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AFFI commends Congress for approval of the Healthy, Hunger-Free Kids Act

American Frozen Food Institute (AFFI) President and CEO Kraig R. Naasz today commended the U.S. House of Representatives for approving the Healthy, Hunger-Free Kids Act of 2010, which now heads to President Obama for his signature and enactment after having passed the Senate in August.

3 Dec 2010

Cell Therapeutics submits pixantrone NDA application to treat non-Hodgkin's lymphoma

Cell Therapeutics, Inc. today announced that it has submitted a formal appeal to the Office of New Drugs in the U.S. Food and Drug Administration's Center for Drug Evaluation and Research regarding the agency's decision from earlier this year on the pixantrone New Drug Application to treat relapsed/refractory aggressive non-Hodgkin's lymphoma.

3 Dec 2010

Sentara Heart Hospital commences procedures in AtriCure DEEP AF feasibility trial

Sentara Heart Hospital is breaking new ground in cardiac care and treatment. Surgeons and Cardiologists at Sentara Heart Hospital are first to begin enrolling and performing trial cases in the AtriCure DEEP AF feasibility trial. The first procedure in the country was performed in a new, state-of-the-art hybrid operating room at Sentara Heart Hospital by Jonathan Philpott, M.D., Director of the Sentara Atrial Fibrillation Surgery Program, Ian Woollett, M.D., and John Onufer, M.D., Medical Director of Cardiac Electrophysiology.

3 Dec 2010

Democrats confident food safety bill will be resolved despite procedural error; Child nutrition bill set for house vote

The Hill's Healthwatch Blog: "Senate Democrats say an error in the food-safety bill passed Tuesday can be resolved in time to send the legislation to President Obama by the end of the year. Two senior leadership aides confirmed that the bill the Senate approved, 73-25, inadvertently contained tax provisions that, under the Constitution, must originate in the House of Representatives. That means the bill must be passed a second time by the Senate, giving critics such as Sen. Tom Coburn (R-Okla.) another chance to block it" (Rushing and Lillis, 12/1).

3 Dec 2010

Mushrooms are good source of vitamin D

The Institute of Medicine (IOM) recently released the results of its 24-month review on dietary reference intakes (DRIs) for vitamin D and calcium, which validated the importance of vitamin D as an essential nutrient for promoting bone health. The committee set the recommended intake level at 600 IU, which is triple the previously recommended amount from 1997.

3 Dec 2010

Doctors still prescribe higher-dose menopausal hormone therapy pills

Doctors across the country are still prescribing higher-dose menopausal hormone therapy pills, despite clinical evidence that low doses and skin patches work just as well and carry fewer health risks. That's what researchers at the Stanford University School of Medicine found in a study that will be published online Dec. 2 in Menopause: The Journal of the North American Menopause Society.

3 Dec 2010

Teva comments on Lovenox’s patent infringement lawsuit

Teva Pharmaceutical Industries Ltd. commented today on the patent infringement lawsuit filed by Momenta Pharmaceuticals, Inc. and Sandoz Inc.

3 Dec 2010

New inexpensive filtering technology to kill disease-causing bacteria in water

With almost one billion people lacking access to clean, safe drinking water, scientists are reporting development and successful initial tests of an inexpensive new filtering technology that kills up to 98 percent of disease-causing bacteria in water in seconds without clogging. A report on the technology appears in Nano Letters, a monthly American Chemical Society journal.

3 Dec 2010

AtriCure initiates enrollment in DEEP AF feasibility trial

AtriCure, Inc., a medical device company and a leader in cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, announced initial patient enrollment in its DEEP AF feasibility trial. The first procedure was performed in a new, state-of-the-art hybrid room at Sentara Norfolk General Hospital in Norfolk, Virginia by Jonathan Philpott, M.D., Director of the Sentara Atrial Fibrillation Surgery Program, Ian Woollett, M.D., and John Onufer, M.D., Medical Director of Cardiac Electrophysiology.

3 Dec 2010

FDA accepts to file PMA application for LightTouch Cervical Scanner

Guided Therapeutics, Inc. announced that it was notified by the U.S. Food and Drug Administration (FDA) that the company's premarket approval application (PMA) for the LightTouch Cervical Scanner, for patients at risk for cervical cancer, is suitable for filing.

3 Dec 2010

Africa can produce enough food to feed itself, study says

Africa is capable of producing enough food to feed itself within a single generation, according to "a study released to coincide with a meeting of several African leaders in Tanzania on Thursday, as well as U.N. talks on slowing climate change in Cancun, Mexico," Reuters reports (Doyle, 12/2).

3 Dec 2010

FDA accepts IND application to initiate human clinical trial to evaluate BNC

QR Pharma, Inc., a developer of novel drugs to treat Alzheimer's disease (AD), announced today that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) to begin human clinical trials and evaluate the safety and efficacy of the company's second product, bisnorcymserine (BNC).

3 Dec 2010

AstraZeneca announces FDA Advisory Committee meeting outcome for vandetanib NDA

AstraZeneca today announced the outcome of the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee meeting to discuss the New Drug Application (NDA) for AstraZeneca's investigational drug, vandetanib, for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer (MTC).

2 Dec 2010

Spherix announces results of D-tagatose Phase 3 trial for Type 2 diabetes

Spherix Incorporated, an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced results from its first Phase 3 trial post hoc analysis in which the higher body mass index (BMI) of the U.S. population relative to the Indian population was a likely key contributor to the more positive effects of D-tagatose in the lowering of HbA1c levels in the U.S. population. Initial results were announced on October 7.

2 Dec 2010

FDA approves IDE application to initiate Tryton Side Branch Stent System for coronary artery disease

Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced U.S. Food and Drug Administration (FDA) conditional approval for an Investigational Device Exemption (IDE) application to initiate the pivotal trial to evaluate the Tryton Side Branch Stent System for the treatment of coronary artery disease.

2 Dec 2010

FDA panel rejects expansion of drug label

The New York Times: A Food and Drug Administration advisory committee on Tuesday rejected a bid to change the labels of two drugs to say they can reduce the risk of prostate cancer. "If the drugs were approved for that purpose, they would be only the second class of cancer-prevention drugs on the market."

2 Dec 2010

FDA approves Abiomed to begin MINI-AMI trial to evaluate Impella 2.5

Abiomed, Inc., a leading provider of breakthrough heart support technologies, today announced it has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin MINI-AMI, a prospective, randomized, controlled multi-site trial to assess the potential role of the Impella 2.5 in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI).

2 Dec 2010

Covidien's iDrive powered stapling system granted FDA 510(k) clearance

Covidien, a leading global provider of healthcare products and recognized innovator in surgical stapling applications, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the iDrive™ powered stapling system. This reusable stapling platform is battery-powered, enabling one-handed push-button operation of all primary controls and a reduction in the required firing force when compared to traditional endomechanical surgical staplers.

2 Dec 2010

First Edition: December 2, 2010

Today's health policy headlines include news about how the debt panel's plan would boost costs for seniors on Medicare; how parts of the GOP are making clear their positions regarding health reform "repeal and replace" strategy; and how limited health plans faced critics at a Senate hearing.

2 Dec 2010

New book on interactions between HIV and rural livelihoods in sub-Saharan Africa

AIDS epidemics continue to threaten the livelihoods of millions of people in sub-Saharan Africa. Three decades after the disease was first recognized, the annual death toll from AIDS exceeds that from wars, famine and floods combined. Yet despite millions of dollars of aid and research, there has previously been little detailed on-the-ground analysis of the multifaceted impacts on rural people.

2 Dec 2010