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FDA clears PROLOR Biotech's Phase II clinical trial of hGH-CTP

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial in the U.S. of its longer-acting version of human growth hormone, hGH-CTP.

24 Aug 2010

First Edition: August 24, 2010

In today's headlines, a federal court judge blocks the Obama administration's stem cell policy. Meanwhile, state action related to health reform and health policy continues.

24 Aug 2010

Raptor Pharmaceutical updates on cysteamine bitartrate Phase 3 clinical trial in cystinosis patients

Raptor Pharmaceutical Corp.,provides updates on timelines related to its clinical programs including the pivotal Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

24 Aug 2010

EDAP's gross profit reduces 5.1% in 2010 second quarter

EDAP TMS SA, the global leader in therapeutic ultrasound, announced today financial results for the second quarter ended June 30, 2010. The Company outlines strategic initiatives to counter the continuing weak global economic climate.

24 Aug 2010

PEM scanners demonstrate improved specificity with high sensitivity in breast cancer diagnosis: Study

In a recent study presented at the American Association of Physicists in Medicine (AAPM) 52nd Annual Meeting, researchers at the University of Washington showed that 18FDG dose for Positron Emission Mammography (PEM) may be reduced by as much as 70% without altering image quality.

24 Aug 2010

Spaulding Clinical becomes world’s largest provider for Mortara Surveyor telemetry-monitoring capability

Spaulding Clinical Research, a Phase 1 Clinical Pharmacology Research Unit and Core ECG Lab announced today that renovation of the clinic's second floor, which was completed on Aug. 20, has made Spaulding Clinical the largest provider of Mortara Surveyor telemetry-monitoring capability in the clinical research world.

24 Aug 2010

Epilepsy Therapy Project, EF announce recipients of New Therapy Grants Program

The Epilepsy Therapy Project (ETP) and the Epilepsy Foundation (EF) today announced the latest grant recipients of its New Therapy Grants Program, a unique joint venture of the non-profit epilepsy organizations, to advance promising epilepsy research in clinical development. The grant awards, totaling approximately $200,000 in funding, will support an experimental gene therapy that directly targets epileptogenic brain tissue, as well as an electrode system that has the potential to improve the efficacy of surgical therapies for certain epilepsy syndromes.

24 Aug 2010

CAHG adopts new integrated marketing communications network model

Corbett Accel Healthcare Group is now CAHG, having adopted a new integrated marketing communications network model designed to deliver MarketMovingIdeas® in support of their clients' brands. Complementing the new agency network brand is a new vision, We Grow Leaders, which reflects the agency network's devotion to the development of leadership brands, ideas and talent.

24 Aug 2010

FDA OOPD awards Soligenix $1.2M for orBec Phase 3 study in acute gastrointestinal Graft-versus-Host-Disease

Soligenix, Inc., a late-stage biopharmaceutical company, announced today that it has been awarded a three year $1.2 million clinical research grant by the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA) pursuant to its Orphan Products Development (OPD) Program.

24 Aug 2010

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

Genzyme Corporation announced today that the two-year follow-up results from the phase 2 clinical trial of its investigational therapy known as eliglustat tartrate have been accepted for publication in the journal Blood. The results have been pre-published on the journal's website and are available to subscribers.

23 Aug 2010

InSite Vision initiates Phase 1/2 clinical trial of ISV-303

InSite Vision Incorporated, a company developing novel ophthalmic therapeutics, today announced the initiation of a Phase 1/2 clinical trial of ISV-303, a topical anti-inflammatory product intended to reduce the pain and inflammation associated with ocular surgery. ISV-303 combines a low dose of the non-steroidal anti-inflammatory bromfenac with InSite Vision's proprietary DuraSite technology.

23 Aug 2010

Epicept receives refusal to file letter on new drug application

EpiCept Corporation today announced that it received a refusal to file letter from the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Ceplene(histamine dihydrochloride).

23 Aug 2010

GM-CSF protein reduces AD pathology, reverses memory loss: Study

A signaling protein released during rheumatoid arthritis dramatically reduced Alzheimer's disease pathology and reversed the memory impairment of mice bred to develop symptoms of the neurodegenerative disease, a new study by the University of South Florida reports. Researchers found that the protein, GM-CSF, likely stimulates the body's natural scavenger cells to attack and remove Alzheimer's amyloid deposits in the brain.

23 Aug 2010

Hepatitis E vaccine successful in clinical trial: Study

In a Clinical trial in China, a vaccine has been found to protect against Hepatitis E. Hepatitis E virus, usually spread via contaminated food and faeces usually runs its course before the patient recovers. However it can cause severe illness in elderly people and has a mortality rate of 1 to 3 percent. It can also kill 5 to 25 percent of affected pregnant women and those who survive can suffer high rates of miscarriage. Around a third of the world's population have been infected by the virus say researchers.

22 Aug 2010

US oncology announces its contributions in development of 42 novel cancer therapies

US Oncology, Inc., the nation's leading integrated oncology company, announced today that in less than two decades it has played a role in the development of 42 novel cancer therapies approved by the US Food and Drug Administration.

21 Aug 2010

Research finds association between pain quality and patient functioning in carpal tunnel syndrome

For carpal tunnel syndrome sufferers, itching and throbbing are pain qualities most responsible for impaired functioning and sleep disruption, according to new research reported in The Journal of Pain.

21 Aug 2010

Tasigna receives approval for chronic myeloid leukemia in Canada

Tasigna (nilotinib) capsules have been approved with conditions in Canada as a new therapy for patients with CML, in the chronic phase (first phase) of the disease. Patients must be resistant to or intolerant of at least one prior therapy, including (Pr)Gleevec (imatinib mesylate), an established standard of care.

20 Aug 2010

Human neural stem cells restore motor function in mice with chronic spinal cord injury

StemCells, Inc. announced today the publication of new preclinical data demonstrating that the Company's proprietary human neural stem cells restore lost motor function in mice with chronic spinal cord injury. This is the first published study to show that human neural stem cells can restore mobility even when administered at time points beyond the acute phase of trauma, suggesting the prospect of treating a much broader population of injured patients than previously demonstrated.

20 Aug 2010

UCI study is first to show reversal of long-term hind-limb paralysis

A UC Irvine study is the first to demonstrate that human neural stem cells can restore mobility in cases of chronic spinal cord injury, suggesting the prospect of treating a much broader population of patients.

20 Aug 2010

SIR-Spheres safe, effective for patients with colorectal cancer liver metastases who have failed chemotherapy

Radioactive yttrium-90 labelled resin microspheres (SIR-Spheres; Sirtex Medical, Sydney, Australia) appear to be a safe and effective treatment for patients with colorectal cancer liver metastases who have failed available chemotherapy options, according to the final results of a prospective clinical multi-centre phase II trial conducted by the Italian Society of Locoregional Therapies in Oncology (SITILO) and published in the British Journal of Cancer.

20 Aug 2010

Clinical Trial News and Research

FDA clears PROLOR Biotech's Phase II clinical trial of hGH-CTP

First Edition: August 24, 2010

Raptor Pharmaceutical updates on cysteamine bitartrate Phase 3 clinical trial in cystinosis patients

EDAP's gross profit reduces 5.1% in 2010 second quarter

PEM scanners demonstrate improved specificity with high sensitivity in breast cancer diagnosis: Study

Spaulding Clinical becomes world’s largest provider for Mortara Surveyor telemetry-monitoring capability

Epilepsy Therapy Project, EF announce recipients of New Therapy Grants Program

CAHG adopts new integrated marketing communications network model

FDA OOPD awards Soligenix $1.2M for orBec Phase 3 study in acute gastrointestinal Graft-versus-Host-Disease

Genzyme announces publication of phase 2 clinical trial results of eliglustat tartrate for Gaucher disease

InSite Vision initiates Phase 1/2 clinical trial of ISV-303

Epicept receives refusal to file letter on new drug application

GM-CSF protein reduces AD pathology, reverses memory loss: Study

Hepatitis E vaccine successful in clinical trial: Study

US oncology announces its contributions in development of 42 novel cancer therapies

Research finds association between pain quality and patient functioning in carpal tunnel syndrome

Tasigna receives approval for chronic myeloid leukemia in Canada

Human neural stem cells restore motor function in mice with chronic spinal cord injury

UCI study is first to show reversal of long-term hind-limb paralysis

SIR-Spheres safe, effective for patients with colorectal cancer liver metastases who have failed chemotherapy

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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