Opinion | ‘We Cannot Treat Dead People’: What We Heard This Week
“We cannot treat dead people.” — White House Office of National Drug Control Policy Director Rahul Gupta, MD, MPH, discussing whether to focus on opioid treatment or trafficking. “Thank you for reminding me why I do this.” — Stuart Bloom, MD, regarding feedback he hears from physicians who see his musical show “How to Avoid […]
FDA Greenlights New Myasthenia Gravis Drug
The FDA approved rozanolixizumab-noli (Rystiggo), a neonatal Fc receptor blocker, to treat adults with generalized myasthenia gravis (gMG), UCB announced Tuesday. The drug is the first approved to treat both of the two most common subtypes of gMG patients — those who are anti-acetylcholine receptor (AChR)-positive and those who are anti-muscle-specific tyrosine kinase (MuSK) antibody-positive. […]
Racial, Ethnic Disparities Persist in OUD Treatment
Black and Hispanic patients with a disability had a tougher time getting medication to treat opioid use disorder (OUD) despite frequent contact with healthcare providers, Medicare claims data showed. Within 180 days of an index OUD-related event, Black patients received a prescription for buprenorphine 12.7% of the time, Hispanic patients 18.7% of the time, and […]
Novel Drug Authorized for Critically Ill COVID-19 Patients
The FDA has issued an emergency use authorization (EUA) for vilobelimab (Gohibic) to treat critically ill adults with COVID-19. In the EUA for the first-in-class monoclonal anti-human complement factor C5a antibody, the agency specified that the therapy be initiated within 48 hours of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). It is given at […]
Isotretinoin REMS Still Needed, But Its Burden Could Be Reduced, FDA Staff Says
A risk evaluation and mitigation strategy (REMS) for the use of isotretinoin to treat severe acne is still very much needed, but there are ways to lighten its burden on patients and providers, according to FDA staff. For example, because of the drug’s risk of causing birth defects if taken while patients are pregnant, prescribing […]
Investigational ALS Drug May Have Clinical Benefit, FDA Staff Says
Tofersen, an investigational antisense drug developed to treat amyotrophic lateral sclerosis (ALS) associated with a mutation in the SOD1 gene (SOD1-ALS), may have clinical benefit, FDA reviewers indicated in briefing documents ahead of an advisory committee meeting. On Wednesday, the Peripheral and Central Nervous System Drugs Advisory Committee will vote on whether evidence supporting a […]
First Treatment Approved for Rare Genetic Neurologic Disorder
The FDA approved trofinetide (Daybue), the first drug to treat adult and pediatric patients age 2 and older with Rett syndrome, drugmaker Acadia Pharmaceuticals announced Friday. “Now, for the first time after decades of clinical research, healthcare providers finally have a treatment option to address a range of core behavioral, communication, and physical symptoms for […]
Alzheimer’s Drug Lecanemab Wins FDA Approval
Lecanemab (Leqembi) was approved under the accelerated approval pathway to treat Alzheimer’s disease, the FDA announced on Friday. The anti-amyloid should be started only in patients with mild cognitive impairment or who are at the mild dementia stage of Alzheimer’s disease, the population studied in clinical trials, the agency noted, and the drug label indicates […]
High-Intensity Billing for ‘Treat and Release’ ED Visits Has Shot Up Since 2006
High-intensity billing during “treat and release” emergency department (ED) visits rose dramatically over the last two decades, according to an observational study. From 2006 to 2019, the share of treat-and-release visits at the ED (those where patients were not admitted) that included high-intensity billing jumped from 4.8% to 19.2%, reported researchers led by Alexander Janke, […]
Positively charged nanomaterials treat obesity anywhere you want
Researchers have long been working on how to treat obesity, a serious condition that can lead to hypertension, diabetes, chronic inflammation, and cardiovascular diseases. Studies have also revealed a strong correlation of obesity and cancer — recent data show that smoking, drinking alcohol, and obesity are the biggest contributors to cancer worldwide. The development of […]