Welcome to this week’s roundup of the most insightful and impactful articles from the sister publications of Dermatology Times, all under One MJH Life Sciences. Our network brings together expert perspectives, clinical advancements, and industry updates to keep clinicians informed and ahead of the curve. From cutting-edge treatments to practice management strategies, here’s a look at the top stories shaping the field of medicine.
As reported by Pharmaceutical Commerce, artificial intelligence is transforming pharmacovigilance by helping drugmakers convert massive volumes of fragmented safety data into actionable insights. Once viewed primarily as a regulatory requirement, drug safety is now a strategic priority, with AI enabling faster detection of critical signals across unstructured sources such as social media and call center data. By moving beyond basic automation to predictive “intelligent action,” AI can cut safety-related costs by more than 50%, free experts to focus on complex decision-making, strengthen trust with regulators and patients, and streamline global workflows. The article highlights a broader shift in which drug safety is evolving into a competitive advantage, with AI offering the potential to both enhance patient safety and accelerate access to new therapies.
As reported by OncLive, the FDA has accepted and granted priority review to a new drug application for gedatolisib (PF-05212384) in patients with hormone receptor–positive, HER2-negative, PIK3CA wild-type advanced breast cancer, setting a PDUFA goal date of July 17, 2026. The NDA is supported by phase 3 VIKTORIA-1 trial data showing significant progression-free survival (PFS) benefits with gedatolisib-based regimens: patients receiving gedatolisib plus fulvestrant and palbociclib achieved a median PFS of 9.3 months versus 2.0 months with fulvestrant alone, while the gedatolisib–fulvestrant doublet achieved a median PFS of 7.4 months. Gedatolisib is a differentiated, multi-target PI3K/AKT/mTOR pathway inhibitor designed to provide comprehensive pathway suppression in both PIK3CA-mutant and wild-type disease. Although interim overall survival analyses did not meet statistical significance thresholds, objective response rates were substantially higher in the gedatolisib arms, and the safety profile was consistent with known PAM pathway inhibition, supporting its potential as a new treatment option in this population.
As reported by Neurology Live, a multicenter, randomized, double-blind, placebo-controlled phase 2a trial found that NLX-112, a first-in-class and highly selective 5-HT1A receptor agonist, was safe, generally well tolerated, and showed promising efficacy in patients with troublesome levodopa-induced dyskinesia (LID) in Parkinson disease. Published in Movement Disorders in early 2025, the study met its primary endpoint with no serious adverse events and no clinically significant changes in vital signs, ECGs, or laboratory values, while secondary and exploratory endpoints showed significant reductions in dyskinesia and parkinsonism scores versus placebo, along with greater improvement on the Clinical Global Impression of Change (53% vs 29%). Notably, NLX-112 reduced LID without diminishing levodopa’s antiparkinsonian effects and instead further improved parkinsonism, suggesting a distinct and complementary mechanism of action. These findings build on prior phase 1 and preclinical data and support continued development of NLX-112, which has also received orphan medicinal product designation in Europe for spinocerebellar ataxia.
As reported by Drug Topics, a review published in US Pharmacist highlights that over-the-counter (OTC) medications, including antihistamines, decongestants, and analgesics, remain essential for safely and effectively managing cold, flu, fever, cough, and other minor ailments in children and adolescents, while underscoring the pharmacist’s critical role in preventing misuse. Although OTC products are widely used by families—nearly half of parents report giving OTC medicines to children under 5—evidence shows that commonly used agents such as acetaminophen and ibuprofen are similarly effective and well tolerated for pediatric fever when dosed appropriately, with ibuprofen offering modest advantages at standard OTC doses. At the same time, concerns persist around inappropriate use of cough and cold products in very young children, reinforcing the need for pharmacist-led education, dosing guidance, and vigilance as the OTC landscape continues to expand with newer, more accessible formulations.
As reported by Diagnostic Imaging, the FDA has granted 510(k) clearance to Aidoc for a new CT-based artificial intelligence triage platform encompassing 14 cleared indications, including 11 newly authorized uses. Built on Aidoc’s Clinical AI Reasoning Engine (CARE), the software is designed to streamline radiology workflows across emergency and ambulatory settings and will be deployed via the Aidoc aiOS enterprise platform. According to the company, studies supporting the newly cleared indications demonstrated a mean sensitivity of 97% and mean specificity of 98%. Experts note that consolidating detection of multiple acute conditions into a single AI-driven workflow represents a significant operational shift for radiology departments, with the potential to accelerate diagnosis, improve efficiency, and enhance patient outcomes.
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