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Mylan confirms lawsuit relating to Estradiol Transdermal System ANDA

Mylan Inc. today confirmed that the company has been sued by Vivelle Ventures LLC, Noven Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Estradiol Transdermal System, USP (Twice-Weekly), 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day.

2 Mar 2011

Allergan initiates AGN-214868 Phase II trials in post herpetic neuralgia and overactive bladder

Syntaxin, a biotechnology company developing novel biopharmaceuticals to control cell secretion, today announces its partner Allergan, Inc has initiated two Phase II trials to evaluate the safety and efficacy of its re-targeted endopeptidase drug candidate AGN-214868. The Phase II trials will be focused on patients with post herpetic neuralgia (PHN) and overactive bladder.

2 Mar 2011

Neuralstem announces initiation of NSI-189 Phase Ia trial for major depressive disorder

Neuralstem, Inc. announced that the first subject was dosed yesterday in a Phase Ia trial to evaluate the safety of its drug, NSI-189, which is being developed for the treatment of major depressive disorder and other psychiatric indications. NSI-189 is the lead compound in Neuralstem's neurogenerative small molecule drug platform. This phase of the trial is in healthy volunteers and seeks to determine the maximum tolerated single dose.

2 Mar 2011

Scientists at retrovirus conference present findings on microbicide gel, Truvada, male circumcision, ART care by nurses

At the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston on Monday, researchers "suggested the potential" of a gel containing the antiretroviral drug tenofovir to reduce the risk of anal HIV transmission, TIME's "Healthland" blog reports.

2 Mar 2011

Geron's hESC derived GRNCM1 halts remodeling process and preserves cardiac function in acute heart damage

Geron Corporation today announced preclinical study data showing positive effects of GRNCM1, Geron's cardiomyocyte product derived from human embryonic stem cells (hESCs), in a small animal model of acute heart damage. Administering GRNCM1 by injection into the heart resulted in greater resistance to induced arrhythmias, halted adverse cardiac remodeling and preserved mechanical function compared to controls.

2 Mar 2011

NCI sponsors multi-center phase 2 study of entinostat-anastrozole combination in triple negative breast cancer

Syndax Pharmaceuticals, a clinical-stage epigenetics oncology company, announced the National Cancer Institute (NCI) will sponsor a multi-center phase 2 study of Syndax's lead product entinostat, a novel inhibitor of histone deacetylases (HDAC), and anastrozole, an aromatase inhibitor, in postmenopausal women with operable triple negative breast cancer to evaluate biomarkers and surrogates for response.

2 Mar 2011

OneWorld Health receives FDA clearance for iOWH032 phase 1 trials to treat secretory diarrhea

The Institute for OneWorld Health (iOWH) announced a major milestone in the fight against cholera. The Food and Drug Administration (FDA) granted iOWH permission to begin phase 1 trials for iOWH032, a drug to treat secretory diarrhea. This is the first submission of an Investigational New Drug application for a completely new chemical entity by a non-profit of this size to receive such rapid FDA clearance, and it could be the first synthetic drug of its kind for diarrheal diseases.

2 Mar 2011

Bayhill's BHT-3034 receives FDA IND clearance for treatment of myasthenia gravis

Bayhill Therapeutics Inc, a clinical-stage biopharmaceutical company utilizing its proprietary BHT-DNA™ platform to develop novel and targeted autoimmune and immune-mediated disease treatments, today announced the successful clearance of an IND with the US FDA for BHT-3034, a disease-modifying DNA plasmid vaccine immunotherapy for patients with the autoimmune neuromuscular junction disease myasthenia gravis.

1 Mar 2011

Millennium, Seattle commence brentuximab vedotin phase I trial in patients with ALCL

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company today announced that they have initiated a phase I clinical trial of brentuximab vedotin in combination with chemotherapy for the treatment of newly diagnosed systemic anaplastic large cell lymphoma patients.

1 Mar 2011

Tenofovir gel more effective than oral tablet for HIV treatment: Study

In the first study to make head-to-head comparisons between tenofovir gel and oral tenofovir - two promising approaches for preventing HIV in women - researchers found that daily use of the vaginal gel achieved a more than 100-times higher concentration of active drug in vaginal tissue than did the oral tablet, while, compared to the gel, the tablet used daily was associated with a 20-times higher active drug concentration in blood.

1 Mar 2011

Positive preliminary data from SB-728-902 Phase 1 trial against HIV/AIDS presented at 18th CROI

Sangamo BioSciences, Inc. announced today the presentation of positive preliminary clinical data from its Phase 1 trial.

1 Mar 2011

Omni Bio to expand Type 1 diabetes Phase I/II trial from 15 to 50 patients

Omni Bio Pharmaceutical, Inc., an emerging biopharmaceutical company formed to acquire, license, and develop existing therapies for indications with substantial commercialization potential, has committed to expand its Phase I/II human clinical trial in recently diagnosed Type 1 diabetes patients from 15 patients to 50.

28 Feb 2011

TCD announces first patient treated in its TCD-717 Phase I trial

Traslational Cancer Drugs Pharma, S.L. (“TCD”) announced today that the first patient was treated on Friday the 18th of February with TCD-717 in a Phase I study performed in patients with advanced solid tumors. TCD-717 is a first-in-class, small molecule that precisely inhibits Choline Kinase Alpha, an enzyme heavily involved in the carcinogenic process. A total of 30 patients are planned to be treated in the trial, which will be conducted in accordance with FDA approval, in two leading medical centers in the U.S. The Principal Investigators are Dr. Julie Brahmer at the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital in Baltimore; and Dr. Patricia LoRusso at the Barbara Ann Karmanos Cancer Institute in Detroit.

28 Feb 2011

ACT Biotech files SPA with FDA for telatinib combination Phase 3 trial for stomach cancer

ACT Biotech, Inc., a biopharmaceutical company focused on the development of highly targeted, oral therapeutics for the treatment of cancer, announced today that it has filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase 3 trial of telatinib in combination with chemotherapy for the first-line treatment of patients with advanced stomach cancer.

28 Feb 2011

Regeneron's ARCALYST meets primary, secondary endpoints in second Phase 3 gout flare study

Regeneron Pharmaceuticals, Inc. announced that in a second Phase 3 study (PRE-SURGE 2) in gout patients initiating allopurinol therapy, ARCALYST (rilonacept) met the primary and all secondary study endpoints. The primary endpoint was the number of gout flares per patient over the 16-week treatment period.

28 Feb 2011

Aeterna Zentaris receives $2.5M net sales milestone payment from Cowen Royalty

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrinology, today announced that it had received a net sales milestone of $2.5 million from Cowen Healthcare Royalty Partners, L.P..

28 Feb 2011

Celgene's ISTODAX sNDA granted FDA Priority Review classification for progressive/relapsed PTCL

Celgene Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review classification to its Supplemental New Drug Application (sNDA) regarding ISTODAX (romidepsin) for injection for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy.

28 Feb 2011

Positive results from Trius torezolid Phase 1 lung study

Trius Therapeutics, Inc. today announced results from its Phase 1 clinical trial to evaluate the ability of torezolid to penetrate into the lung for potential use to treat lung infections. In this study a 200 mg dose of torezolid phosphate was administered orally once-daily for three days to healthy adult volunteers. The trial achieved its primary goal of establishing the steady-state plasma pharmacokinetics and distribution of active drug into epithelial lining fluid (ELF).

28 Feb 2011

Immunitor to present latest results from imm01 trial in tuberculosis patients at African conference

Immune Network Ltd. advises that Immunitor will present latest results from its imm01 clinical trial in tuberculosis patients in Abuja, Nigeria at the 18th Union TB and Lung Diseases Conference of the African Region, 2nd to 5th March, 2011.

28 Feb 2011

MEPs, OETC visit new TB vaccine trial site to express support for candidate development

Emergent BioSolutions Inc. announced that a joint delegation of Members of the European Parliament and representatives from the Oxford-Emergent Tuberculosis Consortium today visited the trial site where MVA85A, the world's most clinically advanced tuberculosis vaccine candidate in development, is being studied in a Phase IIb infant efficacy clinical trial.

28 Feb 2011

Drug Trial News

Mylan confirms lawsuit relating to Estradiol Transdermal System ANDA

Allergan initiates AGN-214868 Phase II trials in post herpetic neuralgia and overactive bladder

Neuralstem announces initiation of NSI-189 Phase Ia trial for major depressive disorder

Scientists at retrovirus conference present findings on microbicide gel, Truvada, male circumcision, ART care by nurses

Geron's hESC derived GRNCM1 halts remodeling process and preserves cardiac function in acute heart damage

NCI sponsors multi-center phase 2 study of entinostat-anastrozole combination in triple negative breast cancer

OneWorld Health receives FDA clearance for iOWH032 phase 1 trials to treat secretory diarrhea

Bayhill's BHT-3034 receives FDA IND clearance for treatment of myasthenia gravis

Millennium, Seattle commence brentuximab vedotin phase I trial in patients with ALCL

Tenofovir gel more effective than oral tablet for HIV treatment: Study

Positive preliminary data from SB-728-902 Phase 1 trial against HIV/AIDS presented at 18th CROI

Omni Bio to expand Type 1 diabetes Phase I/II trial from 15 to 50 patients

TCD announces first patient treated in its TCD-717 Phase I trial

ACT Biotech files SPA with FDA for telatinib combination Phase 3 trial for stomach cancer

Regeneron's ARCALYST meets primary, secondary endpoints in second Phase 3 gout flare study

Aeterna Zentaris receives $2.5M net sales milestone payment from Cowen Royalty

Celgene's ISTODAX sNDA granted FDA Priority Review classification for progressive/relapsed PTCL

Positive results from Trius torezolid Phase 1 lung study

Immunitor to present latest results from imm01 trial in tuberculosis patients at African conference

MEPs, OETC visit new TB vaccine trial site to express support for candidate development

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