Clinical

The approval follows 5 months after Bristol-Myers Squibb submitted phase 3 results of the Checkmate-066 trial for FDA review.

Two months after being granted a Breakthrough Therapy designation by the FDA for metastatic renal cell carcinoma (mRCC), nivolumab was today approved by regulators for treating mRCC patients who have failed a certain type of prior therapy.

A state-led program, initiated in 2003, has nearly doubled screening colonoscopy rates in New York City and also eliminated racial and ethnic disparities in the process.

What we're reading, November 23, 2015: Oregon and California both pass laws that authorize pharmacists to prescribe birth control; the US and Europe are approving more drugs; and Turing discounts Daraprim just 50% and only for hospitals.

A recent study published by JAMA Surgery intended to pinpoint risk factors for hospital readmission in patients who underwent an emergency general surgery procedure, in hopes of finding out what decreases readmissions in the long run.

A pharmacist who engages in formulary decisions, a medical director for population management for a private health exchange, and an innovations leader at a pharmacy benefit manager, took to the podium at the Patient-Centered Oncology Care meeting on November 20, 2015, to discuss cost-saving strategies in oncology and whether benefit managers can play a role in reining-in some of these costs.

While the FDA could regulate diagnostic tests the way they are in Europe-through simple verification that the test is accurate-the FDA has not chosen to do that and comes closer to requiring clinical utility, explained Bruce Quinn, MD, PhD, senior director at FaegreBD Consulting.

At the Patient-Centered Oncology Care 2015 meeting, held November 19-20, 2015, in Baltimore, Maryland, keynote speaker Julie M. Vose, MD, MBA, FASCO, president of the American Society of Clinical Oncology provided perspectives on the challenges faced by oncologists as the healthcare system transitions to define and incorporate value in the care delivered.

Eligibility for prescription coverage and family income significantly influenced women's decisions to continue hormonal therapy and prevent recurrence of breast cancer, the authors found.

A majority of life sciences companies are planning on acquisitions and are targeting companies with a personalized medicine focus.

This is the company's third biosimilar Biologics License Application in the United States.

A weight-loss cell phone app alone did not help overweight young adults sustain weight loss any better than a written handout did.

Although, data on predictive risk factors for chronic obstructive pulmonary disease has been limited until now, researchers from the United Kingdom recently developed a model for predicting exacerbation risk using data obtainable from primary care.

What we're reading, November 18, 2015: global drug spending is expected to grow 30% in 5 years; Robert M. Califf, MD, sits through mostly friendly senate confirmation hearing for FDA nomination; and moderate coffee consumption could reduce some risks of death.

The drug is estimated to cost close to $13,000 per month.

It is time to regulate laboratory-developed tests that cost Medicare $9.7 billion in the year 2012 alone.

What we're reading, November 17, 2015: misunderstanding of antibiotics has fueled the rise of drug-resistant superbugs; healthcare leaders overwhelmingly support government intervention to curb rising cost of drugs; and the FDA wants more regulation on laboratory-developed tests.

The drug was approved based on results of 2 open-label studies that showed reduction in tumor burden of patients who had previously received multiple lines of therapy.

When to screen and how to screen remain controversial issues in prostate cancer.

In a session at the Fall Managed Care Forum 2015, in Las Vegas, Nevada, cardiology expert Harold Bays MD, FTOS, FACC, FACE, FNLA, emphasized the importance of greater adherence to evidence-based practice guidelines, and the relevance of treatment with omega-3 fatty acids in hypertriglyceridemia.

Pulmonary arterial hypertension (PAH) is characterized by nonspecific symptoms, which can lead to a delay in diagnosis. Without treatment, patients with PAH have a poor prognosis, but development and availability of PAH-specific therapies have improved the overall prognosis of the disease.

According to the CDC, while smoking rates are seeing a steady decline, rates for uninsured and adults on Medicaid are more than twice those for adults with private health insurance.

A study in The European Journal of Public Health finds conversation on preventive vaccination against HPV can motivate participation in preventive screening for cervical cancer.

Evaluating adverse events of medications plays a vital role in post-marketing surveillance of clinical research, but how effective are these results when it comes to influencing public response? A recent study indicates a concerning public response.

A retrospective study conducted at the Mayo Clinic found improved OS and PFS in ovarian cancer patients with a history of oral contraceptive use.

A forced closing of Health Republic Insurance of New York has left many in need of immediate coverage.

What we're reading, November 11, 2015: annual flu shots may reduce the effectiveness of the vaccine; Democrats call for changes to the so-called Cadillac tax; and Millennium Health files for chapter 11 bankruptcy.

A new study finds that off-label drug use is associated with higher rates of adverse drug events in adults.

The approval comes after a priority review of the combination that blocks activity of 2 MAPK proteins: BRAF and MEK.

Published in JAMA Oncology, the trial found an association between loss of heterozygosity and cancer-free survival in patients who had been diagnosed with oral premalignant lesions.