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Fujirebio Diagnostics receives FDA 510(k) clearance for Risk of Ovarian Malignancy Algorithm test

Fujirebio Diagnostics, the industry leader in oncology biomarker assays, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the company's HE4 Test in an algorithm called ROMA (HE4 EIA + ARCHITECT CA 125 II) to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery.

7 Sep 2011

Duodenal switch may lead to more weight loss but more complications: Study

A less usual and common type of obesity surgery may spur more weight loss than its far more popular cousin, gastric bypass - but at the price of greater long-term risks, researchers reported.

6 Sep 2011

FDA reviews safety issues of bisphosphonates for osteoporosis

An advisory committee for U.S. Food and Drug Administration meets Friday to review the safety of a popular class of osteoporosis drugs called bisphosphonates amid worry that their long-term use could cause rare fractures of the thighbones and affect the jawbone. The committee will evaluate whether women should temporarily stop using the drugs or use them for only a few years.

6 Sep 2011

New head louse treatment shows promise

The common head louse has been seen to be resistant to time-tested treatments. However a new Food and Drug Administration-approved hair rinse, Natroba, could put an end to that.

6 Sep 2011

FDA stalls the blood-thinner Xarelto’s approval citing inadequate evidence

The Food and Drug Administration (FDA) said in a staff report released today that “there is insufficient information about the drug to determine whether it is safe for use with its proposed labeling.” Their report questions its safety and effectiveness, saying a new study is needed.

6 Sep 2011

Tick-borne disease in US blood supply

A tick-borne infection known as Babesiosis, which can cause severe disease and even death, is becoming a growing threat to the U.S. blood supply, government researchers said on Monday.

6 Sep 2011

Discovery Labs files Complete Response to FDA for SURFAXIN to treat RDS in premature infants

Discovery Labs, Inc. today announced that, on September 2, 2011, it submitted its Complete Response to the 2009 Complete Response Letter issued by the U.S. Food and Drug Administration (FDA) for SURFAXIN(lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants.

6 Sep 2011

First Edition: September 6, 2011

Today's early morning highlights from the major news organizations include reports from a GOP presidential candidate forum in South Carolina and analysis of what to expect as Congress returns to Washington.

6 Sep 2011

ICS, Quintiles enter agreement with Pacira to support launch of EXPAREL

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced that it has entered into agreements with Quintiles Commercial US, Inc. and Integrated Commercialization Services, Inc. (ICS) to support the anticipated launch of EXPAREL, should it be approved by the Food and Drug Administration (FDA) later this year.

6 Sep 2011

Ontario Liberal Party includes OMA recommended health care policy initiatives in election platform

Ontario's doctors were pleased to learn that the Ontario Liberal Party has included several health care policy initiatives in their election platform as recommended by the Ontario Medical Association.

6 Sep 2011

'Shan Song' finds new way of processing non-genetically modified soybeans

How much did you know about soybeans? How did you find the difference between GM soybeans and non-GM soybeans? How can people find the 'New Market' for traditional non-GM soybeans? You may get the answer if you knew 'Shan Song'.

5 Sep 2011

McDonald’s menus to include calorie counts in Britain

In an advancement against rising rates of obesity nearly 1,200 McDonald's restaurants in the U.K. will this week begin displaying the calorie count of each food and drink item on their wall-mounted menu boards.

5 Sep 2011

Gilead to amend design of ongoing clinical trials against chronic hepatitis C

Gilead Sciences, Inc. today announced that, in consultation with the U.S. Food and Drug Administration (FDA), the company will amend the design of ongoing clinical trials to discontinue dosing of GS 9190 in hepatitis C-infected patients who are receiving that compound in combination with pegylated interferon and ribavirin, and another direct-acting antiviral agent.

5 Sep 2011

Scientists sequence ten variants of E. coli O104:H4 outbreak strain across the world

Ten variants of the deadly Escherichia coli strain that hit Germany in May 2011 have been sequenced across the world. The unprecedented level of collaboration across the scientific community should give insight into how the outbreak arose, says a scientist at the Society for General Microbiology's Autumn Conference 2011.

5 Sep 2011

Study reveals why bad eating habits persist even when the food does not taste good

Do you always get popcorn at the movies? Or snack while you're on the couch watching television? A new paper by USC researchers reveals why bad eating habits persist even when the food we're eating doesn't taste good. The study also reveals the surprisingly simple ways we can counter our habits to gain control over what we eat.

3 Sep 2011

Refugee self-settlement may provide 'lasting' solutions to humanitarian crises

In this New York Times' "Opinionator" blog post, journalist and author Tina Rosenberg examines the contrasts between refugee situations in rural camps -- such as Dadaab in Kenya, where tens of thousands have sought relief from drought and famine in Somalia -- and more urban areas, such as cities in Syria, Lebanon and Jordan, where approximately 1.6 million Iraqi refugees are living.

3 Sep 2011

Plerixafor drug shows promise against WHIM syndrome

A new study reports that a drug already approved by the Food and Drug Administration for use in patients undergoing a bone marrow transplant may also have promise for treating people who have a rare immune deficiency known as WHIM syndrome.

3 Sep 2011

Going bananas may help kids breathe easier

Going bananas may help kids breathe easier. Children who ate just one banana a day had a 34% less chance of developing asthmatic symptoms, according to new British research.

3 Sep 2011

Roche Diagnostics terminates sales and distribution agreement with Response

Response Biomedical Corporation today announced that Roche Diagnostics has terminated, effective September 30, 2011, the sales and distribution agreement between Roche and Response dated June 25, 2008. Under the terms of that agreement and related agreements, Roche Diagnostics had agreed to distribute Response's cardiovascular point-of-care (POC) tests on the RAMP® 200 Reader in the US.

From Roche Sequencing and Life Science 2 Sep 2011