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GFAP levels predict brain injury, death in critically ill children on ECMO

Johns Hopkins Children's Center scientists have discovered that high blood levels of a protein commonly found in the central nervous system can predict brain injury and death in critically ill children on a form of life support called extra-corporeal membrane oxygenation or ECMO.

23 Nov 2010

Frequent hemodialysis improves left ventricular mass, physical health than conventional treatment

Frequent hemodialysis improved left ventricular mass (heart size) and self-reported physical health compared to conventional hemodialysis for kidney failure, according to the Frequent Hemodialysis Network (FHN) Daily Trial funded by the National Institutes of Health and the Centers for Medicare & Medicaid Services.

23 Nov 2010

AADA releases updated position statement on isotretinoin usage

The American Academy of Dermatology Association (AADA) recently updated its position statement on the use of isotretinoin. The position continues to state that patient safety is dermatologists' primary concern and that the AADA is committed to the safe and responsible use of isotretinoin, which is the most effective treatment for severe acne.

23 Nov 2010

Researcher develops new method that causes cancer cells to self-destruct

Tulane University researcher W T. Godbey has developed a treatment for cancer using a method that causes cancer cells to self-destruct while sparing surrounding healthy cells.

23 Nov 2010

Compugen announces development of Protein Family Members Discovery Platform

Compugen Ltd. announced today the development of its Protein Family Members Discovery Platform, designed for the discovery of novel protein members belonging to various known and clinically important protein families.

23 Nov 2010

Rate, direction of axon growth in spinal cord can be controlled, study shows

Both the rate and direction of axon growth in the spinal cord can be controlled, according to new research by USC College's Samantha Butler and her collaborators.

23 Nov 2010

Stem cell trial for eye disease receives FDA approval

The second clinical trial involving stem cells from human embryonic cells has received the go-ahead. The news came from Advanced Cell Technology Inc. this Monday. The company announced that the U.S. Food and Drug Administration has cleared the way for its Phase I/II trial of retinal cells for patients with Stargardt’s macular dystrophy, a childhood version of macular degeneration.

22 Nov 2010

Omthera reaches agreement with FDA on SPA for Epanova Phase III trial in patients with very high triglycerides

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of its planned Phase III registration clinical trial of Epanova™, the Company's lead compound for the treatment of patients with very high triglycerides. Epanova is an Omega 3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

22 Nov 2010

Impax initiates challenge of patents relating to WELCHOL

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL® (Colesevelam HCl) for Oral Suspension, 3.75 gm/packet and 1.875 gm/packet.

22 Nov 2010

Humana to acquire Concentra for $790 million

Humana Inc. today announced it has signed a definitive agreement to purchase Concentra Inc., a privately held health care company based in Addison, Texas, for approximately $790 million in cash. Through its affiliated clinicians, Concentra delivers occupational medicine, urgent care, physical therapy and wellness services to workers and the general public from more than 300 medical centers in 42 states.

22 Nov 2010

IsoRay to sell $2.25 million in common stock

IsoRay Inc. has entered a securities purchase agreement with an investor to sell $2.25 million in common stock with the potential of $2,075,000 additional funding through two subsequent short term warrant tranches of 90 days and 180 days assuming an average exercise price of $1.40 and that all Series A and B warrants are exercised. Additional funding will occur if Series C or D warrants are exercised.

22 Nov 2010

Interim results from H.P. Acthar Gel study in patients with advanced diabetic nephropathy

On November 20 at the American Society of Nephrology 43rd Annual Meeting, interim results presented from an ongoing, randomized prospective study conducted independently by James A. Tumlin, MD, at the University of Tennessee College of Medicine Chattanooga indicated that 9 of 15 patients (60%) with advanced diabetic nephropathy who are currently enrolled in the study and have completed or are still undergoing a six month course of treatment with H.P. Acthar ® Gel have exhibited a clinically significant decrease in proteinuria and achieved stabilized renal function.

22 Nov 2010

Stealth Peptides introduces Bendavia clinical candidate at AHA Scientific Sessions

Stealth Peptides, a privately held biopharmaceutical company developing innovative mitochondrial therapies for diseases with significant unmet medical needs, introduced its lead clinical candidate, Bendavia, a novel compound that targets the mitochondrion, at the 2010 American Heart Association's (AHA) Scientific Sessions, Resuscitation Science Symposium.

22 Nov 2010

ImmunGene awarded $244,479 therapeutic discovery project grant under PPACA 2010

ImmunGene, Inc., a privately held drug development company focused on targeted antibody therapeutics with numerous anti-cancer functions built into a single therapy, announced today that it has received a $244,479 grant under The Patient Protection and Affordable Care Act of 2010 (PPACA). The grant was related to the development of ImmunGene's technology which is based on antibody-cytokine fusions that have demonstrated targeted toxicity and added tumor benefits.

22 Nov 2010

Cell Therapeutics announces preliminary results of phase II OPAXIO study for high-grade gliomas

Cell Therapeutics, Inc. announced the preliminary results of a phase II study of paclitaxel poliglumex (OPAXIO) combined with temozolomide (TMZ) and radiotherapy (RT) in patients with newly diagnosed high-grade gliomas.

22 Nov 2010

VYTORIN reduces major vascular events in patients with chronic kidney disease

In a new investigational study of VYTORIN, the cholesterol-lowering medicine from Merck, VYTORIN 10/20 mg reduced the incidence of first major vascular events defined as non-fatal heart attacks or cardiac death, stroke or any revascularization procedure by a highly statistically significant 16.1 percent compared to placebo, Study of Heart and Renal Protection study involved more than 9,000 patients who, on average, had advanced or end-stage chronic kidney disease (CKD)

22 Nov 2010

Phase 3 study of VEGF Trap-Eye regimen meets primary endpoint in patients with wet AMD

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced that in two parallel Phase 3 studies in patients with the neovascular form of age-related macular degeneration (wet AMD), all regimens of VEGF Trap-Eye (aflibercept ophthalmic solution), including VEGF Trap-Eye dosed every two months, successfully met the primary endpoint compared to the current standard of care, ranibizumab dosed every month.

22 Nov 2010

Research indicates possible danger of cancerous tissue development by using stem cells

Research work carried out at the Hebrew University of Jerusalem arouses a cautionary warning in the growing field of the development of stem cells as a means for future treatment of patients through replacement of diseased or damaged tissues by using the patient's own stem cells. The research indicates a possible danger of cancerous tissue development in the use of such cells.

22 Nov 2010

SHARP study shows cholesterol-lowering effective for patients with kidney disease

Around a quarter of all heart attacks, strokes, and operations to open blocked arteries could be avoided in people with chronic kidney disease by using the combination of ezetimibe and simvastatin to lower blood cholesterol levels. That's the conclusion from the world's largest ever randomized trial in kidney disease.

22 Nov 2010

Alexion's Soliris Phase 2 clinical study for aHUS meets primary, secondary endpoints

Alexion Pharmaceuticals, Inc. announced today that a Phase 2 clinical study investigating Soliris (eculizumab) as a treatment for patients with atypical Hemolytic Uremic Syndrome (aHUS) who are resistant to plasma therapy met primary and key secondary endpoints with high levels of statistical and clinical significance, according to results presented today at the American Society of Nephrology (ASN) annual meeting in Denver.

21 Nov 2010

Therapy News and Research

GFAP levels predict brain injury, death in critically ill children on ECMO

Frequent hemodialysis improves left ventricular mass, physical health than conventional treatment

AADA releases updated position statement on isotretinoin usage

Researcher develops new method that causes cancer cells to self-destruct

Compugen announces development of Protein Family Members Discovery Platform

Rate, direction of axon growth in spinal cord can be controlled, study shows

Stem cell trial for eye disease receives FDA approval

Omthera reaches agreement with FDA on SPA for Epanova Phase III trial in patients with very high triglycerides

Impax initiates challenge of patents relating to WELCHOL

Humana to acquire Concentra for $790 million

IsoRay to sell $2.25 million in common stock

Interim results from H.P. Acthar Gel study in patients with advanced diabetic nephropathy

Stealth Peptides introduces Bendavia clinical candidate at AHA Scientific Sessions

ImmunGene awarded $244,479 therapeutic discovery project grant under PPACA 2010

Cell Therapeutics announces preliminary results of phase II OPAXIO study for high-grade gliomas

VYTORIN reduces major vascular events in patients with chronic kidney disease

Phase 3 study of VEGF Trap-Eye regimen meets primary endpoint in patients with wet AMD

Research indicates possible danger of cancerous tissue development by using stem cells

SHARP study shows cholesterol-lowering effective for patients with kidney disease

Alexion's Soliris Phase 2 clinical study for aHUS meets primary, secondary endpoints

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