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Keryx Biopharmaceuticals reaches SPA agreement for Phase 3 clinical program for Zerenex

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical program for Zerenex(TM) (ferric citrate), its iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD).

6 Jan 2010

EnVivo Pharmaceuticals announces initiation and dosing of patients in Phase 2b study of EVP-6124

EnVivo Pharmaceuticals today announced the initiation and dosing of patients in a Phase 2b study of its EVP-6124 compound, a selective alpha-7 nicotinic agonist in patients with schizophrenia. EnVivo is conducting the multi-center, dose ranging, placebo controlled, three-month study in the U.S. and Europe.

6 Jan 2010

Study indicates efficacy of antidepressants varies significantly depending on symptom severity

An analysis of randomized trials indicates that compared with placebo, the magnitude of benefit of antidepressant medications varies with the severity of depressive symptoms, and may provide little benefit for patients with mild or moderate depression, but appear to provide substantial benefit for patients with very severe depression, according to an article in the January 6 issue of JAMA.

6 Jan 2010

Health Canada approves Zyclara Cream for multiple actinic keratoses

Health Canada has approved Zyclara™ (imiquimod) Cream 3.75%, a topical prescription treatment for multiple actinic keratoses (AK) located on the face or balding scalp in adults. Actinic Keratosis is a common skin condition that can lead to squamous cell carcinoma, a form of non-melanoma skin cancer, if left untreated.

6 Jan 2010

Phase 2 study evaluating VBL Therapeutics' lead compound VB-201 initiated

VBL Therapeutics today announced the initiation of a Phase 2 efficacy and safety study evaluating lead compound VB-201 for the treatment of patients with psoriasis. VB-201 is poised to be a first-in-class, orally-administered immune response modifier expected to reduce inflammation in a broad range of conditions such as psoriasis.

5 Jan 2010

LifeVantage announces Protandim human clinical trials for non-alcoholic steatohepatitis

LifeVantage Corporation, the maker of Protandim® and TrueScience(TM) Anti-Aging Cream, science-based solutions to oxidative stress, announced today that the Company's flagship product, Protandim, a patented dietary supplement composed of five highly synergistic "indirect antioxidants", is currently the subject of two human clinical trials at the University of Colorado, Denver.

5 Jan 2010

January issue of Chest presents new studies on COPD

A new study shows that poor lung function during adolescence and through midlife may be influenced by several factors, including birth weight, height, and gender.

5 Jan 2010

St. John's wort not effective in treating IBS

A Mayo Clinic research study published in the January issue of the American Journal of Gastroenterology finds that St. John's wort is not an effective treatment for irritable bowel syndrome (IBS). While antidepressants are frequently used to treat IBS, to date, no study has examined the success of using the herbal supplement St. John's wort in treating IBS.

5 Jan 2010

Anti-inflammatory prescription drug reduces the risk of common skin cancer in humans

A widely-available anti-inflammatory prescription drug can reduce the risk of a common skin cancer in humans, according to a researcher at Stanford's School of Medicine.

5 Jan 2010

New chemoprevention therapy for skin cancer

People with the heritable disorder of the skin called Gorlin syndrome who are genetically predisposed to develop basal cell carcinoma of the skin may have a new chemoprevention therapy on the horizon.

5 Jan 2010

Talampanel slows progression of amyotrophic lateral sclerosis

A drug already used to treat symptoms of epilepsy has potential to slow the muscle weakening that comes with amyotrophic lateral sclerosis (ALS), scientists report after completing a Phase II clinical trial-an early, small-scale test to show if the drug works and continues to be safe.

5 Jan 2010

Headline results from first phase III study of Balaglitazone announced

Dr. Reddy’s Laboratories Ltd. and Rheoscience, a subsidiary of Nordic Bioscience A/S, today announced the headline results from the first phase III study for their investigational agent, Balaglitazone.

4 Jan 2010

DSPA submits lurasidone NDA to the FDA

Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lurasidone, an investigational atypical antipsychotic agent for the treatment of schizophrenia. The application, submitted on December 30, 2009, includes data from more than 40 clinical studies involving more than 2,500 lurasidone-treated patients.

4 Jan 2010

D-Pharm commences enrollment in MACSI Phase III clinical study for acute ischemic stroke

D-Pharm Ltd announced enrollment of patients with acute ischemic stroke into its Phase III clinical study of DP-b99 (MACSI). The first patient has been enrolled at the Wolfson Medical Center, Israel. The MACSI trial involves numerous medical centers in the US, Canada, Europe, Israel, South Africa, South Korea and Brazil. DP-b99 is D-Pharm's most advanced product developed for protection of brain cells suffering from restricted blood and oxygen supply (ischemia).

3 Jan 2010

Multivariable analyses identify epidemiological risk factors for ovarian cancer

Concentrations of the biomarkers CA125, human epididymis protein 4 (HE4), and mesothelin began to rise 3 years before clinical diagnosis of ovarian cancer, according to a new study published online December 30 in the Journal of the National Cancer Institute. However, the biomarkers became substantially elevated only in the last year prior to diagnosis.

31 Dec 2009

UB neurobiologist studies the impact of acute and chronic caffeine consumption in young people

Caffeine is a stimulant drug, although legal, and adults use it widely to perk themselves up: Being "addicted" to caffeine is considered perfectly normal.

30 Dec 2009

Santarus submits rifamycin SV MMX IND to the FDA

Santarus, Inc., a specialty biopharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) requesting approval to begin a Phase III clinical program evaluating rifamycin SV MMX® in patients with travelers’ diarrhea.

30 Dec 2009

Significant limitations in new Ginkgo biloba study published in JAMA, says ABC

New research findings published this week on a standardized Ginkgo biloba extract are very limited and the public should focus on the well-documented cognitive and cardiovascular benefits of ginkgo, said the American Botanical Council (ABC), an independent nonprofit research and education organization.

30 Dec 2009

Ginkgo biloba does not slow rate of cognitive decline in older adults

Older adults who used the herbal supplement Ginkgo biloba for several years did not have a slower rate of cognitive decline compared to adults who received placebo, according to a study in the December 23/30 issue of JAMA.

30 Dec 2009

Projects investigating placebo effects in Parkinson's disease receive funds

The Michael J. Fox Foundation for Parkinson's Research announced funding for two projects investigating the placebo effect in Parkinson's disease.

30 Dec 2009

Placebo News and Research

Keryx Biopharmaceuticals reaches SPA agreement for Phase 3 clinical program for Zerenex

EnVivo Pharmaceuticals announces initiation and dosing of patients in Phase 2b study of EVP-6124

Study indicates efficacy of antidepressants varies significantly depending on symptom severity

Health Canada approves Zyclara Cream for multiple actinic keratoses

Phase 2 study evaluating VBL Therapeutics' lead compound VB-201 initiated

LifeVantage announces Protandim human clinical trials for non-alcoholic steatohepatitis

January issue of Chest presents new studies on COPD

St. John's wort not effective in treating IBS

Anti-inflammatory prescription drug reduces the risk of common skin cancer in humans

New chemoprevention therapy for skin cancer

Talampanel slows progression of amyotrophic lateral sclerosis

Headline results from first phase III study of Balaglitazone announced

DSPA submits lurasidone NDA to the FDA

D-Pharm commences enrollment in MACSI Phase III clinical study for acute ischemic stroke

Multivariable analyses identify epidemiological risk factors for ovarian cancer

UB neurobiologist studies the impact of acute and chronic caffeine consumption in young people

Santarus submits rifamycin SV MMX IND to the FDA

Significant limitations in new Ginkgo biloba study published in JAMA, says ABC

Ginkgo biloba does not slow rate of cognitive decline in older adults

Projects investigating placebo effects in Parkinson's disease receive funds

Achieving and maintaining ISO 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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