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FDA removes partial clinical hold on CytRx's aldoxorubicin clinical trials

FDA removes partial clinical hold on CytRx's aldoxorubicin clinical trials

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced that the United States Food and Drug Administration has removed the partial clinical hold on the Company's aldoxorubicin clinical trials. [More]
AMRI awarded NIH contract for drug development services

AMRI awarded NIH contract for drug development services

AMRI today announced it received a 10-year federal contract award from the National Institutes of Health for drug development and manufacturing services. This NIH/National Institute of Neurological Disorders and Stroke award will support NIH's Drug Manufacturing and Formulation Program (DMFP), which is a component of the Blueprint Neurotherapeutics Network (BPN). [More]
Aptose begins APTO-253 clinical study in patients with relapsed or refractory hematologic malignancies

Aptose begins APTO-253 clinical study in patients with relapsed or refractory hematologic malignancies

Aptose Biosciences Inc., a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, today announced dosing of the first patient in its Phase 1b clinical study of APTO-253 in patients with relapsed or refractory hematologic malignancies. [More]
CytRx reports positive interim results from aldoxorubicin Phase 2 trial for HIV-related Kaposi's Sarcoma

CytRx reports positive interim results from aldoxorubicin Phase 2 trial for HIV-related Kaposi's Sarcoma

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced positive interim results from its ongoing Phase 2 clinical trial evaluating the safety and efficacy of aldoxorubicin for the treatment of Kaposi's Sarcoma (KS) in HIV-infected patients. [More]
CytRx reports positive interim results from aldoxorubicin Phase 2 trial for treatment of GBM

CytRx reports positive interim results from aldoxorubicin Phase 2 trial for treatment of GBM

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced positive interim results from its ongoing Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer. [More]
Synthetic Biologics doses first patient in SYN-004 Phase 1b trial to prevent C. difficile infection

Synthetic Biologics doses first patient in SYN-004 Phase 1b trial to prevent C. difficile infection

Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced that enrollment has initiated and the first patient was dosed in a Phase 1b clinical trial of SYN-004, an investigational oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infection, antibiotic-associated diarrhea and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy. [More]
Can-Fite BioPharma begins dosing in CF102 Phase II liver cancer trial

Can-Fite BioPharma begins dosing in CF102 Phase II liver cancer trial

Can-Fite BioPharma Ltd., a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, today announced that it has dosed the first patient in a Phase II trial for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. [More]
Alizé Pharma completes two Phase I clinical trials of AZP-531 in healthy volunteers, obese subjects

Alizé Pharma completes two Phase I clinical trials of AZP-531 in healthy volunteers, obese subjects

Alizé Pharma SAS, an Alizé Pharma group company specialized in the development of biopharmaceuticals to treat metabolic disorders and rare diseases, announces today the completion of two Phase I clinical trials with its unacylated ghrelin analog AZP-531 in 76 healthy volunteers and overweight or obese subjects. [More]
Epizyme presents EPZ-5676 Phase 1 trial results for acute leukemia at ASH 2014

Epizyme presents EPZ-5676 Phase 1 trial results for acute leukemia at ASH 2014

Epizyme, Inc., a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, announced today the presentation of results from the company’s Phase 1 trial of EPZ-5676, a potent and selective inhibitor of the DOT1L histone methyltransferase (HMT). [More]
ContraVir begins pharmacokinetic study of FV-100 for treating shingles

ContraVir begins pharmacokinetic study of FV-100 for treating shingles

ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that it has initiated a pharmacokinetic (PK) study of FV-100, the Company's clinical-stage antiviral for treating shingles. [More]
Daiichi Sankyo releases new formulation of LIXIANA 60 mg Tablets

Daiichi Sankyo releases new formulation of LIXIANA 60 mg Tablets

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has launched a new formulation of LIXIANA 60 mg Tablets (JAN: Edoxaban Tosilate Hydrate, INN: edoxaban, approval to market: September 26, 2014; NHI drug price listing: November 25, 2014) in Japan for the recently approved indications: the prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and the treatment and recurrence prevention of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary thromboembolism (PE)]. [More]
Novo Nordisk reports positive data from Novoeight phase 3 study in people with haemophilia A

Novo Nordisk reports positive data from Novoeight phase 3 study in people with haemophilia A

Today, Novo Nordisk announced a new analysis of phase 3 data demonstrating people with haemophilia A who had the highest annualised bleeding rate (ABR) during initial treatment with Novoeight (Antihemophilic Factor [Recombinant]) showed the largest reduction in bleeding over the duration of treatment. [More]
CytRx's clinical trials for aldoxorubicin placed on partial clinical hold

CytRx's clinical trials for aldoxorubicin placed on partial clinical hold

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced that the Company has received written notice from the United States Food and Drug Administration that its clinical trials for aldoxorubicin have been placed on partial clinical hold. [More]
3SBio enters into exclusive license agreement with PharmAbcine for Tanibirumab

3SBio enters into exclusive license agreement with PharmAbcine for Tanibirumab

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced it has entered into an exclusive license with PharmAbcine, Inc. for the development, manufacturing and marketing of Tanibirumab, an anti-VEGFR2/KDR antibody for cancer in the territory of Greater China (including Mainland China, Taiwan, Hong Kong and Macau) and several emerging countries, including Thailand, Brazil and Russia. [More]
Nonlinear correlation between axitinib dose, dBP increase

Nonlinear correlation between axitinib dose, dBP increase

A pharmacokinetic–pharmacodynamic model shows that diastolic blood pressure rises with increasing doses of axitinib in patients with metastatic renal cell carcinoma, US researchers report, although this relationship is not linear. [More]

Drug combination shows promise in patients with newly diagnosed multiple myeloma

The investigational drug ixazomib taken orally in combination with lenalidomide and dexamethasone shows promise in patients with newly diagnosed multiple myeloma, according to the results of a phase 1/2 study published in the journal Lancet Oncology. [More]
Breakthrough study shows novel molecular imaging drug to detect early prostate cancer

Breakthrough study shows novel molecular imaging drug to detect early prostate cancer

A novel study demonstrates the potential of a novel molecular imaging drug to detect and visualize early prostate cancer in soft tissue, lymph nodes and bone. The research, published in the November issue of the Journal of Nuclear Medicine, compares the biodistribution and tumor uptake kinetics of two Tc-99m labeled ligands, MIP-1404 and MIP-1405, used with SPECT and planar imaging. [More]
Light-activated diabetes drug: an interview with Dr David Hodson

Light-activated diabetes drug: an interview with Dr David Hodson

We've known about chemicals that can be light-activated for about five to ten years now. They’ve mainly all been applied to neurons and, more specifically, the retina. Nobody has ever really looked at any tissues outside of the nervous system. [More]
CytRx provides overview of clinical development programs, reports 2014 Q3 financial results

CytRx provides overview of clinical development programs, reports 2014 Q3 financial results

CytRx Corporation (CYTR), a biopharmaceutical research and development company specializing in oncology, today reported financial results for the three months ended September 30, 2014, and also provided an overview of recent accomplishments by and upcoming milestones for its clinical development programs. [More]
FDA recommens approval of Daiichi Sankyo's once-daily SAVAYSA for patients with NVAF

FDA recommens approval of Daiichi Sankyo's once-daily SAVAYSA for patients with NVAF

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 9 to 1 to recommend approval of once-daily SAVAYSA (edoxaban) 60 mg dosing regimen for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF). [More]