical commences enrollment in Retrieve 2 pivotal U.S. IDE trial of new Vena Cava Filter

PuraMed BioScience completes clinical study of LipiGesic M for treating acute migraine

FDA grants Angion Biomedica's BB3 therapeutic Fast Track and Orphan Drug product designations

Adeona completes $1 million equity financing and provides update on Zinthionein ZC clinical study

CTI submits expanded PIP to EMEA for pixantrone MAA for relapsed or refractory, aggressive NHL

Nottingham researchers undertake new clinical trial on hearing loss

EC approves change in posology of Circadin from 3 weeks to 3 months of treatment

Study: ONGLYZA and metformin improve HbA1c levels for adult patients with type 2 diabetes at 76-weeks

Shire presents positive data from TKT-025 EXT Phase I/II study for VPRIV in type 1 Gaucher disease patients

Chelsea reports positive outcome from DMC review of droxidopa Phase II trial in fibromyalgia

QR Pharma to present clinical data from mechanism of action study in MCI patients at ICAD 2010

Compugen's CGEN-15001 recombinant fusion protein abolishes spontaneous relapses in animal model of MS

Genentech's second Phase III ICON7 study of Avastin in ovarian cancer meets primary endpoint

ThromboGenics to present microplasmin Phase III trial data at 28th ASRS and 10th EURETINA Congress

Studies on VIAject and Vialog presented at 70th American Diabetes Association sessions

Oxycyte PFCE decreases mortality after onset of decompression sickness in porcine model study

Study results of triple combination therapy in patients with diabetes and hypertension presented at ADA 2010

Afinitor more than doubles progression-free survival in advanced pancreatic NET: Study

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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