The Rx Recap: August 24-29

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.

How FDA Incentives and Patient Advocacy Accelerate Rare Disease Drug Development in Biopharma

In Part 2 of his interview with BioPharm International, Dan Williams, PhD, CEO of SynaptixBio, discusses how regulatory incentives and patient engagement are accelerating rare-disease drug development. Building on part 1, Williams highlights the impact of FDA’s priority review voucher system, particularly the Rare Pediatric Disease designation, which offers companies both expedited review and the potential to sell vouchers for up to $150 million to reinvest in research. He also emphasizes the critical role of patient advocacy groups in shaping meaningful therapies, noting that firsthand patient input drives drug development forward. Together, these financial incentives and collaborations are helping biotech innovators bring rare-disease treatments to patients faster and more effectively.

FDA Grants Fast Track Designation to Stenoparib for Advanced Ovarian Cancer

OncLive reports that the FDA has granted fast track designation to stenoparib (2X-121), an investigational oral inhibitor of PARP1/2 and tankyrase 1/2, for patients with advanced ovarian cancer. Developed by Allarity Therapeutics, stenoparib is designed to both block DNA repair and disrupt WNT signaling, offering a differentiated therapeutic approach. The designation follows encouraging findings from an earlier phase 2 trial, where patients identified through Allarity’s Drug Response Predictor companion diagnostic experienced clinical benefit beyond 20 weeks. A new phase 2 study, launched in June 2025, is now enrolling patients with recurrent, platinum-resistant or platinum-ineligible ovarian cancer to further evaluate safety, efficacy, and optimal dosing. According to Allarity CEO Thomas Jensen, the FDA’s decision highlights the urgent need for new treatment options and the potential for stenoparib to improve outcomes in this difficult-to-treat population.

Recall Alert: Cyclobenzaprine Tablets May Contain Wrong Medication

The Educated Patient reports that Unichem Pharmaceuticals has recalled one lot of cyclobenzaprine 10 mg tablets after bottles were found to contain meloxicam 7.5 mg instead. The mix-up poses serious risks, including heart problems, bleeding, kidney damage, or severe allergic reactions—especially for those already on NSAIDs, blood thinners, or with meloxicam allergies. The recalled lot (GMML24026A, exp. Sept 2027, NDC 29300-415-19) was distributed nationwide. Patients should stop use, return the product to their pharmacy, and seek medical care if symptoms occur. Questions can be directed to Inmar at 1-877-840-5109 or rxrecalls@inmar.com, and issues should be reported to the FDA’s MedWatch program.

FDA Approves Updated 2025-2026 COVID-19 Vaccine for Patients 65 Years and Older

Drug Tropics reports that the FDA has approved a supplemental biologics license application for Comirnaty, Pfizer and BioNTech’s LP.8.1-adapted monovalent COVID-19 vaccine, for the 2025–2026 season. The updated formulation is indicated for adults 65 and older as well as patients 5 through 64 with at least one high-risk condition. The decision follows the FDA’s May 2025 recommendation to use the LP.8.1 strain for fall vaccinations, citing stronger immune responses compared with prior JN.1- and KP.2-adapted vaccines. Clinical trial data (NCT07069309) demonstrated safety, tolerability, and enhanced immunogenicity across high-risk populations, reinforcing the vaccine’s role in preparing for seasonal surges of respiratory illnesses. Experts emphasize stocking vaccines, antivirals, and preventive resources ahead of the fall and winter months to protect vulnerable groups.

New Tool Accurately Assesses Infant Development from 16 Days of Birth

Contemporary OB/GYN reports that Northwestern University has developed the NIH Baby Toolbox, a validated, standardized tool to assess language, cognitive, motor, and social-emotional skills in infants as young as 16 days through 42 months. Published in Infant Behavior and Development, the tool fills a critical gap left by prior assessments that only measured development beginning at age 3. Using videos and eye-tracking on an iPad app, the toolbox allows for early detection of developmental delays—when interventions are most effective—and has been validated in a diverse group of 2,500 infants and toddlers. Investigators highlight its scalability, affordability, and ease of use compared with existing measures, noting that it enables clinicians, researchers, and educators to track development reliably from infancy into adulthood.

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