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Fibrocell submits azficel-T Phase II study protocol with FDA to treat restrictive burn scars

Fibrocell Science, Inc. announced today that is has submitted to the U.S. Food & Drug Administration (FDA) the company's Phase II clinical study protocol to evaluate the safety and efficacy of Fibrocell's lead therapy, azficel-T, in improving the range of motion, function and flexibility, in patients with existing restrictive burn scars.

15 May 2012

HIV prevention treatment must include medical, behavorial approaches: APA

A drug that has been shown to prevent HIV infection in a significant number of cases must be combined with behavioral approaches if the U.S. health care establishment is to succeed in reducing the spread of the virus, according to the American Psychological Association.

14 May 2012

Congress wrestles with medical research funding, FDA approval processes

Medical research advocates warn Congress about the dire impact that automatic spending cuts scheduled to take effect in January would have on efforts to control disease and develop life-saving treatments. Also in the news, how the concept of "fast-track" Food and Drug Administration approvals is playing on Capitol Hill.

14 May 2012

First U.S. outpatient trial of UVA-developed artificial pancreas

The University of Virginia School of Medicine has launched the first U.S. outpatient trial of a UVA-developed artificial pancreas that could make it easier for type 1 diabetes patients to manage their condition.

14 May 2012

Eggs for breakfast associated with greater satiety and reduced calorie consumption

New research presented at the 19th European Congress on Obesity in Lyon, France reports that eating eggs for breakfast is associated with greater satiety and reduced calorie consumption at lunch than eating wheat-based breakfast foods like ready-to-eat breakfast cereal. Participants in the study reported feeling fuller following the egg breakfast and tests of their hunger hormone levels supported their self-reported observations.

14 May 2012

FDA clears Bioness smaller leg cuff for use with L300 Foot Drop System

Bioness Inc. today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a smaller leg cuff for use with the company's L300 Foot Drop System.

14 May 2012

U-Systems somo•v Automated Breast Ultrasound system granted FDA PMA approvable letter

U-Systems, the leader in automated breast ultrasound, announced today it has received a PMA approvable letter from the U.S. Food and Drug Administration's (FDA) for the company's somo•v® Automated Breast Ultrasound (ABUS) system.

14 May 2012

Neusoft Medical introduces NeuViz 64 multi-slice CT scanner

Neusoft Medical Systems Co., Ltd., a wholly-owned subsidiary of Neusoft Corporation, today announced its introduction of NeuViz 64 multi-slice CT scanner into the global market. This device, developed independently by Neusoft Medical, debuted at the 67th China International Medical Equipment Fair (CMEF) Spring 2012.

14 May 2012

Boston Scientific launches Innova Self-Expanding Bare-Metal Stent System in Europe

Boston Scientific Corporation announces CE Mark and European market launch of the Innova Self-Expanding Bare-Metal Stent System, which is designed to treat peripheral vascular lesions in arteries above the knee, specifically the superficial femoral artery (SFA) and proximal popliteal artery (PPA). The company plans to launch the product immediately in Europe and other CE Mark countries.

14 May 2012

FDA clears MAQUET's new MEGA larger volume intra-aortic balloon catheters

MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new MEGA 7.5Fr. 30cc and 40cc intra-aortic balloon (IAB) catheters. These new, larger volume catheters will allow clinicians to provide patients with greater hemodynamic support, regardless of their height.

14 May 2012

Phase II trial to examine effects of resveratrol on individuals with mild to moderate dementia

A national, phase II clinical trial examining the effects of resveratrol on individuals with mild to moderate dementia due to Alzheimer's disease has begun as more than two dozen academic institutions recruit volunteers in the coming months. R. Scott Turner, M.D., Ph.D., director of Georgetown University Medical Center's Memory Disorders Program, is the lead investigator for the national study.

14 May 2012

HealthFitness praises IOM for in-depth report on obesity in the U.S.

In some 478 pages, the Institute of Medicine laid out a thorough case this week to re-cast the nation's growing obesity problem as both an individual and societal responsibility to solve. Despite both private and public efforts over the past decade to address the problem, obesity-related illnesses cost an estimated $190 billion a year in the first five years of the millennium.

14 May 2012

Event addresses FDA's recent draft guidelines for development of biosimilar products

Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (Alliance) outlined five areas of concern that the U.S. Food and Drug Administration (FDA) should resolve before they allow biosimilar medications on the U.S. drug market in prepared testimony for the FDA's May 11th public hearing. The event addressed the FDA's recent draft guidelines for the development of biosimilar products.

14 May 2012

Chronic asthma sufferers may have new hope for relief due to two BWH research studies

Chronic asthma sufferers may have new hope for relief due to two new research studies that are getting underway at Brigham and Women's Hospital (BWH). Researchers from BWH's Asthma Research Center are exploring whether two new therapies will relieve asthma symptoms.

14 May 2012

CRT-D cost-effective treatment for mildly symptomatic heart failure patients

Medtronic, Inc. today announced findings from an economic analysis of the landmark RAFT (Resynchronization / Defibrillation in Ambulatory Heart Failure Trial) trial demonstrating that cardiac resynchronization therapy with defibrillation (CRT-D) is a cost-effective treatment for mildly symptomatic heart failure patients.

14 May 2012

FDA ADAC recommends approval of Quad for HIV-1 infection

Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults.

14 May 2012

HIV community supports rapid OTC testing

Who's Positive, a national HIV awareness organization, today announced the results of a year-long online survey measuring support for over-the counter (OTC) HIV testing. The organization will present these results at the upcoming U.S. Food and Drug Administration (FDA) Blood Products Advisory Committee (BPAC) on May 15, 2012.

11 May 2012

NBHA commends FDA for continuing investigation of bisphosphonate treatment for osteoporosis

In response to today's Perspective pieces published in the New England Journal Of Medicine, the National Bone Health Alliance (NBHA), a public-private partnership bringing together the expertise and resources of its 42 members from the private and non-profit sectors to collectively advance bone health and prevent disease, commends the U.S. Food and Drug Administration (FDA) for continuing to investigate the risks and benefits of long-term bisphosphonate treatment.

11 May 2012

Anti-epilepsy drug phenobarbital stunts neuronal growth

A brain study in infant rats demonstrates that the anti-epilepsy drug phenobarbital stunts neuronal growth, which could prompt new questions about using the first-line drug to treat epilepsy in human newborns.

11 May 2012

Damaging consequences of potential spending cuts to medical research

The report "Sequestration: Health Research at the Breaking Point," released today by Research!America, demonstrates the damaging consequences of potential automatic spending cuts, or sequestration, to the nation's medical research enterprise and public health, and offers examples on how these cuts would delay scientific discoveries that could lead to new treatments and cures for deadly diseases.

11 May 2012

Food News and Research

Fibrocell submits azficel-T Phase II study protocol with FDA to treat restrictive burn scars

HIV prevention treatment must include medical, behavorial approaches: APA

Congress wrestles with medical research funding, FDA approval processes

First U.S. outpatient trial of UVA-developed artificial pancreas

Eggs for breakfast associated with greater satiety and reduced calorie consumption

FDA clears Bioness smaller leg cuff for use with L300 Foot Drop System

U-Systems somo•v Automated Breast Ultrasound system granted FDA PMA approvable letter

Neusoft Medical introduces NeuViz 64 multi-slice CT scanner

Boston Scientific launches Innova Self-Expanding Bare-Metal Stent System in Europe

FDA clears MAQUET's new MEGA larger volume intra-aortic balloon catheters

Phase II trial to examine effects of resveratrol on individuals with mild to moderate dementia

HealthFitness praises IOM for in-depth report on obesity in the U.S.

Event addresses FDA's recent draft guidelines for development of biosimilar products

Chronic asthma sufferers may have new hope for relief due to two BWH research studies

CRT-D cost-effective treatment for mildly symptomatic heart failure patients

FDA ADAC recommends approval of Quad for HIV-1 infection

HIV community supports rapid OTC testing

NBHA commends FDA for continuing investigation of bisphosphonate treatment for osteoporosis

Anti-epilepsy drug phenobarbital stunts neuronal growth

Damaging consequences of potential spending cuts to medical research

Understanding cultivated meat and its global potential eBook

Improving healthcare sustainability through carbon data

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

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