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Friday, April 11, 2014

Guerbet : FDA Approves Lipiodol® (Ethiodized Oil) Injection for Imaging of Tumors in Adults with Known Hepatocellular Carcinoma

Guerbet
FDA Approves Lipiodol® (Ethiodized Oil) Injection for Imaging of Tumors in Adults with Known Hepatocellular Carcinoma (HCC) 

Guerbet LLC, USA (April 10, 2014) Princeton (NJ), Guerbet, a pioneer in the field of contrast agents for medical imaging announced that Lipiodol® was approved by the US Food and Drug Administration pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act indicated for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC). HCC is the most common primary liver tumor and represents the third-leading cause of cancer-related death in the world, with prevalence in US estimated to affect in the range of 35,000 U.S. patients in 2013.

As previously announced in October 2013, Lipiodol has received an orphan-drug designation for management of patients with known HCC.

"Guerbet is pleased to have been granted approval for use of Lipiodol in patients with known HCC. This product has been supplied during the past three years under a temporary importation program. Guerbet’s efforts to improve the availability of Lipiodol in the USA are in line with our company mission offering reliable and innovative solutions to improve the efficacy of Interventional Radiology procedures”, commented Massimo Carrara, Guerbet US General Manager... [PDF] Guerbet's press Release - PDF Communiqué de Presse Guerbet -

Monday, March 11, 2013

FIRST EUROPEAN PATENT FOR OSE PHARMA FOR ITS TARGETED IMMUNE THERAPY FOR LUNG CANCER

OSE PharmaParis, France, January 31, 2013 - OSE Pharma SA, dedicated to severe orphan lung diseases announces the allowance of its first patent in Europe related to OSE2101, its targeted cancer immune therapy product in phase 3 for lung cancer - the product OSE2101 developed by OSE Pharma targets 5 tumor antigens with 10 epitopes -an epitope is a small peptide or a fragment of tumor antigen. The patent covers a composition comprising these epitopes. They produce a response of particular cells named T cytotoxic, able to destroy the tumor cells expressing these tumor antigens.

The 5 tumor associated antigens (HER2/neu; P53; CEA; MAGE2; MAGE3) were selected due to the poor prognosis established when overexpressed in particular in lung cancer named Non-Small Cell Lung Cancer (NSCLC) and for the increasing risk when these Tumor antigens are associated.

The lung cancer is the leading cause of cancer death in the world and the Non Small Cell Lung cancers(NSCLC 88% of lung cancer) amounted to 1,41 million new cases each year with a high level of mortality: 1.21 million deaths. The HLA A2 positive patients (HLA A2 is a requirement for the immune T cytotoxic response) are the target population of OSE2101 and are representing 45% of the NSCLC population. This HLA A2 biomarker is a poor prognosis factor associated with an increasing invasive risk. This population of HLA A2 positive patients is the basis of the demand of an orphan drug status filed by OSE Pharma. The need of innovative drug is critically needed due to this aggressive NSCLC disease often discovered at late stage. Despite aggressive treatments, the 5-year relative survival rates are about 24% for patients with regional disease and less than 4% for patients with metastatic disease... OSE Pharma's Press Release -

Monday, June 4, 2012

Provence Technologies and Neuroptis Biotech partner to develop a new compound for treating dry eye syndrome

Neuroptis Biotech Marseille, France, and Paris, France, 21 May, 2012 - Provence Technologies to optimize and transfer the production process for ML7, Neuroptis Biotech’s dry eye drug candidate

Provence Technologies, a service provider of specialist fine chemistry, and Neuroptis Biotech, specializing in the discovery and development of innovative therapies in neurology and ophthalmology, announce today the further strengthening of their collaboration for transferring the chemical development of Neuroptis Biotech’s drug candidate, ML7, and producing the first GMP batches before the end of 2012.

Provence TechnologiesML7 is a drug candidate for the treatment of dry eye syndromes. It is the first of a new therapeutic class and has the potential to provide a targeted and effective therapeutic remedy for the millions of people suffering from dry eye syndrome, Gougerot-Sjögren syndrome, and inflammations, especially ones caused by allergies. Provence Technologies and Neuroptis Biotech have already collaborated successfully in developing a synthetic pathway for ML7, manufacturing the first non-GMP batches, and devising associated analytical methods. The two companies have embarked on the process optimization phase to facilitate the transfer of the compound and the start of production on an industrial scale, scheduled for September this year... [PDF] Provence Technologies' Press Release - Neuroptis Biotech's Press Release - [PDF] Communiqué de Presse de Provence Technologies -

Wednesday, May 9, 2012

Vexim Continues Its Development and Sets up in Germany to Directly Market the SpineJack® Range

Vexim
TOULOUSE, France - Vexim, a Med-Tech company that specializes in minimally invasive treatment of vertebral fractures (called “minimally invasive anatomical restoration”), announces the creation of its German subsidiary in Ulme (between Stuttgart and Munich). Vexim GmbH will be responsible for promoting and marketing the SpineJack® range in Germany, in addition to training German physicians.

Germany is one of our key markets and we have decided to directly market SpineJack from February 2012 so as to ensure that our rollout and training plan is a success but also to maximize profits on German soil,” declared Vexim’s CEO Vincent Gardès. “The team we are recruiting will allow us to establish and maintain close relations with physicians, a necessary condition to guarantee our lasting presence in Germany.”...[PDF] Vexim's Press Release -

Tuesday, April 17, 2012

The French company Keosys, signs 10 international contracts within Clinical Research

Keosys
March 2012 - The French company Keosys, signs 10 international contracts within Clinical Research - For the past 6 years, Keosys has provided expertise for oncology clinical research trials utilizing innovative solutions in medical imaging and telecommunications. Keosys’ collaboration with the academic institutions is based on the implementation of a standardized, central reading platform for the academic multicentric clinical studies at major french and european institutions. Among these: EORTC (European Organization for Research and Treatment of Cancer), GELARC (Adult Lymphoma Study Group – Clinical Research) which is member of the European Lymphoma institutes, SFMN (French Society of Nuclear Medicine), UNICANCER (French Comprehensive Cancer Centers group), and VUmc (VU University medical center).

Medical imaging harmonization and standardization within clinical studies.

The aim is to standardize medical imaging workflow from the patient image acquisition (based on scanner qualification process), to the expert reading/assessment (based on the development of oncology follow-up tools for therapy response evaluation). Keosys’ innovative technology succeeds in reducing phase III study costs related to exam centralization of approximately 40% compared to current institutional processes...

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 ...About Keosys

 Keosys is an innovative company composed of a team of experts in medical imaging, IT and telecommunications. In 2011, after 10 years of scientific and academic collaboration within clinical research in nuclear medicine and radiology, Keosys has become a key player establishing 10 keen international partnerships with renowned institutions such as the EORTC, SNM, SFMN, and GELARC… Those partnerships are based on the supply of IMAGYS [TM] technology, medical imaging cloud services for exam centralization of patients enrolled in clinical studies (phase I-II). Medical imaging workflow via IMAGYS [TM] enables imaging exam availabilities in a timely manner offering optimized cost management in full compliance with regulation in force and the European and American GCPs (Good Clinical Practices)... [PDF] Keosys' Press Release -

Thursday, March 29, 2012

Domain Therapeutics : EUR 933,000 grant for schizophrenia project

Domain Therapeutics
Strasbourg, France, March 13, 2012 - GPCR specialist will lead EUR 5.1 million ATHOS Project to develop new therapie -

Domain Therapeutics, a biopharmaceutical company focussed on the discovery and early development of small molecules targeting G-Protein Coupled Receptors (GPCRs), one of the most important classes of drug targets, announced that ATHOS project has been selected for French government funding. ATHOS aims to develop new drug candidates and identify therapeutic targets for schizophrenia.

Total funding will amount to EUR 5.1 million over three years. Some 45 per cent of the ATHOS budget will be provided by central and regional government organizations, including the grant of EUR 933,000 to Domain Therapeutics.

Schizophrenia is a disease of the central nervous system generally starting in adolescence and becoming a chronic condition. It typically exhibits a dissociation of the personality, giving rise to auditory hallucinations, paranoid delirium and attention disorders. These problems affect not only the patient’s mental health but also life expectancy, which is 12 years shorter than that of the general population. Schizophrenia and related conditions affect 2-3 per cent of the world population but existing treatments do not improve the cognitive disturbances resulting from the disease and some patients remain completely resistant to available treatments... 

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...About Domain Therapeutics S.A. 

Domain Therapeutics is a biopharmaceutical company located in Strasbourg, France, dedicated to the discovery and early development of small molecules targeting G-Protein Coupled Receptors (GPCRs), one of the most important classes of drug targets. Domain Therapeutics identifies and develops drug candidates using its DTect-All (TM) innovative proprietary technology. The company’s portfolio is composed of new chemical entities ranging from hits to optimized leads for leading indications such as schizophrenia, Parkinson's disease, and diabetes... [PDF] Domain Therapeutics' Press Release -

Thursday, March 15, 2012

Echosens introduces the new FibroScan® 502 Touch with CAP™ (Controlled Attenuation Parameter) in Asia [APASL 2012]

Echosens
16/02/2012 - At the 2012 Conference of the Asian Pacific Association for the Study of the Liver (APASL) taking place this year in Taipei from February 16th to February 19th, Echosens, a pioneer and major player in non-invasive hepatic diagnosis, will present for the first time in Asia its latest product, the new FibroScan® 502 Touch, widening the range of FibroScan® devices now available.

Equipped with a new and more ergonomic tactile interface, and based on patented Vibration-Controlled Transient Elastography (VCTE™), the latest FibroScan®provides a reliable, accurate and reproducible assessment of liver tissue stiffness. This technology, developed by Echosens, is unique in measuring liver stiffness at a pre-determined and controlled 50 Hz frequency...

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...About Echosens and Fibroscan 

FibroScan is designed to quantify hepatic stiffness and ultrasound attenuation (CAP™) in a non-invasive manner in chronic liver diseases assessment.

Founded in 2001, Echosens supplies its products in more than 70 countries through a global network of suppliers. It dedicates a major portion of its activity to research and development in order to invent new medical devices and open up new medical perspectives. The organization works in close cooperation with health professionals and patients’ associations to facilitate management and therapeutic monitoring of patients. To date, there are more than 500 peer-reviewed publications which attest to the efficacy of FibroScan® in clinical practice...[PDF] Echosens' Press Release -