ARS Pharmaceuticals announced its submission of a supplemental new drug application to the FDA for neffy 1 mg for the treatment of type 1 allergic reactions in children who weigh between 33 lb and 66 lb. This announcement comes after the FDA approved neffy epinephrine nasal spray for emergency treatment of type 1 allergic reactions, including anaphylaxis, in pediatric and adult individuals weighing at least 66 lb in early August. Healio spoke with Richard Lowenthal, MS, MSEL (MBA), cofounder, president and CEO of ARS Pharmaceuticals, about the new FDA submission and what it entails for t ..read more

The number of congenital syphilis-related stillbirths increased annually from 2016 to 2022 in the U.S. while the proportion of cases resulting in stillbirth remained stable, researchers reported in Obstetrics & Gynecology. In an analysis of congenital syphilis cases reported to the CDC, researchers also found that lack of prenatal care and inadequate syphilis testing were the most likely contributors to the rising stillbirth rate. “Although diagnosis and treatment of syphilis before pregnancy prevents all congenital syphilis, early identification of syphilis during pregnancy and ..read more

Researchers confirmed that head and neck melanomas have distinct biological characteristics that make it more adverse to patients yet more responsive to immunotherapy, according to a study. “There is accumulating evidence that primary cutaneous head and neck melanoma may represent a distinct clinicopathological entity compared to cutaneous melanoma of other sites, with different patient demographics, primary melanoma pathological features and outcomes,” Andrew T. Li, MBBS, of the Melanoma Institute Australia, Royal Prince Alfred Hospital and Faculty of Medicine and Health at the ..read more

Remote BP monitoring and collaborative telehealth visits with a pharmacist improved BP control among patients at rural nephrology clinics and reduced hospitalization, a speaker reported. Alexander Chang, MD, MS, nephrologist and associate professor in the department of nephrology and the department of population health sciences at Geisinger Health in Danville, Pennsylvania, presented the results of a study to evaluate a remote monitoring and telehealth program for BP control at the Hypertension Scientific Sessions. “In our study, we developed a program that builds off what others have ..read more

Adults who drink caffeinated beverages such as coffee or tea may have a lower risk for developing multiple cardiometabolic diseases compared with adults with low or no intake, according to study findings. In an analysis of data from the UK Biobank published in The Journal of Clinical Endocrinology & Metabolism, researchers found drinking 100 mg caffeine or more per day lowered the risk for cardiometabolic disease including type 2 diabetes, coronary heart disease and stroke compared with drinking less than 100 mg caffeine per day. The largest risk reduction was seen among those consuming ..read more

Many recently recalled cardiovascular devices did not undergo premarket testing prior to FDA approval, and postmarket studies of the devices were slow and infrequent, researchers reported. The results of a cross-sectional analysis to evaluate the rigor of premarket and postmarket studies of CV devices recalled from 2013 to 2022 were published in the Annals of internal Medicine. “Safety concerns sometimes arise once devices are in clinical use, particularly as devices are used in more patients and with longer follow-up than during premarket testing. When safety issues arise, devices may be ..read more

Adults with idiopathic pulmonary fibrosis met the primary endpoint of absolute change in FVC with 52-week oral nerandomilast, an investigational phosphodiesterase 4B inhibitor, vs. placebo, according to FIBRONEER-IPF topline results. “This is the first IPF phase 3 trial in a decade to meet its primary endpoint,” Ioannis Sapountzis, PhD, head of global therapeutic areas at Boehringer Ingelheim, said in a press release, adding that the announcement represents the next step in the company’s long history in researching this disease. “IPF has a high unmet need for patients ..read more

Adults with asthma and/or COPD who received 23 text messages about preventer inhaler use over 26 weeks had improved inhaler adherence, according to a poster presented at the European Respiratory Society International Congress. “This clinical trial illustrates that a simple and low-cost text message intervention can meaningfully impact medication adherence in patients with asthma and/or COPD, and even improve symptom control,” John Luke Twelves, MD, medical director at Lindus Health, and colleagues wrote on the poster. In a randomized controlled trial, Twelves and colleagues ..read more

Most recipients of early liver transplant for severe alcohol-related liver disease live in close proximity to transplant centers, which are more likely to be in socially advantaged areas, according to research in Gastro Hep Advances. “Some LT centers have adopted the practice of early liver transplants (ELT) for candidates with severe alcohol-related liver disease (ALD) and less than 6-month alcohol-free periods,” James Flanary, of the department of surgery at Johns Hopkins University, and colleagues wrote. “The practice defers some or all addiction interventions until after ..read more

With more than 13 million U.S. adults having seriously considered suicide last year, the National Strategy for Suicide Prevention plan released in April uses a comprehensive approach to prevent suicide, according to an HHS statement. Additional data from the Substance Abuse and Mental Health Services Administration show that approximately 4 million adults planned a suicide attempt last year and nearly 2 million attempted suicide. This September, National Suicide Prevention Month serves as a reminder that this crisis is ongoing and impacts people of all ages. To address this nationwide problem ..read more