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Tips on healthy eating post-surgery

Good nutrition, with adequate calories and protein, is important to healing and recovery after major surgery. But the stress of surgery and follow-up care can depress the appetite, alter the taste of food and make it difficult to eat and digest food, sometimes for weeks or months.

20 Mar 2010

Impact of plastics on human health and ecosystems

Plastics surround us. A vital manufacturing ingredient for nearly every existing industry, these materials appear in a high percentage of the products we use every day. Although modern life would be hard to imagine without this versatile chemistry, products composed of plastics also have a dark side, due in part to the very characteristics that make them so desirable-their durability and longevity.

20 Mar 2010

FDA panel favors approval with conditions of Medtronic's Revo MRI SureScan pacing system

Medtronic, Inc.today announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted unanimously in favor of approval with conditions of the Revo MRI™ SureScan™ pacing system designed as MR Conditional, or safe for use in Magnetic Resonance Imaging (MRI) systems under specified conditions.

20 Mar 2010

High dose of Zocor could lead to muscle injury, warns FDA

The U.S. Food and Drug Administration today warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg.

20 Mar 2010

ELCA's 49-page draft social statement on genetics

The Evangelical Lutheran Church in America released March 18 a 49-page draft social statement on genetics, a framework for discussion on a variety of current topics in the field including certain advances in medicine, reproductive cloning, human embryonic stem cells, and animal and plant genetic engineering.

20 Mar 2010

Recent releases in Global Health

A Lancet study performed a systematic review of HIV prevention and treatment services targeting injecting drug users (IDUs) globally based on the availability of "core interventions for IDUs: needle and syringe programmes (NSPs), opioid substitution therapy (OST) and other drug treatment, HIV testing and counselling, antiretroviral therapy (ART), and condom programmes." The authors conclude, "although the number of countries with core HIV prevention services is growing … worldwide, there are few countries in which the level of intervention coverage is sufficient to prevent HIV transmission" (Mathers et al., 3/20).

20 Mar 2010

Bovie Medical receives FDA marketing clearance for BOSS bipolar sintered steel coagulation device

Bovie Medical Corporation, a manufacturer and marketer of electrosurgical products, today announced the Company received clearance from the Food and Drug Administration (FDA) to market its proprietary BOSS™ bipolar sintered steel coagulation device. The BOSS™ is the latest device based on Bovie’s saline enhanced sintered steel technology.

19 Mar 2010

Cedars-Sinai Neurovascular Center's clinical trial of minimally invasive stenting procedure for TIA

Individuals between 30 and 80 years of age, who have had a transient ischemic attack (TIA) or non-severe stroke within the past 30 days, and who cannot be treated surgically, may be eligible to participate in a Phase III clinical trial of a minimally invasive stenting procedure at the Cedars-Sinai Neurovascular Center. The study will focus specifically on patients who have had an intracranial artery narrowed by at least 70 percent and who are experiencing recurrent strokes or TIAs despite being on anti-clotting medication.

19 Mar 2010

ViroPharma to present Cinryze data at Southern European Allergy Society congress

ViroPharma Incorporated today announced the presentation of two abstracts relating to Cinryze™ (C1 esterase inhibitor [human]) therapy at the First International Congress of the Southern European Allergy Society in Florence, Italy.

19 Mar 2010

CHMP issues positive opinion recommending approval of Tarceva as monotherapy for NSCLC

OSI Pharmaceuticals, Inc. announced today that its international partner for Tarceva® (erlotinib), Roche, informed OSI that the European Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of Tarceva as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease following four cycles of standard platinum-based first-line chemotherapy.

19 Mar 2010

A.P. Pharma's NDA for APF530 in prevention of CINV: FDA issues Complete Response Letter

A.P. Pharma, Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for APF530 in the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting.

19 Mar 2010

Global initiative for reducing time taken to introduce new combination TB treatments

Ahead of World TB Day, US Food and Drug Administration Commissioner Margaret Hamburg helped public and private sector partners launch a new collaboration to significantly accelerate the development of combination treatments for tuberculosis — and replace an almost 50-year-old drug regimen. Created by the Global Alliance for TB Drug Development, the Critical Path Institute, and the Bill & Melinda Gates Foundation, the initiative could potentially reduce the time it takes to introduce new combination TB treatments from as much as a quarter century to as few as six years.

19 Mar 2010

Hercules Technology Growth Capital commits over $52.0M in structured debt financing

Hercules Technology Growth Capital, Inc., the leading specialty finance company providing venture debt and equity to venture capital and private equity-backed technology and life science companies at all stages of development, today announced that it has committed over $52.0 million in structured debt financing to new and existing portfolio companies.

19 Mar 2010

FDA restricts the sale, distribution and use of cigarettes and smokeless tobacco

A rule issued today by the Food and Drug Administration underscores the historical progress made towards fighting the nation's number one cause of preventable death: tobacco-related disease.

19 Mar 2010

Mini-laboratory: IVD platform to be presented at Analytica trade show

Many illnesses can be reliably diagnosed through laboratory tests, but these in vitro analyses often use up valuable time. A system developed by Fraunhofer research scientists, which can carry out complex analyses on the spot, will soon be ready for the market.

19 Mar 2010

FDA categorizes Nanosphere's RVNATSP assay on Verigene SP System as "Moderate Complexity"

Nanosphere, Inc., a leader in the development and commercialization of advanced molecular diagnostics systems, received notification from the U.S. Food and Drug Administration (FDA) that its respiratory virus panel (RVNATSP) performed on the Verigene SP System has been categorized as "Moderate Complexity" under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

19 Mar 2010

Stemedica files IND for trial using allogeneic mesenchymal bone marrow cells in patients with ischemic stroke

Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that it has filed an Investigative New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a clinical trial. The trial will assess the safety, tolerability and efficacy of Stemedica's high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke.

19 Mar 2010

Robertson Foundation commits $10.2M for Duke Medicine's cell therapy research

A $10.2 million commitment from the Robertson Foundation to create a state-of-the-art Translational Cell Therapy Center (TCTC) will advance Duke Medicine's pioneering cell therapy research and treatment programs for children and adults with cancer, cerebral palsy, stroke and brain injuries suffered at birth.

19 Mar 2010

FDA approves expanded indication for Boston Scientific's CRT-Ds

Boston Scientific Corporation today announced that the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) has unanimously recommended approval of an expanded indication for its cardiac resynchronization therapy defibrillators (CRT-Ds), including the COGNIS® CRT-D. The panel recommended the expansion include the majority of the studied population of the landmark MADIT-CRT clinical trial, which evaluated the ability of these devices to slow the progression of heart failure in patients with asymptomatic or mild heart failure.

19 Mar 2010

Older adult specialists travel to Haiti to render care at make-shift nursing homes

Two months after the devastating earthquake hit Haiti, the needs of older adults in the region remain an urgent priority. Dr. Martin Gorbien, a geriatrician, and Lauren Kessler, a licensed clinical social worker, both from Rush University Medical Center, will be among the first older adult specialists to travel to Haiti to provide care at make-shift nursing homes.

19 Mar 2010

Food News and Research

Tips on healthy eating post-surgery

Impact of plastics on human health and ecosystems

FDA panel favors approval with conditions of Medtronic's Revo MRI SureScan pacing system

High dose of Zocor could lead to muscle injury, warns FDA

ELCA's 49-page draft social statement on genetics

Recent releases in Global Health

Bovie Medical receives FDA marketing clearance for BOSS bipolar sintered steel coagulation device

Cedars-Sinai Neurovascular Center's clinical trial of minimally invasive stenting procedure for TIA

ViroPharma to present Cinryze data at Southern European Allergy Society congress

CHMP issues positive opinion recommending approval of Tarceva as monotherapy for NSCLC

A.P. Pharma's NDA for APF530 in prevention of CINV: FDA issues Complete Response Letter

Global initiative for reducing time taken to introduce new combination TB treatments

Hercules Technology Growth Capital commits over $52.0M in structured debt financing

FDA restricts the sale, distribution and use of cigarettes and smokeless tobacco

Mini-laboratory: IVD platform to be presented at Analytica trade show

FDA categorizes Nanosphere's RVNATSP assay on Verigene SP System as "Moderate Complexity"

Stemedica files IND for trial using allogeneic mesenchymal bone marrow cells in patients with ischemic stroke

Robertson Foundation commits $10.2M for Duke Medicine's cell therapy research

FDA approves expanded indication for Boston Scientific's CRT-Ds

Older adult specialists travel to Haiti to render care at make-shift nursing homes

Enhancing confidence in chemical ionization spectrometry data eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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