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.
Recent research presented in Psychiatric Times highlights Nutriband’s successful FDA feedback meeting regarding their Aversa abuse-deterrent fentanyl patch. The FDA confirmed the NDA regulatory pathway, provided guidance on CMC plans, manufacturing validation, stability testing, and gave specific feedback on laboratory studies assessing abuse-deterrent properties. These planned in vitro studies will evaluate the effort required to bypass or defeat the deterrent features, addressing concerns about fentanyl abuse, misuse, and accidental exposure. The patch is intended for patients with opioid tolerance needing continuous long-term pain management, combining Nutriband’s abuse-deterrent technology with the FDA-approved fentanyl formulation. If approved, the Aversa patch would be the first abuse-deterrent fentanyl patch, aiming to reduce abuse, diversion, and accidental exposure while maintaining access for patients in need.
Recent reporting by New Beauty highlights some of the standout mature skin products launched this year, showcasing innovations designed to address aging-related concerns such as loss of collagen, wrinkles, dryness, and barrier fatigue. High contenders include Alastin Restorative Skin Complex with TriHex+, praised for improving plumpness and hydration; DefenAge 7X Calming Complex, which targets hidden inflammation; and Future Renew Damage Reversal Night Serum, noted for visible reversal of fine lines and texture issues. Other notable mentions are RoC Retinol Correxion Deep Wrinkle Cream, Dermalogica NeuroTouch Symmetry Serum, and Paula’s Choice 7% Ectoin Booster. While these products are not clinical treatments, they serve as adjuncts to professional skin care, helping support skin health, maintain hydration, and enhance overall appearance alongside in-office procedures.
Recent reporting by Contemporary OB/GYN highlights the newly published European Society of Endocrinology (ESE) Clinical Practice Guideline for Management and Evaluation of Menopause and Perimenopause, endorsed by the Endocrine Society, European Menopause and Andropause Society, and British Menopause Society. The guidelines provide evidence-based recommendations for assessing and managing Premature Ovarian Insufficiency (POI), early menopause, and menopause in middle age, emphasizing that menopause should be considered a spectrum including both perimenopause and postmenopause. Key diagnostic guidance includes identifying perimenopause in women under 40 with menstrual irregularities or vasomotor symptoms, recommending biochemical testing for POI in this group, while women over 45 generally do not require testing. The guidelines also address the use of low-dose versus systemic estrogen, progestogen therapy, and fracture and cardiovascular risk assessments prior to hormone replacement therapy. Clinicians are encouraged to consider individual patient preferences, recognize the broad health implications of delayed diagnosis, and apply structured management to improve quality of life and long-term health outcomes for postmenopausal women.
Recent reporting by Cure highlights that the US FDA has granted fast track designation to JSKN003, an antibody-drug conjugate developed by Alphamab Oncology, for advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC), regardless of HER2 expression. This decision was based on pooled phase 1 and phase 1/2 data from Australia and China showing a 63% overall response rate (ORR) and a median progression-free survival (PFS) of 7.7 months, with higher ORR (72.2%) and PFS (9.4 months) in patients with HER2 IHC 1+, 2+, or 3+ tumors. JSKN003 demonstrated efficacy across different HER2 subgroups, supporting its potential benefit in heavily pretreated patients. The drug, which combines a monoclonal antibody with a cytotoxic payload to selectively target cancer cells, is already under evaluation in phase 3 studies in China and a phase 2 study in the US. Fast track designation is intended to accelerate development and review of therapies addressing serious unmet medical needs, with JSKN003 representing a promising new approach for PROC, a condition characterized by high recurrence and limited treatment options.
Recent reporting by The Center for Biosimilars highlights the FDA’s draft guidance on biosimilar development, aimed at accelerating US biosimilar entry and reducing healthcare costs. The guidance updates criteria for when a comparative efficacy study (CES) may not be needed, emphasizing that advanced analytical and pharmacokinetic studies can often detect subtle differences more effectively. By prioritizing these approaches, the FDA could reduce development costs by $100–$300 million per program and shorten timelines. While the guidance encourages interchangeability and pharmacy-level substitution, practical impact may be limited in states with restrictive laws or for clinic-administered biologics. Despite regulatory progress, a significant “biosimilar void” remains, with many biologics lacking active biosimilar development due to manufacturing complexity, niche markets, and uncertain incentives. The guidance lays important groundwork for faster, cost-effective biosimilar adoption, but further efforts in education, incentives, and manufacturing are needed.
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