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The Rx Recap: June 23-27

Key Takeaways

  • Galleri test improves cancer detection and positive predictive value when added to standard-of-care screening, with high specificity and negative predictive values.
  • School-based dental treatments ART and SDF effectively stop cavity progression in NYC children, with SDF showing lower odds of treatment failure.
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This week, we feature top articles from our sister publications on regulatory updates, clinical trial insights, and more.

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.

Galleri Early Detection Test May Improve Cancer Detection vs SOC Alone

The addition of the Galleri multi-cancer early detection test to standard-of-care (SOC) screening significantly improved cancer detection and positive predictive value compared to SOC alone, according to top-line results from GRAIL Inc.'s PATHFINDER 2 study, Cancer Network reports. Among 6621 individuals screened, 92 (1.4%) were diagnosed with cancer, including 1.5% with additional cancer risk and 1.2% without. Positive predictive values reached 38% overall, with negative predictive values and specificity exceeding 98% across all groups.

Study: School-based treatments stop cavity progression in NYC children

Two school-based dental treatments (atraumatic restorative treatment [ART] and silver diamine fluoride [SDF]) effectively halted cavity progression in most NYC elementary students for up to 4 years, according to results from the CariedAway trial published in JAMA Network Open, Contemporary Pediatrics reports. In a study of over 1,600 children with cavities, SDF prevented worsening in 62% of tooth surfaces and ART in 55%, with SDF showing significantly lower odds of treatment failure. Both treatments were equally effective across levels of disease severity, and neither demonstrated an indirect protective effect on untreated teeth.

FDA Clears Virtually Helium-Free 1.5T MRI System from Siemens Healthineers

The FDA has granted 510(k) clearance for Siemens Healthineers’ Magnetom Flow.Ace, a 1.5T MRI scanner that operates with a virtually helium-free cooling system and no quench pipe, Diagnostic Imaging reports. Unlike conventional MRI systems that consume over 1,000 liters of helium over their lifetime, the Magnetom Flow.Ace uses just 0.7 liters, potentially reducing annual energy consumption by more than 30%. The compact scanner also features AI-powered image reconstruction and a versatile range of coils for both human and veterinary imaging.

Phase 2 SUNRISE-PD Trial to Test BioVie‘s Bezisterim for Early-Stage Parkinson Disease

At the 4th Annual Advanced Therapeutics in Movement and Related Disorders Congress, researchers presented the design of the ongoing phase 2 SUNRISE-PD trial, a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of bezisterim in early-stage Parkinson disease (PD), Neurology Live reports. The 20-week trial features a hybrid decentralized design with in-home nurse visits, remote neurologist oversight, and centralized motor symptom rating, aiming to overcome barriers like mobility and geographic limitations. Eligible participants are aged 41-80 with recent PD diagnoses and no prior dopaminergic treatment. Bezisterim, an investigational oral compound with anti-inflammatory and insulin-sensitizing properties, previously showed improvements in motor symptoms without adverse events in combination with levodopa.

Perfuse Therapeutics shares positive results from Phase 2 clinical trials of PER-001

Perfuse Therapeutics announced positive Phase 2 trial results for PER-001, a first-in-class endothelin antagonist implant for glaucoma and diabetic retinopathy, Opthalmology Times reports. Administered intravitreally every 6 months, PER-001 showed significant vision improvements and potential to reverse progressive vision loss. In glaucoma patients, 22.2% (low dose) and 37.5% (high dose) achieved ≥7 dB improvement in retinal sensitivity vs 0% in controls, with no treated patients experiencing major vision loss. Diabetic retinopathy patients saw enhanced visual function and retinal structure, including +0.9 dB contrast sensitivity gain and reduced macular ischemia.

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