Mary Caffrey

The agency said this was the first such approval, as the purified omega-3 fatty acid is now approved to be used alongside statins to treat elevated cholesterol levels and cut the risk of events such as heart attacks or strokes. The drug was first approved in 2012 for patients with elevated triglycerides.

Governor Henry McMaster, a Republican, announced the waiver plan at an event in Greenville, South Carolina, with CMS Administrator Seema Verma by his side. Some observers see Verma’s promotion of Medicaid work rules in the face of court challenges as a key to her political survival in her feud with HHS Secretary Alex Azar.

The results are sure to generate interest as heart failure with preserved ejection fraction lacks treatment options, but that could change as results are expected in outcomes trials that are studying sodium glucose co-transporter 2 inhibitors in heart failure, both with preserved and reduced ejection fraction.

Although survival rates for multiple myeloma have improved as treatment options have increased, the disease remains incurable, and many patients stop current agents such as lenalidomide or bortezomib due to toxicity. Results of CANDOR involving a triple therapy were presented Tuesday at the 61st American Society of Hematology Annual Meeting and Exposition in Orlando, Florida.

The lead investigator of the study from the Children's Oncology Group said the findings represent a new standard of care.

The study's primary end point, overall survival, showed that patients taking CC-486 had a 31% lower risk of death than those taking placebo.

The French biotech Servier has an agreement with Allogene Therapeutics, through Pfizer, to market its allogenic chimeric antigen receptor (CAR) T-cell product in the United States if it receives FDA approval.

Results presented at ASH support giving ibrutinib as first-line therapy in chronic lymphocytic leukemia (CLL), and future results may offer insights on whether patients can stop therapy once they have undetectable minimal residual disease (MRD).

Results from Avalere Health show that once Medicare patients get through the experience and expense of CAR T-cell therapy, they do well and costs drop significantly.

Successors to the first generation of chimeric antigen receptor (CAR) T-cell treatments will attack multiple targets and address the complexity of the manufacturing process by bringing uniformity to the creation of therapies, presenters said at the 61st American Society of Hematology Annual Meeting and Exposition in Orlando, Florida.

The findings from researchers at The Centers for Disease Control and Prevention (CDC) highlight the public health risks of obesity and type 2 diabetes, which have been tied to recent studies that find rising deaths from heart failure and even an overall drop in US life expectancy, with the long-term rise in obesity playing a role in the decline.

Although the study did not pinpoint the exact mechanism behind the link, the authors wrote that the presence of plaque below the gumline can allow oral bacteria to reach the circulatory system. Certain bacteria that reach the gut can trigger inflammation.

Two recent studies have explored the role of activator protein-1 (AP-1), a transcription factor with a role in skin diseases caused by inflammation, including psoriasis and atopic dermatitis

The findings have important implications, the authors wrote, as the study confirms “the potential clinical utility of empagliflozin for the treatment of obesity and related metabolic disorders, such as insulin resistance, type 2 diabetes, and [nonalcoholic steatohepatitis."

Three straight years of declining life expectancy—from 2014 to 2017—have roots that go back to the 1980s, when the authors say US life expectancy began to lose pace with other countries.

A new study says that more than 1 in 10 of the 17 million cancer survivors in the United States will die from cardiovascular disease (CVD).

BE READY is designed to evaluate the safety and efficacy of bimekizumab, humanized monoclonal IgG1 antibody that targets and neutralizes interleukin- (IL-)17A and IL-17F, a pair of cytokines that propel the inflammatory process through their effects on other messengers in the body that trigger chronic inflammatory response.

Humana outlined its progress in its third annual Value-Based Care Report, which details growth and evolution in this area since 2016, both in the number of agreements and in its spread across more parts of the country.

EMPRISE (Empagliflozin Comparative Effectiveness and Safety) will examine 5 years of real-world data on empagliflozin, which is sold as Jardiance by Eli Lilly and Boehringer Ingelheim. The study is comparing data on empagliflozin with that for dipeptidyl peptidase 4 (DPP-4) inhibitors. This latest interim analysis also features a cohort comparison with glucagon-like peptide 1 (GLP-1) receptor agonists.

Mavacamten is a first-in-class small-molecule therapy that reduces the contractility of cardiac muscles by binding with myosin, a protein involved in muscle contraction that is often affected by a gene mutation in hypertrophic cardiomyopathy.

Data from EVAPORATE, presented at the 2019 American Heart Association Scientific Sessions, may be the start of answering a question that has baffled the research community: just how does icosapent ethyl, sold as Vascepa, prevent heart attacks in patients with high triglycerides?

Sunday’s poster session at the 2019 American Heart Association (AHA) Scientific Sessions in Philadelphia, Pennsylvania, included research that addressed disparities in clinical outcomes, healthcare delivery, and access to payer coverage.

Two additional analyses have come from DAPA-HF, a trial released in September that found the sodium glucose cotransporter 2 inhibitor works equally well in patients with and without diabetes in reducing cardiovascular death and heart failure (HF) events in patients with HF with reduced ejection fraction.

Results from ISCHEMIA, funded by the National Heart, Lung, and Blood Institute, are likely to change practice guidelines, according to commenters who took part in Saturday’s packed presentation at the 2019 American Heart Association Scientific Sessions in Philadelphia, Pennsylvania.

Patients without diabetes who have heart failure saw signficant benefits from the sodium glucose cotransporter 2 inhibitor dapagliflozin, prompting a commenter to ask not if more patients should be taking these drugs but when to start patients on them.

Called Diabetes Can Break Your Heart, the initiative seeks to get doctors and patients talking about the connection between diabetes and heart failure, so that symptoms are not missed and treatment that could prevent heart failure occurs early. A Diabetes Heartbreaker tour, which will feature a virtual reality experience with immersive technology, will kick off this weekend at the American Heart Association Scientific Sessions in Philadelphia.

Former FDA Commissioner Scott Gottlieb, MD, who has returned to the American Enterprise Institute, left FDA in April after 2 whirlwind years that saw a record pace of approvals and policy actions that covered everything from high drug prices to teen vaping. He spoke Friday in Philadelphia at Patient-Centered Oncology Care®, the annual meeting of oncology reimbursement stakeholders held by The American Journal of Managed Care®.

Hypertrophic cardiomyopathy is often an inherited condition and patients may not show symptoms, or those symptoms may be vague, such as fatigue or shortness of breath. The condition can cause varied levels of risk and can result in sudden cardiac death.

Oncology care groups have praised the multipayer Oncology Care Model (OCM) for transforming cancer care through greater focus on care navigation, palliative care, survivorship, and keeping patients out of the emergency department. But there are complaints that practices can be penalized for elements beyond their control—notably, the soaring cost of state-of-the-art immunotherapies that were not on the market when the OCM was conceived.

Researchers at the University of Alabama at Birmingham first isolated the kinase HIPK2 from among hundreds of potential targets by using bioinformatics to hone in on the protein kinase as a target for study.