The FDA has granted de novo clearance to ProciseDx Inc. for its therapeutic drug monitoring tests for Humira and Remicade, as well as their biosimilars, for patients with inflammatory bowel disease (IBD). These tests are the first of their kind authorized by the FDA for these biologic therapies. The tests aim to optimize the care of IBD patients by enabling immediate testing. The Procise ADL and Procise IFX assays quantify drug levels of adalimumab or infliximab in IBD patients using time-resolved fluorescence resonance energy transfer immunoassays. The tests can be performed onsite in hospitals or clinical labs, providing results in…
Author: Abhay Panchal
The paper introduces a deep learning framework, MIPCL, designed to predict the presence or absence of cancer in pancreatic fine-needle aspirations, which are the standard diagnostic procedure for evaluating pancreatic ductal adenocarcinoma. The study emphasizes the importance of accurate diagnosis as a suspicion for malignancy can lead to significant medical interventions. The MIPCL model was found to outperform two other deep learning models, ABMIL and CLAM, in predicting the presence of cancer. The model also offers visualization capabilities, highlighting the most significant regions on a slide that contribute to its final prediction. This can serve as a valuable tool for…
The healthcare landscape in 2024 is being shaped by a confluence of factors including an aging population, transformative technologies, and global economic dynamics. Key trends expected to dominate the sector include:
Alcohol-associated liver disease, one of the most common types of liver disease worldwide, is associated with tremendous morbidity, mortality, and financial costs. Although significant progress has been made in screening and management of patients with early, or nonadvanced, ALD, there remain unmet clinical needs and areas of future prospects in the management. ALD is caused by alcohol use disorder (AUD)—harmful alcohol consumption (=2 drinks per day or >7 per week in females and =3 drinks daily or >14 weekly in males) despite negative physical, social, and interpersonal consequences accompanied by dependence, withdrawal, and tolerance of alcohol.1 Manifestation of ALD varies…
Around 75,000 healthcare workers initiated a planned three-day strike at Kaiser Permanente facilities across the U.S., marking the largest-ever action of its kind in the healthcare sector. The strike involves nurses, medical technicians, and other support staff from various hospitals in states like California, Oregon, Washington, Colorado, Virginia, and Washington D.C. The coalition of unions representing these workers claims that Kaiser Permanente, a leading not-for-profit healthcare network, has not addressed the ongoing staffing issues, leading to workers feeling overburdened and undercompensated. The strike comes after the expiration of the previous contract on September 30. The unions argue that Kaiser needs…
A recent study has found that the use of glucagon-like peptide 1 (GLP-1) agonists for weight loss, when compared with bupropion-naltrexone, is associated with an increased risk of pancreatitis, gastroparesis, and bowel obstruction. However, there was no increased risk for biliary disease. The study, published in JAMA, highlighted that despite these adverse events being rare, they should be considered by patients contemplating the use of these drugs for weight loss. The research was based on a sample of 16 million patients from the PharMetrics Plus database, evaluating gastrointestinal adverse events among new users of GLP-1 agonists between 2006 and 2020.…
United Digestive (UD) is pleased to announce that Mark E. Murphy, MD, FACP, AGAF, from Center for Digestive & Liver Health, has been named “Best Gastroenterologist” in Savannah Magazine’s “The Best of Savannah Doctors 2023” edition. Dr. Murphy’s recognition exemplifies UD’s unwavering commitment to delivering best-in-class patient care. “We are proud of Dr. Mark Murphy’s well-deserved achievement as the ‘Best Gastroenterologist’ in Savannah,” said UD’s Chief Medical Officer John Suh, MD, MPH. “His dedication to excellence in patient care and his exceptional contributions to the field of gastroenterology truly set a high standard for our practice.” Dr. Murphy previously won…
Precede Biosciences, a liquid biopsy company, has come out of stealth mode with a financing of $57 million. The company’s innovative technology focuses on analyzing circulating chromatin to detect genome-wide patterns of gene activation, promotion, and methylation from a mere 1-mL plasma sample. Thought-Provoking Questions/Insights:
The FDA has granted approval to Abrilada, making it the second interchangeable biosimilar to adalimumab. This decision allows Abrilada (adalimumab-afzb, Pfizer) to be substituted for adalimumab (Humira, Abbvie) at the pharmacy level without the need for intervention or notification of the prescribing provider, in states where it’s permitted. The biosimilar is approved for various conditions including rheumatoid arthritis, juvenile idiopathic arthritis, and Crohn’s disease, among others. The FDA’s approval was based on data from the phase 3 REFLECTIONS B538-12 study, which showed similar outcomes between the reference product and Abrilada. Pfizer plans to make Abrilada available by late October, initially…
Robert Schoen, MD, and Dhiraj Yadav, MD — professors at the University of Pittsburgh School of Medicine — received 2024 Research Mentor Awards from the American Gastroenterological Association. They are among 11 recipients selected as “outstanding mentors” in their respective research sections: clinical practice for Dr. Schoen and pancreatic disorders for Dr. Yadav, according to an Oct. 4 news release from the university. Both professors teach in the school’s division of gastroenterology, hepatology and nutrition.