CER Daily Newsfeed

Study Finds Postapproval Cancer Trials Fell After Inflation Reduction Act

(9/17, The ASCO Post) comments “Research published by Zheng et al in Health Affairs Scholar found that the passage of the government price-setting provisions of the Inflation Reduction Act (IRA) was associated with a broad decline in industry-funded oncology trials after first U.S. Food and Drug Administration approval, with disproportionally greater reductions for small-molecule drugs...‘In addition to the therapeutic benefits, small-molecule drugs often provide greater flexibility and convenience for patients, making cancer treatments possible through a pill taken at home,’ said Hanke Zheng, MS, PhD, lead author of the current report and NPC Research Manager. ‘We sought to quantify the impact of their shorter ‘clock' to government price regulation on postapproval clinical trials for oncology.’” Full

J&J's IL-23 Drug Defeats Reigning Champ Sotyktu in Phase 3 Psoriasis Trial

(9/17, James Waldron, Fierce Biotech) reports “...The Protagonist Therapeutics-partnered once-daily oral peptide icotrokinra has beaten Sotyktu across a pair of phase 3 studies, dubbed Iconic-Advance 1 and 2, which enrolled patients with moderate to severe plaque psoriasis. Specifically, icotrokinra showed superior skin clearance at weeks 16 and 24 compared to both Sotyktu and placebo, J&J announced in a Sept. 17 release.” Full

Video: Cost-Effectiveness of Varying Weight Loss Interventions: Elena Losina, PhD

(9/17, Sabrina McCrear, Elena Losina, PhD, The American Journal of Managed Care) “...The glucagon peptide-1 receptor agonist (GLP-1 RA) tirzepatide was found to be more cost-effective than semaglutide when treating patients with knee osteoarthritis and obesity, reported a recent study published in the Annals of Internal Medicine...The American Journal of Managed Care® spoke with corresponding author Elena Losina, PhD, codirector of the Orthopedics and Arthritis Center for Outcomes Research at Brigham and Women’s Hospital, about paired QALYs of GLP-1 RAs and diet and exercise, GLP-1 RAs and bariatric surgery, or just bariatric surgery.” View Video

ICH’s M14 Guideline Sets Global Standard For Non-Interventional RWD Studies

(9/17, Vibha Sharma, Pink Sheet) reports “...A new guideline finalized by the International Council of Harmonisation is expected to reshape how non-interventional drug safety studies use real-world data, bringing clarity, consistency, and global alignment.” Subscription Required