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Captisol-enabled Melphalan meets primary end points in phase 2 pivotal trial

Captisol-enabled Melphalan meets primary end points in phase 2 pivotal trial

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, today announced that its pivotal trial of Captisol-enabled (propylene glycol-free) Melphalan met its primary end points. [More]

Symposium focused on Surefire Medical's COSY clinical trial to be held at ECIO meeting

Surefire Medical, Inc. announced that a symposium focused on the Coiling vs. Surefire Infusion System in Y90 (COSY) clinical trial will be held during the European Conference on Interventional Oncology (ECIO) meeting taking place in Berlin, Germany April 23-26. T [More]
Pfizer reports positive results from two tofacitinib Phase 3 trials for moderate-to-severe plaque psoriasis

Pfizer reports positive results from two tofacitinib Phase 3 trials for moderate-to-severe plaque psoriasis

Pfizer Inc. announced today top-line results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials (OPT) Program, OPT Pivotal #1 (A3921078) and OPT Pivotal #2 (A3921079), evaluating the efficacy and safety of tofacitinib, an oral Janus kinase (JAK) inhibitor, the first in a new class of medicines being investigated for the treatment of moderate-to-severe plaque psoriasis. [More]

Cedars-Sinai researchers to receive $8M grant to fund Phase II clinical trial of experimental drug for stroke

​Cedars-Sinai stroke intervention researchers have been informed that the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, will award an $8 million grant to fund a multicenter Phase II clinical trial of an experimental drug for stroke. [More]

IV-administered ketamine effective in patients with chronic PTSD

For the first time, evidence that a single dose of IV-administered ketamine was associated with the rapid reduction of symptoms of post-traumatic stress disorder in patients with chronic PTSD was demonstrated in a proof-of-concept, randomized, double blind crossover study, undertaken by researchers at the Icahn School of Medicine at Mount Sinai in New York City. These findings, according to Mount Sinai researchers, could be the first step toward developing new interventions for PTSD. [More]

ARCA biopharma announces genetic screening of first patient in GENETIC-AF Phase 2B/3 clinical trial

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the first patient has been genetically screened in GENETIC-AF, its Phase 2B/3 adaptive design clinical trial. [More]

Agios begins AG-348 Phase 1 study to treat PK deficiency

Agios Pharmaceuticals, Inc., a leader in the fields of cancer metabolism and inborn errors of metabolism (IEM), today announced dose administration of AG-348 in a Phase 1 study in healthy volunteers. [More]

Cancer Research partners with AstraZeneca and Pfizer to create clinical trial for advanced lung cancer

CANCER RESEARCH UK is partnering with pharmaceutical companies AstraZeneca and Pfizer to create a pioneering clinical trial for patients with advanced lung cancer - marking a new era of research into personalised medicines to treat cancer. [More]

Baxter reports topline results from BAX 111 Phase 3 trial for treatment of von Willebrand disease

Baxter International Inc. today announced topline results from a Phase 3 clinical trial evaluating the safety, efficacy and pharmacokinetics (PK) of BAX 111. BAX 111 is a recombinant von Willebrand factor (rVWF) under investigation for the treatment of bleeding episodes in patients with von Willebrand disease, the most common type of inherited bleeding disorder. [More]
Akebia completes enrollment in ongoing 200-patient Phase 2b study of AKB-6548

Akebia completes enrollment in ongoing 200-patient Phase 2b study of AKB-6548

Akebia Therapeutics, Inc., a biopharmaceutical company focused on the development of novel proprietary therapeutics based on hypoxia-inducible factor (HIF) biology and the commercialization of these products for patients with kidney disease, today announced it has completed enrollment in its ongoing 200-patient Phase 2b study of AKB-6548 for the treatment of anemia associated with chronic kidney disease (CKD) in patients who are not dependent on dialysis. [More]
Effects of PectaSol-C modified citrus pectin in prostate cancer patients to be studied in phase III trial

Effects of PectaSol-C modified citrus pectin in prostate cancer patients to be studied in phase III trial

A phase III clinical trial conducted at the Meir Medical Center in Kfar-Saba, Israel is now recruiting participants to study the effects of dietary supplement PectaSol-C modified citrus pectin (MCP) in controlling prostate specific antigen (PSA) levels in prostate cancer patients. [More]

Obeticholic acid meets primary composite endpoint in Phase III study

Results from an international Phase III study presented today at the International Liver CongressTM 2014 have shown obeticholic acid (OCA) given to patients suffering from Primary Biliary Cirrhosis (PBC) who previously had an inadequate response to, or have been unable to tolerate ursodeoxycholic acid (UDCA), produced meaningful biochemical and clinical improvements. UDCA is the only therapy currently approved to treat PBC. [More]

Vivolux receives FDA clearance to proceed with phase I/II clinical trial of VLX600

Vivolux AB, a drug discovery company specialized in cancer treatment, announced today that the FDA has granted clearance to proceed with VLX600 into the clinical phase I/II. VLX600 is one of the company's promising projects, and which was recently published in the journal Nature Communications. [More]
New drug combination proves effective in treating patients with HCV genotype 1

New drug combination proves effective in treating patients with HCV genotype 1

Treatment options for the 170 million people worldwide with chronic Hepatitis C Virus (HCV) are evolving rapidly, although the available regimens often come with significant side effects. Two multi-center clinical trials led by Beth Israel Deaconess Medical Center show promise for a new option that could help lead to both an increase in patients cured with a much more simple and tolerable all oral therapy. [More]

Impax resubmits NDA for RYTARY providing updated safety and stability information

Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today the resubmission of Impax's New Drug Application (NDA) for RYTARY (IPX066) to the U.S. Food and Drug Administration (FDA). [More]
Abbott completes enrollment of 3 clinical trials to support approval of Absorb Bioresorbable Vascular Scaffold

Abbott completes enrollment of 3 clinical trials to support approval of Absorb Bioresorbable Vascular Scaffold

Abbott (NYSE: ABT) today announced it has completed enrollment of three clinical trials to support approvals of the company's revolutionary Absorb™ Bioresorbable Vascular Scaffold (BVS) in the United States, Japan and China. [More]
BioLineRx to initiate Phase 1/2 clinical trial on new drug candidate for CML treatment

BioLineRx to initiate Phase 1/2 clinical trial on new drug candidate for CML treatment

BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that Prof. Arnon Nagler, Director of the Hematology Division and Bone Marrow Transplantation Center at Sheba Medical Center, Israel, has received final regulatory approval to evaluate BioLineRx's BL-8040 as a treatment for chronic myeloid leukemia (CML) in a Phase 1/2 clinical study. [More]

Genkyotex’s GKT137831 reverses lung fibrosis in new model of idiopathic pulmonary fibrosis

Genkyotex, the leading developer of selective NOX enzyme inhibitors, announced today the publication of data showing that GKT137831, a first in class NOX1 and 4 inhibitor, was able to reverse lung fibrosis associated with aging in a new model of idiopathic pulmonary fibrosis. [More]
Affimed Therapeutics reports additional results from AFM13 phase 1 study on R/R Hodgkin lymphoma

Affimed Therapeutics reports additional results from AFM13 phase 1 study on R/R Hodgkin lymphoma

Affimed Therapeutics AG announced today further results from its phase 1 clinical trial of AFM13 as monotherapy for the treatment of patients with advanced relapsing/refractory (R/R) Hodgkin lymphoma. [More]

Gilead Sciences announces positive results from LDV/SOF phase 2 studies on HCV infection

Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from two Phase 2 studies evaluating investigational all-oral regimens containing the nucleotide analog polymerase inhibitor sofosbuvir (SOF) for the treatment of chronic hepatitis C virus (HCV) infection. [More]