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Phase 2a clinical trial results of VX-809 in patients with CF announced

Vertex Pharmaceuticals Incorporated today announced results from a preliminary analysis of data from a 28-day Phase 2a clinical trial of VX-809 in patients with cystic fibrosis (CF) who are homozygous for the F508del mutation.

4 Feb 2010

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer.

3 Feb 2010

Daiichi Sankyo initiates Phase III trial of edoxaban in reducing recurrent VTE complications

Daiichi Sankyo Company, Limited, announced today that it has initiated a new large-scale pivotal Phase III trial for edoxaban, its investigational oral Factor Xa inhibitor. This new study, called HOKUSAI (pronounced hoe·koo·sigh) VTE, is evaluating the safety and efficacy of edoxaban in reducing recurrent venous thromboembolic (VTE) complications in patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

3 Feb 2010

MV vaccine prevents TB in people with HIV infection

Results from clinical trials conducted in Tanzania show that a new vaccine against tuberculosis, Mycobacterium vaccae (MV), is effective in preventing tuberculosis in people with HIV infection. Findings from the trials, which were conducted by investigators from Dartmouth Medical School in the United States, will be published in the next issue of AIDS, the leading journal in the field of HIV and AIDS research. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, and pharmacy.

3 Feb 2010

Promising results from Soligenix' RiVax vaccine trials against ricin toxin

Soligenix, Inc., a late-stage biotechnology company, announced today the publication of an article in the February 2010 edition of Vaccine, which describes preclinical formulations of RiVax™, its ricin toxin vaccine, with heightened stability. The article was authored by the Company's collaborators at the University of Texas Southwestern Medical Center at Dallas (UT Southwestern) where the vaccine originated. RiVax™ is currently being evaluated in Phase 1 human safety and immunogenicity trials, as well as non-human primate trials for efficacy.

3 Feb 2010

Repros Therapeutics receives FDA confirmation for initiating Androxal IND

Repros Therapeutics Inc. today announced that the Company has received verbal confirmation from the Division of Metabolic and Endocrine Drug Products of the Food and Drug Agency that the Company may initiate its Investigational New Drug Application for the study of oral Androxal® in the treatment of hypogonadal men with Type II Diabetes (T2D) with a Phase IIa trial.

3 Feb 2010

Artefill could be viable for lipoatrophy and non-surgical anti-aging enhancement

Suneva Medical, a privately-held aesthetic medical device company, today announced that two clinical studies suggest Artefill may be a safe, effective, long-term treatment option for age-related and HIV lipoatrophy patients.

3 Feb 2010

GenSpera’s G-115 anti-cancer drug awarded US patent

GenSpera, Inc. announced that its patent application, entitled “Tumor Activated Prodrugs,” has been issued by the United States Patent and Trademark Office (USPTO) as US Patent 7,635,682. The patent covers the composition and potential uses of G-115, GenSpera’s second anti-cancer drug in development.

2 Feb 2010

Vantia Therapeutics initiates Phase IIb trial of VA106483 for nocturia

Vantia Therapeutics, an emerging pharmaceutical company developing novel, small molecule drugs targeting large, underserved medical markets, today announces it has begun its planned Phase IIb trial of its lead development compound VA106483 for nocturia.

2 Feb 2010

RECOTHROM topical hemostat exhibits low rate of anti-product antibody formation

ZymoGenetics, Inc., today announced the publication of pooled safety and immunogenicity observations from eight clinical trials of RECOTHROM in the February issue of the Journal of the American College of Surgeons. The authors concluded that RECOTHROM is a well-tolerated topical hemostatic agent in numerous surgical settings and has a low rate of anti-product antibody formation. In the pooled data from all trials, less than one percent of treated patients developed product-specific antibodies. None of the antibodies neutralized native coagulation proteins.

2 Feb 2010

Phase III study evaluating PEP005 Gel for treatment of AK meets primary clinical endpoint

LEO Pharma today announced that in a Phase III study, PEP005 (ingenol mebutate) Gel, the company's lead candidate for the topical treatment of actinic (solar) keratosis (AK) or pre-cancerous lesions, met its primary clinical endpoint of complete clearance of AK lesions in non-head locations.

2 Feb 2010

Pervasis Therapeutics reaches agreement with FDA on pivotal Phase 3 clinical trial for Vascugel

Pervasis Therapeutics, Inc. today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a pivotal Phase 3 clinical trial for Vascugel®, an investigational new drug for the prevention of hemodialysis access graft failure.

2 Feb 2010

Romark Laboratories commences enrollment in Alinia clinical trial for acute uncomplicated influenza

Romark Laboratories announced that it has initiated enrollment of patients in a clinical trial of Alinia® (nitazoxanide) for treating acute uncomplicated influenza including illness caused by the currently circulating H1N1 strain.

1 Feb 2010

Interim positive data from Phase IIa clinical study of SYN115 for Parkinson’s disease

Synosia Therapeutics today announced interim positive data from a Phase IIa clinical study of an adenosine 2a (A2a) receptor antagonist (SYN115) in Parkinson’s disease.

1 Feb 2010

Clinical results of MedImmune's pivotal trial for motavizumab published

MedImmune today announced that clinical results of its pivotal multinational, randomized, double-masked trial for motavizumab have been published in the current issue of the peer-reviewed publication, Pediatrics: Official Journal of the American Academy of Pediatrics.

30 Jan 2010

$Perifosine holds promise as a single agent for relapsed/refractory Waldenstrom's Macroglobulinemia$

Perifosine holds promise as a single agent for relapsed/refractory Waldenstrom's Macroglobulinemia

Æterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrinology, today announced that an article entitled "Clinical and Translational Studies of a Phase II Trial of the Novel Oral Akt Inhibitor Perifosine in Relapsed or Relapsed/Refractory Waldenstrom's Macroglobulinemia," reporting Phase 2 data demonstrating the single agent activity of perifosine (KRX-0401) for the treatment of advanced Waldenstrom's Macroglobulinemia ("Waldenstrom's"), will appear in the February 1, 2010 issue of the Journal of Clinical Cancer Research.

30 Jan 2010

Positive Phase 2 trial results of Keryx Biopharmaceuticals' KRX-0401 announced

Keryx Biopharmaceuticals, Inc. (the "Company") today announced that an article entitled "Clinical and Translational Studies of a Phase II Trial of the Novel Oral Akt Inhibitor Perifosine in Relapsed or Relapsed/Refractory Waldenstrom's Macroglobulinemia," reporting Phase 2 data demonstrating the single agent activity of KRX-0401 (Perifosine) for the treatment of advanced Waldenstrom's Macroglobulinemia ("Waldenstrom's"), will appear in the February 1, 2010 issue of Clinical Cancer Research.

29 Jan 2010

New guidance may help minimize risks to patient privacy in clinical trials

New guidance published in the open access journal Trials and bmj.com this week sets out how personal information from clinical trials should be shared to help minimize risks to patient privacy.

29 Jan 2010

Diabetes vaccine: Diamyd Medical to file for market approval in 2011

In her comments in today’s quarterly report Elisabeth Lindner, President and CEO of Diamyd Medical, says that the Company’s objective is to file the Diamyd® diabetes vaccine for market approval in 2011 - a goal that isn’t very far off now.

29 Jan 2010

Merge Healthcare deploys etrials eDiary 5.0 platform for global urology clinical trial

Merge Healthcare has successfully deployed its etrials eDiary 5.0 platform to conduct a global Phase II urology clinical trial involving 750 patients for one of the largest pharmaceutical companies in the world. Merge was awarded the project because of its eDiary technology, experience in global ePRO (electronic patient reported outcomes) trials and ability to manage the complex logic required by this study. Underway in 22 countries on 3 continents and in 34 languages, the trial also utilizes Merge’s new eDiary Inventory Module to track shipping and supply of study devices in real-time.

29 Jan 2010

Drug Trial News

Phase 2a clinical trial results of VX-809 in patients with CF announced

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Daiichi Sankyo initiates Phase III trial of edoxaban in reducing recurrent VTE complications

MV vaccine prevents TB in people with HIV infection

Promising results from Soligenix' RiVax vaccine trials against ricin toxin

Repros Therapeutics receives FDA confirmation for initiating Androxal IND

Artefill could be viable for lipoatrophy and non-surgical anti-aging enhancement

GenSpera’s G-115 anti-cancer drug awarded US patent

Vantia Therapeutics initiates Phase IIb trial of VA106483 for nocturia

RECOTHROM topical hemostat exhibits low rate of anti-product antibody formation

Phase III study evaluating PEP005 Gel for treatment of AK meets primary clinical endpoint

Pervasis Therapeutics reaches agreement with FDA on pivotal Phase 3 clinical trial for Vascugel

Romark Laboratories commences enrollment in Alinia clinical trial for acute uncomplicated influenza

Interim positive data from Phase IIa clinical study of SYN115 for Parkinson’s disease

Clinical results of MedImmune's pivotal trial for motavizumab published

Perifosine holds promise as a single agent for relapsed/refractory Waldenstrom's Macroglobulinemia

Positive Phase 2 trial results of Keryx Biopharmaceuticals' KRX-0401 announced

New guidance may help minimize risks to patient privacy in clinical trials

Diabetes vaccine: Diamyd Medical to file for market approval in 2011

Merge Healthcare deploys etrials eDiary 5.0 platform for global urology clinical trial

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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