Chromosomal Crossover News and Research

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Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

Bayer HealthCare Pharmaceuticals Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration voted unanimously that clinical trial and postmarketing data for gadobutrol injection, a macrocyclic 1.0 molar gadolinium-based contrast agent (GBCA), support approval of the product for proposed use in diagnostic magnetic resonance imaging (MRI) in adults and children.

24 Jan 2011

RG7204 Phase III study shows significant survival benefit in patients with metastatic melanoma

Genentech, a member of the Roche Group, today announced that BRIM3, a Phase III clinical study of RG7204, met its co-primary endpoints showing a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma.

19 Jan 2011

Positive results from PLX4032 Phase 3 Trial in patients with metastatic melanoma

Plexxikon today announced positive data from an interim analysis of the BRIM3 trial, a large multi-center Phase 3 clinical study of PLX4032 in patients with previously untreated metastatic melanoma with the BRAF mutation. Patients treated with PLX4032 had an improved overall survival compared to patients treated with dacarbazine, the current standard of care.

19 Jan 2011

TransPharma reports positive results from ViaDerm-Calcitonin Phase 1 trial for musculoskeletal disorders

TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced today successful results of a Phase I clinical trial of its self-applied ViaDerm-Calcitonin product for the treatment of musculoskeletal disorders such as osteoarthritis and musculoskeletal pain.

11 Jan 2011

Positive PK study results from ECLIPSE trial against cardiovascular disease

Omthera Pharmaceuticals, a privately-held emerging specialty pharmaceuticals company, today announced data from its ECLIPSE trial, designed to evaluate the bioavailability of Epanova™, the Company's lead compound for the treatment of very high triglycerides, in comparison to Lovaza®, the leading prescription Omega 3.

10 Jan 2011

Iroko reports positive results from Phase I clinical study of nanotechnology based unique formulation of naproxen

Iroko Pharmaceuticals, LLC today reported the results of the Phase I clinical study of its unique formulation of naproxen, a widely used pain medication, using proprietary, patent protected nanotechnology.

7 Jan 2011

Sanofi-aventis announces publication of positive BSI-201 phase II results for breast cancer

Sanofi-aventis and its wholly-owned subsidiary, BiPar Sciences, today announced that The New England Journal of Medicine published the final phase II data for the investigational drug iniparib demonstrating significant clinical benefit in women with metastatic triple negative breast cancer when iniparib was administered in combination with chemotherapy agents gemcitabine/carboplatin.

6 Jan 2011

Researchers begin placebo-controlled trial to test drug treatment for Rett syndrome

Researchers at Children's Hospital Boston have begun a randomized, placebo-controlled trial to test a potential drug treatment for Rett syndrome, the leading known genetic cause of autism in girls.

16 Dec 2010

Manhattan Pharmaceuticals reports preliminary results from AST-915 Phase 1/2 study in essential tremor

Manhattan Pharmaceuticals, Inc. announced preliminary results today from a Phase 1/2 study of AST-915 for the treatment of essential tremor. Data from this single dose study demonstrated that AST-915 was safe and well tolerated and demonstrated a clear effect on tremor power.

16 Dec 2010

Quality of care for ADHD children poor under Medicaid, says new report

Whatever its final incarnation, the recently enacted landmark Patient Protection and Affordable Care Act will expand Medicaid eligibility and is expected by 2013 to provide coverage, including mental health care, to an estimated 4.1 million children currently uninsured.

13 Dec 2010

Talecris initiates clinical trial to evaluate 2 doses of PROLASTIN-C for emphysema due to AAT deficiency

Talecris Biotherapeutics, Inc. announced today the initiation of a clinical trial evaluating the safety and the pharmacokinetic profile of two doses of PROLASTIN®-C (Alpha(1)-Proteinase Inhibitor [Human]) (A1PI), a therapy indicated for chronic augmentation and maintenance in adults with emphysema due to alpha(1)-antitrypsin (AAT) deficiency. AAT deficiency is a rare, genetic disorder in which low levels of the alpha(1) protein circulating in the lungs can increase an individual's risk of developing emphysema.

10 Dec 2010

Researchers to study effect of resveratrol on impaired IGT in older prediabetic patients

Researchers at Albert Einstein College of Medicine of Yeshiva University have been awarded $600,000 from the American Diabetes Association to study the effect of resveratrol, a chemical compound most notably found in red wine and grapes, on impaired glucose tolerance in older adults.

9 Dec 2010

New objective criteria for evaluating hemostatic efficacy in treatment of VWD

Octapharma USA researchers presented new stringent, objective criteria used in the evaluation of hemostatic efficacy in the treatment of von Willebrand disease and reported on their application of these criteria in clinical trials during the recently completed National Hemophilia Foundation Annual Meeting.

9 Dec 2010

Ginseng may improve thinking ability, but more research is needed

Many people believe that the popular herb ginseng can improve thinking ability and prevent or even treat dementia. However, a comprehensive review of research failed to find convincing evidence of these benefits.

8 Dec 2010

Short Jump training program may help lower risk of knee injuries in women basketball players: Study

A shortened, focused "jump training" program may help to lower the risk of knee injuries in women basketball players, according to a study in the December issue of The Journal of Strength and Conditioning Research, official research journal of the National Strength and Conditioning Association.

8 Dec 2010

Sheathless transradial intervention highly successful in treating complex lesions

Cardiologists from the Mayo Clinic performed sheathless transradial percutaneous coronary intervention (PCI) to remedy complex lesions, achieving a 90% success rate with no radial complications. Standard guiding catheters were used during the procedure. Details of this novel approach—overcoming the last hurdle to greater adoption of transradial PCI in the U.S.—are published in the December issue of Catheterization and Cardiovascular Intervention, the official journal of The Society for Cardiovascular Angiography and Interventions.

7 Dec 2010

Cardiologists achieve 90% success rate in sheathless transradial PCI to remedy complex lesions

7 Dec 2010

Global phase III study to provide novel extended release of topiramate

Data presented yesterday showed that USL255, a novel extended-release (ER) formulation of topiramate, was associated with less fluctuation in topiramate plasma levels than immediate-release (IR) topiramate in healthy volunteers.

7 Dec 2010

PolyMedix presents data on PMX-60056 Phase 1B/2 studies for blood clotting at American Heart Association

PolyMedix, Inc, an emerging biotechnology company focused on developing new therapeutic drugs to treat life-threatening infectious diseases and acute cardiovascular disorders, announced that data from two Phase 1B/2 clinical studies with PMX-60056 were presented today, in oral and poster sessions, at the Annual American Heart Association Scientific Sessions Meeting. PMX-60056 is a synthetic, small-molecule designed to reverse the anti-clotting effects of both heparin and low molecule weight heparin (LMWH).

16 Nov 2010

Biodel reports data on Linjeta formulation for type 1 diabetes at Technology Meeting in Bethesda

Scientists from Biodel Inc. reported new findings from the company's Linjeta, insulin glargine, "smart" basal insulin and stabilized glucagon development programs in poster presentations yesterday and today at the Tenth Annual Diabetes Technology Meeting in Bethesda, MD.

15 Nov 2010

Chromosomal Crossover News and Research

Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

RG7204 Phase III study shows significant survival benefit in patients with metastatic melanoma

Positive results from PLX4032 Phase 3 Trial in patients with metastatic melanoma

TransPharma reports positive results from ViaDerm-Calcitonin Phase 1 trial for musculoskeletal disorders

Positive PK study results from ECLIPSE trial against cardiovascular disease

Iroko reports positive results from Phase I clinical study of nanotechnology based unique formulation of naproxen

Sanofi-aventis announces publication of positive BSI-201 phase II results for breast cancer

Researchers begin placebo-controlled trial to test drug treatment for Rett syndrome

Manhattan Pharmaceuticals reports preliminary results from AST-915 Phase 1/2 study in essential tremor

Quality of care for ADHD children poor under Medicaid, says new report

Talecris initiates clinical trial to evaluate 2 doses of PROLASTIN-C for emphysema due to AAT deficiency

Researchers to study effect of resveratrol on impaired IGT in older prediabetic patients

New objective criteria for evaluating hemostatic efficacy in treatment of VWD

Ginseng may improve thinking ability, but more research is needed

Short Jump training program may help lower risk of knee injuries in women basketball players: Study

Sheathless transradial intervention highly successful in treating complex lesions

Cardiologists achieve 90% success rate in sheathless transradial PCI to remedy complex lesions

Global phase III study to provide novel extended release of topiramate

PolyMedix presents data on PMX-60056 Phase 1B/2 studies for blood clotting at American Heart Association

Biodel reports data on Linjeta formulation for type 1 diabetes at Technology Meeting in Bethesda

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