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Apricus files protocol of PrevOnco Phase 3 clinical trial for FDA SPA program

Apricus Biosciences, Inc., today announced that it has filed the protocol for a proposed Phase 3 clinical trial of PrevOnco, its proprietary treatment for hepatocellular carcinoma (liver cancer), with the U.S. Food and Drug Administration (FDA).

23 Nov 2010

Dangers of excess fructose

More and more people have become aware of the dangers of excessive fructose in diet. A new review on fructose in an upcoming issue of the Journal of the American Society of Nephrology (JASN) indicates just how dangerous this simple sugar may be.

23 Nov 2010

Stem cell trial for eye disease receives FDA approval

The second clinical trial involving stem cells from human embryonic cells has received the go-ahead. The news came from Advanced Cell Technology Inc. this Monday. The company announced that the U.S. Food and Drug Administration has cleared the way for its Phase I/II trial of retinal cells for patients with Stargardt’s macular dystrophy, a childhood version of macular degeneration.

22 Nov 2010

Omthera reaches agreement with FDA on SPA for Epanova Phase III trial in patients with very high triglycerides

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of its planned Phase III registration clinical trial of Epanova™, the Company's lead compound for the treatment of patients with very high triglycerides. Epanova is an Omega 3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

22 Nov 2010

Impax initiates challenge of patents relating to WELCHOL

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL® (Colesevelam HCl) for Oral Suspension, 3.75 gm/packet and 1.875 gm/packet.

22 Nov 2010

FDA grants Impax tentative approval for generic Cymbalta NDA

Impax Laboratories, Inc. confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company's Abbreviated New Drug Application for generic version of Cymbalta® delayed-release (duloxetine hydrochloride) 20, 30 and 60 mg capsules.

22 Nov 2010

FDA grants ACT clearance for Phase I/II clinical trial of hESC derived retinal cells in patients with SMD

Advanced Cell Technology, Inc. announced today that the US Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to immediately initiate a Phase I/II multicenter clinical trial using retinal cells derived from human embryonic stem cells (hESCs) to treat patients with Stargardt's Macular Dystrophy (SMD), one of the most common forms of juvenile macular degeneration in the world. The decision removes the clinical hold that the FDA had placed on the trial.

22 Nov 2010

Grifols launches Flebogamma 10% DIF intravenous immune globulin in the U.S.

Grifols today announced availability of its recently approved Flebogamma® 10% DIF intravenous immune globulin. Grifols is a global healthcare company specializing in bioscience medicines derived from human plasma. Approval from the US Food and Drug Administration (FDA) for Flebogamma® 10% DIF was obtained in July 2010 and final approval in Europe is expected before the end of the year. Today's announcement signals widespread product availability to the US market.

22 Nov 2010

DaVita announces meal planning tool for dialysis patients

DaVita Inc., a leading provider of kidney care services for those diagnosed with end stage renal disease (ESRD) and chronic kidney disease (CKD), offers patients with very restricted diets an easy to use meal planning tool and recipes for their favorite Thanksgiving dinners at DaVita.com.

22 Nov 2010

Variation at gene locus associated with greater reproductive success

Since 1871, when Charles Darwin wrote The Descent of Man, it has been widely accepted that "Variability is the necessary basis for the action of selection." Variability is associated with the ability to adapt, which is clearly beneficial at a species level. But there is increasing evidence that genetic variability may also give rise to advantages at the level of the individual.

22 Nov 2010

OraSure granted FDA approval for final phase studies of OraQuick Rapid HIV-1/2 Antibody Test

OraSure Technologies, Inc., the market leader in oral fluid diagnostics, today announced that the U.S. Food and Drug Administration ("FDA") has granted an investigational device exemption (IDE) for the Company to conduct the final phase of clinical testing for FDA approval of its OraQuick® Rapid HIV-1/2 Antibody Test for sale in the consumer or over-the-counter ("OTC") market.

22 Nov 2010

ImmunGene awarded $244,479 therapeutic discovery project grant under PPACA 2010

ImmunGene, Inc., a privately held drug development company focused on targeted antibody therapeutics with numerous anti-cancer functions built into a single therapy, announced today that it has received a $244,479 grant under The Patient Protection and Affordable Care Act of 2010 (PPACA). The grant was related to the development of ImmunGene's technology which is based on antibody-cytokine fusions that have demonstrated targeted toxicity and added tumor benefits.

22 Nov 2010

VYTORIN reduces major vascular events in patients with chronic kidney disease

In a new investigational study of VYTORIN, the cholesterol-lowering medicine from Merck, VYTORIN 10/20 mg reduced the incidence of first major vascular events defined as non-fatal heart attacks or cardiac death, stroke or any revascularization procedure by a highly statistically significant 16.1 percent compared to placebo, Study of Heart and Renal Protection study involved more than 9,000 patients who, on average, had advanced or end-stage chronic kidney disease (CKD)

22 Nov 2010

Detroit residents could benefit from transforming vacant urban lots into farms, community gardens

Transforming vacant urban lots into farms and community gardens could provide Detroit residents with a majority of their fruits and vegetables.

20 Nov 2010

Lower VAT on alcohol served in pubs may deliver health benefits

Alcoholic drinks served in pubs should be taxed at a lower level than drinks bought from shops, says an expert in this week's BMJ.

20 Nov 2010

Dollar General joins St. Jude Children's Hospital for Thanks and Giving campaign

This holiday season, Dollar General again joins St. Jude Children's Research Hospital for the Thanks and Giving campaign by asking customers to "give thanks for the healthy kids in your life, and give to those who are not."

20 Nov 2010

Consumers want healthier menu items, but do not order them

The question of the moment for restaurant operators: Are the winds of healthy change truly blowing, or is it only so much hot air? Technomic's newest study finds that half of Canadian consumers want healthier menu items, but only about a quarter of them actively consider nutrition when dining out.

20 Nov 2010

Pritzker Olsen files lawsuit against Kanan Enterprises for wrongful death suit

Pritzker Olsen law firm has filed a lawsuit through its local counsel on behalf of the family of Nellie Napier, who died after eating peanut butter contaminated with Salmonella. The wrongful death suit was filed in the Court of Common Pleas, Cuyahoga County, Ohio against Kanan Enterprises, Inc., doing business as King Nut Companies, an Ohio Corporation.

20 Nov 2010

Humana delivers one millionth meal in Well Dine food program

Humana has served nutritious meals to more than 81,000 Humana Medicare Advantage members in 120 cities after a hospital or nursing facility stay since the company's meal-delivery program began in 2006. Yesterday, Well Dine delivered the Humana program's one millionth meal to Humana Medicare Advantage member Sylvia van Dyke, 61, of Knoxville.

20 Nov 2010

Xanodyne to withdraw propoxyphene-containing products from the U.S. market

Xanodyne Pharmaceuticals, Inc. announced today that the company will voluntarily withdraw its Darvon, Darvon-N and Darvocet-N products from the U.S. market in consultation with the U.S. Food and Drug Administration (FDA).

20 Nov 2010