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BioCancell raises $5.1 million by excess demand in public offering

Success for BioCancell Therapeutics Inc. Excess demand in BioCancell's public offering of shares and warrants generated immediate proceeds of $5.1 million, 18% above its stated minimal fundraising goal of $4.3 million.

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

Neurocrine announces results from elagolix Phase II Daisy PETAL study in endometriosis

Neurocrine Biosciences, Inc. today announced results from the open-label portion of the six month Phase II Daisy PETAL study (901 study) using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.

22 Nov 2010

FDA grants ACT clearance for Phase I/II clinical trial of hESC derived retinal cells in patients with SMD

Advanced Cell Technology, Inc. announced today that the US Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to immediately initiate a Phase I/II multicenter clinical trial using retinal cells derived from human embryonic stem cells (hESCs) to treat patients with Stargardt's Macular Dystrophy (SMD), one of the most common forms of juvenile macular degeneration in the world. The decision removes the clinical hold that the FDA had placed on the trial.

22 Nov 2010

Mimetogen initiates MIM-D3 Phase II clinical trial for dry eye disease

Mimetogen Pharmaceuticals Inc., a clinical-stage biotechnology company focused on developing novel small molecule compounds that mimic the effects of neurotrophins, today announced that it has initiated the first human clinical trial evaluating MIM-D3, a mimetic of nerve growth factor (NGF), in a Phase II clinical trial in patients with moderate to severe dry eye disease. MIM-D3 is a small cyclic peptidomimetic of NGF, a naturally occurring protein in the eye that is responsible for the maintenance of corneal nerves and epithelium, mucin and tear production.

22 Nov 2010

Profil Institute expands capabilities to detect cardiac safety signals in diabetes and obesity clinical trials

Profil™ Institute for Clinical Research, Inc., a company specializing in early phase clinical trials for diabetes and obesity, announced today the expansion of its capabilities for cardiac safety and cardiovascular efficacy studies in the company's early phase diabetes and obesity clinical trials.

22 Nov 2010

$S*BIO begins SB1317 Phase 1 clinical trial in patients with advanced/refractory hematologic malignancies$

S*BIO begins SB1317 Phase 1 clinical trial in patients with advanced/refractory hematologic malignancies

S*BIO Pte Ltd today announced that a fourth novel, potential best-in-class compound discovered and developed by S*BIO has entered a Phase 1 clinical trial. The initiation of the study for S*BIO's oral multi-kinase inhibitor, SB1317 or TG02, in patients with advanced/refractory hematologic malignancies has triggered a payment from S*BIO's development and commercialization partner for the program, Tragara Pharmaceuticals.

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

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

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

Bardoxolone methyl treatment may reduce stage of CKD, improve eGFR in kidney function

Reata Pharmaceuticals and Abbott today announced data from a Phase 2b study which suggests that bardoxolone methyl, an investigational treatment for chronic kidney disease (CKD), may reduce the stage of CKD and improve estimated glomerular filtration rate (eGFR) and other measures of kidney function in the majority of patients receiving the drug.

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

Celldex presents ACT III Phase 2 clinical trial data for glioblastoma multiforme at SNO Meeting

Celldex Therapeutics, Inc., today announced the presentation of complete data for the primary endpoint of ACT III, a multi-center, single arm, Phase 2 clinical trial of rindopepimut (CDX-110) in patients with newly diagnosed glioblastoma multiforme (GBM).

21 Nov 2010

Potassium citrate effective for prevention and treatment of osteoporosis: Study

The Western diet creates an acidic environment in the body that removes calcium from bones and may contribute to the development of osteoporosis. Healthy adults who consume the standard US diet sustain a chronic, low-grade state of acidosis that worsens with age as kidney function declines, limiting urinary acid excretion. Reto Krapf, MD (University of Basel, in Bruderholz/Basel, Switzerland) and colleagues designed a study to see if daily alkali as potassium citrate supplement tablets might neutralize these effects.

20 Nov 2010

Psychiatric hospitalization rate decreases among adults with schizophrenia treated with INVEGA SUSTENNA: Study

Schizophrenia is a chronic and disabling brain disorder that affects 1 percent of the U.S. population and results in substantial medical and societal costs, in particular from use of health-care resources. It also can have devastating health-related and social effects on people with the disease, their families and caregivers.

20 Nov 2010

New I-SPY 2 study to evaluate effectiveness of medical treatment for breast cancer

A clinical trial that aims to speed up the study of new treatments for certain subtypes of breast cancer now has a designated study site at the Diane O'Connor Thompson Breast Center at the University of Colorado Hospital.

20 Nov 2010

Insertable cardiac monitors may help physicians diagnose, treat patient with syncope: PICTURE trial

Medtronic, Inc. today announced the publication of data showing that use of its Reveal family of Insertable Cardiac Monitors led to diagnosis and specific treatment for 78 percent (170 of 218) of patients who experienced a recurrent syncopal (fainting) event during the course of the study.

20 Nov 2010

Data from Rockwell Medical's Phase IIb study of SFP presented at ASN meeting

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease, chronic kidney disease, and iron deficiency anemia, announced today that the Company will present new data at the American Society of Nephrology meeting being held in Denver, Colorado, on its late-stage investigational drug Soluble Ferric Pyrophosphate, which is being studied for the treatment of iron-deficiency anemia in ESRD patients.

20 Nov 2010

Clinical Trial News and Research

BioCancell raises $5.1 million by excess demand in public offering

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

Neurocrine announces results from elagolix Phase II Daisy PETAL study in endometriosis

FDA grants ACT clearance for Phase I/II clinical trial of hESC derived retinal cells in patients with SMD

Mimetogen initiates MIM-D3 Phase II clinical trial for dry eye disease

Profil Institute expands capabilities to detect cardiac safety signals in diabetes and obesity clinical trials

S*BIO begins SB1317 Phase 1 clinical trial in patients with advanced/refractory hematologic malignancies

Stealth Peptides introduces Bendavia clinical candidate at AHA Scientific Sessions

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

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

Bardoxolone methyl treatment may reduce stage of CKD, improve eGFR in kidney function

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

Celldex presents ACT III Phase 2 clinical trial data for glioblastoma multiforme at SNO Meeting

Potassium citrate effective for prevention and treatment of osteoporosis: Study

Psychiatric hospitalization rate decreases among adults with schizophrenia treated with INVEGA SUSTENNA: Study

New I-SPY 2 study to evaluate effectiveness of medical treatment for breast cancer

Insertable cardiac monitors may help physicians diagnose, treat patient with syncope: PICTURE trial

Data from Rockwell Medical's Phase IIb study of SFP presented at ASN meeting

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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