Objective: The article examines the objective, findings, and clinical context described in FDA adds generic valganciclovir oral solution. Approach: Approval: FD
The FDA granted final ANDA approval to Alembic Pharmaceuticals for generic valganciclovir oral solution, 50 mg/mL.
The generic is therapeutically equivalent to Valcyte for Oral Solution, the reference-listed product held by CHEPLAPHARM Arzneimittel GmbH.
Valganciclovir is indicated to treat CMV retinitis in adults with AIDS and prevent CMV disease in high-risk kidney, heart, and kidney-pancreas transplant recipients.
The reference product labeling includes CMV prophylaxis for pediatric kidney transplant recipients aged 4 months to 16 years and heart transplant recipients aged 1 month to 16 years.
Valganciclovir carries boxed warnings for hematologic toxicity, impaired fertility, fetal toxicity, mutagenesis, and carcinogenesis; labeling recommends monitoring blood counts and renal function.
Objective: To describe the use of F-18–DPA714 PET/MRI to assess neuroinflammation in a patient with anti-vimentin IgG-associated autoimmune encephalitis and unr
A man in his late 40s with anti-vimentin IgG–associated autoimmune encephalitis had neurologic symptoms despite initially unremarkable cranial and cervical MRI findings.
CSF testing detected anti-vimentin IgG and type III oligoclonal bands, while serum anti-vimentin IgG testing was negative.
F-18–DPA714 PET/MRI showed elevated tracer uptake in the mesial temporal lobe, frontal lobes, and brainstem despite no characteristic MRI abnormalities.
At 3 months, tracer uptake decreased and gait and numbness improved after IVIG induction and ofatumumab maintenance; the report could not determine each treatment’s contribution.
The single-patient report and 3-month follow-up do not establish PET/MRI diagnostic performance, long-term outcomes, or ofatumumab’s independent effectiveness.
A 30-year-old woman had multiple rim-enhancing brain lesions on routine MRI despite no initial fever, pulmonary symptoms, or neurologic abnormalities.
The MRI findings suggested toxoplasmosis or neurocysticercosis, but chest CT showed bilateral 1- to 3-mm pulmonary nodules consistent with miliary tuberculosis.
Sputum PCR detected Mycobacterium tuberculosis complex DNA, whereas sputum cultures and CSF tuberculosis PCR were negative and CSF analysis was unremarkable.
The researchers diagnosed probable parenchymal CNS tuberculosis with miliary pulmonary tuberculosis and treated the patient with antituberculosis drugs and adjunctive corticosteroids.
After 12 months of therapy, brain lesions regressed, and complete clinical and radiologic remission was documented 12 months after treatment.
Objective: To examine associations between anxiety, depressive symptoms, physical activity, and self-reported cognitive difficulties during pregnancy and early
In a longitudinal study of 56 pregnant women, higher anxiety symptoms were associated with more self-reported cognitive difficulties during pregnancy and about 6 weeks postpartum.
Higher depressive symptoms were associated with greater cognitive difficulties, with a significant difference in total cognitive failures postpartum but not during pregnancy.
Meeting physical activity guidelines was not independently associated with statistically significant differences in cognitive functioning.
Prenatal physical activity modified the association between depressive symptoms and cognitive failures, which increased more slowly among women meeting activity guidelines.
The small observational study relied on self-reported measures and cannot establish that physical activity improves cognition or that mood symptoms cause cognitive failures.
Aleš Ryška became chair of the pathology department at age 36 after his predecessor reached the mandatory retirement age and Ryška was the only potential internal candidate.
Ryška had no formal leadership training; he drew on Boy Scout experience and advice from his predecessor, who remained in the department after stepping down.
To preserve his diagnostic and clinical work amid increased administrative duties, Ryška reduced his research activities, a decision he still regrets.
Ryška adopted a democratic approach, discussing proposed changes with the team and avoiding major reforms because the department was functioning well.
He reorganized pathology coverage by creating small specialist groups for lower-volume areas and distributing high-demand work across staff, making the department more flexible.
Objective: To describe variation in morphology, immunohistochemical findings, and clinical course in two patients with pulmonary NUT carcinoma. Approach: Cases:
Two pulmonary NUT carcinomas showed markedly different morphology and immunohistochemical profiles despite sharing the same diagnosis.
One tumor had prominent squamous differentiation and AE1/AE3 and CAM5.2 positivity, whereas the other had only small squamous foci, limited AE1/AE3 staining, and no CAM5.2 staining.
Both tumors expressed p63 and p40, and NUT immunostaining confirmed the diagnosis in each case.
Both patients developed aggressive metastatic disease and died within 5 months to 1 year despite treatment.
The authors stated that negative keratin staining or inconspicuous squamous differentiation does not exclude NUT carcinoma and that diagnosis relies on NUT immunohistochemistry or molecular testing.
Objective: To assess whether exposure to anti-CGRP monoclonal antibodies or propranolol was associated with spontaneous abortion among pregnancies in patients w
In a retrospective cohort of 7,579 pregnancies among patients with pregestational migraine, 1,862 spontaneous abortions occurred by 20 weeks.
Anti-CGRP monoclonal antibody exposure was associated with a 42% higher adjusted hazard of spontaneous abortion.
The estimated risk by 20 weeks was 28.7% under a hypothetical scenario of universal anti-CGRP exposure and 24.5% without exposure.
Propranolol exposure was not associated with an increased hazard of spontaneous abortion, including after bias adjustment for migraine severity.
The observational study could not establish causality, and claims data, residual confounding, and limited exposed pregnancies constrained interpretation.
A conceptual synthesis in Evolution and Human Behavior examined whether magical practices reflect genuine belief or other attitudes, including imagination, symbolism, and make-believe.
The researchers argued that neither genuine belief nor non-doxastic commitment should be treated as the default explanation for magical practice.
Seeking magical help for consequential problems, choosing shamans with better track records, and changing methods after failures were cited as evidence of genuine belief.
Ethnographic examples showed that some people participate in magical rituals despite skepticism, potentially because of social obligations or a desire to hedge against possible efficacy.
The authors proposed a heterogeneous account of attitudes but said available evidence cannot establish how common each attitude is or reliably classify individual practitioners.
Objective: To evaluate whether Diagnostic Orchestrator (DxO), an AI system that selects tests and updates diagnoses as evidence emerges, can improve diagnostic
Diagnostic Orchestrator (DxO) uses large language models to ask questions, request tests, and refine diagnoses as evidence emerges.
In 304 clinicopathological cases, DxO achieved 83% diagnostic accuracy, compared with 36% among physicians with reference materials.
In 325 emergency department encounters, DxO achieved 80% accuracy, compared with 47% among physicians.
For clinicopathological cases, DxO achieved 81% accuracy at an estimated testing cost of $2,241, versus $4,725 for physicians achieving 36% accuracy.
The evaluation used controlled, text-based cases and estimated testing costs, excluding factors such as imaging, pathology slides, incomplete records, and multidisciplinary decisions.
Øystein Soug leads Oncoinvent after a career spanning military training, finance roles in Russia and China, and more than a decade as a CFO.
Oncoinvent is developing Radspherin, a receptor-independent alpha-emitting radiopharmaceutical for cancers that have spread to the abdominal cavity.
Radspherin is delivered directly into the peritoneum to concentrate radiation around residual cancer cells while limiting exposure elsewhere in the body.
Soug discusses lessons from helping bring Xofigo to market and identifies manufacturing and supply chains as persistent radiopharmaceutical challenges.
Soug also discusses new isotopes, delivery methods, combination strategies, Oslo’s radiopharmaceutical sector, and the practical demands of leadership.
A preclinical prime-editing platform engineered therapeutic T cells to resist tacrolimus while remaining sensitive to cyclosporin.
In T cells from 3 patients with HAVCR2-associated lymphoma, prime editing corrected the pathogenic variant in 18.7% to 35.8% of cells and restored TIM-3 expression in up to 44.4%.
In humanized mice, tacrolimus selection increased corrected HAVCR2 sequences to an average of 76.8% of spleen reads after 8 weeks, compared with 9.3% without selection.
Tacrolimus-exposed, edited CD19-directed CAR T cells retained viability, proliferation, and tumor-killing activity, and maintained tumor control in mice with CD19-positive tumors.
The researchers also tested edits for resistance to methotrexate and mycophenolate, with resistance varying by edit.
Objective: To develop a scalable platform for expanding and genetically engineering granulocyte-monocyte progenitors (GMPs) for potential CAR-based cancer immun
Objective: Review the development, applications, strengths, and remaining challenges of comprehensive two-dimensional gas chromatography (GC×GC), as presented i
GC×GC has matured from a specialist technique into a tool used across fields including fuels, environmental monitoring, food, forensics, metabolomics, and breath analysis.
GC×GC’s central strength is separating compounds that co-elute in one-dimensional chromatography, revealing minor constituents hidden beneath larger peaks.
Its structured two-dimensional plots support interpretation in applications such as process monitoring, clinical research, and regulatory testing.
The main barriers have shifted from instrumentation to operator training, time-consuming data processing, and a lack of standardized formats and procedures.
GC×GC is not necessary for every analysis; users should choose it when the analytical question requires resolving co-eluting compounds and its added information justifies the complexity.
Objective: Review developments in dual-comb spectroscopy in the mid-infrared and terahertz regions and compare technologies used to generate frequency combs. Ap
Dual-comb spectroscopy uses two optical frequency combs with slightly different pulse rates to convert optical spectra into electronically measurable radio frequencies.
The technique can acquire detailed spectra rapidly, with high spectral resolution and precise frequency measurements, without moving components used in some conventional instruments.
Mid-infrared spectra capture strong molecular vibrations, while terahertz spectra reveal molecular rotations, weak intermolecular interactions, and collective motions in solids.
The review compared comb-generation technologies and described applications in gas analysis, environmental monitoring, combustion studies, and research on biological materials.
Biomedical applications remain at the research stage, and technical barriers include limited spectral coverage, detector noise, cooling, alignment, complexity, and coherence maintenance.
Objective: To assess whether Raman spectroscopy with spectral barcoding can distinguish RNA from SARS-CoV-2 variants and subvariants. Approach: Samples: Researc
Raman spectroscopy with spectral barcoding distinguished RNA from 20 SARS-CoV-2 variants and subvariants in a laboratory study.
Researchers extracted viral RNA from cell-culture supernatants and analyzed spectra collected with a confocal Raman spectrometer using a 532-nm laser.
The Raman barcodes differed across all 20 samples, whereas principal component analysis distinguished only some strains.
Raman signals reflected RNA structural features, including backbone conformation, base pairing, and secondary structure, rather than identifying individual nucleotide substitutions.
The proof-of-concept study used purified RNA, and recognition of unseen variants and performance with clinical specimens remain untested.
Objective: Report corrections made to the Original Investigation “Lancet Definition vs Other Criteria for Obesity Diagnosis in Adults.” Approach: Results: Place
This first-event self-controlled case series used Hong Kong public health records to assess metabolic abnormalities after antipsychotic initiation in patients aged 6 to 17 years.
Among 15,219 antipsychotic initiators, 497 developed metabolic abnormalities: 115 had hyperglycemia and 447 had dyslipidemia.
Compared with baseline periods, metabolic abnormality incidence was elevated on days 8 to 30 after initiation (IRR, 5.60; 95% CI, 2.93-10.70) and peaked on days 31 to 90 (IRR, 7.71; 95% CI, 5.15-11.55
Incidence remained elevated after 90 days of initial exposure (IRR, 3.94; 95% CI, 2.91-5.33) and during subsequent exposure episodes (IRR, 3.71; 95% CI, 2.51-5.49).
The authors cautioned that increased testing near treatment initiation, delayed detection of preexisting abnormalities, and residual time-varying confounding may have influenced the observed patterns.
Objective: The article examines the objective, findings, and clinical context described in Sleeve and Holster Skin Signs Associated With Dermatomyositis. Approa
A 76-year-old woman with anti-NXP-2-positive dermatomyositis had progressive extremity erythema, proximal weakness, dysphagia, and dysphonia.
Examination showed bilateral erythematous lesions on the lateral upper arms and erythematous-violaceous lesions on the lateral thighs.
Other findings included posterior neck, forehead, and dorsal hand erythema, dilated nailfold capillaries, elevated creatine kinase, and muscle MRI abnormalities.
The sleeve sign affects the lateral upper arms, and the holster sign affects the lateral hips and proximal thighs; both are typically bilateral and symmetric.
Neither sign is pathognomonic, but both are characteristic of dermatomyositis; the holster sign occurs in 40% to 51% of adults, while the sleeve sign is uncommon.