Category: 3. Business

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  • First-Line Bemarituzumab Plus Chemo Hits OS End Point in FGFR2b+ Advanced Gastric Cancer

    First-Line Bemarituzumab Plus Chemo Hits OS End Point in FGFR2b+ Advanced Gastric Cancer

    Image Credit: ©

    Ashling Wahner & MJH Life Sciences Using AI

    The addition of bemarituzumab to mFOLFOX6 (modified oxaliplatin, leucovorin, and fluorouracil) led to a statistically significant and clinically meaningful improvement in overall survival (OS) vs placebo plus chemotherapy in patients with HER2-negative, unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer harboring FGFR2b overexpression, meeting the primary end point of the phase 3 FORTITUDE-101 trial (NCT05052801).1

    Findings announced by Amgen also showed that the most common treatment-emergent adverse effects (AEs) reported in more than 25% of patients treated in the bemarituzumab arm comprised reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect, and dry eye. Although instances of ocular AEs were consistent with prior phase 2 data and occurred in both treatment arms, they were reported at a higher rate frequency and severity in the phase 3 bemarituzumab group.

    Detailed data from the prespecified interim analysis will be presented at an upcoming medical meeting.

    “Most patients with gastric cancer are diagnosed at an advanced stage, with poor prognosis, low survival rates, and limited therapeutic options,” Jay Bradner, MD, executive vice president of Research and Development at Amgen, stated in a news release. “These first positive topline results of an FGFR2b-targeted monoclonal antibody from our phase 3 FORTITUDE-101 study mark a meaningful advance in the development of effective targeted therapy for gastric cancer.”

    FORTITUDE-101 Overview

    The randomized, multicenter, double-blind, placebo-controlled trial enrolled patients at least 18 years of age with histologically documented locally advanced unresectable or metastatic gastric or GEJ cancer not amenable to curative therapy.2 Patients needed to be positive for FGFR2b overexpression, defined 2+ or 3+ staining on at least 10% of tumor cells per centrally performed immunohistochemistry (IHC).

    Other key inclusion criteria included an ECOG performance status of 0 or 1; evaluable disease that could be measurable or non-measurable per RECIST 1.1 criteria; no contraindications to mFOLFOX6; and adequate organ and bone marrow function.

    Patients were excluded if they received prior treatment in the metastatic or unresectable setting; however, previous neoadjuvant, adjuvant, and perioperative therapy was permitted if completed more than 6 months prior to first dose of study treatment. Other exclusion criteria included any prior treatment with a selective FGFR inhibitor; HER2-positive disease; untreated or symptomatic central nervous system disease or brain metastases; and clinically significant cardiac disease.

    A total of 547 patients enrolled across the study at 300 sites across 37 countries.1 Patients were randomly assigned to receive bemarituzumab plus mFOLFOX6 or placebo plus mFOLFOX6.

    Along with the primary end point of OS, secondary end points included progression-free survival, objective response rate, duration of response, disease control rate, quality of life, and safety.2

    Bemarituzumab is also being investigated in the phase 3 FORTITUDE-102 study (NCT05111626), where patients with previously untreated gastric cancer are being randomly assigned to receive bemarituzumab in combination with chemotherapy and nivolumab (Opdivo) or placebo plus chemotherapy and nivolumab. Data from this study are expected to read out in the second half of 2025.1

    After the safety and tolerability of the combination of bemarituzumab, chemotherapy, and nivolumab were evaluated in the first nonrandomized part of the study, patients with locally advanced unresectable or metastatic, histologically documented gastric or GEJ adenocarcinoma are being randomly assigned between the 2 arms in the second part of the study. Notably, patients being enrolled to the randomized portion are required to have centrally confirmed FGFR2b overexpression per IHC.

    References

    1. Amgen announces positive topline phase 3 results for bemarituzumab in fibroblast growth factor receptor 2b (FGFR2b) positive first-line gastric cancer. News release. Amgen. June 30, 2025. Accessed June 30, 2025. https://www.amgen.com/newsroom/press-releases/2025/06/amgen-announces-positive-topline-phase-3-results-for-bemarituzumab-in-fibroblast-growth-factor-receptor-2b-fgfr2b-positive-firstline-gastric-cancer
    2. Bemarituzumab or placebo plus chemotherapy in gastric cancers with fibroblast growth factor receptor 2b (FGFR2b) overexpression (FORTITUDE-101). ClinicalTrials.gov. Updated February 7, 2025. Accessed June 30, 2025. https://clinicaltrials.gov/study/NCT05052801
    3. Bemarituzumab plus chemotherapy and nivolumab versus chemotherapy and nivolumab for FGFR2b overexpressed untreated advanced gastric and gastroesophageal junction cancer. (FORTITUDE-102). ClinicalTrials.gov. Updated June 12, 2025. Accessed June 30, 2025. https://clinicaltrials.gov/study/NCT05111626

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  • Weight-Loss Drug Maridebart Cafraglutide Shows Efficacy in Phase 2 Trial

    Weight-Loss Drug Maridebart Cafraglutide Shows Efficacy in Phase 2 Trial

    Patients with obesity who received maridebart cafraglutide (MariTide; Amgen), a once-monthly obesity medication, demonstrated weight loss of up to 19.9% in a phase 2 trial (NCT05669599).1 Those with obesity and type 2 diabetes showed weight loss of up to 17%.

    Maridebart cafraglutide is a long-acting peptide–antibody conjugate that combines glucagon-like peptide-1 (GLP-1) receptor agonism and glucose-dependent insulinotropic polypeptide (GIP) receptor antagonism. The 2 identical GLP-1 peptide analogs conjugated to a single monoclonal antibody antagonist to the GIP receptor result in a 21-day half-life, 3 times longer than the FDA approved longest-acting once-weekly anti-obesity medication, semaglutide. The extended half-life can potentially lead to increased access and adherence for those whose health and access to health care are disproportionately affected by socioeconomic status.2 

    The mean percent change in body weight from the obesity cohort from baseline to 52 weeks ranged from −12.3% to −16.2% to −16.2%. | Image Credit: ricka_kinamoto – stock.adobe.com

    “[Maridebart cafraglutide]’s monthly or less frequent dosing has the potential to improve adherence and long-term weight control, providing the opportunity to optimize health outcomes for people living with obesity, type 2 diabetes, and related conditions,” Jay Bradner, MD, executive vice president of Research and Development at Amgen, said in a press release.3 “[Maridebart cafraglutide] delivered strong efficacy, including sustained weight loss without a plateau in the 52-week phase 2 study and meaningful improvements in cardiometabolic risk factors, representing a defining advance for the obesity field.”

    Phase 2 of the trial tested the efficacy, adverse event profile, and safety of maridebart cafraglutide at various doses with and without escalation.1 The study enrolled 592 participants—465 in the obesity cohort and 127 in the obesity-diabetes cohort. The obesity cohort was randomly assigned in a 3:3:3:2:2:2:3 ratio to receive either 52 weeks of maridebart cafraglutide subcutaneously at 140, 280, or 420 mg every 4 weeks without dose escalation; 420 mg every 8 weeks without dose escalation; 420 mg every 4 weeks with either a 4- or 12-week dose escalation; or a placebo. Participants in the obesity-diabetes cohort were randomly assigned in a 1:1:1:1 ratio to receive maridebart cafraglutide over 52 weeks at a dosage of 140, 280, or 420 mg every 4 weeks or a placebo.

    The mean percent change in body weight from the obesity cohort from baseline to 52 weeks ranged from −12.3% to −16.2% (95% CI, −15.0 to −9.7) to −16.2% (95% CI, −18.9 to −13.5). The obesity-diabetes cohort mean percent change in body weight ranged from −8.46% (95% CI, −11.0 to −5.7) to −12.3% (95% CI, −15.3 to −9.2).

    Those in both cohorts who received maridebart cafraglutide also showed a significant difference in the percentage points of glycated hemoglobin (HbA1c) levels when analyzed using the treatment policy estimand. The obesity cohort had a mean difference of –0.32 (95% CI, –0.5 to –0.2) percentage points measuring glycated hemoglobin levels. Similarly, the obesity-diabetes cohort showed a mean difference of –1.43 (95% CI, –1.9 to –0.7) percentage points in glycated hemoglobin. When analyzed using the efficacy demand, the obesity cohort did not show a significant difference in weight loss; however, the obesity-diabetes cohort did, with –2.03 (95% CI, –2.4 to –1.6) percentage points.

    Participants in both cohorts experienced improvement in additional secondary end points, including differences in systolic and diastolic blood pressure, high-sensitivity C-reactive protein (hs-CRP), and select lipid variables. Furthermore, those receiving a dose escalation over 4 or 12 weeks did not show significant differences in primary or secondary end points when compared with those that did not receive dose escalation.

    Adverse events occurred in an average of 93.5% of participants across both cohorts. The most common adverse events (AEs) were gastrointestinal, which included mild to moderate nausea, vomiting, constipation, retching, and diarrhea. There was a lower incidence of adverse events in the groups with dose escalation and those starting at a lower dose across both cohorts.

    Of the 592 participants in the obesity cohort, 8% in the dose escalation group discontinued the trial due to GI AEs, as opposed to the 12% to 17% in the no–dose escalation groups. Similarly, 6% to 16% of participants in the obesity-diabetes cohort discontinued due to GI-related adverse events. Other predefined adverse events varied in severity, ranging from mild to moderate, and included injection-site rash, reactions, and/or urticaria.

    “These results, alongside the phase 1 pharmacokinetics low-dose initiation data, have shaped our phase 3 MARITIME program,” Bradner said.3

    References

    1. Jastreboff AM, Ryan DH, Bays HE, et al. Once-monthly maridebartcafraglutide for the treatment of obesity — a phase 2 trial. New England Journal of Medicine. Published online June 23, 2025. doi:10.1056/nejmoa2504214
    2. Eberly LA, Yang L, Essien UR, et al. Racial, ethnic, and socioeconomic inequities in glucagon-like peptide-1 receptor agonist use among patients with diabetes in the US. JAMA Health Forum. 2021;2(12): e214182. doi:10.1001/jamahealthforum.2021.4182
    3. Results from Amgen’s phase 2 obesity study of monthly maritide presented at the American Diabetes Association 85th Scientific Sessions. Amgen. June 23, 2025. Accessed June 25, 2025. https://www.amgen.com/newsroom/press-releases/2025/06/results-from-amgens-phase-2-obesity-study-of-monthly-maritide-presented-at-the-american-diabetes-association-85th-scientific-sessions

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  • OLAF supports coordinated crackdown on cross-border counterfeit cigarette network in Italy and Romania

    OLAF supports coordinated crackdown on cross-border counterfeit cigarette network in Italy and Romania

    Press release no 18/2025
    PDF version

    The European Anti-Fraud Office (OLAF) played an important coordination role in a large-scale joint operation that dismantled a cross-border criminal network involved in the illicit production and smuggling of counterfeit cigarettes, with estimated evaded duties totalling approximately €9.8 million.

    The network, coordinated by Romanian, Moldovan, and Italian nationals, operated illegal production facilities in both Romania and Italy, with significant quantities of counterfeit tobacco products destined for distribution across the European Union.

    The operation, carried out on 3 June 2025, was the result of extensive intelligence sharing between OLAF, Romanian authorities—including the Economic Crime Investigation Directorate of the General Police Inspectorate (I.G.P.R.), Caraș-Severin County Police (I.P.J. Caraș-Severin), and the Directorate for Investigating Organised Crime and Terrorism (D.I.I.C.O.T.)—and the Italian Guardia di Finanza and Bologna Economic Police Unit.

    In Romania, coordinated searches in Timiș and Arad counties led to the seizure of approximately 25 million cigarettes stored in 2,500 boxes. Four individuals were arrested in Timiș County while handling smuggled goods. Two other suspects were detained by D.I.I.C.O.T. on 4 June.These actions were supported by the Romanian Customs Authority.

    Simultaneously, in Italy, a clandestine cigarette factory was discovered in an industrial area in the Emilia-Romagna region. The site was equipped with high-end machinery for replicating branded packaging. Investigators seized 14 tonnes of counterfeit cigarettes, more than 10 tonnes of unprocessed tobacco, and a large quantity of packaging materials.

    The scale of the illicit operation underscores the financial threat posed to the EU’s budget and legitimate trade. OLAF’s role was instrumental in ensuring swift cross-border cooperation, highlighting its mandate to protect the EU’s financial interests and combat organised fraud. 

     

    OLAF mission, mandate and competences:
    OLAF’s mission is to detect, investigate and stop fraud with EU funds.    

    OLAF fulfils its mission by:
    •    carrying out independent investigations into fraud and corruption involving EU funds, so as to ensure that all EU taxpayers’ money reaches projects that can create jobs and growth in Europe;
    •    contributing to strengthening citizens’ trust in the EU Institutions by investigating serious misconduct by EU staff and members of the EU Institutions;
    •    developing a sound EU anti-fraud policy.

    In its independent investigative function, OLAF can investigate matters relating to fraud, corruption and other offences affecting the EU financial interests concerning:
    •    all EU expenditure: the main spending categories are Structural Funds, agricultural policy and rural development funds, direct expenditure and external aid;
    •    some areas of EU revenue, mainly customs duties;
    •    suspicions of serious misconduct by EU staff and members of the EU institutions.

    Once OLAF has completed its investigation, it is for the competent EU and national authorities to examine and decide on the follow-up of OLAF’s recommendations. All persons concerned are presumed to be innocent until proven guilty in a competent national or EU court of law.

    For further details:

    Pierluigi CATERINO
    Spokesperson
    European Anti-Fraud Office (OLAF)
    Phone: +32(0)2 29-52335  
    Email: olaf-mediaec [dot] europa [dot] eu (olaf-media[at]ec[dot]europa[dot]eu)
    https://anti-fraud.ec.europa.eu
    LinkedIn: European Anti-Fraud Office (OLAF)
    X: x.com/EUAntiFraud
    Bluesky: euantifraud.bsky.social

    If you’re a journalist and you wish to receive our press releases in your inbox, please leave us your contact data.

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  • Echo360 2025 e³ Tech Grants Program

    Echo360 2025 e³ Tech Grants Program

    Over $100,000 in financial and technology grants awarded globally to support educators and innovation

    NEW YORK, July 1, 2025 /PRNewswire/ — Echo360, the global leader in transformative learning and AI-powered education technology, today announced the recipients of its 2025 e³ Tech Grants Program, awarding more than $100,000 in combined financial and technology support to educators and researchers worldwide. Now in its fifth year, the e³ Tech Grants Program reinforces Echo360’s ongoing commitment to advancing transformative teaching and learning through targeted investment and hands-on resources.

    “As educational institutions face mounting financial stress, from flat or declining funding to enrollment volatility, every dollar counts,” said Murad Velani, President and CEO of Echo360. “Our 2025 grant awards demonstrate how Echo360 stands shoulder to shoulder with educators, equipping them not only with needed funding, but with technologies and training that amplifies instructional innovation around the world.”

    Echo360 Grantmaking: Legacy of Support
    Since 2021, Echo360 e³ Tech Grants have advanced edtech learning equity, engagement, and evidence through two types of awards:

    1. Impact Grants: Financial support for empirical pedagogical research and proof–of–concept projects
    2. Innovation Grants: Technology access grants, offering the EchoSystem AI enriched platform, including GoReact, the market leading AI Video Assessment tool.

    This reflects a long-standing commitment by Echo360 to fund innovation and supply tools that scale across classrooms, labs, and corporate training environments globally.

    Higher Ed Under Pressure
    Colleges and universities around the world continue to grapple with daunting financial headwinds. A 2025 Fitch Ratings report warns many U.S. institutions face “deteriorating” finances due to enrollment declines and rising costs. In the U.K., the Universities and Colleges Employers Association (UCEA) notes one in three schools operates at a deficit. Meanwhile, Australia’s Universities Accord highlights financial sustainability as a sector-wide concern.

    “The Echo360 grant is enabling us to create high-quality, multi-angle videos that we anticipate will transform how physiotherapy students engage with complex manual techniques,” said Julie Bayliss, Lecturer in the Curtin School of Allied Health and 2025 grant recipient. “We believe that this technology will give students the flexibility to learn at their own pace while ensuring equitable access to expert demonstrations; something we couldn’t have achieved without this support.”

    2025 e3 Tech Grant Highlights
    Recipients of the 2025 awards span three regions:

    APAC:

    • Murdoch University
    • RMIT University
    • La Trobe University
    • University of Queensland
    • Queensland University of Technology
    • Curtin University
    • Australian Catholic University
    • Australian National University
    • Swinburne University of Technology
    • Unitec
    • Box Hill Institute

    EMEA:

    • St. George’s University of London
    • Queen Mary University
    • University of Nottingham

    NORTH AMERICA:

    • Allen University
    • Gallaudet University
    • Loyola Marymount University
    • Colorado State University
    • Schreiner University
    • University of Houston–Clear Lake
    • Saint Michael’s College
    • Northampton Community College
    • Rowan School of Osteopathic Medicine
    • Capital University
    • Wilkes Community College
    • University of Nebraska Medical Center
    • Virginia Commonwealth University School of Nursing
    • Forsyth Technical Community College

    Full grant details and application information available at www.echo360.com/company/grants.

    About Echo360
    Echo360 is the global edtech leader enabling transformative learning experiences for education and business through the Echosystem™, the world’s first and only enterprise Learning Transformation Platform™ (LTP™). Serving over 2,000 customers and 5 million learners, instructors, trainers, and frontline workers across the Americas, EMEA, and APAC, Echo360 integrates content creation (EchoInk™), video management (EchoVideo™), engagement (EchoEngage™), and assessment (EchoExam™)—now extended by GoReact’s AI-powered video-based skill assessment and feedback. Echo360; Transforming Learning.

    About e3 Tech Grants: The e³ Formula
    Echo360’s global commitment is embodied in these core values:
    – Equity – Ensuring every learner is supported regardless of environment or access
    – Engagement – Promoting active, immersive learning experiences
    – Evidence – Driving innovation through measurable outcomes

    CONTACT INFORMATION:
    Jeff Peterson
    Echo360
    612-859-0488
    [email protected]

    SOURCE echo360

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  • Intuit Introduces Ground-Breaking Virtual Team of AI Agents to Fuel Growth for Businesses :: Intuit Inc. (INTU)

    Intuit Introduces Ground-Breaking Virtual Team of AI Agents to Fuel Growth for Businesses :: Intuit Inc. (INTU)





    AI agents and trusted AI-enabled human experts available in Intuit QuickBooks assist businesses with saving time, making smarter decisions, and driving better money outcomes

    MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–
    Intuit Inc. (Nasdaq: INTU), the global financial technology platform that makes Intuit TurboTax, Credit Karma, QuickBooks, and Mailchimp, today announced a transformative set of proactive Intuit AI agents that will dramatically improve how businesses run and grow. These agents will automate workflows and when combined with human experts will deliver real-time insights and improve cash flow for businesses.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250701338560/en/

    A more powerful QuickBooks on the Intuit platform with new AI agents.

    The new AI agents, embedded in the Intuit platform, create a more powerful QuickBooks that provides businesses with a virtual team working on their behalf while the customer is always in control. The agents transform how work is done and help customers grow, completing workflows across customer relationship management, financial analysis, payments, accounting, and more, saving businesses up to 12 hours a month.1 Their ability to seamlessly connect data across multiple applications proactively gives customers a 360-view of their business metrics and overall performance – all in one place. The result: 78% of customers say Intuit’s AI makes it easier for them to run their business; and 68% state it allows them to spend more time growing their business.2 These AI agents are also able to work along-side trusted AI-enabled human experts to provide businesses with additional expertise and support.

    “Intuit’s AI-driven expert platform is transforming how businesses run and grow with first-of-its-kind agentic AI experiences,” said Sasan Goodarzi, Intuit CEO. “When our vast amounts of data and AI capabilities are combined with the power of trusted human experts, Intuit’s uniquely designed, integrated platform unlocks next-level efficiencies, profitability, and growth for businesses.”

    These new, done-for-you experiences are part of a completely redesigned and personalized QuickBooks web layout. The homepage is transformed into a striking display of customizable widgets with a powerful business feed that shows real-time intelligent insights, recommendations, and summarizes the workflows and tasks completed by the AI agents. Customers can seamlessly collaborate with human experts and connect to additional Intuit products, services, and third-party apps to truly realize the benefits and power of one integrated platform that drives next-level business efficiencies and growth, all in one place. In addition to the new web experience, the QuickBooks mobile app also has a new, modern interface that delivers the benefits of AI agents on the go.

    Introducing Intuit AI agents: A virtual team that does virtually everything

    Intuit’s new AI agents will help businesses – at every stage – scale, enabling them to grow on a platform they know and trust. The AI agents complete day-to-day tasks, including managing customer leads, tracking payments, sending invoices, and reconciling a business’s books. In addition, new, integrated collaboration tools allow a business owner and their accountant to seamlessly communicate and work together in QuickBooks. With the automation of workflows, collaboration with trusted experts, and the ability to deliver real-time, personalized, and actionable insights, businesses move faster, operate smarter, and uncover greater efficiencies and growth.

    • Payments Agent: Optimizes and grows cash flow by getting businesses paid an average of 5 days faster3 with tailored acceleration strategies that predict late payments, automate invoice tracking, and create and send invoices and reminders.

    • Accounting Agent: Automates bookkeeping and transaction categorization, and assists in reconciliation, delivering cleaner, more accurate books.

    • Finance Agent: Provides a comprehensive approach to the financial management of growing, mid-market businesses with robust reporting, KPI analysis, and scenario planning and forecasting based on performance and peer benchmarking, helping finance teams make smart decisions to achieve financial goals.

    “I need more time to be able to invest back into my business,” said Kurtis Graham, founder, COSIGN Enterprises, LLC. “Intuit’s AI can help me save several hours a month and drive revenue for my business. That’s a win-win for my business.”

    Customer Hub: AI agents that strengthen relationships and fuel business growth

    The Customer Hub, included in most QuickBooks Online plans, will provide two new virtual agents that automate and streamline the sales and customer relationship management (CRM) process, managing new leads and existing customers in one place to deliver delightful customer experiences and stronger relationships.

    • Customer Agent: Sources leads, drafts personalized email responses, suggests and schedules meetings based on engagement data, and tracks every customer opportunity in the sales cycle.

    • Marketing Agent: Coming later this year, it will automate audience management, campaign execution, and content creation to deliver impactful acquisition and retention marketing campaigns via Mailchimp.

    Intuit AI agents for growing businesses

    In the coming months, Intuit AI agents will be available for larger and growing businesses to tackle more complex tasks and boost productivity even further, enabling these businesses to scale with speed.

    • Payroll Agent: Proactively collects time and attendance data from your employees and runs payroll when you say so.

    • Project Management Agent: Manages project quotes, milestones, and budgets so businesses stay on track.

    For more than 40 years, Intuit has been leading the industry in delivering impactful customer experiences that help millions of consumers and businesses put more money in their pockets, helping them achieve their business and financial goals with less effort and complete confidence. The launch of Intuit’s transformational AI agents is the latest innovation powered by Intuit’s platform, bringing artificial intelligence and human intelligence together to power prosperity for its customers. Now, businesses and their accountants have access to a virtual team that saves them time, simplifies the day-to-day running of a business, and helps accountants more confidently and quickly advise clients on key decisions.

    Availability

    The new web and mobile interfaces, integrated AI agents and human experts, and Customer Hub will start rolling out on July 1 to a range of QuickBooks Online products and customers in the US.

    About Intuit

    Intuit is the global financial technology platform that powers prosperity for the people and communities we serve. With approximately 100 million customers worldwide using products such as TurboTax, Credit Karma, QuickBooks, and Mailchimp, we believe that everyone should have the opportunity to prosper. We never stop working to find new, innovative ways to make that possible. Please visit us at Intuit.com and find us on social for the latest information about Intuit and our products and services.

    Money movement services are provided by Intuit Payments Inc., licensed as a Money Transmitter by the New York State Department of Financial Services. For more information about Intuit Payments’ money transmission licenses, please visit https://www.intuit.com/legal/licenses/payment-licenses/.

    Feature availability varies by product.

    Experts only available with QuickBooks Live.

    1. 45% of customers save 12 hours each month on monthly bookkeeping with the new AI-powered bank feed. Based on a survey commissioned by Intuit of QuickBooks Online customers using the new AI-powered bank feed features as of April 2025.

    2. Based on a survey commissioned by Intuit of QuickBooks Online customers using Intuit Assist as of November 2024.

    3. Based on U.S. Intuit Assist Beta customers using outstanding invoice notifications and AI-drafted invoice reminder features, compared to customers sending standard invoice reminders to the same customers, from January 2024 to August 2024. Not available in QuickBooks Online Advanced.

    This information is intended to outline our general product direction, but represents no obligation and should not be relied on when making a purchasing decision. Additional terms, conditions and fees may apply with certain features and functionality. Eligibility criteria may apply. Product offers, features, and functionality are subject to change without notice.

    Jen Garcia, Intuit

    Jennifer_garcia@intuit.com

    Source: Intuit Inc.

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  • SAS places record order for 55 E195-E2 to power growth and regional connectivity

    SAS places record order for 55 E195-E2 to power growth and regional connectivity

    Scandinavian Airlines (SAS) has entered into an agreement to acquire 45 Embraer (NYSE: ERJ; B3: EMBR3) E195-E2 aircraft, with purchase rights for an additional 10 aircraft — the largest SAS jet order direct from a manufacturer since 1996. This milestone agreement supports SAS’ long-term fleet renewal strategy, which is focused on increasing efficiency, reducing emissions, and unlocking future growth opportunities from its global hub in Copenhagen as well as across its Scandinavian and international network.

    The first aircraft deliveries from Embraer are scheduled to begin in late 2027, with further deliveries extending over approximately four years. Excluding purchase rights, the value for the order is approximately US$4 billion.

    “This is a defining moment for SAS,” says Anko van der Werff, President & CEO, SAS. “The Embraer E195-E2 is a world-class aircraft, combining outstanding performance with excellent fuel efficiency and comfort. This aircraft is key to enabling future growth and improved connectivity across Scandinavia and beyond. We’ve taken the time to make the right decision — and this major investment reflects our confidence in the future and the strength of the agreement we’ve secured.”

    The E195-E2 will play a vital role in optimizing SAS’ operations and enhancing connectivity across Scandinavia and Europe. Its size and range are ideally suited to complement SAS’ existing fleet and route structure, allowing for more frequencies, better network flexibility, and lower trip costs.

    Built for the future of sustainable aviation
    “The E2 is central to our strategy to build a modern, efficient fleet with strong performance. It enables us to serve more routes with lower emissions, better economics, and a premium experience for our passengers,” adds Van der Werff. “Together with Embraer, we are setting the course for the next chapter of SAS.”

    The E2 family of aircraft has already been tested with 100% sustainable aviation fuel (SAF) and is in the process of being fully certified to fly on 100% SAF in the foreseeable future. Today blends of up to 50% SAF are already achievable.

    Arjan Meijer, President and CEO Embraer Commercial Aviation, says: “We are thrilled to deepen our partnership with SAS through this landmark deal. The E2 is the quietest single aisle jet available today – 29% more fuel efficient and with a 62% reduction in noise footprint over the previous generation jet, the E195-E2 is a game-changer in terms of efficiency, performance, and passenger comfort. We are confident that these aircraft will play a crucial role in SAS’ fleet renewal and expansion strategy, supporting their ambitious growth plans and enhancing their operational capabilities.”

    Powered by Pratt & Whitney’s advanced PW1900G GTF engines, the E195-E2 delivers double-digit reductions in fuel burn, emissions, and noise compared to previous-generation aircraft. The new fleet will help lower SAS’ environmental footprint and reinforce its position as a driving force in reducing aviation’s climate impact.

    This order marks another step in SAS’ future-focused transformation, supporting a modernized fleet and improved travel experience. SAS continues to strengthen its overall network and international reach while enhancing connectivity between regional cities and global destinations through more seamless and sustainable operations.

    This order was facilitated by the support of Skyworks Holding.

    SAS was recently ranked as the world’s most punctual airline*, a testament to the company’s commitment to operational excellence and reliability.

    *SAS ranked No. 1 out of 660 airlines globally for on-time performance in April and May 2025 (source: Cirium).


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  • Bocodepsin/Binimetinib Is Tolerable, Shows Combinatorial Activity in NRAS-Mutant Metastatic Melanoma

    Bocodepsin/Binimetinib Is Tolerable, Shows Combinatorial Activity in NRAS-Mutant Metastatic Melanoma

    NRAS-Mutant Metastatic Melanoma |

    Image credit: © Artur – stock.adobe.com

    The combination of the oral histone deacetylase (HDAC) inhibitor bocodepsin (OKI-179) and binimetinib (Mektovi) had a manageable safety profile and produced initial responses in patients with NRAS-mutant metastatic melanoma, according to data from the phase 2 portion of the phase 1b/2 NAUTILUS trial (NCT05340621) presented during the 2025 ASCO Annual Meeting.1

    Findings from the primary analysis showed that patients treated with the combination achieved a median progression-free survival (PFS) of 6.7 months. Among 20 evaluable patients, the overall response rate was 30%.

    Regarding safety, the combination was found to be tolerable. The most common toxicities occurring in more than 10% of patients were dermatitis acneiform (21%), anemia (17%), and thrombocytopenia (17%). No grade 3/4 toxicities were seen in more than 10% of patients, including no high-grade rash.

    “Initial response data in patients with NRAS-mutant melanoma are supportive of potential combinatorial activity of a MEK inhibitor and HDAC inhibitor bocodepsin with longer PFS than what is typically seen with MEK inhibition alone,” lead study author Rodabe N. Amaria, MD, and colleagues wrote in a poster presentation of the data. “MEK inhibition and HDAC inhibition warrant further study in a larger patient cohort.”

    Amaria is an assistant professor in the Department of Melanoma Medical Oncology, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center in Houston, Texas.

    Dive Into the Background and Design of the NAUTILUS Trial

    Activating NRAS mutations occur in 15% to 20% of metastatic melanoma cases. The MEK inhibitor binimetinib has demonstrated modest single-agent activity in this setting, with an ORR of 15% and a median PFS of 2.8 months. Preclinical studies have shown that HDAC inhibitors can potentiate the efficacy of MEK inhibitors in RAS pathway–driven melanomas by concurrently suppressing 2 DNA repair pathways. Bocodepsin, a novel, oral, Class I–selective HDAC inhibitor, has been associated with low-grade toxicities and demonstrated synergistic activity with binimetinib in NRAS-mutant melanoma models, supporting the inception of the NAUTILUS trial.

    NAUTILUS was comprised of a phase 1b dose-escalation and a phase 2 single-arm study.2 The phase 1 portion enrolled patients with advanced solid tumors without activating RAS pathway alterations; phase 2 included patients with NRAS-mutant metastatic melanoma who previously received or were ineligible for immune checkpoint inhibitor therapy.

    In the dose-escalation study, patients received either 200 mg (cohort 1; n = 8) or 300 mg (cohort 2; n = 6) of bocodepsin administered on a 4-days-on/3-days-off schedule, in combination with binimetinib at 45 mg twice daily.1 The 300 mg dose of bocodepsin was established as the recommended phase 2 dose (RP2D) and was subsequently used in all 22 patients enrolled in the single-arm phase 2 portion.

    In phase 1b, the primary end points were identification of the maximum tolerated dose and the RP2D.2 In phase 2, the primary end point was objective response rate (ORR), with secondary end points including safety and pharmacokinetics.1,2

    The median age of patients in the phase 2 portion of NAUTILUS (n = 24) was 69 (range, 39-82).1 The majority of patients were female (53%) and had an ECOG performance status of 1 (71%). The median number of prior lines of therapy was 3 (range, 1-9), and lactate dehydrogenase levels were elevated in 41% of patients.

    Interim data from NAUTILUS showed that, as of the safety data cutoff of July 6, 2023, no dose-limiting toxicities were observed with the combination in either cohort 1 or cohort 2, and adverse effects (AEs) were generally manageable with supportive care or dose interruptions/ reductions.2 The most common treatment-related AEs were as expected based on the agents’ individual safety profiles, and no grade 4/5 TRAEs were observed.

    At an efficacy data cutoff of September 26, 2023, the ORR per RECIST 1.1 criteria among all response-evaluable patients with NRAS-mutant metastatic melanoma in phase 1 and phase 2 (n=16) was 38%; this was comprised entirely of partial responses. Stable disease was also achieved by 38% of patients, and 25% experienced disease progression.

    References

    1. Amaria R, Duvivier H, Tsa K, et al. Nautilus, a phase 1b/2 trial of combining oral HDAC inhibitor (HDACi) with MEK inhibitor (MEKi) in patients with NRAS-mutated metastatic melanoma (MM): Results from the phase 3 ECHELON-3 study. J Clin Oncol. 2025, 43(suppl 16):9552.doi:10.1200/JCO.2025.43.16_suppl.9552
    2. Amaria R, Duvivier H, Tsa K, et al. Novel strategy for RAS-pathway targeting: Initial results from a phase 1b/2 clinical trial of the oral HDAC inhibitor bocodepsin (OKI-179) combined with binimetinib in patients with RAS-pathway mutated solid tumors and NRAS mutated melanoma. Mol Cancer Ther. 2023; 22(suppl 12):PR012. doi:10.1158/1535-7163.TARG-23-PR012

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  • Finance firms’ claim to be ‘saving the world’ was a mistake, says City veteran | Financial sector

    Finance firms’ claim to be ‘saving the world’ was a mistake, says City veteran | Financial sector

    Pension funds and institutional investors made a “huge mistake” and exaggerated their role in environmental, social and government (ESG) issues to promote their products, the outgoing chair of Aberdeen Group, Douglas Flint, has said.

    Flint, who has chaired the recently rebranded fund manager since 2019, said “ridiculously extravagant claims” had been made by some companies, which were driven by a mindset that their job was “not really about investing money: we’re just jolly good people and we’re saving the world”.

    Flint, who also chaired HSBC between 2010 and 2017, told a City of London net zero conference on Monday that those claims may have been over-egged, in a way that put them at legal risk, particularly in the US.

    “Our industry then made a kind of huge mistake. It became a marketing thing: let’s tell everyone we’re saving the world, we’re saving the planet,” he said, in comments first reported by the Financial Times.

    The legal risks have risen in recent months after a severe drop in support for ESG issues in the US. Rightwing activists and politicians have targeted financial companies for supporting climate policies, having been emboldened by policymakers in Trump’s administration, which pushed for a resurgence in oil and gas production.

    The ESG backlash has spooked some companies, worried that they could be targeted by lawsuits and blacklisting that could harm their US business. Even before Trump took office in November, Texas added NatWest to a growing list of companies accused of boycotting its oil industry, in a move that threatened the UK bank’s business with the US state.

    For others, the ESG backlash has provided an opportunity to scrap international green initiatives that some bosses claim make their businesses less competitive. High profile investors including BlackRock and State Street have cancelled membership in voluntary schemes such as the Climate Action 100+ group in recent months.

    Although US companies have led the charge in dropping ESG commitments, there are growing fears that UK investors could follow suit, meaning there will be less pressure on publicly listed companies, whose shares they hold, to reduce their carbon footprint.

    That could be compounded by a potential watering down of the Labour party’s manifesto pledge to ensure that FTSE 100 companies – as well the City’s banks, asset managers, insurers and pension funds – adopt “credible” climate transition plans in line with the Paris agreement’s pledge to limit the rise in global temperatures to 1.5C.

    Last week, a consultation on those rules showed the government was exploring less rigorous rules as part of a drive to cut red tape and compliance costs. One of the options being considered would mean the government “will not require an entity to have a discrete transition plan or to set climate targets in line with a particular climate goal”.

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    “The focus remains on the impact of the environment and climate on business profits, not the impact of business on the planet,” Mark Cliffe, a visiting fellow at the Global Systems Institute, University of Exeter, said. “Given the lack of clarity on the government’s own climate plans, let alone the backtracking in the US and elsewhere, this is likely to lead to further backsliding on businesses’ commitments to climate action.”

    Last week, a Department for Energy Security and Net Zero spokesperson said the government was “committed to making the UK the sustainable finance capital of the world.

    “The consultation we have launched seeks stakeholder views on a range of approaches to transition plans, including on climate alignment, as part of our commitment to take forward the manifesto commitment in full.”

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  • DLA Piper South Africa promotes three senior lawyers

    Global law firm DLA Piper has announced three promotions in its Corporate, Finance, and Litigation and Regulatory practices in its Johannesburg office. Associates Callie Jo Bouman, Malachizodok Mpolokeng and Dharshini Naidoo have all been promoted to Senior Associate.

    • Callie-Jo has experience of working on a wide range of domestic, cross-border and multinational transactions for public and private companies across the energy and natural resources, financial services, investment management and funds, professional services, real estate and technology sectors.
    • Malachizodok has advised clients on a wide range of banking and corporate finance transactions, including project and infrastructure finance, leveraged finance, debt restructuring, acquisition finance and debt capital markets transactions.
    • Dharshini advises clients on competition law matters including merger control across Africa and investigations into prohibited practices such as cartels and abuse of dominance.

    The Corporate practice has also appointed a new Senior Associate, Annastasia Nair. Annastasia has experience in general corporate and commercial law, corporate governance, due diligence investigations, corporate reorganisations and M&A.

    Johannes Gouws, Country Managing Partner, South Africa, commented: “We would like to congratulate our newly promoted Senior Associates and wish them the very best on this career milestone. The growth of our teams highlights our dedication to achieving excellence for clients globally and is testament to our commitment to nurturing talent in South Africa.”

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