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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

VIVUS submits a NDA to the FDA for obesity drug Qnexa

VIVUS, Inc., a biopharmaceutical company developing innovative, next-generation medical therapies to address unmet needs in obesity, diabetes and sexual health, announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of Qnexa, its investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.

30 Dec 2009

Merck discontinues MK-1903 niacin receptor agonist development program with Arena Pharmaceuticals

Arena Pharmaceuticals, Inc. announced today Merck and Co., Inc.'s decision (through an affiliate) to discontinue development of MK-1903, an investigational niacin receptor agonist to treat atherosclerosis being developed under its research collaboration with Arena. Merck also informed Arena that the company will not continue the collaboration.

24 Dec 2009

Researchers mix active drug and placebo to maximize drug benefits for efficient treatment

Researchers used the placebo effect to successfully treat psoriasis patients with one quarter to one half of their usual dose of a widely used steroid medication, according to an early study published online today in the journal Psychosomatic Medicine.

23 Dec 2009

US Phase 2 clinical trial of RVX-208 commenced by Resverlogix

Resverlogix Corp. ("Resverlogix" or the "Company") announced today that it has begun dosing patients in its US Phase 2 clinical trial lead by Cleveland Clinic. This trial will examine RVX-208, Resverlogix's oral small molecule therapy for the treatment of atherosclerosis, in patients with stable coronary artery disease (CAD).

23 Dec 2009

Magnetic stimulation therapy can treat depression

Magnetic stimulation therapy can beat depression when medication and therapy haven't worked, according to the December issue of Mayo Clinic Health Letter.

23 Dec 2009

Niacin may not be beneficial for type 2 diabetic patients

High-density lipoprotein (HDL), known as "good" cholesterol, isn't as protective for people with type 2 diabetes, according to research reported in Circulation: Journal of the American Heart Association.

22 Dec 2009

Darbepoetin alfa does not reduce cardiovascular problem in anemic patients on dialysis

An international study authored by a UT Southwestern Medical Center researcher has concluded that the anemia drug darbepoetin alfa works no better than a placebo in several other applications previously thought to be promising.

22 Dec 2009

Eritoran well tolerated in Phase II trial for severe sepsis

The investigational compound, eritoran tetrasodium ("eritoran," also known as E5564) appeared to be well tolerated in patients with severe sepsis in a Phase II trial published in the January issue of Critical Care Medicine, the official journal of the Society of Critical Care Medicine, the largest multiprofessional organization dedicated to ensuring excellence and consistency in the practice of critical care.

22 Dec 2009

School intervention programs may promote psychological well-being among adolescents

A new study which has been conducted at the University of Bologna shows that brief psychological interventions in school may increase well-being among adolescents and these results persist after 6 months

22 Dec 2009

Grant of $1 million awarded to develop new treatments for dyskinesia

The Michael J. Fox Foundation for Parkinson's Research has awarded $1 million for a clinical study aiming to make a critical step toward the development of new treatments for dyskinesia, the excessive and uncontrollable movements that are a complication of long-term dopamine replacement therapy in patients with Parkinson's disease.

22 Dec 2009

Positive interim results from Idera Pharmaceuticals' IMO-2125 Phase 1 clinical trial for HCV

Idera Pharmaceuticals, Inc. today announced positive interim results from a Phase 1 clinical trial of IMO-2125 in patients with chronic hepatitis C virus infection (HCV). IMO-2125 is an agonist of Toll-like Receptor 9 that Idera designed to treat HCV by inducing endogenous interferon-alpha and other Th1-type cytokines and chemokines.

21 Dec 2009

CPEX Pharmaceuticals completes enrollment in Nasulin Phase 2a clinical trial

CPEX Pharmaceuticals, Inc. today announced that the ongoing Phase 2a clinical trial of Nasulin™, the Company’s intranasal insulin candidate, has now completed enrollment. The study was initiated in February of this year and randomized 94 subjects. Results are expected at the end of the first quarter or beginning of the second quarter of 2010.

21 Dec 2009