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BioMarin completes BMN 195 Phase 1 clinical trial for Duchenne muscular dystrophy

BioMarin Pharmaceutical Inc. announced today that it has completed the Phase 1 clinical study of BMN 195, a small molecule utrophin up-regulator, for the treatment of Duchenne muscular dystrophy (DMD). The Phase 1 clinical trial was a single-center, double-blind, placebo-controlled, single-dose escalation study followed by a multiple-dose escalation study in healthy volunteers.

3 Aug 2010

VertiFlex enrolls 150 patients in Superion Interspinous Spacer IDE clinical trial

VertiFlex, Inc., a leading innovator of minimally invasive and motion preserving spinal surgery technologies, today announced that 150 patients have been enrolled in its pivotal IDE clinical trial of the Superion Interspinous Spacer (ISS).

3 Aug 2010

Patrys secures funding of up to A$15 million to support advancement of clinical products

Patrys Limited (ASX: PAB), a company focused on the development of natural human antibodies for the treatment of cancer, announced today that it has secured up to A$15 million in funding.

3 Aug 2010

Study: hGH linked to PROLOR's CTP technology increases half-life, bioactivity

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today reported publication of a preclinical study in the current on-line edition of the journal Endocrinology showing that human growth hormone (hGH) linked to PROLOR's carboxyl terminal peptide (CTP) technology has significantly increased half-life and bioactivity compared to commercially available hGH. The publication, which is authored by PROLOR researchers, will also be included in the September print edition of Endocrinology.

2 Aug 2010

Lexicon acquires equity shares of Symphony Icon Holdings

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today announced that it has exercised a restructured purchase option under its drug development financing collaboration with Symphony Icon Holdings LLC and acquired all the equity of Symphony Icon, Inc., thereby reacquiring all rights to LX1031, LX1032, LX1033 and the other drug programs subject to the collaboration.

2 Aug 2010

GRS announces Martin as European General Manager, Executive Vice President of Global Development

Global Research Services, LLC (GRS), an international cardiovascular clinical research organization (CRO) serving pharmaceutical, biotech and medical device companies with comprehensive clinical trial management services, announced today that Benoît Martin, a seasoned executive with more than a decade of leading international CRO business units, has been named as the European General Manager and Executive Vice President of Global Development.

2 Aug 2010

Research findings point to new ways to improve quality of future trials through better training

Practitioners of clinical medicine are familiar with learning curves, and strategies like simulation are increasingly used to minimize learning-curve effects on clinical care. Because similar learning curves have been hinted at in some clinical trials, researchers at Duke University Medical Center studied the phenomenon in the data record of a large, multi-site clinical trial. Their findings point to ways to improve the quality of future trials through better training and simulation exercises.

31 Jul 2010

Angiotech reports $61.9 million total revenue for second-quarter 2010

Angiotech Pharmaceuticals, Inc. today announced its financial results for the second quarter ended June 30, 2010.

31 Jul 2010

Opportunity in European embolization coil market leads to major acquisitions in 2010: MRG

According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, high market opportunity in the European embolization coil market has led to several major acquisitions in 2010. The European market alone was valued at approximately $100 million in 2009, making successful niche competitors in this market attractive acquisition targets.

30 Jul 2010

FDA lifts hold, allows Geron to proceed with Phase I clinical trial of GRNOPC1 in spinal cord injury

Geron Corporation announced today that the U.S. Food and Drug Administration (FDA) has notified the company that the clinical hold placed on Geron's Investigational New Drug (IND) application has been lifted and the company's Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury may proceed.

30 Jul 2010

$Pivotal PINNACLE trial results of VELCADE in patients with relapsed/refractory MCL released$

Pivotal PINNACLE trial results of VELCADE in patients with relapsed/refractory MCL released

Millennium: The Takeda Oncology Company today reported new correlative science data from the pivotal PINNACLE trial of VELCADE (bortezomib) in patients with relapsed/refractory mantle cell lymphoma. The data, derived from an analysis of archived tumor samples, tested pre-specified biomarkers for their association with time to progression and response to treatment with VELCADE in patients with relapsed MCL.

30 Jul 2010

Cancer Research UK launches new £18 million Biotherapeutics Development Unit

Cancer Research UK's Drug Development Office marks the launch of its Biotherapeutics Development Unit (BDU) today (Friday) with the manufacture of its first product - an antibody for treating a range of cancers.

30 Jul 2010

SynCo Bio Partners extends collaboration with Versartis

SynCo Bio Partners today announced an extension of its successful collaboration with Versartis, Inc. following the recent initiation of a Phase 1 clinical trial in type 2 diabetes mellitus (T2DM) patients with monthly dosing of VRS-859. This news comes less than 12 months since the parties entered into a strategic partnership to manufacture Versartis' lead product VRS-859 (exenatide-XTEN).

30 Jul 2010

Bio-Path commences dosing in Liposomal Grb-2 Phase I cancer study

Bio-Path Holdings, Inc.,, a biotechnology company with drug development operations in Houston, Texas, announced today that the first patient has been dosed in a Phase I study of its cancer drug candidate, Liposomal Grb-2 (L-Grb-2 or BP-100-1.01), in patients with Acute Myeloid Leukemia (AML), Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukemia (ALL) or Myelodysplastic Syndrome (MDS).

30 Jul 2010

Medtronic launches Defeat-HF clinical trial to evaluate SCS for heart failure

Medtronic, Inc. today announced the global launch of the Defeat-HF (Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure) clinical trial. It is the industry's first prospective, randomized study evaluating the clinical feasibility of spinal cord stimulation, or neurostimulation, to improve clinical signs and symptoms of heart failure.

30 Jul 2010

Intra-Cellular Therapies ITI-007 Phase Ib/II clinical trial for schizophrenia meets primary endpoint

Intra-Cellular Therapies, Inc. today announced the results from a Phase Ib/II clinical trial in patients with schizophrenia with ITI-007, the Company's unique, investigational new drug for the treatment of schizophrenia. The trial met its primary endpoint demonstrating that ITI-007 was safe and well-tolerated in patients with stabilized schizophrenia.

30 Jul 2010

Geron second-quarter net loss decreases to $17.0 million

Geron Corporation today reported financial results for the three and six months ended June 30, 2010.

30 Jul 2010

Supplementation of vitamin D protects vascular systems: Study

Vitamin D deficiency is associated with arterial stiffness, a risk factor for heart disease and stroke, in black teens according to a new study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM). Black teens taking vitamin D supplementation of 2,000 international units (IU) per day had a decrease in central arterial stiffness.

30 Jul 2010

New study shows vitamin D deficiency is associated with arterial stiffness

Vitamin D deficiency is associated with arterial stiffness, a risk factor for heart disease and stroke, in black teens according to a new study accepted for publication in The Endocrine Society's www.endo-society.org. Black teens taking vitamin D supplementation of 2,000 international units per day had a decrease in central arterial stiffness.

29 Jul 2010

Antigenics second-quarter net loss attributable to common stockholders decreases to $5.2 million

Antigenics Inc. reported today its results for the quarter ended June 30, 2010.

29 Jul 2010

Clinical Trial News and Research

BioMarin completes BMN 195 Phase 1 clinical trial for Duchenne muscular dystrophy

VertiFlex enrolls 150 patients in Superion Interspinous Spacer IDE clinical trial

Patrys secures funding of up to A$15 million to support advancement of clinical products

Study: hGH linked to PROLOR's CTP technology increases half-life, bioactivity

Lexicon acquires equity shares of Symphony Icon Holdings

GRS announces Martin as European General Manager, Executive Vice President of Global Development

Research findings point to new ways to improve quality of future trials through better training

Angiotech reports $61.9 million total revenue for second-quarter 2010

Opportunity in European embolization coil market leads to major acquisitions in 2010: MRG

FDA lifts hold, allows Geron to proceed with Phase I clinical trial of GRNOPC1 in spinal cord injury

Pivotal PINNACLE trial results of VELCADE in patients with relapsed/refractory MCL released

Cancer Research UK launches new £18 million Biotherapeutics Development Unit

SynCo Bio Partners extends collaboration with Versartis

Bio-Path commences dosing in Liposomal Grb-2 Phase I cancer study

Medtronic launches Defeat-HF clinical trial to evaluate SCS for heart failure

Intra-Cellular Therapies ITI-007 Phase Ib/II clinical trial for schizophrenia meets primary endpoint

Geron second-quarter net loss decreases to $17.0 million

Supplementation of vitamin D protects vascular systems: Study

New study shows vitamin D deficiency is associated with arterial stiffness

Antigenics second-quarter net loss attributable to common stockholders decreases to $5.2 million

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