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Approval of New Patch Tests for the Diagnosis of Allergic Contact Dermatitis: An FDA Public Workshop

Rabin, Ronald L; Aquino, Marcella; Atwater, Amber Reck; Belsito, Donald; Brod, Bruce A; Chen, Jennifer; DeKoven, Joel; Ehrlich, Alison; Fonacier, Luz; Fowler, Joseph; Hamann, Curt; Lu, Yun; Mahler, Vera; Pacheco, Karin; Taylor, James S; Warshaw, Erin; Flamm, Alexandra; Yu, JiaDe
Contact dermatitis (CD) is the 5th most common skin disease1 and affects 15-20% of the general population over their lifetimes.2 Currently, the T.R.U.E. TEST® is the only FDA-approved diagnostic product to aid in the diagnosis of Allergic Contact Dermatitis. To address that diagnostic gap, the US Food and Drug Administration held a public workshop in October 2025. These proceedings summarize the workshop presentations and discussions.
PMID: 42844652
ISSN: 2162-5220
CID: 6073993

Temporal and transcriptional programming of effector memory B cells shapes vaccine platform-dependent humoral immunity

Nellore, Anoma; Fucile, Christopher; Scharer, Christopher D; Murray, Page; Geer, Jack T; Lemonds, Jacey; Mousseau, Betty; Zhou, Fen; Zumaquero, Esther; Akhter, Jobaida; Ivanova, Ellie; Navarro, Valeria Estrada; Goepfert, Paul A; Duerr, Ralf; Herati, Ramin S; Rosenberg, Alexander D; Lund, Frances E; Randall, Troy D
This study investigates how influenza vaccine platform shapes the memory B cell responses that underlie durable antibody protection. Using fluorescent hemagglutinin (HA) probes, the authors compared HA-specific IgD-negative B cells in adults who received either live attenuated influenza vaccine (LAIV) or inactivated influenza vaccine (IIV). Both platforms induced circulating T-bet+ HA+ B cells with similar phenotypic features, but their relationship to antibody outcomes diverged sharply: while these cells track with durable IgG responses after IIV, only early (day 7-14) T-bet+ HA+ B cell frequencies predicted durable IgA responses after LAIV. Single-cell transcriptional profiling further revealed that LAIV and IIV elicit distinct effector-memory B cell states, including an LAIV-enriched, terminally differentiated TBX21/ZEB2-high population with limited plasmablast recall potential. Together, these findings show that influenza vaccination drives platform-dependent diversification of HA-specific B cell states, highlighting the need for vaccine-platform-specific correlates of immune protection.
PMCID:13635500
PMID: 42835247
ISSN: 2589-0042
CID: 6073931

Cardiovascular magnetic resonance derived myocardial strain: applications, acquisition techniques, analysis, and reporting

Gulsin, Gaurav S; Ambale-Venkatesh, Bharath; Axel, Leon; Bluemke, David A; Captur, Gabriella; Cavalcante, João L; Ennis, Daniel B; Epstein, Frederick H; Gerber, Bernhard; Hanneman, Kate; Kawel-Boehm, Nadine; Kelle, Sebastian; Kramer, Christopher M; Lima, Joao A C; Lamb, Hildo J; Lu, Minjie; Marwick, Thomas H; Romano, Simone; Young, Alistair A; McCann, Gerry P
Myocardial strain imaging enables quantification of cardiac deformation. Cardiovascular magnetic resonance imaging (CMR) is well suited for strain assessment due to the ability to image in any given plane with high spatial and contrast resolution. CMR strain measures have incremental diagnostic and prognostic utility over conventional clinical imaging parameters across disease states. Routine integration of CMR strain assessment in clinical practice has been hindered by the lack of agreement on imaging protocols and analysis methods, variability due to noise sensitivity, and a paucity of robust normative age-, sex- and ethnicity-specific reference ranges. In recognition of the expanding applications of strain techniques in clinical and research CMR, this joint SCMR/RSNA/EACVI scientific statement integrates data from original research studies, guidelines, and opinions from experts across the field to guide responsible and evidence-based utilization of CMR strain.
PMID: 42851042
ISSN: 2047-2412
CID: 6074041

Temporal and transcriptional programming of effector memory B cells shapes vaccine platform-dependent humoral immunity

Nellore, Anoma; Fucile, Christopher; Scharer, Christopher D; Murray, Page; Geer, Jack T; Lemonds, Jacey; Mousseau, Betty; Zhou, Fen; Zumaquero, Esther; Akhter, Jobaida; Ivanova, Ellie; Navarro, Valeria Estrada; Goepfert, Paul A; Duerr, Ralf; Herati, Ramin S; Rosenberg, Alexander D; Lund, Frances E; Randall, Troy D
This study investigates how influenza vaccine platform shapes the memory B cell responses that underlie durable antibody protection. Using fluorescent hemagglutinin (HA) probes, the authors compared HA-specific IgD-negative B cells in adults who received either live attenuated influenza vaccine (LAIV) or inactivated influenza vaccine (IIV). Both platforms induced circulating T-bet+ HA+ B cells with similar phenotypic features, but their relationship to antibody outcomes diverged sharply: while these cells track with durable IgG responses after IIV, only early (day 7-14) T-bet+ HA+ B cell frequencies predicted durable IgA responses after LAIV. Single-cell transcriptional profiling further revealed that LAIV and IIV elicit distinct effector-memory B cell states, including an LAIV-enriched, terminally differentiated TBX21/ZEB2-high population with limited plasmablast recall potential. Together, these findings show that influenza vaccination drives platform-dependent diversification of HA-specific B cell states, highlighting the need for vaccine-platform-specific correlates of immune protection.
PMCID:13635500
PMID: 42835247
ISSN: 2589-0042
CID: 6073932

Outpatient step-up dosing of teclistamab and talquetamab in relapsed or refractory

Shah, Kunal; Forrest, Paul; Garg, Ananya; Kolluru, Pranav; Kaminetzky, David; Morgan, Gareth J; Braunstein, Marc; Lahoud, Oscar; Davies, Faith E
BACKGROUND:Bispecific T-cell-engaging antibodies against BCMA and GPRC5D demonstrate high efficacy in relapsed/refractory multiple myeloma (RRMM) but are associated with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), traditionally prompting inpatient monitoring when commencing therapy. Contemporary step-up dosing and prophylactic strategies may enable safe outpatient administration. PATIENTS AND METHODS/METHODS:We conducted a single-center retrospective study evaluating outpatient step-up dosing (SUD) of teclistamab or talquetamab in adults with RRMM. Patients met institutional outpatient eligibility criteria and received standard pre-medications; prophylactic tocilizumab was administered at physician discretion. The primary endpoint was incidence and severity of CRS/ICANS. Secondary endpoints included SUD completion, healthcare utilization, and need for hospitalization. RESULTS:Thirty-eight patients underwent 43 outpatient SUD initiations (teclistamab n = 30; talquetamab n = 13). Median age was 72 years, and disease burden was high. SUD completion occurred in 93%. CRS occurred in 26% of initiations and was exclusively grade 1-2; no grade ≥ 3 CRS occurred. One possible grade III ICANS event (2%) occurred after completion of SUD. CRS incidence was similar with and without prophylactic tocilizumab (29% vs 32%). Most events occurred during the first two step-up doses. Hospitalization occurred in 5 (12%) SUD initiations for CRS/ICANS events and overall healthcare utilization was modest. CONCLUSION/CONCLUSIONS:Outpatient administration of teclistamab and talquetamab SUD in RRMM is feasible and safe with low rates of low-grade CRS. Toxicities occur early and are manageable with structured monitoring, supporting outpatient delivery in appropriately selected patients.
PMID: 42837800
ISSN: 1873-5835
CID: 6073941

Medicare and Bureau of Health Workforce and Funded Primary Care Residency Positions

Hayes, Rachael W; Dapkins, Isaac P
PMID: 42832212
ISSN: 1538-3598
CID: 6073890

Pancreatic Cancer KRAS Breakthrough: Drug Graveyard No More

Yu, Peter Y; Oberstein, Paul E; Maitra, Anirban; Hidalgo, Manuel
Pancreatic ductal adenocarcinoma (PDAC) remains a highly lethal malignancy and has long been regarded as a therapeutic "drug graveyard", with modest gains from cytotoxic combination chemotherapy and numerous novel agents failing to show benefit in clinical trials. The quest to directly target RAS has moved from concept to reality with the FDA approval of daraxonrasib (Rasonque) for adults with metastatic PDAC who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. Here we discuss a wave of clinical trials that are poised to change this narrative and usher in the era of RAS-targeted therapy. Given the flood of compounds and combinations, we focus on therapies that have advanced to phase 3 clinical trials. Collectively, these studies demonstrate how RAS-targeted therapies are poised to transform the PDAC treatment landscape. The current generation of trials will determine whether these emerging strategies can translate into durable survival gains and turn PDAC from a "drug graveyard" into a drug haven for novel therapies.
PMCID:13644853
PMID: 42836735
ISSN: 1557-3265
CID: 6073935

Public Awareness and Perceptions of Stem Cell Therapy for Stroke: A Cross-Sectional Survey Study

Kumar, Shreya P; Kumar, Prasanna V
Background Stroke remains a leading cause of death and long-term disability. Although stem cell-based approaches are being investigated as possible regenerative strategies for stroke, public perceptions of their potential benefits, risks, mechanisms, and clinical use are not well-characterized. This exploratory survey described responses to an investigator-developed questionnaire about stem cell therapy for stroke. Methods A 10-item cross-sectional questionnaire was distributed electronically through Google Forms (Google, Inc., Mountain View, CA) to 36 individuals in a convenience sample; 26 completed questionnaires were received (response rate: 72.2%). The questionnaire was investigator-developed and was not validated as a measure of factual knowledge, clinical efficacy, or safety. Responses were categorized as "yes," "no," or "maybe"; one item used time-based response categories. Counts and percentages were calculated using the total number of completed questionnaires as the denominator. The survey was independently conducted as a student-led summer academic project and did not undergo review by an institutional review board, school ethics committee, or independent ethics authority. Results Twenty-six responses were analyzed. For the item asking whether embryonic stem cells are effective in stroke treatment, eight respondents (30.77%) selected "yes," 16 (61.54%) selected "maybe," and two (7.69%) selected "no." For the item asking whether stem cell treatment has advantages for stroke, 21 respondents (80.77%) selected "yes," four (15.38%) selected "maybe," and one (3.85%) selected "no." "Maybe" was the majority or joint-most-frequent response for six of 10 items, including items about animal testing, adverse effects, alternative regenerative treatments, and use during pregnancy. Conclusions In this small convenience sample, responses to an investigator-developed questionnaire suggested favorable perceptions of possible benefits of stem cell therapy for stroke, alongside frequent uncertainty about safety, mechanisms, the timing of improvement, and use in special populations. Because the questionnaire was not validated as a factual-knowledge instrument, findings should be interpreted strictly as descriptive perceptions rather than as evidence of respondents' medical knowledge, treatment confidence, or the clinical efficacy or safety of stem cell therapy. Larger studies using validated instruments and representative sampling are needed.
PMCID:13634582
PMID: 42831189
ISSN: 2168-8184
CID: 6073881

Cardiovascular magnetic resonance derived myocardial strain: applications, acquisition techniques, analysis, and reporting

Gulsin, Gaurav S; Ambale-Venkatesh, Bharath; Axel, Leon; Bluemke, David A; Captur, Gabriella; Cavalcante, João L; Ennis, Daniel B; Epstein, Frederick H; Gerber, Bernhard; Hanneman, Kate; Kawel-Boehm, Nadine; Kelle, Sebastian; Kramer, Christopher M; Lima, Joao A C; Lamb, Hildo J; Lu, Minjie; Marwick, Thomas H; Romano, Simone; Young, Alistair A; McCann, Gerry P
Myocardial strain imaging enables quantification of cardiac deformation. Cardiovascular magnetic resonance imaging (CMR) is well suited for strain assessment due to the ability to image in any given plane with high spatial and contrast resolution. CMR strain measures have incremental diagnostic and prognostic utility over conventional clinical imaging parameters across disease states. Routine integration of CMR strain assessment in clinical practice has been hindered by the lack of agreement on imaging protocols and analysis methods, variability due to noise sensitivity, and a paucity of robust normative age-, sex- and ethnicity-specific reference ranges. In recognition of the expanding applications of strain techniques in clinical and research CMR, this joint SCMR/RSNA/EACVI scientific statement integrates data from original research studies, guidelines, and opinions from experts across the field to guide responsible and evidence-based utilization of CMR strain.
PMID: 42851042
ISSN: 2047-2412
CID: 6074040

Approval of New Patch Tests for the Diagnosis of Allergic Contact Dermatitis: An FDA Public Workshop

Rabin, Ronald L; Aquino, Marcella; Atwater, Amber Reck; Belsito, Donald; Brod, Bruce A; Chen, Jennifer; DeKoven, Joel; Ehrlich, Alison; Fonacier, Luz; Fowler, Joseph; Hamann, Curt; Lu, Yun; Mahler, Vera; Pacheco, Karin; Taylor, James S; Warshaw, Erin; Flamm, Alexandra; Yu, JiaDe
Contact dermatitis (CD) is the 5th most common skin disease1 and affects 15-20% of the general population over their lifetimes.2 Currently, the T.R.U.E. TEST® is the only FDA-approved diagnostic product to aid in the diagnosis of Allergic Contact Dermatitis. To address that diagnostic gap, the US Food and Drug Administration held a public workshop in October 2025. These proceedings summarize the workshop presentations and discussions.
PMID: 42844652
ISSN: 2162-5220
CID: 6073994