Radically different
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Nature Biotechnology, Published online: 28 April 2026; doi:10.1038/s41587-026-03145-w
The first-of-its-kind genetic medicine treats a rare and profound otoferlin-related hearing loss, and will be made available by Regeneron for free in the United States.
An artificial intelligence (AI) model developed at the Mayo Clinic can detect very early signs of pancreatic cancer from CT scans of the abdomen that are normally invisible to the human eye.
Researchers tested the Radiomics-based Early Detection MODel (REDMOD) and found it was able to identify 73% of very early pancreatic ductal adenocarcinoma. In contrast, only 39% of these cases were identified by radiologists.
Around 67,530 Americans are expected to be diagnosed with pancreatic cancer in 2026. It has a very poor prognosis, around 13% survival at five years, largely because it is often diagnosed at a late stage.
“Early detection of pancreatic ductal adenocarcinoma is the most powerful approach to improve survival,” write lead author Ajit Harishkumar Goenka, MD, a researcher and clinician at the Mayo clinic, and colleagues in the journal Gut.
“However, this objective is fundamentally impeded by the morphologically normal appearance of the pancreas on conventional imaging during its curable pre-clinical phase.”
To try and tackle the issue of early diagnosis, Goenka and team developed REDMOD to analyze very early signs of pancreatic cancer on computed tomography (CT) scans that are normally very hard to detect with the human eye.
As part of the study the researchers evaluated 219 routine CT scans of the abdomen from patients who later developed pancreatic cancer. They also included 1243 matched controls scans of people who had not developed cancer.
After the AI model was developed and trained the researchers tested it in 63 pre-diagnostic cases and 430 controls. These scans were taken around 16 months before the cancer cases were diagnosed.
REDMOD correctly identified 73% people who would later develop pancreatic cancer, while radiologists looking at the same scans only picked up about 39% of cases. The ability of the model to identify people without the disease was also good and it correctly identified 88% of people who did not have pancreatic cancer. When patients had repeat scans, the AI’s risk score was very consistent, agreeing 90–92% of the time.
“The demonstrated ability of the framework to consistently detect these occult signals on a large clinically oriented dataset, combined with its high longitudinal stability and validated specificity, establishes a robust foundation for AI-augmented early detection,” write Goenka and colleagues.
“While prospective validation is paramount to confirm clinical utility, the REDMOD framework represents a significant advance towards shifting the paradigm for sporadic pancreatic ductal adenocarcinoma from a late-stage symptomatic diagnosis to proactive pre-clinical interception, offering tangible hope for improving outcomes in this challenging disease.”
The post AI Model Can Detect Very Early Pancreatic Cancer from CT Scans appeared first on Inside Precision Medicine.
The four health system CEOs summoned before a Congressional committee Tuesday likely breathed sighs of relief early in the hearing, when it became clear they had friends in the audience.
Instead, committee members largely blamed the other party’s health care policies for driving U.S. health care prices to levels inaccessible to many Americans.
The hearing was part of the House Ways and Means Committee’s effort to understand the root causes of rising health care costs in the U.S. It comes three months after the committee heard from the CEOs of the country’s largest health insurers, who largely deflected blame onto hospitals and drugmakers.
In attendance were the CEOs of some of the country’s largest health systems: HCA Healthcare, a for-profit system of 190 hospitals, and CommonSpirit Health, a nonprofit system of 158 hospitals. The CEOs of New York-Presbyterian and North Carolina’s ECU Health were also there.
For decades, systemic lupus erythematosus (SLE) has resisted tidy solutions, a shapeshifting autoimmune disease that crosses into different organ systems, flares without warning, and leaves cumulative damage in its wake. More than three million people worldwide live inside that uncertainty, navigating cycles of remission and relapse that can erode health over time. Treatments have advanced, but slowly and often not far enough to fundamentally change the trajectory of disease.
Genentech’s obinutuzumab (marketed as Gazyva) is gaining regulatory momentum after submitting a supplemental Biologics License Application (sBLA) to expand its use into SLE, as it repurposes an established immuno-oncology biologic therapy. The U.S. Food and Drug Administration (FDA) is expected to make a decision by the end of 2026 on the label expansion for obinutuzumab, which was first approved on November 1, 2013, for treating previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil.
SLE is not a single-pathway disease. It is a systemic autoimmune condition in which the immune system misfires, attacking healthy tissues across the body. Skin, joints, blood vessels, and vital organs, particularly the kidneys, can all be affected by the disease. In roughly half of patients, lupus nephritis develops within five years of diagnosis and significantly increases the risk.
B cells, a type of white blood cell that makes antibodies, are at the heart of this problem. In lupus, these cells generate autoantibodies that target the body’s own structures, triggering chronic inflammation. Over time, repeated flares can lead to irreversible organ damage.
Even diagnosing lupus can be a challenge. Its symptoms mimic those of other diseases, and its presentation varies widely from patient to patient. Delays of two to six years are common, time during which the disease can quietly progress. Against this backdrop, the need for therapies that do more than manage symptoms and actually alter disease biology has become increasingly pressing.
That urgency is what makes the Phase III ALLEGORY trial so consequential. Designed as a randomized, double-blind, placebo-controlled study, ALLEGORY evaluated obinutuzumab in adults with active SLE who were already receiving standard therapy. The goal was not just to see if the drug worked, but to measure whether it could meaningfully shift disease outcomes.
The primary endpoint was the SLE Responder Index 4 (SRI-4), a composite metric that captures improvement across multiple dimensions of disease activity. At 52 weeks, 76.7% of patients receiving obinutuzumab attained an SRI-4 response, in contrast to 53.5% in the placebo group. That difference is both statistically significant and clinically meaningful, representing a substantial improvement in disease control.
In addition, patients treated with obinutuzumab experienced fewer disease flares, reduced reliance on glucocorticoids, and higher rates of remission. In fact, remission rates more than doubled compared to placebo. A greater proportion of patients also reached consistent, low disease activity states, an increasingly important benchmark for a disease defined by unpredictability.
What sets obinutuzumab apart is not just its efficacy but how it works. Traditional lupus therapies often rely on broad immunosuppression to dampen the immune system as a whole to control inflammation. While this approach can be effective, it comes with trade-offs, including increased susceptibility to infections and long-term toxicity.
Obinutuzumab takes a more targeted route. It is a glycoengineered, type II anti-CD20 monoclonal antibody designed to bind to a protein expressed on the surface of certain B cells. Once attached, it triggers both direct cell death and enhanced immune-mediated cytotoxicity, leading to potent depletion of the B cells that drive lupus pathology. This dual mechanism allows for a more precise intervention by focusing on the source of disease activity rather than suppressing the immune system indiscriminately. The distinction is more than technical. It represents a broader shift in immunology toward therapies that are not only effective but also strategic.
Regarding safety risk, the data from ALLEGORY offers reassurance. Adverse events were somewhat more frequent in the treatment group, but the overall safety profile remained consistent with what is already known about the drug. Importantly, no new safety signals were identified. In context, the benefit-risk balance appears favorable, particularly given the magnitude of clinical improvement observed. For clinicians, that balance is critical. Lupus is a chronic disease that often requires long-term management, making tolerability as important as efficacy.
If approved for SLE, obinutuzumab would become the first anti-CD20 therapy specifically indicated for the condition, a milestone that could reshape the treatment landscape. It would also expand a therapeutic arsenal that has remained limited for far too long. Despite decades of research, only a small number of therapies have been approved for lupus, so many patients have limited options.
For patient advocates, the significance is immediate and tangible. Albert T. Roy, president and CEO of the Lupus Research Alliance, emphasized both the burden of disease and the promise of new treatments. “The filing submission for Gazyva is a significant step and could provide another treatment option for people with systemic lupus erythematosus (SLE),” Roy told Inside Precision Medicine. “With only two approved therapies for SLE, the potential availability of another option is significant.”
Obinutuzumab enters a field that is changing quickly, with new technologies expanding the possibilities of immune-targeted therapies. Among the most promising are CAR T-cell therapies. They’re also on the far end of the complexity scale, especially as autologous therapies, which involve the extraction of a patient’s T cells, genetically engineering them to target specific immune cells, and reinfusing them into the body. Early studies in lupus have shown intriguing results.
But there are practical limitations. CAR T-cell therapies are resource-intensive, requiring specialized manufacturing, inpatient care, and significant infrastructure. They remain in early-stage trials for lupus and are not yet widely accessible.
The way Roy sees it, monoclonal antibodies like obinutuzumab offer a different path that balances innovation with scalability. “Both approaches target B cells—drivers of lupus pathogenesis—but they work differently,” explained Roy. “Monoclonal antibodies like Gazyva are easier to scale and administer to patients in an outpatient setting, making them more accessible and cost-effective. CAR T immunotherapies, by contrast, require a more complex manufacturing process, as well as inpatient care to prepare the patient for the CAR T infusion. Additionally, CAR T immunotherapies are in early-phase clinical trials, where safety and efficacy are still being evaluated in lupus.”
The accessibility of obinutuzumab could prove definitive. Even if approved, obinutuzumab will not automatically transform lupus care. Several challenges remain. Awareness is one. Both patients and healthcare providers need to understand where this therapy fits and who is most likely to benefit. Access is another. As with many biologic therapies, cost and insurance coverage will play a significant role in determining availability.
Then there is the question of personalization. Lupus is a heterogeneous disease, and responses to treatment can vary widely. Identifying biomarkers or clinical characteristics that predict response to B-cell depletion will be essential for helping clinicians improve outcomes.
“The biggest challenges are awareness, education, and access,” said Roy. “If approved by the FDA, patients and providers need to know that this therapy could be an option and understand who may benefit most from it. Given the heterogeneity of lupus, Gazyva might not work for everyone, but having another option would be a big win for patients and their providers.
The emergence of obinutuzumab reflects a broader transformation in lupus research and care. The field is moving away from a reactive model, treating flares as they occur, toward a proactive one aimed at preventing them altogether. There is growing emphasis on reducing or eliminating long-term steroid use, which has long been a cornerstone of lupus treatment but carries significant side effects. At the same time, researchers are exploring combination strategies and new therapeutic targets, building on the foundation of B-cell biology.
The ultimate goal is ambitious but increasingly plausible: sustained remission, potentially even without ongoing therapy. “We’re excited about the potential of Gazyva to build on what’s been shown in lupus nephritis and extend those benefits to a broader lupus population,” Roy said. “Looking ahead, we hope the field continues to shift from broad immunosuppression to targeted therapies, with a continued focus on reducing reliance on steroids and, ultimately, achieving drug-free remission.
Obinutuzumab does not solve lupus. It does not eliminate the complexity of the disease or the challenges that come with it. But it does signal something important: progress that is measurable, meaningful, and potentially transformative. For patients who have long navigated a landscape of limited options and uncertain outcomes, that progress matters. It offers not just another treatment but a different kind of treatment grounded in precision, backed by strong clinical data, and designed with real-world use in mind.
If the regulatory path leads to approval, obinutuzumab could mark the beginning of a new chapter in lupus care defined less by compromise and more by control. And for a disease that has long resisted both, that shift may be the most powerful development yet.
The post FDA Accepts Label Expansion of Immuno-Oncology Drug to Lupus appeared first on Inside Precision Medicine.
Background: Suicide helplines increasingly employ chat services to aid those in urgent need, but the wording and structure of text-driven exchanges may affect their effectiveness. Objective: Given the association of cognitive distortions with depression and anxiety, this study investigated their prevalence in the language of individuals seeking help from the Dutch 113 suicide helpline. Methods: We observed the prevalence of cognitive distortions for both help seekers and counselors in a large volume of chat sessions (N=71,148) of the Dutch 113 suicide chat helpline using natural language processing. The results were compared to 2 large collections of online text data from Dutch social media and web content. Results: We found that nearly all types of cognitive distortions are more prevalent in the language of help seekers compared to the control group of helpline counselors. Distortions of the personalizing, emotional reasoning, and mental filtering types were, respectively, 20.22, 7.87, and 4.53 times more prevalent among help seekers, revealing a distinct pattern of thought and language among individuals affected by suicidality. Conclusions: Our results raise the prospect of improving the effectiveness of online therapeutic interventions that target cognitive distortions through lexical analysis that detects the cognitive and lexical markers of suicidality.
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