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Biogen Idec initiates enrollment in Phase II BG-12 combination trial for relapsing-remitting multiple sclerosis

Biogen Idec today announced enrollment of the first patient in a multicenter Phase II clinical trial designed to evaluate its investigational oral therapy BG-12 (dimethyl fumarate) in combination with commonly used first-line treatments in patients with relapsing-remitting multiple sclerosis (RRMS).

15 Jun 2010

BIOTRONIK announces commercial availability of new ProMRI Pacing Systems

BIOTRONIK SE & Co. KG, a leading manufacturer of high-quality implantable cardiac devices and pioneer of wireless remote monitoring technologies, announced today the commercial availability of its new ProMRI Pacing Systems — Evia pacemaker series and Safio pacing leads — providing European patients the first portfolio of bradycardia systems that are compatible with Magnetic Resonance Imaging scans under specific conditions.

15 Jun 2010

Alexion's Soliris may benefit patients with thrombotic microangiopathy from uncontrolled complement activation

Researchers reported today that Soliris® (eculizumab), a first-in-class terminal complement inhibitor developed by Alexion Pharmaceuticals, Inc., may provide clinical benefits to patients with thrombotic microangiopathy (TMA) resulting from uncontrolled complement activation. TMA, the formation of blood clots in capillaries and small arteries, can lead to life-threatening damage in multiple organs including kidney failure, thrombocytopenia (abnormally low platelet count) and anemia.

15 Jun 2010

Pieris commences PRS-050 anti-VEGF Anticalin Phase I clinical trial for cancer

Pieris AG announced today the initiation of a Phase I clinical trial in cancer patients for its lead program, PRS-050, an anti-VEGF Anticalin. The trial is an open-label, dose-escalating evaluation of the compound's safety and tolerability in patients with solid tumors. Conducted at three sites in Germany, the trial is underway and patients from the first cohort have been dosed.

15 Jun 2010

SIRS-Lab, Analytik Jena partner in molecular sepsis diagnostics

SIRS-Lab GmbH and Analytik Jena AG, also based in Jena, will be strengthened by working together in the field of molecular sepsis diagnostics. As part of this cooperation, Analytik Jena subsidiary AJ Innuscreen GmbH will provide the partner with a platform for automated isolation of nucleic acids with the associated reagent system worth almost half a million euro.

15 Jun 2010

Innovacell Biotechnologie commences enrollment in urocell Phase IIb study for bladder weakness

"First patient in" is the call from the Innsbruck firm, Innovacell Biotechnologie AG, as the first patient was recruited at the MHAT Plovdiv clinic in Bulgaria for the Phase IIb study of the advanced therapy medicinal product, urocell®. The clinical study will be conducted, beside Bulgaria, in the Czech Republic, Germany, Poland and Romania at more than 50 clinics.

15 Jun 2010

Aeterna Zentaris to present poster on AEZS-130 growth hormone secretagogue/ghrelin receptor agonist at 92nd ENDO

Aeterna Zentaris Inc. a late-stage drug development company specialized in oncology and endocrine therapy, today announced that a poster on its oral synthetic growth hormone secretagogue/ghrelin receptor agonist, AEZS-130, will be presented at the upcoming 92nd Annual Endocrine Society (ENDO) Meeting and Expo, which will be held June 19 through 22, 2010 at the San Diego Convention Center in San Diego, California.

15 Jun 2010

Xoft reports clinical benefits of isotope-free electronic radiation therapy for treatment of cancer

The clinical benefits of isotope-free electronic radiation therapy delivered directly to cancer sites with minimal exposure to surrounding healthy tissue continues to be substantiated by multiple publications, according to Xoft, Inc., developer of the Axxent Electronic Brachytherapy, eBx System. The leading provider of FDA-cleared Electronic Brachytherapy Systems, Xoft provides systems for single-dose intraoperative radiation therapy and accelerated brachytherapy applications.

15 Jun 2010

ULURU present Altrazeal at 2010 WOCN/WCET joint conference

ULURU Inc. announced today that six posters detailing clinical experience using Altrazeal™ Transforming Powder Dressing will be presented at the 2010 Joint Conference of the Wound Ostomy and Continence Nurses Society (WOCN) and World Council of Enterostomal Therapists (WCET) on June 14-16 in Phoenix, Arizona.

15 Jun 2010

FDA grants HeartWare approval for IDE destination therapy study of Ventricular Assist System

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted HeartWare conditional approval to begin enrollment in an Investigational Device Exemption (IDE) destination therapy clinical study for the HeartWare® Ventricular Assist System.

15 Jun 2010

Researchers establish link between air pollution and SDB

Researchers from Brigham and Women's Hospital and the Harvard School of Public Health have established the first link between air pollution and sleep-disordered breathing, a known cause of cardiovascular diseases.

15 Jun 2010

VA Federal Supply Schedule Service approves CTT as vendor for Calmare Pain Therapy Treatment

Competitive Technologies, Inc. announced today that the Department of Veterans Affairs' Federal Supply Schedule Service has accepted CTT's application to be an approved vendor for its Calmare® Pain Therapy Treatment. This decision will enable CTT to sell Calmare Pain Therapy to physicians throughout the Federal government, with the expectation of significant sales in that market sector, which includes the Department of Veterans Affairs, the Department of Defense, the Indian Health Service, the Bureau of Prisons, and State Veteran Homes.

15 Jun 2010

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

Genzyme Corporation announced today that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). This designation covers patients with relapsing-remitting forms of the disease.

15 Jun 2010

Insulin-producing beta cells can proliferate in patients recently diagnosed with type 1 diabetes: Researchers

Researchers from the Peninsula Medical School, working in collaboration with colleagues from Glasgow Royal Infirmary and the University of Brighton, have used a unique collection of pancreas specimens taken from patients who died soon after diagnosis of type 1 diabetes to show that they respond to the ongoing process of destruction by inducing their islet cells to proliferate.

15 Jun 2010

New path involving "innocent spectators" to defeat systemic sclerosis

There is a new path to defeat systemic sclerosis, also called scleroderma because of the hardening of the skin of the patients (from Greek skleros, "hard", and derma, "skin"). This path involves the B-cell of the immune system, so far only considered "innocent spectators," as Catholic University rheumatologist Gianfranco Ferraccioli, among the authors of the important research, puts it.

14 Jun 2010

UCB announces availability of Vimpat oral solution formulation

UCB today announced the availability of an oral solution formulation of Vimpat- (lacosamide) C-V, an antiepileptic drug (AED) for add-on treatment of partial-onset seizures in people with epilepsy age 17 years and older. Vimpat 10 mg/mL solution is now available in U.S. pharmacies.

14 Jun 2010

Ingen Technologies' new SMART Nasal Cannula unveiled at Alpha-1 19th National Education Conference

Ingen Technologies, Inc., a medical device manufacturer with an emerging new medical product line for the respiratory market worth an estimated $4 billion in the U.S. and $8 billion globally, unveiled their new SMART Nasal Cannula in Orlando-Florida last week at the Alpha-1 19th Annual National Education Conference.

14 Jun 2010

Esperion, Cleveland Clinic collaborate to research new HDL therapies for cardiovascular disease

Esperion Therapeutics, a privately held biopharmaceutical company working to discover, develop and commercialize treatments for cardiovascular and metabolic diseases, today announced the establishment of a collaborative research agreement with Cleveland Clinic, one of the world's leading academic medical centers. The collaboration will work to advance research targeting new HDL therapies to treat cardiovascular disease.

14 Jun 2010

Calistoga Pharmaceuticals presents CAL-101 PI3K inhibitor data at European Hematology Association Congress

Calistoga Pharmaceuticals, Inc., the leader in the development of isoform-selective phosphatidylinositol 3 kinase (PI3K) inhibitors for the treatment of cancer and inflammatory diseases, today presented preclinical and clinical data on CAL-101, the Company's oral, delta selective PI3K inhibitor at the 15th Congress of the European Hematology Association in Barcelona, Spain.

14 Jun 2010

Telormedix initiates Phase I/II clinical study of TMX-101 for treating NMIBC

Telormedix, a clinical stage biopharmaceutical company focused on targeted immunity in the treatment of cancer and other diseases, today announced the start of a Phase I/II clinical study of TMX-101 for the treatment of Non-Muscle Invasive Bladder Cancer. TMX-101 is an immunotherapeutic compound and Telormedix has already recruited the first patients for this clinical study.

14 Jun 2010

Therapy News and Research

Biogen Idec initiates enrollment in Phase II BG-12 combination trial for relapsing-remitting multiple sclerosis

BIOTRONIK announces commercial availability of new ProMRI Pacing Systems

Alexion's Soliris may benefit patients with thrombotic microangiopathy from uncontrolled complement activation

Pieris commences PRS-050 anti-VEGF Anticalin Phase I clinical trial for cancer

SIRS-Lab, Analytik Jena partner in molecular sepsis diagnostics

Innovacell Biotechnologie commences enrollment in urocell Phase IIb study for bladder weakness

Aeterna Zentaris to present poster on AEZS-130 growth hormone secretagogue/ghrelin receptor agonist at 92nd ENDO

Xoft reports clinical benefits of isotope-free electronic radiation therapy for treatment of cancer

ULURU present Altrazeal at 2010 WOCN/WCET joint conference

FDA grants HeartWare approval for IDE destination therapy study of Ventricular Assist System

Researchers establish link between air pollution and SDB

VA Federal Supply Schedule Service approves CTT as vendor for Calmare Pain Therapy Treatment

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

Insulin-producing beta cells can proliferate in patients recently diagnosed with type 1 diabetes: Researchers

New path involving "innocent spectators" to defeat systemic sclerosis

UCB announces availability of Vimpat oral solution formulation

Ingen Technologies' new SMART Nasal Cannula unveiled at Alpha-1 19th National Education Conference

Esperion, Cleveland Clinic collaborate to research new HDL therapies for cardiovascular disease

Calistoga Pharmaceuticals presents CAL-101 PI3K inhibitor data at European Hematology Association Congress

Telormedix initiates Phase I/II clinical study of TMX-101 for treating NMIBC

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