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June 2, 2026

ADHD Drug CTx-1301 Receives Complete Response Letter

Kathryn Wighton
June 2, 2026
2 min

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Objective: To report on the FDA's Complete Response Letter regarding CTx-1301 for ADHD. Key Findings: The FDA's feedback was limited to specific CMC information

Cingulate's CTx-1301 received a Complete Response Letter from the FDA regarding its New Drug Application for ADHD treatment.
The FDA's feedback focused on Chemistry, Manufacturing and Controls requests, with no current concerns about clinical safety or efficacy.
Cingulate plans to submit the requested information to the FDA, with related CMC work already in progress.
CTx-1301 is designed as a once-daily, multi-core tablet for timed release of dexmethylphenidate throughout the day.
The FDA accepted the NDA for review in October 2025, with a target action date of May 31, 2026, but CTx-1301 remains investigational.

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June 2, 2026

FDA Approves Ensitrelvir to Prevent COVID-19 After Exposure

Kathryn Wighton
June 2, 2026
3 min

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Objective: To report the FDA approval of ensitrelvir for postexposure prophylaxis of COVID-19. Key Findings: Ensitrelvir reduced the risk of symptomatic COVID-1

The FDA has approved ensitrelvir (XOCOVA) for postexposure prophylaxis of COVID-19 in individuals aged 12 and older.
Ensitrelvir is the first oral option approved to prevent COVID-19 following exposure to an infected individual.
The approval was based on the phase 3 SCORPIO-PEP trial, which enrolled 2,387 participants exposed to symptomatic COVID-19.
Ensitrelvir reduced the risk of symptomatic COVID-19 by 67% compared to placebo among uninfected participants.
The most common adverse events with ensitrelvir were headache, diarrhea, and cough, with overall rates similar to placebo.

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The Ophthalmologist

June 2, 2026

Does Iris Color Affect Atropine?

June 2, 2026
3 min

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Objective: To investigate whether iris color influences the efficacy of low-dose atropine in myopia management. Key Findings: Safety-related ocular effects of l

A post-hoc meta-analysis examined the influence of iris color on the efficacy of low-dose atropine in myopia management.
The study found that children with non-brown irides showed significantly less myopia progression with atropine 0.01% compared to placebo.
No significant treatment effect was observed in children with brown irides treated with atropine 0.01%, suggesting potential reduced efficacy.
Atropine 0.05% did not show iris color-related differences in efficacy, indicating higher concentrations may overcome potential limitations.
The findings raise questions about tailoring atropine dosing based on iris color, though the authors caution against immediate practice changes.

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The Ophthalmologist

June 2, 2026

Dual Light Therapy Device for Dry Eye and OSD Management

June 2, 2026
2 min

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Objective: To introduce the eye-light® device for managing ocular surface diseases (OSD) and dry eye. Key Findings: Eye-light® has shown greater improvements in

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The Medicine Maker

June 2, 2026

This Week’s Biopharma News: New Approvals, Appeals, and AI

June 2, 2026
5 min

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Objective: To summarize recent developments in biopharmaceutical approvals and collaborations. Key Findings: LYTENAVA could be the first FDA-approved ophthalmic

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The Pathologist

June 2, 2026

Root of Cause

June 2, 2026
1 min

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Objective: To reflect the significance of specimens in understanding health and guiding healing as stated by Jessica Luna. Key Findings: No key findings reporte

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The Pathologist

June 2, 2026

Uncovering Hidden Genetic Causes of Infertility

June 2, 2026
3 min

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Objective: To evaluate the effectiveness of long-read whole genome sequencing (WGS) in identifying genetic variants linked to unexplained infertility and recurr

Long-read whole genome sequencing (WGS) may simplify genetic testing for unexplained subfertility and recurrent pregnancy loss.
The study involved 96 individuals from fertility centers in Asia, evaluating the effectiveness of HiFi long-read sequencing.
Pathogenic or likely pathogenic variants were identified in 4.8% of individuals, with about one in 10 couples carrying significant genetic variants.
The sequencing identified variants linked to conditions like premature ovarian insufficiency and spermatogenic failure in both partners.
Challenges include the difficulty in detecting balanced chromosomal rearrangements and the high cost of long-read sequencing.

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The Medicine Maker

June 2, 2026

The Case for Simulating Pregnancy

Jessica Allerton
June 2, 2026
11 min

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Objective: To discuss the role of pharmacokinetic modeling in addressing gaps in drug use during pregnancy and its implications for dosing and research. Key Fin

Karen Yeo emphasizes the importance of pharmacokinetic modeling in addressing drug use gaps during pregnancy.
Pregnant women are often excluded from clinical trials, leading to limited data for informed treatment decisions.
Physiological changes during pregnancy significantly affect drug metabolism, necessitating tailored dosing guidelines.
Physiologically based pharmacokinetic modeling can identify data gaps and foster collaboration for better drug research.
Improving communication and evidence availability is crucial for encouraging pregnant women to participate in clinical research.

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Frontiers In Oncology

June 2, 2026

ZNF25 as an immunotherapy target: pan-cancer biomarker potential and mechanistic exploration in glioma

Xiaohong Yi
Xianwen Zhang
Lijun Huang
Yuhui Chen
Maochun You
Hongyi Jia
Lefeng Hou
Chao Hu
Kun Huang
Yumei Wang
June 2, 2026

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Objective: To investigate the significance of ZNF25 as a potential biomarker across various cancers and to elucidate its molecular mechanisms, particularly in g

ZNF25 is identified as a potential biomarker in ovarian cancer, with its significance in other malignancies remaining largely unclear.
A systematic pan-cancer analysis revealed ZNF25's associations with poor prognosis and immune infiltration across multiple cancer types.
Functional assays demonstrated that ZNF25 knockdown inhibited glioma cell proliferation and migration.
Transcriptomic analysis indicated that ZNF25 promotes glioma progression through positive modulation of the PI3K-AKT pathway.
The study highlights ZNF25's potential as a diagnostic and prognostic biomarker, particularly relevant to glioma.

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Frontiers In Oncology

June 2, 2026

Case Report: A rare case of over 45 years’ survival in a patient with tonsillar adenoid cystic carcinoma

Mingzhu Wang
Tingyao Ma
Yue Zhao
Shujing Zhang
Xuelian Wang
Guoliang Yang
Xi Zhao
Yixuan Liu
Tian Ye
Mengmeng Li
Jun Wu
Lanlan Xuan
Xiaohong Chen
Zheng Yang
June 2, 2026

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Objective: To report an unusual case of tonsillar adenoid cystic carcinoma (TACC) with a 47-year disease trajectory. Key Findings: The patient exhibited a prolo

Tonsillar adenoid cystic carcinoma (TACC) is a rare malignancy with a long disease trajectory and unpredictable clinical behavior.
The patient, diagnosed in 1977, experienced a prolonged indolent phase lasting over 40 years before rapid disease progression.
Molecular profiling of the recurrent lesion in 2018 revealed NOTCH2 copy number gain and structural variants in MTOR and SPEN.
The patient underwent multiple treatments, including tonsillectomy, radiotherapy, and radical resection, throughout her disease course.
The patient died in 2024 due to complications from progressive intracranial and systemic metastases.

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Frontiers In Endocrinology

June 2, 2026

Baseline serum metabolites predict fractures in individuals who were Black and had type 2 diabetes

Carolyn Chlebek
Valerie Bussberg
Niven R. Narain
Michael A. Kiebish
Yu-Hua Tseng
Clifford J. Rosen
Matthew D. Lynes
June 2, 2026

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Objective: To identify serum metabolite differences at baseline that may predict fracture risk in Black individuals with Type 2 Diabetes Mellitus (T2D). Key Fin

Type 2 Diabetes Mellitus (T2D) increases fracture risk, particularly in Black individuals who have unique metabolic profiles.
The study analyzed 465 metabolites in serum from 571 Black participants with T2D to identify predictors of fracture risk.
One significant metabolite, 7,8-dihydrofolate, was found at higher levels in participants who later fractured.
Several metabolites related to the tricarboxylic acid cycle were reduced in participants who later experienced fractures.
The findings suggest altered systemic metabolism may play a role in fracture risk among Black individuals with T2D.

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Frontiers In Immunology

June 2, 2026

Gut microbiota and sepsis-associated acute kidney injury: a narrative review

Hui Zhang
Bingling Fan
Ruze Ma
Ruowen Jiang
Zan Qin
Xueping Qu
Junwu Wang
Jiawei Xue
Caixia Wang
Xiaoqin Liu
Litao Guo
June 2, 2026

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Objective: To synthesize current knowledge on how sepsis-driven gut dysbiosis compromises intestinal barrier integrity and contributes to sepsis-associated acut

Sepsis-associated acute kidney injury (SA-AKI) has a high incidence of 40% to 50% and a mortality rate up to 70% in ICU patients.
Gut dysbiosis during sepsis leads to compromised intestinal barrier integrity, allowing bacterial products to enter circulation and activate systemic inflammation.
Specific microbial signatures linked to AKI include increased Clostridium asparagiforme and decreased Roseburia spp., along with elevated uremic toxin-producing bacteria.
Gut-derived metabolites like indoxyl sulfate and trimethylamine N-oxide promote renal inflammation and fibrosis, contributing to kidney injury.
Therapeutic strategies targeting the gut microbiota, such as fecal microbiota transplantation and probiotic supplementation, may offer new treatment avenues for SA-AKI.

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Frontiers In Immunology

June 2, 2026

Gut microbiota modulation in the prevention and treatment of heat stroke

Zhenglian Wang
Jun Yan
Jing Xiao
Weijun Guo
Maolin Deng
June 2, 2026

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Objective: To summarize current findings on how modulation of the gut microbiota may improve intestinal thermotolerance and strengthen barrier function, providi

Heat stroke (HS) is increasingly prevalent due to climate change, characterized by rapid temperature elevation and potential organ failure.
Intestinal injury plays a critical role in HS pathogenesis, leading to increased permeability and systemic inflammation.
Heat-induced gut dysbiosis results in reduced beneficial bacteria and overgrowth of pathogens, contributing to mucosal inflammation.
Probiotics may help mitigate HS severity by enhancing gut microbiota balance and improving intestinal barrier function.
Current evidence on gut microbiota's role in HS primarily comes from animal studies, necessitating cautious interpretation for human application.

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Frontiers In Immunology

June 2, 2026

Predicting response to immunochemotherapy in EGFR-mutant lung adenocarcinoma after third-generation TKI resistance using CT radiomics-based habitat imaging

Shuai Qie
Yasong Shi
Jingyun Li
Sicong Jia
Xiaoping Yin
June 2, 2026

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Objective: To develop and validate a CT-based habitat radiomics model for predicting response to immunochemotherapy in EGFR-mutant lung adenocarcinoma patients

A CT-based habitat radiomics model was developed to predict immunochemotherapy outcomes in EGFR-mutant lung adenocarcinoma after TKI resistance.
The study included 475 patients, with 332 in the training cohort and 143 in the validation cohort, utilizing K-means clustering for tumor subregion analysis.
The combined model achieved an AUC of 0.904 in the training cohort and 0.890 in the validation cohort, outperforming other predictive models.
Kaplan–Meier analysis indicated significant survival differences, with high-risk groups showing shorter overall survival in both cohorts.
The model's high negative predictive value suggests potential to reduce unnecessary treatments in predicted non-responders, warranting further validation.

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Frontiers In Pediatrics

June 2, 2026

Case Report: Torque teno virus identified in pleural effusion of pediatric severe Mycoplasma pneumoniae pneumonia: diagnostic and therapeutic implications

Jiaxin Liang
Hanwei Ma
Yuanxiao Li
Xingxing Dai
Xingchuan Li
June 2, 2026

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Objective: To report two pediatric cases of severe Mycoplasma pneumoniae pneumonia (MPP) complicated by massive pleural effusion and to explore the diagnostic u

Mycoplasma pneumoniae pneumonia can lead to massive pleural effusion in 1%-20% of pediatric cases, requiring careful clinical management.
Targeted next-generation sequencing identified macrolide-resistant Mycoplasma pneumoniae and Torque teno virus in pleural effusion of two children.
Both pediatric patients recovered after closed thoracic drainage and adjusted anti-mycoplasma therapy based on resistance findings.
Torque teno virus detection in pleural fluid remains uncertain in clinical significance and may indicate immune perturbation rather than pathogenicity.
Broader pathogen testing in pleural fluid could enhance diagnostic evaluation in complex infections, warranting further controlled studies.

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Frontiers In Psychiatry

June 2, 2026

Colorism and eating disorders (ED) among BIPOC: expanding the skin tone trauma model to conceptualize a pathway

Ashley Acle
June 2, 2026

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Objective: To examine the relationship between colorism, skin tone trauma, and eating disorders (ED) among BIPOC populations, focusing on specific cultural fact

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Jama Network Open

June 2, 2026

Sexual Orientation–Related Discrimination Among LGB+ Medical Students With Disabilities

Zoie C. Sheets
Mytien Nguyen
Jasmine K.M. Lopez
Amy Addams
Christopher J. Moreland
Dowin Boatright
Lisa M. Meeks
June 2, 2026

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Objective: To examine experiences of discrimination based on sexual orientation at the intersection of LGB+ and disability identities among medical students. Ke

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Jama Network Open

June 2, 2026

Immigration Status and Time to Accessing Publicly Funded Flash Glucose Monitoring Systems

Mary N. Elias
Sara Allin
Joanna Yang
Maria Chiu
Baiju R. Shah
Fangyun Wu
Tara Gomes
June 2, 2026

Summary
Takeaways
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Poll

Objective: To examine the association between immigration status and time to access the flash glucose monitoring (FGM) system among Ontario residents with insul

Flash glucose monitoring (FGM) systems improve diabetes management by reducing hemoglobin A1c levels and self-monitoring blood glucose needs.
In Ontario, FGM systems were added to the Ontario Drug Benefit formulary in 2019, providing coverage for eligible insulin-requiring diabetes patients.
Barriers to accessing FGM systems exist for immigrants, particularly those recently arrived, due to financial constraints and lack of familiarity with the health system.
Individuals with lower income levels face additional out-of-pocket costs and information gaps that hinder their access to publicly funded drug programs.
The study aimed to investigate the impact of immigration status on the time taken to access FGM systems among eligible Ontario residents.

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