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Critical Diagnostics receives FDA clearance for Presage ST2 Assay

Critical Diagnostics, a U.S.-based biomarker company focused on cardiovascular diseases, announced today that the U.S. Food and Drug Administration has cleared the company's Presage ST2 Assay for use as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.

16 Dec 2011

Hologic receives FDA approval for Cervista HTA system to detect cervical cancer

Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today that the U.S. Food and Drug Administration (FDA) has approved its Cervista HTA (high throughput automation) system for use with the Company's previously approved Cervista human papillomavirus (HPV) HR test.

From Hologic, Inc. 16 Dec 2011

SU2C, MRA announce new Dream Team dedicated to melanoma research

Stand Up To Cancer (SU2C), the Melanoma Research Alliance (MRA) and SU2C's scientific partner, the American Association for Cancer Research (AACR), today announced a new Dream Team dedicated to melanoma research. Jeffrey M. Trent, Ph.D., and Patricia M. LoRusso, D.O., will lead the Dream Team project entitled "Personalized Medicine for Patients with BRAF Wild-Type (BRAFwt) Cancer."

15 Dec 2011

Senate Democrats seek justification for Plan B decision

Thirteen Democrats and one independent expressed disappointment in Health and Human Services Secretary Kathleen Sebelius' decision to block younger teenagers from buying the "Plan B" emergency contraceptive without a prescription. Meanwhile, a federal judge says he will review the decision.

15 Dec 2011

Tips from Calorie Control Council

It's that time of year when extra calories lurk around every corner - baked goods at the office, cocktails and snacks at holiday parties, chocolates in stockings and holiday meals that can average more than 4,500 calories and 220 grams of fat, according to the Calorie Control Council. All these extras can add up to weight gain during the holiday season.

15 Dec 2011

Poor handling of oranges in squeezing machines stimulates bacterial contamination

Scientists from the University of Valencia in Spain have analysed fresh orange juice squeezed by machines in catering establishments. They have confirmed that 43% of samples exceeded the acceptable enterobacteriaceae levels laid down by legislation. The researchers recommend that oranges are handled correctly, that juicers are washed properly and that the orange juice is served immediately rather than being stored in metal jugs.

15 Dec 2011

Viewpoints: Berwick's advice; Romney's wager; Fighting AIDS

Dr. Donald Berwick, who was blocked by Republicans from serving a full term as the administrator of the agency that runs Medicare and Medicaid, has been speaking out. He makes a compelling case about the harm caused by partisan demagoguery and about the need for health care professionals to take the lead in implementing reforms.

15 Dec 2011

AtheroNova establishes clear development plan for AHRO-001 after positive FDA feedback

AtheroNova Inc., a biotech company focused on the research and development of compounds to regress atherosclerotic plaque has established a clear development plan, including Phase I and Phase II protocol outlines, based on the recently finalized minutes of its pre-IND meeting with the U.S. Food and Drug Administration (FDA) for its AHRO-001, a compound for the treatment of atherosclerosis.

15 Dec 2011

FDA approves modernized labeling for ViroPharma's Vancocin Capsules

ViroPharma Incorporated today announced the modernization of labeling for Vancocin (vancomycin hydrochloride, USP) Capsules made effective through the U.S. Food and Drug Administration's (FDA) approval of a supplemental new drug application.

15 Dec 2011

Researchers develop mouse model to investigate fenugreek allergy

A mouse model to investigate allergy to fenugreek has been developed by Norwegian researchers. The model can also be used to study cross-reactivity to peanut, soy and lupin, major food allergens with public health relevance.

15 Dec 2011

FDA warnings to gastric banding centers

The Food and Drugs Administration (FDA) has come out with warning letters to eight California healthcare organizations and one marketing firm for failing to provide adequate risk information in their advertisements for an implanted gastric band.

14 Dec 2011

Salix submits Crofelemer NDA to FDA for treatment of HIV-associated diarrhea

Salix Pharmaceuticals, Ltd. today announced that the Company has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for Crofelemer for the proposed treatment of HIV-associated diarrhea.

14 Dec 2011

Hydrogel regenerates healthy, scar-free tissue on skin damaged by severe burns

Johns Hopkins researchers have developed a jelly-like material and wound treatment method that, in early experiments on skin damaged by severe burns, appeared to regenerate healthy, scar-free tissue.

14 Dec 2011

Viewpoints: The high cost of treating patients who may die; Young girls and Plan B

You've probably heard that we spend a lot of money on patients who die. It's true. ... But what about my patient? How could it be that we were prudent with health care dollars because he lived, but would have been described as wasteful had he died? Doctors in an emergency room cannot know which will occur. They do not have divining rods that direct them to patients they can save and away from those they can't. Rather, caring for the sick means caring for people who may die.

14 Dec 2011

FDA allows marketing of Infrascanner Model 1000 for intracranial hematomas diagnosis

The U.S. Food and Drug Administration today allowed marketing of the first hand-held device intended to aid in the detection of life-threatening bleeding in the skull called intracranial hematomas, using near-infrared spectroscopy.

14 Dec 2011

Early warning systems helping aid agencies respond to potential 'food crisis' in Sahel region

Africa's Sahel region is facing a potential "food crisis," "but the good news is that the world's Famine Early Warning System Network (FEWS NET) is giving West African countries and donor nations a period of time to prepare, says the aid group Oxfam," the Christian Science Monitor reports.

14 Dec 2011

Iowa: GOP presidential debate turns up campaign heat

With the Iowa caucuses fast approaching, new political ads are hitting the airwaves, and Saturday night's debate draws lots of fact-checking by news organzations.

13 Dec 2011

Incyte announces further analyses from Jakafi Phase III trial on myelofibrosis

Incyte Corporation today announced that further analyses from the global, pivotal Phase III clinical program of Jakafi (ruxolitinib or INC424) are being presented at the 2011 American Society of Hematology (ASH) Annual Meeting.

13 Dec 2011

Millions of people in African Sahel need food assistance, U.N. agencies say

"Millions of people in Africa's Sahel region need urgent help to cope with food shortages brought on by erratic rainfall and drought, and at least one million children in the area face malnutrition next year, U.N. agencies warned," AlertNet reports.

13 Dec 2011

Scientists discover how intestinal tract influences B cells to prevent infection

Researchers at the University of Toronto have found an explanation for how the intestinal tract influences a key component of the immune system to prevent infection, offering a potential clue to the cause of autoimmune disorders like rheumatoid arthritis and multiple sclerosis.

13 Dec 2011