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New research: Significant number of HCV patients in the U.S. does not have health insurance coverage

New research has determined that patients in the U.S. with hepatitis C virus are twice as likely to not have health insurance coverage compared with those without the disease.

24 Feb 2011

FDA approves sBLA for CSL's Hizentra to treat PI

CSL Behring announced today that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application to extend the shelf life of Hizentra, Immune Globulin Subcutaneous, 20% Liquid, from 24 months to 30 months.

24 Feb 2011

Lack of health insurance limits Hepatitis C patients' access to latest antiviral therapy

New research has determined that patients in the U.S. with hepatitis C virus (HCV) are twice as likely to not have health insurance coverage compared with those without the disease. In fact researchers found only a third of HCV infected Americans have access to antiviral therapy; the remaining are either uninsured or not candidates for therapy due to treatment contraindications. Details of this study are published in the March issue of Hepatology, a peer-reviewed journal of the American Association for the Study of Liver Diseases (AASLD).

24 Feb 2011

PhRMA: 460 medicines in development for rare diseases

America's biopharmaceutical research companies are intensifying research into rare diseases, which often are among the most devastating to patients and complex for researchers. A record 460 medicines for rare diseases are in late stages of the pipeline, either in clinical trials or awaiting Food and Drug Administration (FDA) review, according to a report released today by the Pharmaceutical Research and Manufacturers of America (PhRMA).

24 Feb 2011

Study finds link between fasting serum glucose levels and in-hospital mortality in elderly non-diabetic patients

A two-country hospital study of 808 elderly patients found a strong association between high, undiagnosed blood glucose in non-diabetic patients and increased hospital death rates, according to the March issue of IJCP, the International Journal of Clinical Practice.

24 Feb 2011

Stereotaxis reports first-ever use of Niobe Magnetic Navigation System to treat hypertension

Stereotaxis, Inc. announced today the first-ever use of its Niobe® Magnetic Navigation System in a renal artery ablation procedure for the treatment of chronic hypertension that was not treatable with medication.

24 Feb 2011

Study findings support therapeutic approach for common form of MS

In an effort to develop therapeutic remedies for multiple sclerosis, scientists debate two possible interventional approaches - but they're on opposite sides of the spectrum. Researchers at Wayne State University's School of Medicine, however, have reached a definitive conclusion as to which approach is correct, putting an end to a long-disputed issue.

24 Feb 2011

Stamford Hospital to participate in US FDA Expanded Access Treatment IND program for Generex Oral-lyn

Generex Biotechnology Corporation announced today that Stamford Hospital has agreed to participate in the United States Food and Drug Administration Expanded Access Treatment Investigational New Drug Program for Generex Oral-lyn, the Company's proprietary buccal insulin spray product for the treatment of patients with diabetes.

24 Feb 2011

FDA approves ONGLYZA to treat type 2 diabetes patients with renal impairment

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration has approved the inclusion of data from two clinical studies in an update to the ONGLYZA U.S. Prescribing Information for adult type 2 diabetes patients.

24 Feb 2011

EpiCept 2010 fourth quarter net loss is $0.06 per share

EpiCept Corporation today announced operating and financial results for the fourth quarter and full year ended December 31, 2010, and provided an update on its key business initiatives.

24 Feb 2011

ViewRay's radiotherapy treatment planning and delivery software receives FDA marketing clearance

ViewRay™, Inc., a privately held medical device company, has received U.S. FDA marketing clearance for its radiotherapy treatment planning and delivery software.

24 Feb 2011

Oncolytics completes patient enrollment in REOLYSIN trial to treat metastatic colorectal cancer

Oncolytics Biotech Inc. announced today that enrollment has been completed in a U.K. translational clinical trial investigating intravenous administration of REOLYSIN in patients with metastatic colorectal cancer prior to surgical resection of liver metastases.

23 Feb 2011

ACT receives patent for its single-blastomere technology

Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today that it has been issued a patent on its "single-blastomere" technique. Patent Number 7,893,315 broadly covers ACT's proprietary single-blastomere technology that provides a non-destructive alternative for deriving human embryonic stem cell lines.

23 Feb 2011

Novo Nordisk submits rFXIII BLA to FDA for treatment of inherited bleeding disorder

Novo Nordisk announced today that a Biologic License Application has been submitted to the U.S. Food and Drug Administration requesting the approval of a recombinant factor XIII compound for the vast majority of patients with congenital factor XIII deficiency, an inherited bleeding disorder.

From Novo Nordisk 23 Feb 2011

Ibio acquires Orphan Drug Designation and Fabry disease therapeutic program from Kentucky

iBio, Inc. today announced it has acquired Orphan Drug Designation for plant-produced human alpha galactosidase A and related property rights from an affiliate of Kentucky Bioprocessing LLC and has initiated a program, based on its iBioLaunch platform, to develop an improved version of the enzyme for therapy of Fabry disease.

23 Feb 2011

Aestus commences ATx08-001 phase 2 trial to evaluate efficacy of novel pain therapeutic

Aestus Therapeutics, Inc., announced today that it has initiated screening of patients for a clinical trial to evaluate the efficacy of its novel pain therapeutic, ATx08-001. This placebo-controlled, two-dose level study will test the efficacy of ATx08-001 in reducing the pain following an outbreak of shingles.

23 Feb 2011

Diabetes technology granted patent in Australia

Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) a global company pioneering the development of a cell implant therapy to treat diabetes and neurodegenerative diseases, has been granted a patent by the Australian Patent Office for IMMUPEL(tm), LCT's industry-leading technology for encapsulating living cells prior to transplantation.

23 Feb 2011

Healthcare professionals need evidence-based education, guidance about CAM use in maternity care

Complementary and alternative medicine is increasingly popular in maternity care, but healthcare professionals need formal evidence-based education and guidance about its use, according to a review in the March issue of the Journal of Advanced Nursing.

23 Feb 2011

USPTO issues patent to Synergy's SP-333 for treatment of IBD

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal disorders and diseases, announced today that on February 1, 2011 the U.S. Patent and Trademark Office issued U.S. Patent No. 7,879,802, covering Synergy's novel drug candidate SP-333 to treat inflammatory bowel disease.

23 Feb 2011

Pretreatment with FDA-approved drug allows successful pregnancies in radiation-exposed rhesus monkeys

A strategy developed by Massachusetts General Hospital (MGH) researchers to shield the ovaries of female mammals from the damaging effects of radiation and chemotherapy has passed an important milestone. A collaborative study with investigators from Oregon Health and Sciences University (OHSU), published online in the journal Fertility and Sterility, reports that brief preexposure of the ovaries to an FDA-approved agent called FTY720 preserved the fertility of female rhesus monkeys exposed to potentially lethal doses of radiation.

23 Feb 2011

Therapy News and Research

New research: Significant number of HCV patients in the U.S. does not have health insurance coverage

FDA approves sBLA for CSL's Hizentra to treat PI

Lack of health insurance limits Hepatitis C patients' access to latest antiviral therapy

PhRMA: 460 medicines in development for rare diseases

Study finds link between fasting serum glucose levels and in-hospital mortality in elderly non-diabetic patients

Stereotaxis reports first-ever use of Niobe Magnetic Navigation System to treat hypertension

Study findings support therapeutic approach for common form of MS

Stamford Hospital to participate in US FDA Expanded Access Treatment IND program for Generex Oral-lyn

FDA approves ONGLYZA to treat type 2 diabetes patients with renal impairment

EpiCept 2010 fourth quarter net loss is $0.06 per share

ViewRay's radiotherapy treatment planning and delivery software receives FDA marketing clearance

Oncolytics completes patient enrollment in REOLYSIN trial to treat metastatic colorectal cancer

ACT receives patent for its single-blastomere technology

Novo Nordisk submits rFXIII BLA to FDA for treatment of inherited bleeding disorder

Ibio acquires Orphan Drug Designation and Fabry disease therapeutic program from Kentucky

Aestus commences ATx08-001 phase 2 trial to evaluate efficacy of novel pain therapeutic

Diabetes technology granted patent in Australia

Healthcare professionals need evidence-based education, guidance about CAM use in maternity care

USPTO issues patent to Synergy's SP-333 for treatment of IBD

Pretreatment with FDA-approved drug allows successful pregnancies in radiation-exposed rhesus monkeys

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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