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AMRI reports financial and operating results for Q4 and FY 2014

AMRI reports financial and operating results for Q4 and FY 2014

AMRI today reported financial and operating results for the fourth quarter and full year ended December 31, 2014. [More]
Synthetic Biologics reports positive results from SYN-004 Phase 1b trial to prevent C. difficile infection

Synthetic Biologics reports positive results from 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 positive topline safety and tolerability results from a Phase 1b clinical trial of SYN-004, the Company's investigational oral beta-lactamase enzyme designed to protect the microbiome and prevent Clostridium difficile (C. difficile) infection, antibiotic-associated diarrhea and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy. [More]
Regulus Therapeutics reports top-line results from RG-101 clinical study for HCV treatment

Regulus Therapeutics reports top-line results from RG-101 clinical study for HCV treatment

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced top-line results from the 4 mg/kg cohort and additional results from the 2 mg/kg cohort in a completed clinical study evaluating RG-101, a wholly-owned, GalNac-conjugated anti-miR targeting microRNA-122 ("miR-122"), for the treatment of hepatitis C virus infection ("HCV"). [More]
Researchers devise new technique to deliver cancer treatment

Researchers devise new technique to deliver cancer treatment

A team of researchers has devised a new way to target tumors with cancer-fighting drugs, a discovery that may lead to clinical treatments for cancer patients. [More]
Bionomics initiates BNC210 Phase 1b clinical trial in healthy volunteers

Bionomics initiates BNC210 Phase 1b clinical trial in healthy volunteers

Bionomics Limited has initiated a Phase 1b clinical trial in healthy volunteers of BNC210, the Company's drug candidate in development for the treatment of anxiety and depression. [More]
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

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]
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