Tag: Clinical trial

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New €25 Million BioReliance Testing Facility Opens at Merck KGaA Global Headquarters in Germany

MilliporeSigma opened a new €25 million BioReliance® testing facility at the company’s global headquarters in Darmstadt, Germany. The facility expands access to commercial drug substance and drug product release testing as well as stability testing for biopharmaceutical companies developing and commercializing therapies in Europe, according to the company.

“As demand for biologics and novel therapies continues to grow, our customers need reliable, compliant testing capabilities closer to where their products are developed and commercialized,” said Paolo Carli, head of advanced solutions for the life science business of Merck KGaA. “Our new testing facility combines best-in-class analytical characterization services with more than 75 years of BioReliance expertise to help our European customers move critical therapies toward patients with greater speed and confidence.”

The 2,000-square-meter facility is designed to help customers meet European requirements for in-region drug substance and drug product release testing and to expand the company’s ability to support customers from drug development through commercialization. The site will also offer GMP-compliant stability studies for monoclonal antibodies and cell therapies, addressing the growing demand for biologics testing across Europe.

Located close to major clinical trial sites in Germany, France, Spain, the Netherlands, Belgium and Italy, the Darmstadt facility is strategically positioned to support biopharmaceutical companies seeking to release drug products into European markets, pointed out Carli. By adding these capabilities in the heart of Europe, the company is strengthening its support for customers managing increasingly complex development, quality and regulatory requirements, he added.

A MilliporeSigma spokesperson noted that the BioReliance sites form a global testing network that allows customers to scale across geographies and work with the company across continents. Among the company’s leading technologies is the Blazar® platform, which moves the biosafety testing paradigm from traditional methods to rapid molecular approaches to significantly reducing testing timelines for virus detection.

The Aptegra® CHO genetic stability testing streamlines a previously complex and time-intensive process into a single assay, continued the spokesperson.

MilliporeSigma lists the opening of the Darmstadt facility as one of several significant investments the company has made to grow its global contract testing footprint. In 2024, the company opened a €290 million biosafety testing facility in Rockville, MD, and expanded biosafety testing capacity by 40% across its Glasgow and Stirling sites through a €22 million investment. The company also cites the new BioReliance facility as reflecting the firm’s continued commitment to its global headquarters in Darmstadt, where €2.5 billion has been invested since 2015.

The post New €25 Million BioReliance Testing Facility Opens at Merck KGaA Global Headquarters in Germany appeared first on GEN – Genetic Engineering and Biotechnology News.

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<![CDATA[Oral THC/CBD combo rapidly eases severe dementia agitation in phase 2 trial, with sustained 12-week benefit and similar safety to placebo.]]>
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Englumafusp alfa plus glofitamab in B cell non-Hodgkin lymphoma: a phase 1 trial

Nature Medicine, Published online: 16 July 2026; doi:10.1038/s41591-026-04533-0

Combining the CD19–4-1BBL co-stimulatory molecule englumafusp alfa with the bispecific antibody glofitamab in patients with relapsed or refractory aggressive B cell non-Hodgkin lymphoma showed acceptable safety signals and encouraging preliminary clinical responses, with mechanistic data supporting the rational choice of therapy.

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A Self-Guided Mobile Mindfulness Intervention Embedded in Daily Routines for Adults With Mild to Moderate Psychological Distress: Randomized Controlled Trial

Background: Mobile mindfulness interventions have shown promise for reducing anxiety and depressive symptoms, but sustaining engagement remains a persistent challenge. Many digital programs still rely on formal practice that requires dedicated time, which may be difficult to integrate into daily life. Objective: This randomized controlled trial evaluated Habitual Mindfulness Practice (HMP), a self-guided mobile mindfulness intervention that embeds brief practices into recurring daily routines, among adults with mild to moderate psychological distress. Outcomes were compared with those of Traditional Mindfulness (TM), Mindfulness-Based Psychoeducation (MBP), and a waitlist control (WL). Methods: Adults aged 18 to 65 years with mild to moderate symptoms of anxiety or depression were randomly assigned in a 1:1:1:1 ratio to HMP, TM, MBP, or WL (N=686). All procedures were conducted online, and the intervention was fully self-guided, with outcomes assessed using self-report measures. The intervention lasted 21 days, with assessments conducted at baseline, postintervention, and 3-month follow-up. Primary outcomes were depressive and anxiety symptoms. Secondary outcomes included mindfulness, cognitive emotion regulation, affective balance, and interpersonal difficulties. Postintervention group differences were examined, controlling for baseline scores, and longitudinal trajectories were evaluated across the active intervention conditions. Results: At postintervention, significant group effects were observed for depressive symptoms (=28.67, <.001, ηp²=0.11) and anxiety symptoms (=30.11, <.001, ηp²=0.12). Both HMP and TM showed lower depressive and anxiety symptom scores than MBP and WL. TM showed lower postintervention anxiety than HMP (=.04), whereas depressive symptoms did not differ significantly between HMP and TM (=.63). The mindfulness practice conditions also showed more favorable postintervention outcomes for mindfulness, affective balance, interpersonal difficulties, and emotion regulation. Improvements in depressive and anxiety symptoms were generally maintained at follow-up among the active intervention conditions, although maintenance of secondary outcomes varied across measures. Postintervention outcome data were available for 55.2% (379/686) of randomized participants, and follow-up outcome data were available for 24.1% (124/515) of participants in the active intervention conditions. HMP and TM did not differ significantly in practice duration, engagement, or satisfaction. Conclusions: A routine-embedded, self-guided mobile mindfulness intervention may be a feasible approach for reducing mild to moderate psychological distress. HMP produced benefits broadly comparable to those of traditional app-delivered mindfulness, but it did not confer advantages in engagement or short-term efficacy. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400093771; https://tinyurl.com/3d6tky8v
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enDigital Postpartum Support for Early Risk Identification Among Postpartum Women: Formative Randomized Evaluation and Exploratory Predictive Modeling Study

Background: The postpartum period represents a critical window for maternal health, yet many individuals lack sustained support and timely identification of physical and mental health risks. Digital health interventions offer a scalable approach to extend care beyond clinical settings. Yet, key elements, including real-world challenges, usability, and effectiveness of such platforms, are insufficiently characterized in this literature. Objective: This study aimed to conduct a formative randomized evaluation to assess the feasibility, engagement, and preliminary signals of impact of the Joyuus platform and to examine the potential for early identification of postpartum health risks. Methods: We conducted a 12-week randomized evaluation with postpartum participants recruited through community-based organizations. Participants were randomized to either the Joyuus intervention or standard postpartum care. Primary and secondary outcomes included the Barkin Index of Maternal Functioning, the Edinburgh Postnatal Depression Scale (EPDS), the State-Trait Anxiety Inventory, and the Connor-Davidson Resilience Scale. Analyses were conducted using an intention-to-treat approach with linear regression models adjusting for baseline values. Engagement metrics (ie, sessions, time on site, and feature use) were captured through in-app analytics. An exploratory predictive model was developed using baseline clinical, behavioral, and demographic variables to identify individuals at risk for postpartum depression. Results: Baseline characteristics were generally balanced across arms, and no statistically significant differences were observed in education, income, or marital status. No statistically significant differences were found between treatment and control groups in the 12-week changes for the primary or secondary outcomes. Mean EPDS scores were 9.7 in the intervention group and 9.3 in the control group. In the sample, 60 (45.5%) of the 132 participants met the criteria for elevated depression (EPDS score ≥11 or a positive response to question 10 on self-harm), indicating a high burden of symptoms within the study population. Engagement with the platform was highest during the first 4 weeks. Among intervention participants, 80% created an account. Participants reported high levels of perceived usefulness, ease of use, and relevance of content. Qualitative analysis of open-ended survey responses highlighted limited awareness of postpartum-specific resources and a preference for simple, accessible information. An exploratory predictive model demonstrated a recall of 0.89 and a precision of 0.73 in identifying individuals at risk for postpartum depression, suggesting the feasibility of early risk identification using integrated data inputs. Conclusions: Joyuus demonstrated feasibility and acceptability but did not produce statistically significant improvements in maternal functioning or maternal health outcomes over 12 weeks. Joyuus identified high rates of depressive symptoms and early engagement patterns, which suggest an opportunity for earlier identification of risk and intervention during the postpartum period. Exploratory modeling results indicate the potential for data-driven approaches to support earlier detection. Future work includes optimizing engagement strategies and expanding validation of predictive detection to improve postpartum surveillance and outcomes. Trial Registration: ClinicalTrials.gov NCT05876559; https://clinicaltrials.gov/study/NCT05876559?cond=postpartum%20joyuus&viewType=Card&rank=1
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Specialist Rehabilitation Providers’ Experiences With an Online Self-Compassion Course: Reflexive Thematic Analysis

Background: Rehabilitation health care providers (HCPs) report high levels of burnout. Self-compassion interventions have shown beneficial effects on HCP burnout, but they have never been explored in specialist rehabilitation settings where challenges may differ. Objective: This study aimed to explore the experiences of specialist rehabilitation HCPs with an online Self-Compassion for Healthcare Communities (SCHC) course aimed at providing tools to regulate emotional well-being, including burnout. Methods: Semistructured qualitative interviews (n=20) with specialist rehabilitation HCPs were used to explore experiences with the SCHC course. A reflexive thematic analysis study design was chosen to highlight participants’ insights, and inductive coding was undertaken to analyze data and organize findings into themes. Results: Six themes that reflected HCPs’ experiences with the course were constructed: (1) the nature of working in rehabilitation; (2) different perspectives on burnout in specialist rehabilitation; (3) a new perspective, less self-criticism, more self-compassion; (4) growing recognition of the importance of compassion for oneself and others; (5) challenges engaging with the SCHC course; and (6) challenges to sustaining self-compassion in specialist rehabilitation. Conclusions: Specialist rehabilitation HCPs who participated in the SCHC course developed a new understanding of the importance of fostering self-compassion and compassion for others. This shift may have supported HCPs in navigating workplace challenges, and HCPs described experiencing changes that could help with burnout, improve their care of patients and relationships with colleagues. Trial Registration: ClinicalTrials.gov NCT05997082; https://clinicaltrials.gov/study/NCT05997082?cond=self%20compassion%20rehab&viewType=Card&rank=1
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Parkinson’s Drug Candidate Enhances Levodopa Therapy While Reducing Side Effects

Scientists have identified a compound that could improve the benefits of levodopa treatment for patients with Parkinson’s disease while delaying or preventing side effects that commonly develop with long-term use. The discovery was made at Sinopia Biosciences, a spinout of the University of California San Diego that analyzes large biological datasets to identify novel therapeutic approaches for preventing and managing side effects of existing drugs.

Preclinical findings published today in Science Translational Medicine suggest the drug candidate could significantly enhance the performance of the most effective and widely used treatment for Parkinson’s. If confirmed in clinical trials, the approach could represent a major advancement in the treatment of this increasingly prevalent neurodegenerative condition.

Levodopa can dramatically improve Parkinson’s symptoms, especially during the early stages of the disease. Over time, however, its effects start wearing off between doses, and within five years of treatment, about 40% of patients develop dyskinesia—a complication involving erratic and involuntary movements. Amantadine is currently the only approved drug to treat dyskinesia induced by levodopa, but its psychiatric and vascular side effects significantly limit its use. 

“Virtually every Parkinson’s patient takes levodopa,” said Aarash Bordbar, PhD, chief executive officer, chief scientific officer and co-founder of Sinopia Biosciences. “But patients face two major problems with the drug: the reappearance of Parkinson’s symptoms and dyskinesia. There is no drug that can be added to levodopa to address both simultaneously in a robust manner, and that’s what our drug candidate is doing.”

Bordbar’s team analyzed transcriptomics data to understand how levodopa changes gene expression patterns in the striatum, a brain region involved in movement control. The results were compared with a dataset of gene expression changes induced by existing drugs, allowing the researchers to identify compounds that activated the same transcriptional programs responsible for levodopa’s motor benefits while opposing gene expression programs linked to dyskinesia side effects. 

“Maximizing clinical benefits of therapeutics while minimizing adverse effects is a central challenge in drug development,” said Bordbar. “By focusing on the pharmacology of an effective drug rather than disease biology alone, the approach prioritizes pathways with demonstrated clinical relevance, increasing translational potential.” 

The team identified a promising candidate in trapidil, a drug that has been used for over 50 years in Japan to treat angina. The drug targets PKA-III, a protein involved in movement and dopamine responses within the brain. The researchers then designed a new compound based on trapidil and tested it in mouse and macaque models of Parkinson’s disease.

Results showed that the drug candidate could offer a dual benefit to Parkinson’s patients, simultaneously improving the motor benefits of levodopa while delaying or preventing treatment-related complications—potentially benefiting both long-term users and patients who are newly starting levodopa therapy.

Based on these findings, Bordbar believes there’s a high chance Sinopia’s drug candidate will succeed in clinical trials. This is further supported by the fact the compound is based on a drug that has been safely used for decades. The company is currently completing the toxicology studies required ahead of the first-in-human clinical trial, which is expected to begin next year. 

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