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Curis reports net loss of $2.1 million for second-quarter 2010

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today reported its financial results for the second quarter ended June 30, 2010.

3 Aug 2010

Celsion reports net loss of $2.6M for second-quarter 2010

Celsion Corporation, a biotechnology drug development company, today announced financial results for the second quarter and six months ended June 30, 2010 and addressed the progression of the clinical trials of ThermoDox, Celsion's heat activated liposomal encapsulation of doxorubicin. ThermoDox is currently being evaluated in the Phase III HEAT trial for the treatment of hepatocellular carcinoma and in a Phase I/II trial for patients with recurrent chest wall breast cancer.

3 Aug 2010

First patient treated in Phase Ib expansion study of CUDC-101

Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the first patient has been treated in a Phase Ib expansion study for CUDC-101 in patients with advanced head and neck, gastric, breast and liver cancers.

3 Aug 2010

Particles of iron oxide enhance tumor visibility through MRI

Tiny particles of iron oxide could become tools for simultaneous tumor imaging and treatment, because of their magnetic properties and toxic effects against brain cancer cells. In mice, researchers from Emory University School of Medicine have demonstrated how these particles can deliver antibodies to implanted brain tumors, while enhancing tumor visibility via magnetic resonance imaging (MRI).

3 Aug 2010

ArQule, Daiichi Sankyo announce decision to advance ARQ 197 into Phase 3 clinical trial for NSCLC

ArQule, Inc. and Daiichi Sankyo Co., Ltd. today announced that they will move forward with a Phase 3 clinical trial of ARQ 197, a small molecule inhibitor of the c-Met receptor tyrosine kinase, in patients with non-small cell lung cancer (NSCLC). In connection with this decision, the sponsor company, Daiichi Sankyo, will file a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for a trial comparing ARQ 197 plus erlotinib against erlotinib plus placebo.

3 Aug 2010

Methods to boost neutralizing antibody may prevent HIV-1 transmission

Monkeys repeatedly immunized with a particular form the HIV-1 envelope glycoprotein generated antibodies capable of neutralizing diverse strains of HIV-1, according to a paper published online in the Journal of Experimental Medicine on August 2.

3 Aug 2010

Researchers discover manipulation of microRNA-29a shows potential of novel IBS treatment

A possible cause of irritable bowel syndrome has been traced to a small piece of RNA that blocks a substance protecting the colon membrane, leading to hostile conditions that can produce diarrhea, bloating and chronic abdominal pain.New research shows that this RNA segment sends signals that stop the activity of the gene that produces glutamine, an amino acid. Previous research has linked a shortage of glutamine in the gut with the seepage of toxins and bacteria through the intestinal wall, irritating nerves and creating disease symptoms.

3 Aug 2010

BioMarin provides update on PEG-PAL Phase 2 clinical study for phenylketonuria

BioMarin Pharmaceutical Inc. announced today an update in the Phase 2 clinical study of PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) for the treatment of phenylketonuria (PKU). Data reported in this announcement reflect preliminary results as of July 23, 2010. Complete top-line results are expected in the fourth quarter of 2010.

3 Aug 2010

BioMarin reports $0.5 million GAAP net loss for second-quarter 2010

BioMarin Pharmaceutical Inc. today announced financial results for the second quarter of 2010. GAAP net loss was $0.5 million ($0.01 per diluted share) for the second quarter of 2010, compared to GAAP net income of $1.3 million ($0.01 per diluted share) for the second quarter of 2009. Non-GAAP net income was $8.6 million ($0.08 per diluted share) for the second quarter of 2010, compared to non-GAAP net income of $9.0 million ($0.09 per diluted share) for the second quarter of 2009.

3 Aug 2010

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

Clinical Trial News and Research

Curis reports net loss of $2.1 million for second-quarter 2010

Celsion reports net loss of $2.6M for second-quarter 2010

First patient treated in Phase Ib expansion study of CUDC-101

Particles of iron oxide enhance tumor visibility through MRI

ArQule, Daiichi Sankyo announce decision to advance ARQ 197 into Phase 3 clinical trial for NSCLC

Methods to boost neutralizing antibody may prevent HIV-1 transmission

Researchers discover manipulation of microRNA-29a shows potential of novel IBS treatment

BioMarin provides update on PEG-PAL Phase 2 clinical study for phenylketonuria

BioMarin reports $0.5 million GAAP net loss for second-quarter 2010

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

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