Clinical

An immunotherapy developed by Amgen and approved by the FDA for the treatment of acute lymhoblastic leukemia in December 2014 has now received coverage assurance from Medicare, following an initial rejection.

With unprecedented activity in the area of precision medicine, with the successful development of several targeted therapies, the FDA has been in the forefront of efforts to ensure timely access to, and the safe and effective use of, these therapies.

Researchers in Boston have started collecting blood samples from newborn infants with the intent to sequence their entire genome

The network, PEDSnet, combines big data from electronic health records with family engagement

As personalized medicine rapidly becomes an effective tool for combating cancer, payers are exploring new, value-based payment paradigms. These trends will soon intersect, and depending on how they are structured, the new payment models could accelerate or stifle personalized medicine's progress.

An emergency department screening and testing program based on birth cohort screening and injectable drug use found a high prevalence of the hepatitis C virus antibody among the cohorts tested, and identified several barriers to clinical implementation of the process.

Results from the CHAARTED trial have found that 6 cycles of chemotherapy combined with ADT early in the treatment of metastatic prostate cancer significantly improved overall survival than with ADT alone.

A retrospective study in The Lancet Oncology has identified a strong correlation between reduced risk of endometrial cancer and oral contraceptive agents.

As clinical targets in more common malignancies emerge, testing and treatment options will increase. Balancing these choices with the high costs of new technology will be the challenge to ensure value in oncology care.

While scientists agree that NGS is the way of the future, payers are as yet apprehensive on the value afforded by the tests to clinical decisions.

Research conducted at the Duke University School of Medicine indicates triple therapy may increase risk of bleeding in geriatric patients with myocardial infarction who have a stent.

In oncology, the shift from a "companion diagnostic" to a "companion therapeutic" paradigm is in high gear. While the noise and confusion is leading many payers to avoid coverage, they can benefit by proactively taking steps to integrate precision oncology to better manage quality, access, and cost of cancer care.

A research team at the Barts Cancer Institute in London has identified a 3-protein molecular signature in pancreatic cancer patients.

The discovery could lead to targeted therapy in triple negative breast cancer patients.

A study published in the American Journal of Preventive Medicine shows that grip strength of young, healthy adults could prove useful in the diagnosis of diabetes and hypertension.

The study found that the geriatric population in the United States receives prescriptions for mental health drugs at more than twice the rate that younger adults do, but they present a lower rate of seeking psychiatric care.

Congressman Frank Pallone, Jr (D-NJ), explains the purpose of the National Institutes of Health Innovation Fund, which allows the organization to find cures for diseases that don't have 1 yet.

A study published in JAMA Oncology presents a new tool that can predict disease recurrence in oropharyngeal cancer patients.

Urologists at Cancer Research UK have identified 5 distinct genomic signatures in prostate cancer that can have important implications on treatment decisions.

A report released by the California Association of Health Plans projects a huge cost expenditure even if a small proportion of the state's hep C patients are treated with the potentially curative medications.

New research studies show that anti-inflammatory agents can improve survival as well as quality of life in cancer patients.

Physicians at the Brigham and Women's Hospital have published results from a proof-of-concept study that used mass spectrometry in almost real-time to detect and delineate pituitary tumors from normal tissue.

The California Department of Public Health has announced participation in a pilot project with St. Joseph Health to better understand cancer trends in California.

Drug manufacturers often fail to stick to the 15-day timeframe of reporting serious adverse events to the FDA, a new study in JAMA Internal Medicine reports.

At the ongoing annual ACS NSQIP Conference in Chicago, physicians from the Thomas Jefferson University Hospital in Philadelphia presented a risk score tool that can predict a person's dependence on mechanical ventilation post surgery.

This week Bristol-Myers Squibb's phase 3 nivolumab study ended early because renal cell carcinoma patients were experiencing significantly better overall survival, the American Society of Clinical Oncology called for the inclusion of more geriatric patients in trials, and Medicaid expansion states are finding more people enrolling than they planned.

The Sanofi and Regeneron therapy, to be marketed as Praluent, was among the most-anticipated FDA approvals of the year. Late-day reports put pricing at $40 a day wholesale, well above estimates, although insurers will seek discounts.

The FDA approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus genotype 3 infections.

A study published in Nature Medicine has identified a gene signature that can predict cancer patient outcomes across a wide spectrum of malignancies.

The study has policy implications since Americans 65 and older are eligible for Medicare, and trustees reported this week that the hospital fund will only be solvent until 2030.