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Dietary fat and heart disease

New research shows the type of fat is much more important than total fat in determining an individual's risk of heart disease - and that there are numerous factors beyond dietary fat that affect one's risk - leading to a shift in the age-old dietary fat and heart disease paradigm.

25 May 2010

FDA approves Watson Pharmaceuticals' generic version of VALTREX tablets

Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for Valacyclovir Hydrochloride tablets, USP, in the 500 and 1000 mg strengths, the generic equivalent to GlaxoSmithKline, LLC's VALTREX tablets.

25 May 2010

New strategies defined to reduce salt levels in ready meals

Today's busy lifestyles leave little time to prepare meals from fresh ingredients, resulting in the popularity of ready prepared meals. However, these meals contain relatively high levels of salt and health agencies throughout the world are recommending a reduction in non-discretionary sodium from salt- and sodium-containing additives used in the manufacture of these meals.

25 May 2010

NIH, FDA launch new portal to provide easier access to online reporting

The Food and Drug Administration and the National Institutes of Health today launched a new Web site that, when fully developed, will provide a mechanism for the reporting of pre- and post-market safety data to the federal government.

25 May 2010

Economic access becomes primary research focus in public health nutrition

Ensuring access to healthy, affordable foods is a top priority in tackling the obesity epidemic in the United States. Over the course of the last six months, the Institute of Medicine, United States Department of Agriculture, The White House and First Lady Michelle Obama have taken an interest in improving access to affordable and nutritious foods.

25 May 2010

One-third of Minnesotans understate their weight problems

When it comes to self-perceptions about their own healthy weight, many Minnesotans appear to be adapting Garrison Keillor's famous quip: "I believe in looking reality straight in the eye and denying it."

25 May 2010

Delphinus Medical Technologies secures $8M in venture capital to commercialize SoftVue system

The Barbara Ann Karmanos Cancer Institute announced today that its spin-off company Delphinus Medical Technologies, LLC, has secured $8 million in venture capital to start the commercialization process of SoftVue, an alternative to mammography.

25 May 2010

FDA issues 510(k) clearance to Simplexa Influenza A H1N1 (2009) test on 3M Integrated Cycler

Quest Diagnostics Incorporated, the world's leading provider of diagnostic testing, information and services, today announced that the U.S. Food and Drug Administration has issued 510(k) clearance to the Simplexa Influenza A H1N1 (2009) test on the 3M Integrated Cycler. The Simplexa test, developed and manufactured by Quest Diagnostics' Focus Diagnostics business, is the first to be cleared by the FDA for use as an aid in the detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA.

25 May 2010

DU receives $17.5M as gift to establish Knoebel Center for the Study of Aging

Betty Knoebel, widow of Denver food services pioneer Ferdinand "Fritz" Knoebel, has given the University of Denver $17.5 million, among the largest gifts in its history. DU will use the gift to establish the Knoebel Center for the Study of Aging and to support the School of Hotel, Restaurant and Tourism Management in DU's Daniels College of Business.

25 May 2010

Abbott's new FreeStyle Lite blood glucose test strips receive FDA clearance

Abbott today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its new FreeStyle Lite blood glucose test strips. The new FreeStyle Lite test strips minimize interference during blood glucose testing and are designed to offer a better testing experience.

24 May 2010

Somanetics' Vital Sync bedside monitor system receives FDA clearance

Somanetics Corporation announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to expand features on its Vital Sync bedside monitor and research data aggregation system. The clearance allows for interface with a broader range of bedside devices, display of derived parameters of calculated clinical indices, and an automated events trigger to alert clinicians when patient parameters fall outside desired thresholds.

24 May 2010

Repligen's RG2833 granted orphan drug designation for treatment of Friedreich's ataxia

Repligen Corporation announced today that the Office of Orphan Products Development of the Food and Drug Administration has granted orphan drug designation to RG2833, a selective histone deacetylase 3 inhibitor for the treatment of Friedreich's ataxia. Orphan drug designation qualifies Repligen to receive seven years of marketing exclusivity in the United States if the company is the first to obtain marketing approval for RG2833 for the treatment of Friedreich's ataxia.

24 May 2010

FDA clears Simplexa Influenza A H1N1 (2009) test

The U.S. Food and Drug Administration today announced it has cleared the Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 Influenza Virus in patients with signs and symptoms of respiratory infection.

24 May 2010

Pro-Pharmaceuticals plans to submit Phase III trial design for DAVANAT to FDA

Pro-Pharmaceuticals, Inc., the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced plans to submit a Phase III trial design for DAVANAT to the U.S. Food and Drug Administration during the second half of 2010. The Company has added the talent of Peter G. Traber, M.D., to its FDA approval strategy and trial design team.

24 May 2010

NormOxys raises $17.5M in Series B financing round

NormOxys, Inc., a biotechnology company developing a novel class of small molecule drugs which enhance the body's ability to deliver oxygen to diseased tissues, today announced that it has raised $17.5 million in a Series B financing round. The financing was led by a new investor, Care Capital, LLC, with participation from existing venture investor Index Ventures.

24 May 2010

Dole Nutrition Handbook recognized with prestigious Living Now Book Award

Dole Food Company, Inc. is pleased to have received the prestigious Living Now Book Award for the Dole Nutrition Handbook: What You Need to Eat And How To Live For A Longer Healthier Life. The gold medal award is the top honor in the competition's Nutrition & Diet category. On Earth Day each year, the Jenkins Group - an organization dedicated to promoting books that enrich readers' lives in Earth friendly ways - presents the Living Now Book Awards to honor "books for better living."

24 May 2010

ZyGEM announces acquisition of MicroLab Diagnostics

ZyGEM Corp. Ltd., today announced that it has acquired MicroLab Diagnostics Inc., a private company developing microfluidic devices for rapid DNA testing. ZyGEM intends to market products integrating its unique DNA extraction and reagents and detection assays with the breakthrough microfluidic chip technology developed by MicroLab, which will operate as a business unit of the new company.

24 May 2010

Salix Pharmaceuticals announces availability of Xifaxan tablets for reducing risk of overt HE recurrence

Salix Pharmaceuticals, Ltd. today announced the availability of Xifaxan (rifaximin) 550 mg tablets for the reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. Those HE patients may now fill their Xifaxan 550 mg prescriptions in U.S. pharmacies and should speak with their doctors about this important treatment option.

24 May 2010

Ortho-McNeil Pharmaceutical pleads guilty for promoting epilepsy drug Topamax for psychiatric use

Ortho-McNeil Pharmaceutical LLC, a subsidiary of Johnson & Johnson, pled guilty today in U.S. District Court in Boston to one count of misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting its epilepsy drug Topamax for uses that were not approved by the FDA. The company was also sentenced at today's hearing.

24 May 2010

Filing of Clinical Data's NDA for vilazodone accepted for FDA review

Clinical Data, Inc., today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for vilazodone for the treatment of major depressive disorder.

24 May 2010