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Critical Diagnostics' high sensitivity Presage ST2 Assay receives CE Mark approval

Critical Diagnostics announced today that it has received CE (Conformité Européenne) Mark for its high sensitivity Presage ST2 Assay and is commencing commercialization in Europe. The product is indicated for use as an aid in risk stratification of patients with heart failure or acute coronary syndrome. This regulatory milestone marks the first time that an assay has become commercially available for the clinical measurement of the biomarker soluble ST2.

7 Jan 2011

MMRF awards $3 million under 2010 Biotech Investment Awards program

The Multiple Myeloma Research Foundation (MMRF) today announced that it has awarded $1 million to each of three Boston-area biotech companies through its 2010 Biotech Investment Awards program: Constellation Pharmaceuticals, Inc., Epizyme, Inc. and Karyopharm Therapeutics, Inc. Since the inception of this MMRF program in 2006, $11 million has been committed to 11 biotech companies in multi-year, results-driven funding for the development of innovative treatments for patients with multiple myeloma.

7 Jan 2011

Amorfix's AD diagnostic assay detects aggregated beta amyloid in spinal fluid

Amorfix Life Sciences, a product development company focused on diagnostics and therapeutics for misfolded protein diseases, today announced preliminary results indicating that their human Alzheimer's disease (AD) diagnostic assay can detect a signal from aggregated beta amyloid in the spinal fluid (CSF) from AD patients.

7 Jan 2011

FDA approved KOMBIGLYZE XR for type 2 diabetes mellitus now available in pharmacies

Bristol-Myers Squibb Company, and AstraZeneca today announced that KOMBIGLYZE™ XR (saxagliptin and metformin HCl extended-release), approved by the U.S. Food and Drug Administration (FDA) on November 5, 2010, is now available by prescription in pharmacies across the United States.

7 Jan 2011

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc. today announced the dosing of the first patient in the third phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone. The primary endpoint is an overall responder rate based on the change from baseline in the reported frequency of spontaneous bowel movements (SBMs).

7 Jan 2011

Dendreon provides U.S. commercialization and European strategy updates for PROVENGE

Dendreon Corporation today announced several updates regarding the U.S. commercialization of PROVENGE® (sipuleucel-T), the European strategy for PROVENGE, and progress on its pipeline.

7 Jan 2011

BIND Biosciences commences BIND-014 Phase 1 clinical trial in cancer

BIND Biosciences announced today that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetic profile of BIND-014 in cancer patients. BIND-014, the first product candidate to enter clinical evaluation from BIND's broad proprietary Medicinal Nanoengineering platform, is a targeted polymeric nanoparticle containing the cytotoxic agent, docetaxel.

7 Jan 2011

Study finds combined treatments safe and effective for severe acute pancreatitis

The use of combined treatments for severe acute pancreatitis is safe and effective in managing the disease, resulting in shorter hospitalizations and fewer radiological procedures than standard therapy, according to a study in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association (AGA) Institute. In a related study, doctors found that patients with infected pancreatic necrosis were able to avoid surgery through primary conservative treatment, which is in-patient medical treatment.

7 Jan 2011

Single cellular crisis shatters chromosomes in cancer causation

Remarkable new research overthrows the conventional view that cancer always develops in a steady, stepwise progression. It shows that in some cancers, the genome can be shattered into hundreds of fragments in a single cellular catastrophe, wreaking mutation on a massive scale.

7 Jan 2011

ASBP raises concern over FDA recommendations to lower BMI requirements for lap-band surgery

The American Society of Bariatric Physicians (ASBP) is concerned that the FDA advisory panel recommended lowering the BMI requirement for lap-band surgery, while the FDA recently denied two new obesity medications. Bariatric surgery is drastic and expensive and carries higher morbidity and mortality risks than lifestyle interventions or medication. Patients who could have otherwise lost weight in a non-surgical medical bariatric program may now be encouraged to skip medical therapy and jump directly to surgery.

7 Jan 2011

Chromosome shattering seen in two to three percent of all cancers

Most of the time cancer seems to creep up gradually over time; cells become premalignant, then increasingly abnormal before they become cancerous. But sometimes cancers seem to pop up as if out of nowhere. Now, researchers reporting in the January 7th issue of the journal Cell, a Cell Press publication, have new evidence to explain how that can happen.

7 Jan 2011

BG Medicine enters agreement to develop galectin-3 test for Siemens' automated immunoassay platforms

BG Medicine, Inc. announced today that it has entered into an agreement with Siemens Healthcare Diagnostics Inc., a division of Siemens Healthcare, one of the world's largest suppliers of clinical diagnostics to the healthcare industry, for the development and commercialization of a galectin-3 test for Siemens' automated immunoassay platforms for clinical laboratories.

7 Jan 2011

Plexxikon, Genentech enter PLX4032 co-promotion agreement

Plexxikon, Inc., announced today that it has signed an agreement with Genentech to co-promote PLX4032 (RG7204) in the United States. PLX4032, an oral, novel kinase inhibitor that targets the oncogenic BRAF mutation, is being tested in late-stage clinical trials for the treatment of metastatic melanoma.

7 Jan 2011

Cell Medica enters EBV-associated cancer research collaboration with CAGT and Baylor College of Medicine

Cell Medica, a leading cellular therapeutics company which develops, manufactures and markets cellular immunotherapy products for the treatment of infectious disease and cancer, is pleased to announce an exclusive license agreement and research collaboration with the Center for Cell and Gene Therapy (CAGT), Baylor College of Medicine (Houston, Texas), for the commercialization of an innovative cell-based treatment for cancers associated with the oncogenic Epstein Barr virus (EBV).

7 Jan 2011

Intrexon Corporation, ZIOPHARM enter partnership to develop, commercialize DNA-based therapeutics

ZIOPHARM Oncology, a small molecule late-stage oncology drug development company, and Intrexon Corporation, a next generation synthetic biology company, announced today a global exclusive channel partnership in oncology where ZIOPHARM will develop and commercialize DNA-based therapeutics using Intrexon's UltraVector Technology.

7 Jan 2011

Spirogen, Genentech enter multi-year ADC research collaboration and license agreement

Spirogen Ltd. a leading oncology-focused company developing DNA sequence targeted agents, announced a multi-year research collaboration and license agreement with Genentech, a member of the Roche Group.

7 Jan 2011

Study examines link between media consumption, eating disorders among adolescent girls in Fiji

For parents wanting to reduce the negative influence of TV on their children, the first step is normally to switch off the television set. But a new study suggests that might not be enough. It turns out indirect media exposure, i.e., having friends who watch a lot of TV, might be even more damaging to a teenager's body image.

7 Jan 2011

ANAVEX 2-73 named 2010's 'most promising trial drug' by Alzheimer's Weekly

Anavex Life Sciences Corp. announced today that ANAVEX 2-73 has been named 2010's "most promising trial drug" by the editorial staff at Alzheimer's Weekly. The publication selected the ANAVEX 2-73 trial from a field of over 100 trials that treat dementias such as Alzheimer's and following the review of more than 10,000 articles.

7 Jan 2011

Biomarker study yields diagnostic blood test candidate for detection of Alzheimer's disease

OPKO Health, Inc. today announced the publication of a biomarker study yielding its diagnostic blood test candidate for the detection of Alzheimer's disease.

7 Jan 2011

Cells that give rise to neurons maintain high levels of ROS

For years, the majority of research on reactive oxygen species (ROS) - ions or very small molecules that include free radicals - has focused on how they damage cell structure and their potential link to stroke, cardiovascular disease and other illnesses.

7 Jan 2011

Medical Condition News

Critical Diagnostics' high sensitivity Presage ST2 Assay receives CE Mark approval

MMRF awards $3 million under 2010 Biotech Investment Awards program

Amorfix's AD diagnostic assay detects aggregated beta amyloid in spinal fluid

FDA approved KOMBIGLYZE XR for type 2 diabetes mellitus now available in pharmacies

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

Dendreon provides U.S. commercialization and European strategy updates for PROVENGE

BIND Biosciences commences BIND-014 Phase 1 clinical trial in cancer

Study finds combined treatments safe and effective for severe acute pancreatitis

Single cellular crisis shatters chromosomes in cancer causation

ASBP raises concern over FDA recommendations to lower BMI requirements for lap-band surgery

Chromosome shattering seen in two to three percent of all cancers

BG Medicine enters agreement to develop galectin-3 test for Siemens' automated immunoassay platforms

Plexxikon, Genentech enter PLX4032 co-promotion agreement

Cell Medica enters EBV-associated cancer research collaboration with CAGT and Baylor College of Medicine

Intrexon Corporation, ZIOPHARM enter partnership to develop, commercialize DNA-based therapeutics

Spirogen, Genentech enter multi-year ADC research collaboration and license agreement

Study examines link between media consumption, eating disorders among adolescent girls in Fiji

ANAVEX 2-73 named 2010's 'most promising trial drug' by Alzheimer's Weekly

Biomarker study yields diagnostic blood test candidate for detection of Alzheimer's disease

Cells that give rise to neurons maintain high levels of ROS

Innovating for impact: Jordi Labs on aligning methodologies with FDA expectation

Exploring the role of confocal-based high-content imaging in advancing core facilities

Transforming Cardiovascular Care: Insights from Mina Makar at AstraZeneca

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