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BDSI to discuss planned BEMA Granisetron IND with the FDA

BioDelivery Sciences International, Inc. announced that the company has been granted a meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned Investigational New Drug (IND) application for BDSI’s antiemetic (anti-nausea and vomiting) product candidate, BEMA Granisetron. The meeting will take place on March 17, 2010. The company will discuss with the FDA clinical development and regulatory plans for BEMA Granisetron, which is anticipated to enter Phase 1 studies in the second quarter of 2010.

13 Jan 2010

Spectrum Pharmaceuticals achieves its enrollment target in second of two apaziquone Phase 3 trials

Spectrum Pharmaceuticals today announced that the second of two Phase 3 pivotal clinical trials of apaziquone has achieved its enrollment target. The two trials enrolled more than 1600 patients with non-muscle invasive bladder cancer. As per the collaboration agreement with Allergan, a $1.5 million milestone payment will be paid to Spectrum Pharmaceuticals.

13 Jan 2010

Bevacizumab drug shows promise to slow tumor growth in lung cancer patients

Phase II study results of the agent ASA404 showed promise in patients with either squamous or non-squamous non-small cell lung cancer (NSCLC).

13 Jan 2010

Scientists identify fast-acting compound to improve cognitive function impairments

A fast-acting compound that appears to improve cognitive function impairments in mice similar to those found in patients with progressive Alzheimer's disease has been identified by scientists at Wake Forest University School of Medicine and the Vanderbilt University Medical Center Program in Drug Discovery.

13 Jan 2010

Caffeine abstinence: An ineffective and potentially distressing tinnitus therapy

New research has found giving up caffeine does not relieve tinnitus and acute caffeine withdrawal might add to the problem. This is the first study of its kind to look at the effect of caffeine consumption on tinnitus.

13 Jan 2010

AARDA pleased with FDA's approval of RA drug ACTEMRA

Friday, January 8, 2010, the Food and Drug Administration (FDA) approved ACTEMRA® (tocilizumab), a new biologic response modifier for adult patients with moderately to severely active rheumatoid arthritis (RA).

13 Jan 2010

Research suggests variation of CETP gene is linked to lowered risk of dementia and AD

Preliminary research suggests that variation of a gene for a plasma protein is associated with slower age-related memory decline and a lower risk of dementia and Alzheimer disease (AD), according to a study in the January 13 issue of JAMA.

13 Jan 2010

Patient enrollment in Spherix's global Phase 3 clinical trial NEET completed

Spherix Inc., an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced the completion of patient enrollment in its global Phase 3 clinical trial NEET (70971-004), which is evaluating the safety and efficacy of D-tagatose as an oral treatment for Type 2 diabetes mellitus.

12 Jan 2010

Scientists go beyond single-gene models to probe inborn heart defects

Studying genes that regulate early heart development in animals, scientists have solved a puzzle about one gene's role, finding that it acts in concert with a related gene. Their finding contributes to understanding how the earliest stages of heart development may go awry, resulting in congenital heart defects in humans.

12 Jan 2010

Vion Pharmaceuticals files SPA for Onrigin-LDAC combination Phase II/III trial

VION PHARMACEUTICALS, INC. announced today that it had filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase II/III trial of its oncology therapeutic Onrigin™ (laromustine) Injection in combination with low-dose Ara-C (LDAC) in elderly patients with newly diagnosed acute myeloid leukemia (AML). The primary objective for the Phase III part of this study is to determine if Onrigin™ plus LDAC improves overall survival compared with LDAC alone.

12 Jan 2010

Abraxis Bioscience awards John Wayne Cancer Institute $1M grant for identifying new cancer biomarkers

A $1 million grant from Abraxis Bioscience, Inc. to a world-famous research laboratory at John Wayne Cancer Institute at Saint John’s Health Center could help save lives of cancer patients by helping doctors more rapidly assess whether a treatment is working or not.

12 Jan 2010

Women with high BP face greater risk for dementia later in life

High blood pressure may put women at greater risk for dementia later in life by increasing white matter abnormalities in the brain, report researchers from the University of Pittsburgh Graduate School of Public Health in a study published online in the Journal of Clinical Hypertension.

12 Jan 2010

Enrollment complete in Dune Medical Devices' MarginProbe pivotal clinical trial

Dune Medical Devices today announced the completion of patient enrollment in the MarginProbe™ pivotal clinical trial. The MarginProbe procedure provides surgeons with real-time detection of cancer at the edges of the tissue removed during breast conservation surgery (BCS), which is the only way to ensure the complete removal of the tumor from the breast. The randomized, controlled trial includes 664 women who underwent BCS at one of 21 leading medical facilities, with 18 in the US and three in Israel.

12 Jan 2010

ALS TDI to receive grant of $1.6M for research and development of potential therapeutics for ALS

In recognition of multiple studies connecting ALS to military service, the 2010 Defense Appropriations Act, signed by President Obama on December 22, 2009, provided for the grant of $1.6 million for research and development of potential therapeutics for Amyotrophic Lateral Sclerosis (ALS, Lou Gehrig's disease).

12 Jan 2010

3D structure of PI3Kdelta: An important drug target for a wide range of diseases

Intellikine announced today the publication of an article entitled, "The p110delta structure: mechanisms for selectivity and potency of new PI(3)K inhibitors," now available as an advanced online publication at Nature Chemical Biology.

12 Jan 2010

ARKRAY's Assure Platinum Blood Glucose Monitoring System launched in the U.S.

ARKRAY, Inc., the world's 5th largest manufacturer of diabetes self-monitoring systems, has officially launched the new Assure Platinum Blood Glucose Monitoring System.

12 Jan 2010

Older patients with acute myeloid leukemia may benefit from decitabine drug

Older patients with acute myeloid leukemia (AML) might benefit from a drug that reactivates genes that cancer cells turn off, according to research at Washington University School of Medicine in St. Louis and collaborating institutions.

12 Jan 2010

Increased doses of erlotinib drug may lead to better outcomes in lung cancer patients

Although erlotinib is an approved second-line therapy for lung cancer, its management is complicated by side effects that get worse as the dose increases.

12 Jan 2010

Evidence-based care for lung cancer patients results in an average cost savings of 35%, says study

A study recently conducted by US Oncology and Aetna finds that evidence-based care for patients with non-small cell lung cancer (NSCLC) results in an average cost savings of 35 percent over 12 months while demonstrating equivalent health outcomes. The study, which compared patients treated with evidence-based guidelines (also known as ‘on pathway’) to those treated with non-evidence-based guidelines (also known as ‘off pathway’), was published in the peer-reviewed Journal of Oncology Practice.

12 Jan 2010

Market for chronic tophaceous gout medications will be led by drug that resolves tophi in less than a year

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in the U.S. and Europe, a drug that resolves tophi in less than one year would become the patient share leader in the chronic tophaceous gout patient subpopulation and would be used in the vast majority of patients who suffer severe tophaceous gout, according to surveyed U.S. and European rheumatologists.

12 Jan 2010

Medical Condition News

BDSI to discuss planned BEMA Granisetron IND with the FDA

Spectrum Pharmaceuticals achieves its enrollment target in second of two apaziquone Phase 3 trials

Bevacizumab drug shows promise to slow tumor growth in lung cancer patients

Scientists identify fast-acting compound to improve cognitive function impairments

Caffeine abstinence: An ineffective and potentially distressing tinnitus therapy

AARDA pleased with FDA's approval of RA drug ACTEMRA

Research suggests variation of CETP gene is linked to lowered risk of dementia and AD

Patient enrollment in Spherix's global Phase 3 clinical trial NEET completed

Scientists go beyond single-gene models to probe inborn heart defects

Vion Pharmaceuticals files SPA for Onrigin-LDAC combination Phase II/III trial

Abraxis Bioscience awards John Wayne Cancer Institute $1M grant for identifying new cancer biomarkers

Women with high BP face greater risk for dementia later in life

Enrollment complete in Dune Medical Devices' MarginProbe pivotal clinical trial

ALS TDI to receive grant of $1.6M for research and development of potential therapeutics for ALS

3D structure of PI3Kdelta: An important drug target for a wide range of diseases

ARKRAY's Assure Platinum Blood Glucose Monitoring System launched in the U.S.

Older patients with acute myeloid leukemia may benefit from decitabine drug

Increased doses of erlotinib drug may lead to better outcomes in lung cancer patients

Evidence-based care for lung cancer patients results in an average cost savings of 35%, says study

Market for chronic tophaceous gout medications will be led by drug that resolves tophi in less than a year

How can microdialysis benefit drug development

Global and Local Efforts to Take Action Against Hepatitis

Addressing Important Cardiac Biology Questions with Shotgun Top-Down Proteomics

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