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FDA approves Cyberonics re-designed AspireHC generator

Cyberonics, Inc. today announced that the United States Food and Drug Administration (FDA) has approved its re-designed AspireHC (High Capacity) generator, which was the subject of a voluntary product withdrawal in August 2011.

4 Jan 2012

Arena, Eisai collaborate in response to FDA's lorcaserin Complete Response Letter

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that Arena has submitted its response to the Complete Response Letter (CRL) issued by the US Food and Drug Administration (FDA) following review of the lorcaserin New Drug Application (NDA).

4 Jan 2012

$Yakult Honsha commences perifosine Phase 1/2 trial for refractory advanced colorectal cancer in Japan$

Yakult Honsha commences perifosine Phase 1/2 trial for refractory advanced colorectal cancer in Japan

Aeterna Zentaris Inc. today announced that its Japanese partner, Yakult Honsha, has initiated a Phase 1/2 trial in Japan to assess the safety and efficacy of the Company's PI3K/Akt inhibitor, perifosine, in combination with chemotherapeutic agent, capecitabine, in patients with refractory advanced colorectal cancer ("CRC").

4 Jan 2012

CMS assigns J-code for Eisai's Halaven Injection to treat breast cancer

Eisai Inc. announced today that the Centers for Medicare and Medicaid Services (CMS) has assigned a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code for Halaven (eribulin mesylate) Injection.

4 Jan 2012

Positive results from Can-Fite BioPharma's CF102 Phase 1/2 study on HCC

Can-Fite BioPharma Ltd, a biotechnology company developing small molecule drugs for the treatment of inflammatory, and liver diseases, traded on the Tel Aviv Stock Exchange announced today the successful results of the Phase 1/2 study of its drug candidate CF102 in the treatment of hepatocellular carcinoma.

4 Jan 2012

Origin of osteoporosis could be directly linked to manganese depletion

The loss of manganese could mean that calcium does not stick to bones and could cause osteoporosis. This is the new theory put forward by researchers at the University of Castilla-La Mancha (UCLM) in Spain after studying deer antlers.

3 Jan 2012

AirStrip's mobile patient monitoring applications receive CE Mark

AirStrip Technologies, Inc. has received CE Mark certification to market its innovative mobile patient monitoring applications in the European Community as well as other international territories outside Europe, company officials announced today.

3 Jan 2012

Many obese people in denial mode: Survey

According to a new survey only six per cent of overweight people believe they should be described as obese. Three quarters of those with an obese body mass index underestimated their weight category, according to the Yougov poll of 2,065 people.

3 Jan 2012

Hormone Adiponectin linked to dementia in women: Study

New research has shown that there may be a possible connection between a hormone found in body fat and the risk of dementia, adding to the growing evidence on the potential link between the condition and diabetes.

3 Jan 2012

Gestational diabetes along with poverty raises risk of ADHD in the child: Study

According to a new study pregnant mothers with gestational diabetes are more likely to have kids with attention deficit hyperactivity disorder. Additionally if they have a poorer socioeconomic status, the child is 14 times more likely to be diagnosed with the behavioral disorder, researchers at Queens College and Mount Sinai School of Medicine found.

3 Jan 2012

TrovaGene acquires license to mutations of SF3B1 splicing factor in CLL

TrovaGene, Inc., a developer of trans-renal molecular diagnostics, today announced that it has obtained an exclusive worldwide license to mutations of the SF3B1 splicing factor, which have been shown to be associated with disease progression and chemotherapy response in patients suffering from chronic lymphocytic leukemia.

3 Jan 2012

Ampio completes enrollment phase of Australian Ampion In Knee trials

Ampio Pharmaceuticals, Inc., a company that discovers and develops new uses for previously approved drugs and new molecular entities, today announced that it is has completed the expanded patient enrollment phase of its Ampion In Knee (AIK) trials in Australia.

3 Jan 2012

Astellas, AVEO announce results of tivozanib and sorafenib comparison trial on RCC

AVEO Pharmaceuticals, Inc. and Astellas Pharma Inc. today announced that tivozanib demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1, a global, randomized Phase 3 clinical trial evaluating the efficacy and safety of investigational drug tivozanib compared to sorafenib in 517 patients with advanced renal cell carcinoma.

3 Jan 2012

Combination of biomarkers indicates high risk of Alzheimer's in the future

Physician Oskar Hansson and his research group are studying biomarkers - substances present in spinal fluid and linked to Alzheimer's disease. The group has studied close to 140 people with mild memory impairment, showing that a certain combination of markers (low levels of the substance beta-amyloid and high levels of the substance tau) indicate a high risk of developing Alzheimer's disease in the future.

3 Jan 2012

InSightec completes enrollment in ExAblate Neuro clinical study for Essential Tremor

InSightec Ltd, the global leader in MR guided Focused Ultrasound therapy, announced today that it has completed enrollment in the world's first feasibility study evaluating the use of MRgFUS for treatment of Essential Tremor, using ExAblate Neuro at University of Virginia, Charlottesville, Virginia.

3 Jan 2012

Lundbeck invests in Ossianix to focus on biotherapeutics for CNS disorders

Ossianix, Inc. today announced a strategic investment by H. Lundbeck A/S in the form of a Convertible Promissory Note. The proceeds from Lundbeck's investment is expected to allow Ossianix to generate biopharmaceuticals for the treatment of nervous system disorders by utilizing Ossianix's proprietary single domain antibody platform modeled on the shark vNAR structure.

3 Jan 2012

FDA sets Feb. 9 for ODAC meeting to review CTI's resubmitted pixantrone NDA

Cell Therapeutics, Inc. (CTI) announced today that on February 9, 2012 the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review CTI's resubmitted New Drug Application (NDA) for pixantrone for the treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) in patients who failed two or more lines of prior therapy.

3 Jan 2012

Adiponectin may play a role in development of all-cause dementia and AD in women

A hormone derived from visceral fat called adiponectin may play a role as a risk factor for development of all-cause dementia and Alzheimer disease (AD) in women, according to a study published Online First by the Archives of Neurology, one of the JAMA/Archives journals.

3 Jan 2012

DBS safe and effective for treatment-resistant depression in patients with unipolar MDD or BP

A new study shows that deep brain stimulation (DBS) is a safe and effective intervention for treatment-resistant depression in patients with either unipolar major depressive disorder (MDD) or bipolar ll disorder.

3 Jan 2012

Adolescents diagnosed with schizophrenia appear to show greater brain GM volume loss

Adolescents diagnosed with schizophrenia and other psychoses appear to show greater decreases in gray matter volume and increases in cerebrospinal fluid in the frontal lobe compared to healthy adolescents without a diagnosis of psychosis, according to a report in the January issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

3 Jan 2012