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Click here to view CAP Molecular Testing Guidelines for Selection of Lung Cancer Patients!

Biodesix announces results in Phase III Lung Cancer Diagnostic Study; First Prospective Biomarker-Stratified Validation Study in Oncology. Click here to view the press release!

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Overcoming Challenges in the Management of Obesity: A Closer Look at Emerging Therapeutic Options.

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Announcing the NAMCP Medical Directors Lung Cancer Resource Center. Click here to visit the website.

Be sure to check out the study results of Verinata's Non-Invasive Prenatal Technology. Click here to view the press release.

On Aug 19, 2013, the FDA issued a label change for ADCETRIS® (brentuximab vedotin). Below is a copy of the updated USPI for your review. Key label changes found within the attachments include:

1. Dosage and Administration Section 1: 16 cycle limitation has been removed from the label. New label states "Continue treatment until disease progression or unacceptable toxicity"

2. Warnings and Precautions Section 5: Growth factor support added for consistency with Dose Modification in section 2.2


CLICK HERE to view the USPI.

The Academy of Oncology Nurse Navigators white paper, "Assessing the Creative Application and Usefulness of NSider: A Tactical Tool for the Oncology Nurse Navigator" was published in the journal, The Oncology Nurse-APN/NP.

Click here to view the white paper.


 




MANAGED HEALTHCARE NEWS
Click Here to visit the Population Health Management Institute

How the government shutdown affects healthcare
By Pamela Lewis Dolan
The Affordable Care Act, known as Obamacare, is at the center of the budget debate that has resulted in a government shutdown. But one of the ironies of the situation is that the program will remain funded. It even reached a major milestone — the launch of the insurance exchanges — on Oct. 1, the same day other areas of government were forced to place employees on furlough. The ACA, as well as Medicare and Medicaid, are not affected by the shutdown. But other areas of healthcare, particularly those in the public health arena, don’t fall under the same exceptions and were forced into limbo.
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Exchanges will raise US healthcare costs
Bloomberg
Ignore the inevitable startup glitches. The new health insurance exchanges will work just fine — in the sense that all government health care programs work: Many people will ultimately become dependent on them for coverage. That won't mean the exchanges have fulfilled their promise, however.
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The unsettled healthcare law
Los Angeles Times
Ever since Obamacare's stormy passage in early 2010, Democrats have been waiting anxiously for the program to go into effect and hoping that a dose of reality would calm the partisan battles over the health insurance plan. Once everything was up and running, they hoped, skeptical Americans would see that Obamacare was a good idea all along — and reward the party that brought it to them.
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FDA: NEW TREATMENTS & TECHNOLOGY


FDA issues final mobile medical app guidance
By Pamela Lewis Dolan
The U.S. Food and Drug Administration recently issued its final guidance on mobile health apps, ending a two-year wait for developers. The FDA, which issued a draft guidance in July 2011, said it intends to exercise its enforcement discretion and not regulate apps except for those that present a risk to patients if they do not work as intended. While some industry groups were happy the FDA made good on its promise to release the document before the end of fiscal year 2013, others say the FDA should have waited a little longer.
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PRODUCT SHOWCASE
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Government shutdown halts FDA product submissions and other functions
PharmExecBlog
Planning to submit to the FDA today? Think again. The agency put a forced pause on key services and functions — and furloughed 6,620 FDA employees — as a result of last night's government shutdown. Stephen King, a member of CDER's communications team at FDA, said in an email that "no new regulatory submissions that have fees attached" — including NDAs — "will be accepted for 2014 until the date of enactment of a 2014 appropriation or a Continuing Resolution."
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Shutdown looming, FDA approves new depression drug from Lundbeck, Takeda
FierceBiotech
Regulators at the FDA stamped an approval on Brintellix, a new therapy to treat major depression from Lundbeck and Takeda, just hours before the government prepared to hunker down in a partial shutdown. Investigators sent their application in with a battery of late-stage results for Brintellix.
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PREVENTION & WELLNESS
Click Here to visit the Center for Preventive Health and Lifestyle Medicine


Is exercise the best medicine? Studies show big benefit
USA Today
Exercise may be as effective as medication in preventing early death in people who've had heart attacks or strokes, a new study suggests. "Doctors should give their patients advice about the lifesaving benefits of exercise, and when possible they should refer patients to rehabilitation programs with exercise programs," says the study's lead author, Huseyin Naci, a fellow at Harvard Medical School and a graduate student at the London School of Economics.
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If star athletes sell junk food — is your kid more likely to eat it?
NBC News
NFL star Peyton Manning is nearly as famous for his product pitches as his football passes, building an endorsement empire that has included Papa John's pizza and Oreo cookies. But are your kids grabbing — and consuming — what the quarterback is slinging? The Denver Broncos signal caller is one of the sports world's top hawkers of unhealthy foods and drinks, according to a paper published in the journal Pediatrics.
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Bugs still get through despite gloves, gowns
MedPage Today
Having intensive care workers wear gloves and gowns during all patient contacts did not reduce the risk of transmission of two major multidrug-resistant pathogens, a researcher said. In a large cluster-randomized trial, intensive care units where workers always wore gloves and gowns did not lower the rate at which patients reached a composite endpoint of acquiring vancomycin-resistant enterococcus or methicillin-resistant Staphylococcus aureus.
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GENOMICS & BIOTECH
Click Here to visit the Genomics, Biotech & Emerging Medical Technology Institute


Study: Missing genes may be tied to development of autism
HealthDay News via U.S News & World Report
People with autism are more likely to have gene deletions than those without the disorder, according to a new study. The finding suggests that these deletions may increase the risk of developing autism, a neurodevelopmental disorder marked by difficulties in social interactions and communications.
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Massive DNA study points to new heart drug targets and a key role for triglycerides
redOrbit
Open collaboration among global genetic researchers, coordinated by U-M team, provides strong foundation for further research. A global hunt for genes that influence heart disease risk has uncovered 157 changes in human DNA that alter the levels of cholesterol and other blood fats — a discovery that could lead to new medications.
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Ethical issues as scientists peek into baby genes
The Associated Press via Today
Little Amelia Sloan is a pioneer: Shortly after her birth, scientists took drops of the healthy baby's blood to map her genetic code. Amelia is part of a large research project outside the nation's capital that is decoding the DNA of hundreds of infants. New parents in a few other cities soon can start signing up for smaller studies to explore if what's called genome sequencing — fully mapping someone's genes to look for health risks — should become a part of newborn care. It's full of ethical challenges.
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FEATURED ARTICLE
TRENDING ARTICLE
MOST POPULAR ARTICLE
How the government shutdown affects healthcare
By Pamela Lewis Dolan
The Affordable Care Act, known as Obamacare, is at the center of the budget debate that has resulted in a government shutdown. But one of the ironies of the situation is that the program will remain funded.

Share on FacebookTwitterShare on LinkedinE-mail article
read more
Dawn of a revolution in healthcare
The New York Times
The United States is embarking on a truly historic journey toward near-universal healthcare coverage. Starting Oct. 1, the federal government will make it possible for millions of uninsured Americans who can't get health insurance, or can't afford it, to obtain coverage with the aid of government subsidies.

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What happens to the FDA in a government shutdown?
FierceBiotech
With hope for congressional compromise waning by the hour, the federal government is bracing for its first shutdown in 17 years, and for the FDA, that means furloughing about half its staff and ditching duties it can no longer afford.

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ONCOLOGY
Click Here to visit the Oncology Institute


The cancer genome atlas changes the oncology landscape
Medscape
The first research from a massive collaboration — The Cancer Genome Atlas Pan-Cancer Initiative — has been reported in two analyses and two commentaries published in the October issue of Nature Genetics. The primary findings are that tumors comprise two major genomic categories, regardless of tissue of origin; that tumors across several tissue types share the same oncogenic signature, suggesting that they might be responsive to the same therapies.
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Breast cancer breakdown: Know the signs
ABC News
More American women are surviving breast cancer, thanks in part to screening tests that can help detect it early. But knowing your own breasts can help you spot changes and report them to your doctor between exams.
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Looking for similar articles? Search here, keyword "cancer."




BEHAVIORAL HEALTH
Click Here to visit the Behavioral Health Institute


Study IDs predictors for beating eating disorders
San Francisco Chronicle
Inherent to the challenge of treating an eating disorder is figuring out at what point a treatment has actually worked. In making such a determination, clinical judgment is about the only tool a doctor or counselor has. Relapse rates are startlingly high. New research from Stanford University has begun to pin down more concrete barometers of long-term recovery, physical and mental signs that could indicate whether a patient is ready to end treatment or perhaps might require more.
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Is the teenage brain wired for addiction?
University of Liverpool via The Conversation
As a nation, British people are drinking much more than they used to, which is partly attributable to alcohol being cheaper and more available than ever. Many British teenagers get into the habit early, although recent trends suggest this situation is improving — alcohol consumption among teenagers is slightly lower than it was 10 years ago. Nonetheless, drinking alcohol during adolescence is not a good idea, because the younger one is when one has their first alcoholic drink, the more likely one is to develop problems later on in life. The same is true for cigarette smoking and the use of illicit drugs such as cannabis and cocaine.
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FAST FACTS
"Genital warts have been closely linked with cervical cancer and can cause problems during pregnancy, according to the Mayo Clinic."


TRENDING ARTICLES
Missed last week's issue? See which articles your colleagues read most.

    Why eating artificial sweeteners won't help you lose weight (Nature World News)
'Really confused': Kaiser/NBC poll finds Americans angsting over healthcare law (NBC News)
Who knew that blood, sweat and tears could start a healthcare revolution? (Forbes)
FDA approves 1st presurgical breast cancer drug (The Associated Press via ABC News)

Don't be left behind. Click here to see what else you missed.
 
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