Category: 3. Business

  • Clinical Data Support Use of Low-Carbon Version of Albuterol Metered Dose Inhaler for Asthma

    Clinical Data Support Use of Low-Carbon Version of Albuterol Metered Dose Inhaler for Asthma

    Clinical data confirm that the formulation of the metered dose inhaler (MDI), albuterol (Ventolin; GSK), containing a low-carbon propellant HFA-152a, has therapeutic equivalence and is comparable in safety to salbutamol MDI containing HFA-134a, the current propellant, according to a news release from the manufacturer. These findings support regulatory submissions for a next-generation version of albuterol, referred to as salbutamol outside of the US, which will bring a more sustainable option to patients who have respiratory diseases.

    Albuterol is approved by the FDA for the treatment and prevention of acute or severe bronchospasm in patients with reversible obstructive airway disease, such as asthma and chronic obstructive pulmonary disease (COPD). Albuterol acts on β2-adrenergic receptors, inducing bronchial smooth muscle relaxation and inhibiting immediate hypersensitivity mediator release, particularly from mast cells. Albuterol also affects β1-adrenergic receptors, but the impact is minimal, thereby exerting little effect on a patient’s heart rate.2

    Albuterol is available in various dosage forms and strengths, including an aerosol metered-dose inhaler delivering 90 mcg (base)/actuation, equivalent to 108 mcg of albuterol sulfate; a powder metered-dose inhaler form providing the same values as the aerosol metered-dose inhaler; 2-mg and 4-mg tablets; 4-mg and 6-mg extended-release tablets; nebulized solutions, including 0.083%, 0.5%, 0.63 mg/3 mL, and 1.25 mg/3 mL; and an oral syrup in a concentration of 2 mg/5 mL.2

    In the absence of albuterol’s bronchodilatory effects, patients experiencing bronchospasms may face the risk of catastrophic asphyxiation, emphasizing the crucial need for patients to have a readily available treatment. According to the manufacturers, nearly half a billion people are affected by asthma and COPD worldwide.1,2

    “Healthy air is essential for healthy lungs, and our next-generation [albuterol] has the potential to reduce greenhouse gas emissions by 92% per inhaler. Almost 6 decades after its first development, this medicine remains highly valued by patients and health care professionals and is a key component of our respiratory portfolio. Today, we are one step closer to a reliever MDI that we believe will continue to help patients for many decades to come,” Kaivan Khavandi, senior vice president, global head of respiratory, immunology & inflammation research and development at GSK, said in a manufacturer news release.1

    WHO considers climate change to be the biggest global health issue, and patients with chronic respiratory diseases such as asthma and COPD are particularly susceptible to variable weather conditions and extreme weather events. Short-acting β2-agonists (SABAs) are typically used as reliever medications for the short-term relief of asthma and COPD symptoms; however, they are also responsible for approximately 70% of total inhaler-related greenhouse gas (GHG) emissions. The development of MDI devices that contain low global warming potential (GWP) propellants can reduce the carbon footprint of MDIs while balancing reduced GHG emission goals with patient health and well-being.3

    The aim of the trial was to assess the carbon footprints of albuterol HFA-152a MDI, albuterol HFA-134a MDI, and an albuterol dry-powder inhaler (DPI). For this study, 3 cradle-to-grave lifecycle analyses (LCA) were undertaken to compare the carbon footprints of albuterol HFA-152a MDI, albuterol HFA-134a MDI, and albuterol DPI. Over 600 individual emission factors were calculated from over 2000 data points and categorized into active pharmaceutical ingredient manufacture, micronization, device, formulation and packaging, use phase, distribution, and end-of-life stages.3

    The data show that the average carbon footprint values were about 27.09, 2.24, and 0.76 kg CO2e per device for albuterol HFA-134a MDI, albuterol HFA-152a MDI, and albuterol DPI, respectively, representing an approximate 92% reduction in carbon footprint for albuterol HFA-152a MDI compared with albuterol HFA-134a MDI. The investigators observed that the difference was primarily driven by the patient use phase. These findings suggest that substituting the currently available HFA-134a propellant with a new HFA-152a candidate propellant could substantially reduce the carbon footprint of a SABA reliever.3

    “While low carbon alternatives already exist, such as dry powder and soft mist inhalers, we know that many patients worldwide with both asthma and COPD prefer a[n albuterol] MDI to relieve their symptoms. These data should enable patients to use their preferred inhaler choice. This is a crucial advance to help global health care systems meet their climate targets at the same time as optimizing the care of patients,” Ashley Woodcock, professor of respiratory medicine at the University of Manchester, said in the news release.1

    REFERENCES
    1. GSK. GSK announces positive pivotal phase III data for next-generation low carbon version of Ventolin (salbutamol) metered dose inhaler. News release. October 22, 2025. Accessed October 27, 2025. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-pivotal-phase-iii-data-for-next-generation-low-carbon-version-of-ventolin-salbutamol-metered-dose-inhaler/
    2. National Library of Medicine – National Center for Biotechnology Information. Albuterol. Updated January 10, 2024. Accessed October 27, 2025. https://www.ncbi.nlm.nih.gov/books/NBK482272/
    3. Plank M, Anzueto A, Janson C, Henderson R, Fulmali S, and King J. Decarbonizing Respiratory Care: The Impact of a Low-carbon Salbutamol Metered-dose Inhaler [abstract]. Am J Respir Crit Care Med. 2025;211:A5548. doi:10.1164/ajrccm.2025.211.Abstracts.A5548

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  • Fogarty Innovation and CRF unite to accelerate breakthroughs in cardiovascular medicine

    Fogarty Innovation and CRF unite to accelerate breakthroughs in cardiovascular medicine

    After several years of close collaboration and a relationship rooted in mutual respect and shared vision, Fogarty Innovation is coming together with the Cardiovascular Research Foundation® (CRF®) to create a unified platform for advancing transformative healthcare technologies. This strategic combination strengthens CRF’s leadership in medtech by integrating Fogarty’s renowned expertise in early-stage innovation, creating a powerful, cross-specialty platform to accelerate transformative breakthroughs into patient care. The merger was announced during a special keynote session at the Transcatheter Cardiovascular Therapeutics® (TCT®) meeting.

    This platform unites two mission-driven organizations with a shared vision: to catalyze the next generation of disruptive medical technologies by advancing innovations that have the power to transform patient care and reshape the future of healthcare. It builds on a strong track record of successful collaboration: CRF and Fogarty Innovation have partnered on the TCT MedTech Innovation Forum over the past four years, fostering early-stage innovation and supporting emerging medtech entrepreneurs. Together, they form a powerful alliance poised to accelerate progress in cardiovascular medicine and transform patient care on a global scale. 

    The unified platform will unlock immediate access to world-class incubation, long-term strategic growth, and enhanced philanthropic impact. By combining the deep expertise of both organizations, it will provide unparalleled access to seasoned medtech executives, expand innovation education initiatives, and increase business opportunities in Silicon Valley and beyond – all while accelerating the development of cutting-edge technologies and driving measurable improvements in patient care.

    Fogarty Innovation will continue to carry its name and mission, now serving as CRF’s West Coast innovation hub. Together, CRF and Fogarty Innovation will amplify their collective impact by combining resources, expertise, and leadership – aligning on strategic initiatives to drive innovation and expand their reach across the cardiovascular landscape.

    “We’re thrilled to enter into this partnership with our close friends and colleagues at Fogarty Innovation,” said Juan F. Granada, MD, President and Chief Executive Officer of CRF. “We are entering a groundbreaking era in cardiovascular medicine; one defined by unprecedented technological potential. This move is not just a step forward; it is a bold move to lead the future. By uniting our strengths into a single, purpose-driven platform, we are shaping the development of transformative technologies that will redefine care and bring us closer to a more equitable health care system.”

    Over the past 17 years, Fogarty Innovation has demonstrated that our model of immersive support – through incubation, acceleration, education, and alliances – meaningfully increases the success of innovators in bringing new tools and therapies to clinicians and patients. We are excited to join forces with CRF, as we can now scale that impact globally, giving entrepreneurs a larger stage, stronger resources, and a faster path to delivering transformative care.”

    Andrew Cleeland, CEO of Fogarty Innovation

    “Our partnerships have always been rooted in trust, shared purpose, the highest ethical standards, performance excellence, and a commitment to transform the lives of patients everywhere,” said Martin B. Leon, MD, Founder and Chairman Emeritus of CRF. “CRF’s mission to advance cardiovascular care through research and education will be amplified by Fogarty Innovation, opening new opportunities for collaborations, advanced innovation, and strategic growth – ultimately, impacting the science and practice of medicine worldwide.”

    Source:

    Cardiovascular Research Foundation

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  • PCI With A Sirolimus-Eluting Balloon And Provisional Stenting Shows Comparable Outcomes To Routine DES Implantation For Treatment Of De Novo Coronary

    PCI With A Sirolimus-Eluting Balloon And Provisional Stenting Shows Comparable Outcomes To Routine DES Implantation For Treatment Of De Novo Coronary

    New study results from a large international all-comer population of percutaneous coronary intervention (PCI) candidates found that utilizing a strategy of sirolimus-eluting balloons with bailout stenting only if necessary was noninferior to routine drug-eluting stent (DES) implantation as part of the treatment for de novo coronary artery disease.

    Findings were reported today at TCT® 2025, the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®). TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

    DES are implanted in the vast majority of PCIs with well-established immediate and mid-term outcomes. However, long term follow-up studies have reported annual adverse event rates of 2-4%. This has led to a growing interest in strategies that minimize metallic stent implantation to potentially reduce late events. The study used the SELUTION SLR Drug-Eluting Balloon (DEB) which delivers a sustained drug release maintaining therapeutic tissue concentration for up to 90 days designed to have a similar elution profile to current DES.

    Between August 2021 and July 2024, a total of 3,341 participants were randomized one to one to either the DEB (n=1,671) or DES strategy (n=1,670) at 62 sites in 12 countries across Europe and Asia. Patients with lesion reference vessel diameter (RVD) ≥2.0 and ≤5.0 mm were eligible for inclusion. Baseline characteristics were similar in both groups, with a relatively high proportion of patients presenting with acute coronary syndromes or having high bleeding risk. Randomization occurred after angiography when all target lesions were considered suitable for either strategy and prior to lesion wiring and lesion preparation. Eighty percent of participants treated with the SEB did not require a stent.

    The primary endpoint of target vessel failure, comprised of cardiac death, target vessel-related myocardial infarction and clinically driven target vessel revascularization, occurred in 5.3% of the DEB strategy group and 4.4% of the DES strategy group at one year (Risk Difference 0.91, 95% CI: -0.55, 2.38%, Pnoninferiority=0.02). No acute or late safety concerns were noted with the DEB strategy, with low rates of cardiac death (0.70% vs 1.0%), lesion thrombosis (0.1 %vs 0.3%), and target vessel myocardial infarction (2.7% vs 2.6%) comparable with DES.

    The SELUTION DeNovo trial provides the first comparison of a PCI strategy based on the use of sirolimus-eluting balloons versus systematic implantation of DES in a large international all-comer population of PCI candidates. With no acute or late safety concerns, these results apply to a significant segment of PCI procedures including high-risk patients and complex lesions. We look forward to obtaining five-year data to determine long-term noninferiority or possible superiority of this strategy.”


    Christian M. Spaulding, MD, PhD, Chief, Integrated Interventional Laboratory at European Hospital Georges Pompidou in Paris, France

    The study was funded by M.A. Med Alliance SA (a Cordis Company), Switzerland.

    Dr. Spaulding reported receiving grant /research support from the French Ministry of Health, CERC; consultant fees / honoraria from Medtronic, Techwald, Sanofi, Novartis Sonivie, Valcare and Boston Scientific as well as individual stock(s)/stock options/salary support from Cordis (MedAlliance) and Sonivie.

    The results of the study were presented on Sunday, October 26, 2025, at 11:00 a.m. PT in the Main Arena (Hall A, Exhibition Level, Moscone South) at the Moscone Center during TCT 2025.

    Source:

    Cardiovascular Research Foundation

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  • COMPETE Trial: ITM-11 Tops Everolimus for GEP-NET PFS and OS | Targeted Oncology

    COMPETE Trial: ITM-11 Tops Everolimus for GEP-NET PFS and OS | Targeted Oncology

    Final analysis from the phase 3 COMPETE trial (NCT03049189) demonstrated that ITM-11 (177Lu-edotretide) met its primary and secondary end points in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) compared with everolimus. Data were presented at the 2025 European Society for Medical Oncology (ESMO) Congress on October 18, 2025, by Jaume Capdevila, MD, PhD, Vall d’Hebron University Hospital, and at the NANETS Symposium on October 25.1

    The primary end point was progression-free survival (PFS), which was reached with statistically significant and clinically meaningful improvement. The median PFS was significantly longer in patients administered ITM-11 compared to those administered everolimus. The secondary end point of the trial was overall survival (OS), which was also identified to be higher in patients who were administered ITM-11 vs everolimus.2

    There was a total of 207 patients in the ITM-11 group and 102 patients in the everolimus group. The median ages of both groups were 65 (ITM-11), and 61 (everolimus). Majority of patients in both groups were male. The majority of patients had grade 2, nonfunctional GEP-NETs and had received prior therapy.

    COMPETE Trial Findings

    COMPETE met its primary end point of PFS, which proved to be significantly longer in patients treated with ITM-11 vs everolimus. The central assessment was 23.9 vs 14.1 months (HR, 0.67; 95% CI, 0.48–0.95; P =.022).The local assessment was 24.1 vs 17.6 months (HR, 0.66; 95% CI, 0.48–0.91] P =.010;).

    In the subgroup analysis of PFS by tumor origin, mPFS was found to be numerically longer in GE-NETs and P-NETs in the ITM-11 arm. In GE-NETs the mPFS was 23.9 vs 12 months (HR 0.64, 95% CI, 0.38–1.08; P =.090;). In P-NETs the mPFS was 24.5 vs 14.7 months (HR, 0.70, 95% CI, 0.45–1.09; P =.114;).

    It was also identified that mPFS was numerically longer in grade 1 and significantly longer in grade 2 tumors in the ITM-11 arm. Grade 1 was 30 vs 23.7 months (HR, 0.89, 95% CI, 0.42–1.8; P =.753;), and grade 2 was 21.7 vs 9.2 months (HR 0.55l 95% CI, 0.37–0.82] P =.0003).

    In exploring PFS by prior therapy, it was identified that mPFS was numerically longer in the first line and significantly longer in the second line in the ITM-11 arm. First line data showed the mPFS was not reached in the ITM-11 vs 18.1 months (HR, 0.60, 95% CI, 0.25–1.45; P =.249), and second line data showed 23.9 vs 14.1 months (HR, 0.68; 95% CI, 0.47–0,98] P=.039).

    Overall response rates (ORR), one of the secondary end points of the trial, was found to be significantly higher in the ITM-11 arm. Central assessment was 21.9% vs 4.2% (P <.0001), and local assessment was 30.5% vs 8.4% (P <.0001).

    Safety Profile

    Adverse events (AEs) related to the drug study were experienced by 82% of patients ITM-11 group and 97% of patients in the everolimus group. The most common AEs reported were nausea (30% vs 10.1%), diarrhea (14.3% vs 35.4%), asthenia (25.3% vs 31.3%), and fatigue (15.7% vs 15.2%). These AEs were expected based on the known safety profile of ITM-11.2

    AEs leading to premature study discontinuation were 1.8% vs 15.2% among both groups, respectively, dose modification or discontinuation were 3.7% vs 52.5%, and patients with delayed study drug administration due to toxicity was 0.9% in the ITM-11 group and 0% in the everolimus group.2

    Dosimetry data showed targeted tumor uptake with low exposure to healthy organs, with normal organ absorbed doses well below safety thresholds.

    Patient Characteristics

    Patient inclusion criteria included being 18 or older, having well-differentiated, nonfunctional GE-NET or functional/nonfunctional P-NET; grade 1/2 unresectable or metastatic, progressive, SSRT-positive disease; and being treatment-naive to first-line therapies or progressing under prior second-line therapies.1,2

    Morphologic imagining was conducted in 3-month intervals. The PFS follow-up was done every 3 months after the first 30 days. Long-term follow-up was done every 6 months.

    “With these data combining extensive dosimetry information from more than 200 patients included in a prospective trial, ITM is laying the groundwork for improved therapeutic decision-making by providing important insights into tumor uptake and treatment variability,” Emmanuel Deshayes, MD, PhD, professor in biophysics and nuclear medicine at the Montpellier Cancer Institute in France, said in a news release.2 “It may offer clinically meaningful implications for optimizing individualized patient management.”

    Dosimetry data from COMPETE shaped the design of ITM’s phase 3 COMPOSE (NCT04919226)4 trial with ITM-11 in well-differentiated, aggressive grade 2 or grade 3 SSTR-positive GEP-NET tumors, as well as the upcoming phase 1 pediatric KinLET (NCT06441331) study in SSTR-positive tumors.

    DISCLOSURES: Capdevila noted grants and/or research support from Advanced Accelerator Applications, AstraZeneca, Amgen, Bayer, Eisai, Gilead, ITM, Novartis, Pfizer, and Roche; participation as a speaker, consultant, or advisor for Advanced Acclerator Applications, Advanz Pharma, Amgen, Bayer, Eisai, Esteve, Exelixis, Hutchmed, Ipsen, ITM, Lilly, Merck Serono, Novartis, Pfizer, Roche, and Sanofi; position as advisory board member for Amgen, Bayer, Eisai, Esteve, Exelixis, Ipsen, ITM, Lilly, Novartis, and Roche; and a leadership role and chair position for the Spanish Task Force for Neuroendocrine and Endocrine Tumours Group (GETNE).

    REFERENCES:
    1. Capdevilla J, Amthauer H, Ansquer C, et al. Efficacy, safety and subgroup analysis of 177Lu-edotreotide vs everolimus in patients with grade 1 or grade 2 GEP-NETs: Phase 3 COMPETE trial. Presented at: 2025 ESMO Congress; October 17-20, 2025; Berlin, Germany. Abstract 1706O
    2. ITM presents dosimetry data from phase 3 COMPETE trial supporting favorable efficacy and safety profile with n.c.a. 177Lu-edotreotide (ITM-11) in patients with gastroenteropancreatic neuroendocrine tumors at EANM 2025 Annual Congress. News release. ITM. October 8, 2025. Accessed October 18, 2025. https://tinyurl.com/3nuscs4m
    3. Lutetium 177Lu-Edotreotide versus best standard of care in well-differentiated aggressive grade-2 and grade-3 gastroenteropancreatic neuroendocrine tumors (GEP-NETs) – COMPOSE (COMPOSE). ClinicalTrials.gov. Updated September 10, 2025. Accessed October 18, 2025. https://www.clinicaltrials.gov/study/NCT04919226
    4. Phase I trial to determine the dose and evaluate the PK and safety of lutetium Lu 177 edotreotide therapy in pediatric participants with SSTR-positive tumors (KinLET). ClinicalTrials.gov. Updated September 19, 2025. Accessed October 18, 2025. https://www.clinicaltrials.gov/study/NCT06441331

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  • A home genome project: How a city learning cohort can create AI systems for optimizing housing supply

    A home genome project: How a city learning cohort can create AI systems for optimizing housing supply

    Executive summary

    Cities in the U.S. and globally face a severe, system-wide housing shortfall—exacerbated by siloed, proprietary, and fragile data practices that impede coordinated action. Recent advances in artificial intelligence (AI) promise to increase the speed and effectiveness of data integration and decisionmaking for optimizing housing supply. But unlocking the value of these tools requires a common infrastructure of (i) shared computational assets (data, protocols, models) required to develop AI systems and (ii) institutional capabilities to deploy these systems to unlock housing supply. This memo develops a policy and implementation proposal for a “Home Genome Project” (Home GP): a cohort of cities building open standards, shared datasets and models, and an institutional playbook for operationalizing these assets using AI. Beginning with an initial pilot cohort of four to six cities, a Home GP-type initiative could help 50 partner cities identify and develop additional housing supply relative to business-as-usual projections by 2030. The open data infrastructure and AI tools developed through this approach could help cities better understand the on-the-ground impacts of policy decisions, while also providing a constructive way to track progress and stay accountable to longer-term housing supply goals.

    1. Introduction

    More than 150 U.S. communities now participate in the Built for Zero initiative, a data‑intensive model that has helped several localities achieve “functional zero” chronic or veteran homelessness and dozens more to achieve significant, sustainable reductions. For instance, Rockford, Illinois, became the first U.S. community to end both veteran and chronic homelessness by establishing a unified command center that used real-time, person-specific data to identify individuals experiencing homelessness and strategically target resources to achieve functional zero. The work has revealed an important formula: pairing real‑time, person‑level data integrated across agencies with nimble, cross‑functional teams can drive progress on seemingly intractable social problems.

    Homelessness is typically downstream of shortages of housing supply. In the U.S. alone, there is an estimated 7.1 million‑unit shortage of homes for extremely low-income renters. But no equivalent playbook, standardized taxonomy, or shared data infrastructure exists to holistically address housing supply at the city or regional level. Developers, school districts, transit agencies, financing authorities, and planning departments each steward partial information and property assets that could translate into expanded housing supply.

    Without shared accountability for meeting community housing needs, chronic coordination failure results. Homelessness is one stark result. Individuals and families shuttle between services, attempting to qualify for housing and income assistance while competing for limited housing options. Meanwhile, opportunities to increase housing supply—through repurposing idle land, preserving at-risk units, streamlining development approvals, or other strategies—go unrealized because critical information remains fragmented across agencies or never collected at all.

    When attempting to integrate city-level housing data, most cities confront an unsatisfying choice: license an expensive proprietary suite, outsource a one-off dashboard to consultants, or manually assemble spreadsheets in-house. Some jurisdictions run dual systems—an official internal view and a vendor dashboard—further fragmenting workflows and complicating institutional learning. Among the commercial vendors trying to fill the information void are those offering proprietary suites with parcel visualization, market analytics, scenario modeling features, and/or regulatory particulars. Many are built on public data but packaged behind paywalls that limit transparency, interoperability, and reuse. Several also only cover a handful or a finite number of geographies.

    Without open interfaces, common data standards, or accessible tools, even well-staffed departments struggle to maintain the continuous data integration that drives real outcomes. The manual processes that have enabled breakthrough successes require dedicated teams and sustained funding that most cities cannot maintain through personnel changes and budget cycles. Equally important, fragmented or proprietary data ecosystems can persist because existing arrangements benefit from the opacity—whether by limiting public scrutiny of how housing assets are managed or, as recent cases against rent-setting platforms illustrate, by enabling landlords and data vendors to leverage nonpublic information in ways that reinforce market power and reduce competition. What emerges is a patchwork of partial views—each typically anchored in narrow mandates and reinforced by opaque systems that resist integration.

    While many cities have prototyped tools and surfaced effective approaches to optimizing their housing assets despite these challenges, sustaining and scaling them across contexts requires more than heroic individual efforts. The path forward to unlocking hidden housing supply at scale lies in durable data pipelines, cross-functional teams with clear shared goals, and shared data and playbooks that reduce the transaction costs of doing this important work city-by-city.

    AI’s potential as an accelerant

    Recent breakthroughs in generative AI, computer vision, and geospatial analytics—many of which have only been commercialized since 2023—drastically lower the cost and increase the speed of data integration and analytics. For housing data, early pilots show that machine-learning models can rapidly reconcile parcel IDs across assessor, permit, and utility records; detect latent development sites—such as vacant lots, single-story strip malls, or underutilized garages—by triangulating land-use data with computer-vision analysis of aerial imagery; and forecast supply impacts of zoning tweaks or financing incentives across thousands of parcels.

    However, lessons from Built for Zero and elsewhere would suggest that new forms of technical automation must be paired with common infrastructure and institutional capabilities to drive measurable outcomes. For instance, meta-analyses of cross-agency Integrated Data Systems (IDS) in the U.S. are associated with better targeting and continuous program improvement when paired with governance, standards, and security protocols.

    Early experiments applying machine learning (ML) to housing data (discussed in the next section) suggest that computation alone does not eliminate complexity. Legal nuance, inconsistent document formats, and context-specific exceptions routinely defeat even state-of-the-art data integration and machine learning techniques, requiring manual verification and domain expertise. Even when AI delivers efficiency gains, those improvements alone do not build housing. Without clear protocols, shared taxonomies, and durable governance that elevates domain expertise and supports capacity building, even efficient AI tools risk automating the wrong tasks—or failing when local conditions shift.

    The core challenge of optimizing housing supply is not simply an absence of tools, but the absence of a common and underlying infrastructure, taxonomy, institutional capacity, and incentives for transparent data sharing needed to support computational tools.

    The case for a city-level “Home Genome Project”

    Against this backdrop, a coalition of city housing leaders, community-development practitioners, technologists, and funders gathered in “Room 11”—a 17 Rooms flagship working group aligned with Sustainable Development Goal 11 for sustainable cities and communities—to explore how to harness AI tools to increase housing supply. In a rapid sequence of virtual meetings, the group identified data gaps, transaction costs, and governance hurdles that stall housing production and allocation and identified the key technical and institutional ingredients required to harness AI’s potential value for local decisionmakers.

    Drawing on these insights, this memo suggests standardizing and integrating city-level public data and capabilities should be a primary focus for leveraging AI’s potential value. A concerted international movement, starting with a learning network of cities, could generate the necessary shared inputs required to develop AI systems (a shared data model, data standards and datasets, and machine learning models) and the playbooks for the infrastructure, human capacities, and institutions needed to operationalize AI systems for optimizing city-level housing supply.

    As discussed in Room 11 meetings, the siloed status quo resembles biomedical research before the step-change advances in data sharing and management initiated through the Human Genome Project. By mandating 24-hour public release of DNA sequences across participating laboratories, the HGP’s Bermuda Principles ignited a wave of global discovery that later underpinned AI-driven feats like CRISPR and AlphaFold. When researchers openly shared SARS-CoV-2 genomic sequences in early 2020, it enabled parallel vaccine development that would have been impossible under traditional closed models.

    Housing needs an analogous shift—a “Home Genome Project” (Home GP)—defined by shared data standards, open pipelines, and reciprocal learning norms that convert local experiments into a global commons of actionable knowledge. A de-siloed approach to housing data infrastructure and shared learnings could also provide a more structured brokering mechanism for connecting front-line teams with the resources, expertise, and partnerships they need to scale their solutions.

    Whereas DNA data is inherently structured and universally interpretable, housing data reflects diverse, locally determined rules and contexts, making integration and standardization far more complex. Achieving a Home GP will require careful, collaborative design of data models and standards from the outset, ensuring consistent definitions, quality inputs, and governance frameworks that can sustain large-scale, cross-jurisdictional use.

    By coupling open data standards and city-contributed datasets and ML models with peer-to-peer capacity building, Home GP could help catalyze collaboration, learning, and innovations for increasing housing supply above baseline in 50 partner cities by 2030. Like the Human Genome Project, Home GP would be designed to treat data as critical infrastructure and collaboration as a force multiplier for AI system development. While the start-up phase of Home GP would likely focus on larger cities, the development of the approach would enable integration of data from communities of every size and type—including towns, villages, and counties with unincorporated areas.

    2. Home GP foundations: A cross-section of city-level approaches and progress

    Room 11 discussions unearthed a rich cross-section of city-level experimentation across three key barriers to housing supply. Several cities in the U.S. and globally are making noteworthy inroads. Teams are integrating data and prototyping digital tools to help map existing land assets, simulate the effects of policy interventions on development, and detect and forecast vacancies.

    Different cities possess different raw ingredients—data, models, talent, or political capital—to influence decisionmaking for optimizing housing supply. Cities with massive metropolitan areas like Atlanta are developing bespoke solutions, while data and resourcing constraints faced by smaller cities like Santa Fe (U.S.) are developing more nimble and leaner solutions.

    Mapping existing land assets and development proposals: Atlanta (U.S.) has merged tax-assessor records with other agency spreadsheets into the city’s first live map of every publicly owned parcel; its new Urban Development Corporation can now identify and package land deals across departments instead of hunting for records one by one. London (U.K.) leverages its tight regulatory framework to systematically collect and standardize data from multiple organizations, capturing information on roughly 120,000 development proposals annually. This regulatory process creates opportunities for comprehensive data gathering that feeds into what functions as a digital twin of the planning system. The Greater London Authority’s planning data map has been accessed 23.4 million times in the past year and serves as the evidence base for public-sector planning across the region. Boston’s (U.S.) citywide land audit surfaced a substantial inventory of underutilized public parcels.

    These approaches point toward a “digital twin” approach that gives cities real-time insight into how their built environment is changing—helping planners do long-range scenario planning with more accurate, up-to-date information. A tool like this can also strengthen accountability—by transparently tracking new development, cities can measure progress against housing goals (similar to California’s Regional Housing Needs Allocation process) and hold themselves responsible for delivering results.

    Simulating the effects of policy interventions: Denver (U.S.) is coupling parcel-level displacement-risk models with zoning-and-feasibility simulators so that staff can test how ordinances (like parking minimums or inclusive housing regulations) could impact housing developments before policies reach decisionmakers. Charlotte (U.S.) is moving to automate updates to its Housing Location Tool (an Esri workbook that scores parcel-level properties on development potential based on four dimensions: proximity, access, change, and diversity) and to allow the process to proactively score all parcels and recommend areas for development.

    Vacancy detection: Water-scarce Santa Fe (U.S.) is beginning to mine 15-minute water meter readings to flag homes that sit idle for months and explore incentives for releasing those units for rental use—an information loop that turns a utility dataset into a housing-supply radar.

    Together this range of efforts shows that cities possess different raw ingredients to accelerate the development of new housing supply. What is missing is the infrastructure to convert these opportunities and one-off accomplishments into standardized, repeatable, and shareable playbooks. Just as the Human Genome Project transformed genomics by creating structured vocabularies for machine readability and cross-jurisdictional collaboration, a similar infrastructure and lexicon for describing and cataloging assets such as parcels, vacancies, and zoning types could unlock the innovation and progress needed to meet the country’s urgent housing needs.

    Diagnosing the decision problem in city housing markets

    Room 11 meetings surfaced several incentive, capacity, and governance barriers that need to be overcome to secure more housing.

    1. Demand-driven solutions for surviving the “dashboard valley of death”

    The allure of technology‐driven reform is hardly new. Over the past decade, several public funders and technology companies have supported housing dashboards as potentially scalable solutions to generating real-time insights for local decisionmakers. But most, particularly those built top-down, have achieved only limited uptake owing to the fragility of public data and capacity ecosystems underneath them. Where cities have developed their own tools—like Charlotte’s Housing Locational Tool—the data pipelines often rely on manual, once-a-year updates. This so-called “dashboard valley of death,” a key challenge discussed in Room 11, suggests the need for an alternative strategy to technology development, one where front-line agencies are equipped with common infrastructure and capabilities to self-generate tailored solutions to locally defined problems.

    In this vein, a new generation of tools demonstrates that success is possible when technology serves clearly defined user needs. The Terner Housing Policy Simulator, developed by UC Berkeley’s Terner Center, for example, models housing supply impacts at the parcel level across 25-30 jurisdictions. By combining zoning analysis with economic feasibility modeling—running multiple pro-formas to assess development probability under different scenarios—the tool provides actionable intelligence that cities like Denver are using to evaluate parking minimum reforms and inclusionary housing policies. Similarly, initiatives like the National Zoning Atlas have achieved traction by tackling a foundational data challenge: digitizing and standardizing the country’s fragmented zoning codes, having already mapped over 50% of U.S. land area, including major metros like Houston and San Diego.

    2. Fragmented ownership and authority

    Basic facts about land are often missing. In many local jurisdictions, no single office can confirm which public entity owns which parcel, let alone coordinate how those assets are deployed for housing. In Atlanta, a dedicated central team eventually stitched together assessor files, handwritten ledgers, and transit-authority spreadsheets to build the city’s first unified public-land map. Armed with this new data—and inspired by Copenhagen’s municipal land corporation—the city established an Urban Development Corporation in 2024 to broker multi-agency approvals and unlock dormant parcels for housing. The exercise surfaced more than 40 developable acres that had been hiding in plain sight. Fifty new development projects are underway.

    3. Capacity bottlenecks

    Most local housing departments operate with lean staffing and tight budgets; larger cities may command more resources, but must navigate correspondingly larger and more complex operating environments. Smaller communities may not have data or geospatial departments, or may even have difficulties accessing or understanding their own regulations, including zoning. Either way, the personnel and financial headroom required to sustain continuous data collection, community engagement, and policy iteration remain in short supply. Denver’s team, for example, is forced to guess how inclusionary-housing tweaks will land on developers’ pro-formas—an impossible task without automated modeling support.

    What AI can—and cannot—do for housing supply

    In theory, AI systems can be leveraged to assist in data integration processes by reconciling parcel tables, flagging underused land, and running zoning simulations in minutes rather than months. Successful implementation of these functions could, in turn, help free up local teams to focus on higher-impact activities that move from identifying potential supply to building supply—such as creating new agencies like Atlanta’s Urban Development Corporation, reviewing property records that automated systems cannot interpret, and engaging communities in housing production efforts.

    In practice, however, there are many constraints when attempting to use ML to integrate data and automate inference. As learned in Room 11 conversations, the National Zoning Atlas’ two-year collaboration with Cornell Tech, backed by NSF funding, found that even leading ML models could not reliably parse zoning codes. Despite processing thousands of pages of text, researchers concluded that legal nuance, inconsistent formatting, and local exceptions rendered zoning documents effectively unreadable by AI alone. Atlanta’s experience mapping public land similarly revealed that property ownership records required manual verification—automated systems failed to detect transactions between public agencies that did not trigger tax records. In Charlotte, displacement monitoring still depends on human review to distinguish qualified transactions from multi-parcel or otherwise unqualified sales that the model can’t classify automatically. Collectively, these examples demonstrate that civic data often embeds ambiguity and context-specific nuance that resist full automation.

    A strategy for supporting cities to leverage AI for housing supply

    Room 11 conversations validated the hypothesis that developing more standardized city-level data infrastructures and institutional capabilities will help unlock more opportunities for AI systems to be used to optimize housing supply. Local staff with context and domain expertise are needed to design the inputs and ground-truth the outputs of AI systems, while interpreting and using those inputs in real-world negotiations with developers, residents, and finance authorities. In short, algorithms can deliver speed; local knowledge and policy judgment can turn speed into supply.

    To harness this potential, Home GP’s proposed learning cohorts could be designed to convert isolated pilots into shared public infrastructure. In the same way that the Human Genome Project transformed biomedical research through open datasets, protocols, and collaborative standards that supported downstream AI-enabled technologies like CRISPR, Home GP could create the data commons and institutional capacities cities need to support AI systems for optimizing housing supply.

    This approach builds three core functions:

    • “Vertical ladders” that help each city climb from basic data auditing and management to increasingly sophisticated tools and competencies in its chosen domain. For example, following its first public land use dataset, Atlanta was able to add more and more sophisticated layers of data (e.g., zoning and market data), which in turn enabled more sophisticated inference informing project development.
    • “Horizontal branches” for peer exchange: The city that perfects a vacancy-detection model can lend that module as a template for others to adapt while borrowing, say, a permitting-analytics script in return.
    • Cross-sector brokerage that connects city teams with technical experts, funders, and peer cities—facilitating the partnerships and resource flows essential for turning pilots into sustainable programs. This brokering function, exemplified by organizations like Community Solutions in the homelessness space, has proven critical for scaling local innovations.

    The initial phase of Home GP would develop two pillars of support architecture: (1) shared computational tools (data definitions and standards, datasets, and ML models) that can support context-calibrated AI applications for data integration, pattern recognition, and forecasting housing supply; and (2) an institutional readiness playbook that helps any jurisdiction develop institutional capacities for data integration and AI system deployment.

    1. Shared computational tools: Initial Home GP efforts to develop shared resources might include data integration standards and tools, integrated city-level datasets (land use, zoning, market data), and historical time series data (on either actual as-built conditions or policies) that can be federated and used to train ML predictive models and develop applications. Innovative approaches to inference developed in specific contexts (e.g., Santa Fe’s water use proxy data for vacancies) could be made available for adaptation to other relevant contexts.
    2. Institutional readiness playbook: Room 11 discussions identified at least five institutional enabling conditions for harnessing the potential value of AI tools for which playbooks could be developed through a community-of-practice model:

    a. Impact-focused mandate. A concrete, numeric, and time-bound housing supply target shared across city-level stakeholders and tied to public reporting—e.g., “add 20 percent versus baseline affordable units by 2030.”

    b. Empowered cross-functional teams. Land bank, planning, IT, community liaison—everyone who touches parcels or permits at one table. As in Denver, Atlanta, and Santa Fe, often these mission-driven, cross-functional teams sit within the mayor’s office.

    c. Minimum viable data foundations. A clean parcel table, zoning layer, and permitting feed that update on a regular cadence.

    d. Technical literacy and readiness. Analysts, organizers, and dealmakers who can translate model outputs into negotiations with developers and residents.

    e. Equity guardrails. Bias audits, open-source code, and transparent processes that protect against unintended harm. Denver has already begun developing internal equity review processes as part of its housing data modernization efforts, while Charlotte is focusing on transparent use of displacement data to monitor outcomes.

    While cities serve as the natural starting point for this work, the long-term sustainability of these systems may require thinking beyond municipal boundaries. London’s success in collecting standardized data from roughly 120,000 development proposals annually stems from national legislation—the Town and Country Planning Act—that creates regulatory leverage for data collection. This demonstrates how state and federal policy frameworks can enable the data standardization that cities need. Similarly, Metropolitan Planning Organizations (MPOs) could coordinate cross-jurisdictional housing strategies, while state agencies might maintain regional databases and technical infrastructure at scale. The institutional readiness playbook should therefore anticipate how governance structures can evolve from city-led experiments to more distributed models that leverage policy frameworks and regional coordination.

    3. Next steps and open considerations

    Home GP—hosted initially by a working group of Room 11 organizations—could convene four to six U.S. cities as a proof-of-concept cohort over 12 months. The ultimate goal is to produce open dataset layers released under permissive licenses, reusable AI modules (e.g., for vacancy detection, land-assemblage scoring), and implementation playbooks covering procurement language, governance, and community engagement. A “story bank” could document use cases that demonstrate what cities can achieve with better data.

    Cities would select an appropriate peer-learning format, for example, rotating as lead developer and fast follower can ensure that expertise diffuses rather than concentrates; while a parallel pilot approach might allow cities to adapt quickly to local conditions.

    Critically, the working group would also consider the technical and institutional architecture requirements for data and model standardization. The National Zoning Atlas discovered that standardizing data across jurisdictions was among its consultants’ most technically complex projects. Building an integrated and scalable national or international infrastructure may require specialized partners and/or a unified platform with capabilities no single organization currently possesses.

    To reach this proof-of-concept stage, a prior planning phase would likely be needed to develop a detailed implementation roadmap, including governance structure, data sharing protocols, and potential funding models. This phase could convene municipal Chief Technical Officers, or equivalent, and housing leaders from those cities—bringing together those with technical expertise, housing expertise, and local commitment to investment in housing innovation capacity.

    4. Conclusion: Choosing to build together

    Local leaders already possess many important raw ingredients—granular parcel data, courageous front-line teams, and a new generation of AI tools—to close information gaps that have long stymied housing production. The key need is for civic leaders, government partners, philanthropy, and investors to knit those ingredients into a durable, shared infrastructure— analogous to scientific open-data protocols. By treating data pipelines and AI models as shared public infrastructure—and by learning in public through a cohort architecture that amplifies shared competencies and brings relevant stakeholders together—cities can unlock the transformative potential of AI to close housing supply gaps and make homelessness rare and brief. The goal—50 cities each identifying and unlocking more homes than the currently projected new supply by 2030—is ambitious yet reachable.

    The Brookings Institution is committed to quality, independence, and impact.
    We are supported by a diverse array of funders. In line with our values and policies, each Brookings publication represents the sole views of its author(s).

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  • Promoting Co-Benefit Actions for Positive Environmental and Social Impacts from Renewables – News

    Promoting Co-Benefit Actions for Positive Environmental and Social Impacts from Renewables – News

    Speakers from financial institutions, NGOs, government, and industry highlighted how biodiversity protection, community engagement, and energy development can be mutually reinforcing when built into project design and policy frameworks.

    Examples ranged from solar projects in France that integrate wetland restoration, eco-grazing, and citizen investment, to marine wind farms in the North Sea linked to long-term marine conservation funding. In Uzbekistan, solar developers are protecting tortoise habitats and partnering with local herders to manage grazing. In Qinghai Province, China, large-scale PV parks are reversing desertification while supporting ecological animal husbandry.

     

     

    Industry actors like TotalEnergies are scaling agro-photovoltaic models that combine renewable energy generation with sustainable farming. Policymakers and financial institutions, including the European Bank for Reconstruction and Development (EBRD) and the International Renewable Energy Agency (IRENA), underscored the role of strong policy frameworks, financing incentives, and capacity building to scale these approaches globally. 

    Ecowende is developing the Netherlands’ most ecological offshore wind farm to date—powering 3% of national demand while enhancing North Sea biodiversity—through an innovative, research-driven and collaborative approach supported by IUCN’s Biodiversity Advisory Team, which provides independent review and recommendations on biodiversity goals and targets.

    ecowende graphic

    ecowende graphic 2

    From regulatory tools to community partnerships, the session highlighted that the energy transition can—and must—deliver measurable gains for biodiversity and people.

    The session was moderated by Qiulin Liu from IUCN and speakers included Adonai Herrera-Martínez from EBRD, Aonghais Cook from The Biodiversity Consultancy, Dr. Ma Hao from the Qinghai Provincial Development and Reform Commission, Jinlei Feng from IRENA, Karen Westley from Ipieca, Libby Sandbrook from Fauna & Flora, Sophie Depraz from Ipieca, Steven Dickinson from TotalEnergies, Yu Miao from SPIC Huanghe Hydropower Development Co., Ltd., and Zhang Jiali from the China Renewable Energy Engineering Institute (CREEI)

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  • Lilly’s Omvoh (mirikizumab-mrkz) approved by U.S. FDA as a single-injection maintenance regimen in adults with ulcerative colitis

    Lilly’s Omvoh (mirikizumab-mrkz) approved by U.S. FDA as a single-injection maintenance regimen in adults with ulcerative colitis

    Omvoh now offers patients a simplified maintenance experience with one monthly injection, replacing the previous two-injection regimen

     Omvoh single-injection dosing will be available for U.S. patients in early 2026

    This is the third FDA approval for Omvoh this year, following approvals for Crohn’s disease and a citrate-free formulation

    INDIANAPOLIS, Oct. 27, 2025 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh (mirikizumab-mrkz) for subcutaneous use in adults with moderately to severely active ulcerative colitis (UC).

    “In clinical practice, we see that simplifying maintenance treatment can make a difference in the overall patient experience,” said Miguel Regueiro, M.D., board-certified gastroenterologist specializing in inflammatory bowel disease. “A single monthly injection of Omvoh gives patients a regimen that’s easier to manage alongside the unpredictability of living with ulcerative colitis.”

    The Omvoh single-injection, citrate-free maintenance dose will be available in the U.S. via prefilled pen or prefilled syringe in early 2026. The U.S. approval follows the recent European Union authorization of Omvoh for single-injection maintenance dosing for UC.

    “People living with the constant discomfort and disruption caused by the symptoms of ulcerative colitis need treatments that offer the potential to achieve lasting remission and a convenient dosing option that fits easily into their lives,” said George Salem, M.D., director of Crohn’s and Colitis Center at OU HEALTH. “With this approval, patients who respond to induction therapy with Omvoh can continue maintenance therapy with the convenience of just one injection each month — delivering the same proven results with fewer injections.”

    The single-injection approval is based on results from a Phase 1 study comparing one 200 mg/2 mL subcutaneous injection to two 100 mg/1 mL injections in participants. The study confirmed that Omvoh single-injection is bioequivalent to the previously approved two-injection regimen.1 Treatment with Omvoh for ulcerative colitis starts with 300-mg IV infusions every four weeks, for a total of three infusions, and at Week 12 transitions to subcutaneous self-injection every four weeks for maintenance treatment.

    “At Lilly, we are committed to supporting people living with IBD by delivering meaningful clinical outcomes and continuing to improve their treatment experience,” said Ashley Diaz-Granados, senior vice president of U.S. Immunology at Lilly. “Building on the introduction of a citrate-free formulation of Omvoh earlier this year, this approval further delivers on our commitment by providing patients the same outcomes in a single-injection maintenance regimen that fits more seamlessly into their lives.”

    Omvoh is approved in the U.S. for the treatment of moderately to severely active UC and moderately to severely active Crohn’s disease in adults and has been approved in 45 countries around the world. Through Lilly Support Services™, Lilly offers a patient support program including co-pay assistance for eligible, commercially insured patients.

    INDICATIONS AND SAFETY SUMMARY

    Omvoh® (ahm-VOH) is a medicine used to treat

    • adults with moderately to severely active ulcerative colitis
    • adults with moderately to severely active Crohn’s disease

    It is not known if Omvoh is safe and effective in children under 18 years of age.

    Warnings – Omvoh can cause serious side effects including:

    Serious allergic reactions: Omvoh may cause serious allergic reactions that may need to be treated in a hospital and may be life-threatening. Do not use Omvoh if you have had a serious allergic reaction to mirikizumab-mrkz or any of the ingredients in Omvoh. See the Medication Guide that comes with Omvoh for a list of ingredients. Stop using Omvoh and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:

    • fainting, dizziness, feeling lightheaded
    • swelling of your face, eyelids, lips, mouth, tongue, throat, or trouble swallowing
    • trouble breathing, throat tightening, or wheezing
    • chest tightness
    • fast heartbeat or pounding in your chest
    • severe itching, hives, or redness all over your body
    • sweating

    Infections: Omvoh may lower the ability of your immune system to fight infections and may increase your risk of infections. If you have an infection, your healthcare provider should not start treatment with Omvoh until your infection is gone. Before starting treatment with Omvoh, your healthcare provider should assess you for tuberculosis (TB). If you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Omvoh. Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with Omvoh and after treatment.

    Before starting Omvoh, tell your healthcare provider if you think you have an infection or have symptoms of an infection, such as:

    • fever, sweating, or chills
    • muscle aches and pain
    • cough or shortness of breath
    • blood in your mucus (phlegm)
    • flu-like symptoms
    • headache
    • warm, red, or painful skin or sores on your body
    • diarrhea or stomach pain
    • weight loss
    • nausea or vomiting
    • pain during urination

    After starting Omvoh, tell your healthcare provider right away if you have any symptoms of an infection.

    Liver Problems: Omvoh may cause liver problems. Your healthcare provider should do blood tests to check your liver enzyme and bilirubin levels before treatment, during, and after treatment with Omvoh. Your healthcare provider may hold or stop treatment if needed. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:

    • unexplained rash
    • nausea
    • vomiting
    • stomach-area (abdominal) pain
    • feeling tired
    • loss of appetite
    • yellowing of the skin or the whites of your eyes
    • dark urine

    Common side effects

    The most common side effects of Omvoh in people treated for ulcerative colitis include:

    • upper respiratory infections
    • injection site reactions
    • joint pain
    • rash
    • headache
    • herpes viral infections

    The most common side effects of Omvoh in people treated for Crohn’s disease include:

    • upper respiratory infections
    • injection site reactions
    • headache
    • joint pain
    • elevated liver blood tests

    These are not all the possible side effects of Omvoh.

    Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Before you use Omvoh, review these questions with your doctor:

    • Are you being treated for an infection?
    • Do you have an infection that does not go away or keeps coming back?
    • Do you have TB or have you been in close contact with someone with TB?
    • Do you have any possible symptoms of an infection such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, or pain during urination?

    Tell your doctor about all your medical conditions, including if:

    • You have a history of serious allergic reaction to Omvoh, any infections or liver problems.
    • You need any vaccines or have had one recently. Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during or right after treatment with Omvoh. Tell your healthcare provider that you are taking Omvoh before receiving a vaccine.
    • You are pregnant, or plan to become pregnant. It is not known if Omvoh will harm your unborn baby. There will be a pregnancy registry to collect information about women who are exposed to Omvoh during pregnancy. If you become pregnant while taking Omvoh, you are encouraged to report your pregnancy to Eli Lilly and Company at 1-800-545-5979.
    • You are breastfeeding or plan to breastfeed. It is not known if Omvoh passes into your breastmilk.
    • You take prescription or over-the-counter medicines, vitamins, or herbal supplements.

    How to take
    Follow your healthcare provider’s instructions for using Omvoh. You will receive your first 3 doses of Omvoh through a vein in your arm (intravenous infusion) in a healthcare facility by a healthcare provider every 4 weeks. Each infusion will last about 30 minutes (for ulcerative colitis) or about 90 minutes (for Crohn’s disease). After induction, you will continue to receive Omvoh maintenance doses as self-injections under the skin (subcutaneous injection) every 4 weeks. For these injections, Omvoh is available as prefilled pens or prefilled syringes. (If taking Omvoh for Crohn’s disease, you will need two injections to complete your dose, using either two prefilled pens or two prefilled syringes.) If you give injections at home, you should be trained on the correct way to prepare and inject Omvoh. Do not try to inject Omvoh yourself until you or your caregiver have been shown how to inject. Read the detailed Instructions for Use about how to use and dispose of Omvoh the correct way.

    Learn more
    Omvoh is a prescription medicine. During induction, Omvoh is available as a single-dose vial for intravenous infusion containing 300 mg/15 mL that is administered in a healthcare facility.

    During maintenance, Omvoh is available as:

    • For ulcerative colitis: one 200 mg/2 mL prefilled pen or prefilled syringe.
    • For Crohn’s disease: one 100 mg/mL prefilled pen or prefilled syringe and one 200 mg/2 mL prefilled pen or prefilled syringe.

    For more information, call 1-800-545-5979 or go to omvoh.lilly.com.

    This summary provides basic information about Omvoh but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Omvoh and how to take it. Your doctor is the best person to help you decide if Omvoh is right for you.

    MR CON BS 24OCT2025

    Omvoh® and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

    About Omvoh
    Omvoh (mirikizumab-mrkz) is an interleukin-23p19 (IL-23p19) antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of inflammatory bowel disease.2

    Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company.

    About Lilly
    Lilly is a medicine company turning science into healing to make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer’s disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

    CMAT-02499 10/2025 © Lilly USA, LLC 2025. ALL RIGHTS RESERVED. 

    Trademarks and Trade Names
    All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company’s or their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

    Cautionary Statement Regarding Forward-Looking Statements
    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Omvoh (mirikizumab-mrkz) as a treatment for people with moderate to severe ulcerative colitis and moderate to severe Crohn’s disease and reflects Lilly’s current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Omvoh will receive additional regulatory approvals, or that Omvoh will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly’s expectations, see Lilly’s Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    References
    1 Otani Y, et al. One subcutaneous injection of mirikizumab is bioequivalent to two subcutaneous injections: results from a pharmacokinetic comparability study in healthy participants. 2025 United European Gastroenterology Week. October 4-7, 2025.
    2 Omvoh. Prescribing Information. Lilly USA, LLC. 

    Refer to:        Kelly Hoffman; [email protected]; 765-736-2555 (Lilly media)
                           Michael Czapar; [email protected]; 317-617-0983 (Investors)

    SOURCE Eli Lilly and Company


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  • Exclusive: Germany's SAP mulls new bid for software firm BlackLine, sources say – Reuters

    1. Exclusive: Germany’s SAP mulls new bid for software firm BlackLine, sources say  Reuters
    2. SAP Made Earlier Takeover Approach for Software Firm BlackLine  Bloomberg.com
    3. BlackLine gains on report SAP made takeover approach earlier this year  MSN
    4. Exclusive-Germany’s SAP mulls new bid for software firm BlackLine, sources say  MSN

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  • ENCIRCLE: Percutaneous Transseptal TMVR System in Patients Not Eligible For Surgery or TEER

    ENCIRCLE: Percutaneous Transseptal TMVR System in Patients Not Eligible For Surgery or TEER

    Percutaneous transseptal mitral valve replacement (TMVR) using the SAPIEN M3 system effectively reduced mitral regurgitation (MR) with low rates of complications and mortality in patients who were not candidates for conventional surgery or transcatheter edge-to-edge repair (TEER), according to results of the ENCIRCLE trial presented at TCT 2025 and simultaneously published in The Lancet.

    The trial involved a total of 287 patients from the U.S., Canada, Europe, Israel and Australia who had MR ≥3+, NYHA Class ≥II, and were unsuitable for surgery or TEER due to clinical, anatomic or technical considerations. The balloon-expandable, dedicated SAPIEN M3 mitral transcatheter heart valve was implanted in each patient and follow-up was conducted at 30 days, six months and one year.

    In overall findings, the primary endpoint – the composite of all-cause mortality and rehospitalization for heart failure at one year compared to a pre-specified performance goal of 45% – was 25.2%. All-cause death and heart failure hospitalization rates were 13.9% and 16.7%, respectively. Additionally, improvements in MR grade were observed across all patients, with more than 95% having ≤1+ total MR at 30 days and one year. Researchers also noted the TMVR system had a procedural safety profile similar to TEER and that patients experienced clinically meaningful and durable improvements in symptoms and quality of life.

    “Percutaneous transseptal TMVR had a low mortality rate while providing a significant reduction in [MR] severity and providing meaningful and durable improvements in functional status and quality of life,” said David Daniels, MD. “These findings will help guide clinical practice by providing an alternative treatment option for patients who are not suitable for conventional surgery or TEER procedures.”

    Additionally, Daniels and colleagues say their findings could allow for “future reintervention with percutaneous transseptal mitral valve-in-valve implantation in the event of structural valve deterioration,” noting that “reintervention after failed TEER remains a major limitation.”


    Clinical Topics:
    Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Interventions and Imaging, Interventions and Structural Heart Disease, Angiography, Nuclear Imaging


    Keywords:
    Transcatheter Cardiovascular Therapeutics, TCT25, Angiography, Heart Valve Diseases

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  • Amazon plans to cut 30,000 corporate jobs in response to pandemic overhiring | Amazon

    Amazon plans to cut 30,000 corporate jobs in response to pandemic overhiring | Amazon

    Amazon is planning to cut as many as 30,000 corporate jobs beginning Tuesday, as the company works to pare expenses and compensate for overhiring during the peak demand of the pandemic, according to three people familiar with the matter.

    The figure represents a small percentage of Amazon’s 1.55 million total employees, but nearly 10% of the company’s roughly 350,000 corporate employees. This would represent the largest job cut at Amazon since around 27,000 jobs were eliminated starting in late 2022.

    An Amazon spokesperson declined to comment.

    Amazon has been trimming smaller numbers of jobs over the past two years across multiple divisions, including devices, communications, podcasting and others.

    The cuts beginning this week may impact a variety of divisions within Amazon, including human resources, known as people experience and technology, devices and services and operations, among others, the people said.

    Managers of affected teams were asked to undergo training on Monday for how to communicate with staff following notifications that will start going out via email tomorrow morning, the people said.

    Amazon shares were up 1.5% to $227.53. The company plans to report third quarter earnings on Thursday.

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