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Europe in Medical Technology

Lower Extremity Peripheral Vascular Stent and Balloon Catheter Markets to Exceed $180 Million in Europe by 2013

Positive clinical data, competitor focus, and new drug-eluting technologies to drive lower extremity procedures in Europe , according to Millennium Research Group WALTHAM, Mass., May 28 /PRNewswire/ -- According to Millennium Research Group's (MRG's) European Markets for Peripheral Vasc...

NanoVibronix Receives Wound Healing Indications in Europe for its PainShield(TM) Device

NESHER, Israel, April 21 /PRNewswire/ -- NanoVibronix, a medical device company specializing in applications that implement surface ultrasound waves, announced that its novel device has received CE approval in Europe for additional claims of wound healing. PainShield is the first hands-free, p...

MedImmune Advances Asthma Program with Start of a Phase 2 Trial in Europe and Australia and First U.S.-Based Clinical Trial for Antibody Targeting IL-13

GAITHERSBURG, Md., April 15 /PRNewswire/ -- MedImmune today announced that it has advanced its efforts to develop CAT-354, a potential treatment for patients with asthma, with the start of two new trials with a monoclonal antibody (MAb) targeting interleukin-13 (IL-13). One of the studies is a...

Immunosyn Releases Wound Healing Photographs From the First Phase 'Proof of Concept Trial' in Europe for Treatment of Diabetic Ulcers With Biopharmeceutical SF-1019

LA JOLLA, Calif., Feb. 26 /PRNewswire-FirstCall/ -- Immunosyn Corporation (OTC Bulletin Board: IMYN) received permission from Argyll Biotechnologies, LLC to release before and after wound healing photographs resulting from subcutaneous injections of the biopharmaceutical SF-1019 from the first...

Cepheid Launches New GeneXpert(R) Tests in Europe for Simultaneous, Rapid Detection of Staphylococcus Aureus and Methicillin Resistant Staphylococcus Aureus

Tests for Skin and Soft Tissue Infection and Blood Culture Extend European Product Line for Healthcare Acquired Infections SUNNYVALE, Calif., Dec. 4 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced the European release of Xpert(TM) MRSA/SA-Blood Cultures (BC) and Xper...

Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis

Two International Phase 3 Trials Evaluated Infrequent Dosing of Ustekinumab in Nearly 2,000 Patients HORSHAM, Pa. and BEERSE, Belgium, Dec. 4 /PRNewswire/ -- Centocor, Inc. and Janssen-Cilag International NV announced today that regulatory applications have been submitted ...

Immunosyn Announces Biozyme Lab's Receipt of MHRA Manufacturing License Approval in Europe for the Biopharmaceutical SF-1019

LA JOLLA, Calif., Nov. 28 /PRNewswire-FirstCall/ -- Immunosyn Corporation (OTC Bulletin Board: IMYN) today announced that Biozyme Laboratories has received approval from the MHRA to import base material and manufacture SF-1019 for human use in clinical trials. SF-1019 is a biopharmaceutical fo...

CHMP Recommends Expanded Use of Angiox(R) (Bivalirudin) in Europe for Patients With Acute Coronary Syndromes

Positive Opinion Coincides with Expansion of The Medicines Company into Europe PARSIPPANY, N.J. and ZURICH, Switzerland, Nov. 19 /PRNewswire/ -- The Medicines Company (Nasdaq: MDCO ) today announced that the Committee for Medicinal Products for Human Use (CHMP)...

First Patient Enrolled in Europe in Ovature Phase III Ovarian Cancer Trial

Novogen Limited's subsidiary, Marshall Edwards Inc. (Nasdaq: MSHL ), has made the following announcement: SYDNEY, Australia and NEW CANAAN, Conn., Aug. 27 /PRNewswire-FirstCall/ -- Marshall Edwards, Inc. (Nasdaq: MSHL ) today announced enrolment of the first patient in Eur...

Takeda to Revise Timing of Alogliptin and Alogliptin/ACTOS MAA Filings in Europe

OSAKA, Japan, June 3 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") announced today that it has reviewed the development strategy for the Marketing Authorization Applications (MAAs) for its investigational compounds, alogliptin and alogliptin/ACTOS (generic name: pioglitazone H...

AdvanDx Launches Fast, 90 Minutes Protocol for All CE-IVD Marked PNA FISH(R) Tests in Europe

Pathogen Identification Results in 90 Minutes Direct from Positive Blood Cultures Faster Results to Help Clinicians Improve Antibiotic Selection and Outcomes for Critical Infections WOBURN, Mass. and VEDBAEK, Denmark, April 28 /PRNewswire/ -- AdvanDx today announced that it has launched ...

A First-Line Therapy for Renal Cell Carcinoma that can Increase Overall Survival when Compared with Sutent Would Earn a Higher Patient Share in the United States Than in Europe

Pfizer's Axitinib Earns Decision Resources' Gold-Standard for Renal Cell Carcinoma in 2012, According to a New Report from Decision Resources WALTHAM, Mass., Feb. 26 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare is...

Elsevier is Expanding eClinical Solutions in Europe

COPENHAGEN, Denmark, October 31 /PRNewswire-FirstCall/ -- - DoctorConsult in Germany Marks First of Several Localized Workflow Solutions That Improve Clinician Decision Making and Health Care Business Performance With a deep understanding of healthcare workflow and more than a century of e...

MatTek's EpiDerm In Vitro Tissues Headed for Validation in Europe

Acceptance Will Reduce Animal Use in Cosmetics and Chemicals Testing ASHLAND, Mass., Oct. 8 /PRNewswire/ -- MatTek Corp. today announced that results of a recently completed US and European multi-laboratory "catch-up" validation study on MatTek's EpiDerm in vitro human skin tissue equivalent...

Neuralstem Announces Issuance of Core Technology Patent in Europe

ROCKVILLE, Md., April 28 /PRNewswire-FirstCall/ -- Stem cell company, Neuralstem, Inc., (Amex: CUR ) announced today that the European Patent Office has granted Neuralstem a European patent EP0915968, covering the "Isolation, Propagation and Directed Differentiation of Stem Cells from Embryon...

Diamyd(R) Diabetes Vaccine Receives Approval to Start Phase III Trials in Europe

Diamyd Medical AB ( http://www.omxgroup.com, OMX: DIAM B; http://www.otcqx.com, OTC: DMYDY) STOCKHOLM, Sweden, March 19 /PRNewswire-FirstCall/ -- Diamyd Medical (OMX: DIAM B)(OTC: DMYDY)announced today that the Swedish Medical Products Agency (MPA) has approved the...

Bristol-Myers Squibb and Gilead Sciences Expand Their Alliance to Include Commercialization of ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Europe

PRINCETON, N.J. and FOSTER CITY, Calif., Dec. 11 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY ) and Gilead Sciences, Inc. (Nasdaq: GILD ) today announced an agreement to commercialize ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)...

Biodel Inc. Expands Ongoing Phase III VIAject(TM) Clinical Trials Into Europe

DANBURY, Conn., Sept. 21 /PRNewswire-FirstCall/ -- Biodel Inc. (Nasdaq: BIOD) today announced that the Company has expanded its two ongoing pivotal Phase III clinical trials of VIAject(TM) into Europe. Clinical sites have been initiated in Germany and patient treatment has begun. "We are expa...

BioMosaics' Glypican-3 Blood & Tissue Tests Receive CE Marking in Europe

BURLINGTON, Vt., Sept. 10 /PRNewswire/ -- BioMosaics Inc., a cancer biomarker development company, announced today that it has received CE marking for its proprietary products for the identification of Glypican-3 (GPC3) in human blood and in tissue as in vitro diagnostic tests. This will allow...

Favrille Announces Data From Phase 2 Clinical Trial of FavId for Indolent B-Cell Non-Hodgkin's Lymphoma in Europe

Data Reported at the Congress of the European Hematology Association SAN DIEGO, June 11, 2007 /PRNewswire-FirstCall/ -- Favrille, Inc. , a biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer, announced interim data from a Phase 2 clinical trial...

Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009

...U.S. for homozygous FH in the second half of 2010, with a similar filing in europe shortly afterwards. Data from our Phase 3 study in severe hypercholesterol...y provide the basis for a broader indication. A potential second filing in europe will involve a broader patient population, namely heterozygous FH patients....

Nektar Therapeutics Reports Second Quarter 2009 Financial Results

...ntly in a Phase 1 study in patients with refractory solid tumors. Nektar technology is used in nine approved partnered products in the U.S. or europe today, including UCB's Cimzia(R), Roche's PEGASYS(R) for hepatitis C and Amgen's Neulasta(R) for neutropenia. Nektar is headquartered in San C...

Covance Receives Highest Level of Phase I Accreditation

...ire/ -- Covance Inc. today announced that it has received standard and supplementary accreditation for the conduct of clinical pharmacology in europe by the Medicines and Healthcare products Regulatory Agency (MHRA). This voluntary accreditation process provides clinical trial volunteers and sponso...

Study Results Show That Minimally Invasive Therapy is Successful for Over Two-Thirds of Stroke Patients Treated Outside the Standard Eight-Hour Window

...ould benefit from therapies that could restore their quality of life." Stroke is the third leading cause of death in the United States, Canada, europe and Japan. According to the American Stroke Association, approximately 800,000 Americans each year suffer a new or recurrent stroke. Americans will ...

Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial in Secondary Progressive Multiple Sclerosis

...rolled trial designed to evaluate the safety and efficacy of dirucotide in patients with SPMS. The study was conducted in Canada and nine countries in europe and included 612 patients being administered either dirucotide or placebo intravenously every six months for a period of two years. The primary...

Terumo Cardiovascular Systems Initiates U.S. Clinical Trial for Anaconda(TM) AAA Stent Graft System

.... The Anaconda system is commercially available outside the U.S. where it has been implanted in nearly 4000 patients. It received CE Mark in europe in April 2005. According to the Society of Vascular Surgery, physicians diagnose approximately 200,000 people with AAAs in the U.S. annually....

Lilly and New York City Mayor Michael R. Bloomberg Announce Lilly Agrees to be First Tenant of East River Science Park; Issue Urgent Call for Healthcare Reform that Protects Innovation and Jobs

...types of gastric malignancies such as gastro-esophageal junctional cancer, which will also be evaluated in our study, are increasing in North America, europe and outside of Asia. Gastric cancer is diagnosed more than 21,000 times each year in the United States alone and is the second leading cause of cancer...

Cardica Announces Publication of Pivotal PAS-Port(R) Proximal Anastomosis System Clinical Trial Results

...s. "Used in the United States, Japan and europe during thousands of CABG procedures to date, the P...osis Systems are marketed in the United States and europe and its PAS-Port(R) Proximal Anastomosis System is marketed in the United States, europe and Japan. Forward-Looking Statements ...

Awardees for the 2009 Young Investigator Grant for Probiotics Research Announced

...company has established two science institutes to support its efforts: one in Japan (Yakult Central Institute for Microbiological Research) and one in europe (Yakult Honsha European Research Center for Microbiology ESV). Since developing its overseas network in 1964, Yakult has expanded its business to 32 c...

Lexicon's Drug Candidate LX1032 for Carcinoid Syndrome Receives Orphan Drug Designation From EMEA

...on has obtained orphan drug status. "Gaining orphan designation in europe for LX1032 provides important regulatory and commercial advantages in the d...ment at Lexicon. "We are now well positioned to conduct trials of LX1032 in europe as part of an integrated global development strategy." Lexicon re...

Cytokine PharmaSciences Initiates Phase I Study of Oral Anti-Inflammatory Agent, CPSI-2364

...g focus in the area of women's health, including manufacturing the successful cervical ripening product, the Cervidil(R) vaginal insert (Propess(R) in europe and elsewhere). Cytokine PharmaSciences has three products in clinical development and employs 70 people at its locations in the U.S. and Scotland. F...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

...ubmit marketing applications in the United States, europe and other regions in the first half of 2010." ... States and Marketing Authorization Application in europe and other regions. HGS designed the Phase 3 progra...d Skin Diseases at www.niams.nih.gov , or Lupus europe at www.elef.rheumanet.org . Conferenc...

Tibotec Pharmaceuticals Announces Agreement to Develop and Commercialize a New Fixed-Dose Combination of TMC278 and Truvada(R) With Gilead Sciences

...ral agents, has not been established. Two major phase III trials for TMC278 are currently being conducted in the United States, Canada, Africa, Asia, europe and South America. About Tibotec Pharmaceuticals Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and d...

Schering-Plough Expands Vicriviroc Phase II Study in Treatment-Naive Patients With HIV

...el study is projected to enroll approximately 200 treatment-naive HIV-infected adult patients at more than 35 sites in North America, Central America, europe and South Africa. Patients coinfected with hepatitis B or C may be included in the study. The primary efficacy endpoint of the study is the ...

Elbit Imaging Ltd. Announces - Swiss Team Uses InSightec's ExAblate(R) 4000 Brain System to Treat Patients With Functional Brain Disorders

...rojects, predominantly in the retail sector, located in Central and Eastern europe and in India; (ii) Hotels - Hotel ownership, operation, management and sale...ther mixed-use real projects, predominantly residential, located in Eastern europe and in India; and (v) Other Activities - (a) The distribution and marketing...

deCODE Discovers Second Common Genetic Risk Factor for Atrial Fibrillation and Stroke

... REYKJAVIK, Iceland, July 13 /PRNewswire-FirstCall/ -- Scientists at deCODE genetics (Nasdaq: DCGN ) and colleagues from europe and the United States today report the discovery of a common single-letter variant in the sequence of the human genome (SNP) conferring increased risk...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

...nth, multi-center, randomized, double blind, placebo controlled, parallel dose clinical trial involving 457 RA patients in the U.S., Latin America and europe who had failed to respond to methotrexate alone. The patients were randomly assigned to two cohorts and thus received R788 orally in either 100 mg bi...

Leading Experts Endorse Bioheart's Muscle Stem Cell MyoCell Therapy

...ar to the heart muscle protein." Dr. HJ Duckers, Interventional Cardiologist, Thoraxcenter, Rotterdam discussed the history of the Bioheart trials in europe to date and added that "the myoblast therapy is at this time point the only stem cell therapy that is making the claim to actually induce neomyogenesi...

Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder

...d, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. Cephalon europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology. The company's proprietary products in the ...

Data Demonstrates Long-Term Reduction In Seizure Frequency With Novel Once Daily Anti-Epileptic Zebinix(R)

...Under the terms of a deal with BIAL, announced in February this year, Eisai europe Ltd received a sole license to market, promote and distribute ESL within Europe**. Eisai and BIAL plan to launch Zebinix(R) across europe during 2009 and into 2010, providing a novel and effective treatment to pat...
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