Tag: News Approved

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STAT+: Pharmalittle: We’re reading about a Novartis acquisition, Republicans backing clinical trial diversity, and more

Good morning, and welcome to a new week from STAT’s London outpost, with Andrew Joseph here filling in for Mr. Pharmalot. This country is celebrating its World Cup win last night (or rather, very early this morning local time — lots of bleary-eyed people out in the neighborhood today), and I can only hope that the U.S. will be in the same place tomorrow. Yet the World Cup (and Wimbledon) can’t completely distract from the news of the day, so onto the headlines we go. … 

Novartis is pushing deeper into antibody-drug conjugate development, paying $1.1 billion upfront to buy Myricx Bio for a pipeline based on a novel payload, Fierce Biotech writes. The Swiss pharma company has been slower to buy into ADCs than some of its peers, but it’s made its move with London-based Myricx, which is designing cancer treatments that deliver N-myristoyltransferase inhibitor (NMTi) payloads. It’s a bit of a different approach from other ADCs, which Novartis predicts could tackle resistance and other limitations of existing payloads, broadening the use of ADCs across multiple tumor types. 

While clinical trials got caught up in the Trump administration’s attack on policies related to diversity, equity, and inclusion, congressional Republicans would like to change that, STAT says. Last month, the Republican-controlled House passed a bill, mostly along party lines, to fund the Food and Drug Administration that was accompanied by a report that, while not legally binding, tells agency officials what congressional appropriators expected of them. The report states that it wants the FDA to continue implementing a law that requires companies to give the FDA their plans for diversifying clinical trials.

Continue to STAT+ to read the full story…

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Augmented reality-based fine arts education experiences and adolescents’ perceived reduction in depressive symptoms: a self-report study of associations with psychological resilience, rumination, and emotional regulation

As depressive symptoms among adolescents continue to rise, increasing attention has been directed toward educational contexts that may support psychological well-being. Augmented reality, characterized by immersive, interactive, and multisensory affordances, has been increasingly incorporated into fine arts education. However, it remains insufficiently understood how adolescents’ perceived AR-based fine arts education experiences are associated with psychological resilience, emotional regulation, perceived reduction in rumination, and perceived reduction in depressive symptoms. Using post-course self-report questionnaire data from 518 Chinese adolescents, this study tested a cross-sectional associational model with structural equation modeling, without making causal or clinical claims. The empirical results indicate that adolescents’ perceived AR-based fine arts education experiences were positively associated with self-reported perceived reduction in depressive symptoms. Additionally, these experiences were positively associated with self-reported psychological resilience and perceived reduction in rumination. Self-reported psychological resilience and perceived reduction in rumination were positively associated with self-reported emotional regulation, and this regulation was positively associated with self-reported perceived reduction in depressive symptoms. These findings support a correlational psychological model linking perceived AR-based fine arts education experiences with adolescents’ self-reported psychological perceptions and perceived reduction in depressive symptoms. Theoretically, this study contributes to the literature on arts education, educational technology, and adolescent mental health. Practically, the findings suggest that immersive art-learning environments may be perceived by adolescents as supportive contexts for psychological resources. The innovation of this study lies in reframing AR-based fine arts education experiences as psychologically meaningful educational experiences associated with adolescents’ self-reported psychological perceptions
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Neurophysiological effects of transcranial alternating current stimulation combined with multidisciplinary rehabilitation in Parkinson’s disease

IntroductionMotor impairment in Parkinson’s disease (PD) often becomes inadequately controlled as the disease progresses. Rehabilitation therapy combined with noninvasive neuromodulation has shown benefits, yet the neural mechanisms underlying this remain unclear. This study aimed to identify neurophysiological and brain network features associated with motor improvement following high-intensity transcranial alternating current stimulation (Hi-tACS) combined with multidisciplinary intensive rehabilitation therapy (MIRT).MethodsThis secondary analysis was based on a randomized controlled trial (ChiCTR2300071969). Thirty patients receiving Hi-tACS combined with MIRT were included. Responders were defined as patients achieving a minimal clinically important difference improvement greater than 3.25 points on the Unified Parkinson’s Disease Rating Scale part III. Electroencephalographic spectral analysis, resting-state functional connectivity, and dynamic brain states assessed using hidden Markov modeling were performed. Partial correlation analyses were conducted for group-differentiating measures, controlling for age and disease duration.ResultsCompared with non-responders, responders showed increased temporal high beta frequencies relative power (95%CI 0.85(0.01–1.66), P = 0.047), reduced connectivity between the default mode and sensorimotor networks (95%CI -0.89(-1.71–0.05), P = 0.038), and decreased fractional occupancy of state 3 (95%CI 0.03(0.00–0.28), P = 0.033) and 6 (95%CI 0.02(0.00–0.35), P = 0.038). After Bonferroni correction, only changes in temporal high beta frequencies relative power were negatively correlated with changes in total UPDRS part III scores (R = -0.59, PBON = 0.012) and rigidity subscores (R = -0.74, PBON < 0.001).DiscussionThese results suggest that motor improvement following combined Hi-tACS and MIRT in PD patients is associated with alterations in brain oscillations and network connectivity, particularly in high-beta frequencies. The findings contribute to understanding the neural mechanisms underlying rehabilitation and neuromodulation in PD. Future studies should investigate the long-term effects of this intervention and its applicability in larger, more diverse populations. Moreover, exploring additional biomarkers may help identify individuals who are most likely to respond to this treatment.Clinical Trial Registrationhttps://www.chictr.org.cn, identifer ChiCTR2300071969.
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Disrupted self-referential processing and empathy-based interventions in mental disorders: neural mechanisms, cognitive biases, and therapeutic integration

Self-referential processing (SRP), the mental activity of linking experiences and stimuli to the self, is fundamental to shaping identity, regulating affect, and navigating complex social environments. Disruptions in SRP are increasingly recognized as a transdiagnostic hallmark across psychiatric disorders, including schizophrenia spectrum disorders, major depressive disorder, and anxiety disorders. Such disruptions often manifest as distorted self-perception, negative cognitive-affective biases, and dysfunctional connectivity within key neural networks, particularly the default mode network (DMN) and the medial prefrontal cortex (mPFC). Emerging evidence reveals a dynamic bidirectional relationship between SRP and empathy. Impairments in self-processing may hinder the capacity to accurately infer others’ emotional and cognitive states, while deficits in empathic attunement may reinforce maladaptive self-focus. This interplay contributes to social withdrawal, interpersonal dysfunction, and emotional dysregulation across diagnostic boundaries. Recent therapeutic advances suggest that interventions targeting the interface between SRP and empathy may effectively modulate shared neurocognitive mechanisms. Such interventions include metacognitive therapy, mindfulness-based interventions, and psychedelic-assisted psychotherapy. These therapeutic approaches show preliminary but promising evidence for reducing maladaptive self-focused attention, enhancing emotion regulation, and improving social functioning. This review synthesizes empirical evidence regarding the neural underpinnings of SRP, delineates disorder-specific alterations in self-referential processing, and examines the bidirectional interplay between SRP and empathic functioning. We further outline a conceptual framework for empathy-based interventions targeting SRP dysfunction and propose future directions for precision psychiatry research. Emphasis is placed on developing personalized, mechanism-driven therapeutic strategies informed by computational modeling, transdiagnostic biomarker identification, and digital therapeutic platforms.
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Preliminary testing of a prespecified liability architecture for autism: theory-guided pathogenetic triad models outperform strength-matched alternatives

BackgroundNeuropsychiatric conditions are heterogeneous and mechanistically diverse, yet predictive modeling studies commonly aggregate features without evaluating prespecified liability architectures. The Pathogenetic Triad (PT) is a multilevel framework proposing that diagnostic outcomes reflect the joint configuration of a trait-related domain, cognitive capacity (CC), and neuropathological burden (NB). In autism, the trait-related domain corresponds to autistic personality (AP). We evaluated this framework using out-of-sample prediction as a structured empirical test of architectural coherence rather than as a purely data-driven exercise in classification.MethodsWe analyzed a case–comparison cohort (n = 42, 21 autistic) with dense multimodal characterization, including behavioral phenotyping, psychometric measures, autonomic physiology, structural MRI morphometry, and magnetoencephalographic indices. AP was indexed by the Autism-Spectrum Quotient, CC by Wechsler’s scales of intelligence, and NB by heart-rate variability as a proxy indicator. This multimodal structure enabled direct comparison of theory-constrained PT models with strength-matched, domain-restricted atheoretical combinations. Predictive discrimination was evaluated using leakage-free nested cross-validation with permutation inference.ResultsAcross multiverse specifications, low-dimensional PT models ranked among the strongest models of comparable size and achieved discrimination broadly comparable to higher-dimensional models within this dataset. Matched comparisons indicated that including all three PT domains was associated with systematic advantages relative to alternatives with similar univariate input strength, consistent with complementary configurational information relating to case status.ConclusionsThese findings provide preliminary evidence supporting the Pathogenetic Triad as a multilevel architecture of autism liability. Although based on a small and demographically restricted cohort, this densely characterized dataset permitted explicit comparison of theory-guided and atheoretical model spaces. The results illustrate how prespecified multilevel frameworks can be operationalized and empirically evaluated in neuropsychiatric samples.