ResMed has completed its $340m acquisition of Noctrix Health, adding a newly approved neurostimulation therapy for restless leg syndrome (RLS) to its growing sleep medicine portfolio. The deal brings Noctrix’s flagship product, Nidra, into ResMed’s ecosystem and signals a broader shift in sleep medicine: expanding beyond respiratory disorders into adjacent neurological and sleep-related conditions that affect millions of patients worldwide. For ResMed, the acquisition represents an opportunity to deepen its presence across the sleep care continuum while diversifying beyond its traditional strength in sleep apnoea treatment. Adding a New Category to Sleep Medicine Noctrix’s lead product, Nidra, is a non-pharmacological therapy designed for patients with restless leg syndrome who have not responded adequately to medication. The system consists of wearable cuffs positioned below the knee that deliver mild electrical stimulation to the peroneal nerves. This approach, known as tonic motor activation (TOMAC), activates neural pathways associated with voluntary movement, helping to reduce the uncomfortable sensations and involuntary muscle activity commonly experienced by patients with RLS. Unlike traditional pharmaceutical treatments, Nidra aims to address symptoms without introducing additional drug burden, an increasingly attractive proposition as healthcare systems look to reduce long-term medication dependency. The therapy received de novo clearance from the US Food and Drug Administration in 2023, establishing a new regulatory category for the treatment. A Large and Underserved Patient Population Restless leg syndrome remains one of the most common sleep-related neurological disorders. Research from the American Academy of Sleep Medicine suggests that approximately 13% of Americans report having been diagnosed with the condition. Despite its prevalence, treatment options remain relatively limited, particularly for patients who fail to respond to existing pharmaceutical therapies or experience undesirable side effects. The acquisition gives ResMed access to a sizeable patient population that overlaps significantly with its existing sleep-focused customer base. This creates potential opportunities for integrated diagnosis, treatment, and patient management across multiple sleep disorders. Building a Broader Sleep Health Platform ResMed has historically been best known for its leadership in sleep apnoea treatment through products such as the AirSense continuous positive airway pressure (CPAP) platform. The company also maintains a significant respiratory care business through products including the Astral and Stellar ventilator systems. Adding Nidra extends ResMed’s portfolio into neurostimulation-based sleep therapies and reflects a wider industry trend towards building comprehensive disease ecosystems rather than focusing on individual products. Rather than competing solely within the sleep apnoea market, ResMed is increasingly positioning itself as a broader sleep health company capable of addressing multiple conditions that impact sleep quality and long-term patient outcomes. A Milestone Exit for Angelini Ventures The acquisition also represents the first successful exit for Angelini Ventures, the corporate venture capital arm of Angelini Industries. Launched in 2022 with an initial €300m investment commitment, the fund focuses on biotechnology, medtech, and digital health companies addressing significant unmet medical needs. Angelini participated in Noctrix's $40m Series C financing round in 2022, supporting the company through the final stages of clinical development and commercialisation. The transaction provides an early validation of the fund’s investment strategy and demonstrates continued investor appetite for differentiated medical device companies with strong clinical evidence and regulatory approval. Why This Deal Matters Now The ResMed–Noctrix acquisition highlights several important trends across healthcare and medtech: Non-pharmacological therapies are gaining traction as alternatives to chronic drug treatment. Neurostimulation technologies are expanding beyond traditional neurological applications into sleep medicine. Sleep health is evolving into a broader therapeutic category encompassing multiple disorders. Medtech companies are increasingly acquiring adjacent technologies to create integrated patient ecosystems. Investors continue to reward clinically validated devices that address large unmet patient populations. The transaction also reflects growing recognition that sleep disorders rarely exist in isolation, creating opportunities for companies that can offer comprehensive solutions across diagnosis, treatment, and ongoing patient management. What This Means for the Industry The acquisition signals an important shift in how sleep medicine is developing. Historically dominated by respiratory therapies and pharmaceuticals, the market is increasingly incorporating wearable technologies, neurostimulation devices, and digital health solutions. As healthcare providers seek more personalised and less invasive treatment approaches, therapies such as TOMAC may become an increasingly important part of the sleep medicine toolkit. For ResMed, the acquisition expands both its addressable market and its ability to support patients across a wider range of sleep-related conditions. Summary ResMed’s $340m acquisition of Noctrix Health brings FDA-authorised TOMAC therapy for restless leg syndrome into one of the world's largest sleep medicine platforms. Beyond adding a single product, the deal reflects a broader evolution in sleep healthcare, where companies are moving beyond individual disorders to build integrated ecosystems capable of treating multiple conditions that affect sleep quality and patient wellbeing. As non-drug therapies continue to gain momentum, the acquisition positions ResMed to play a larger role in the future of comprehensive sleep health management. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

Philips has received FDA 510(k) clearance for Elevate Plus, an AI-enabled upgrade to its EPIQ Elite and Affiniti ultrasound systems, alongside CE mark approval in Europe. The update brings a clear strategic message: ultrasound is no longer just an imaging modality — it is becoming an AI-assisted workflow platform designed to standardise clinical decision-making at scale At its core, Elevate Plus combines automation, image enhancement, and embedded decision support tools to reduce variability in routine examinations and improve consistency across operators and care settings. Moving From Imaging to Intelligent Workflow Ultrasound has traditionally been highly operator-dependent, with image quality and interpretation varying significantly based on clinician experience. Philips is positioning Elevate Plus as a response to that challenge. The upgrade introduces AI-driven workflow automation features designed to streamline routine exams and reduce the need for repeat scans, particularly in high-volume clinical environments. A key component is Auto Measure Abdomen, an AI tool that automates common abdominal measurements during scanning. Philips reports accuracy rates above 93% when compared with manual expert readings, suggesting a growing level of reliability in automated clinical measurement. The objective is not to replace clinicians, but to reduce repetitive tasks and minimise variation in routine workflows. AI Decision Support Moves Onto the Ultrasound Cart A notable shift with Elevate Plus is the integration of Koios AI decision support tools directly on-cart within the ultrasound systems. Previously, these tools were only available off-cart and limited to Philips-generated images. Now, clinicians can perform real-time lesion classification during the scan itself, including: ~ Breast lesion classification using Koios BI-RADS Thyroid nodule assessment using Koios TI-RADS These models are trained on large datasets of pathology-confirmed cases, enabling rapid risk stratification at the point of imaging. This shift brings AI closer to the point of clinical decision-making, rather than treating it as a downstream analytical tool. Enhancing Image Quality With AI-Based Processing Alongside workflow automation, Elevate Plus introduces new imaging enhancements designed to improve clarity and diagnostic confidence. These include: XRes Pro+: enhancing tissue detail and boundary definition Super Res MVI Pro: improving microvascular flow visualisation Together, these tools aim to make subtle anatomical and vascular features easier to interpret, particularly in complex or fast-paced clinical environments. The emphasis is on consistency — ensuring that image quality is less dependent on operator skill and more standardised across systems and users. Why This Matters for Clinical Imaging Ultrasound sits at the intersection of high clinical utility and high variability. It is widely used, relatively low-cost, and highly versatile — but historically dependent on operator expertise for both image acquisition and interpretation. AI-enabled systems like Elevate Plus represent a shift toward: Standardised imaging quality across healthcare settings Reduced repeat scanning and improved workflow efficiency Earlier integration of diagnostic support during the exam itself Greater consistency in high-volume diagnostic environments As healthcare systems face increasing demand, these efficiency gains become structurally important rather than merely incremental improvements. A Broader Strategic Direction in Medical Imaging Philips’ latest clearance reflects a wider industry trend: imaging platforms are evolving into integrated diagnostic ecosystems. Rather than separate tools for acquisition, analysis, and interpretation, companies are increasingly embedding AI directly into imaging hardware to support real-time decision-making. This moves ultrasound closer to a fully assisted diagnostic workflow, where automation supports clinicians throughout the entire examination process. Summary The FDA clearance of Philips’ Elevate Plus marks another step in the evolution of ultrasound from a manual imaging tool to an AI-powered diagnostic workflow platform. By combining automated measurements, embedded decision support, and enhanced imaging quality, Philips is aiming to reduce variability, improve efficiency, and support more consistent clinical outcomes across high-demand healthcare environments. More broadly, the upgrade highlights a clear direction for medical imaging: tighter integration between AI, hardware, and clinical decision-making at the point of care. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

Roche has struck a deal worth up to $2.3bn with Nurix Therapeutics to co-develop and co-commercialise bexobrutideg (NX-5948), an oral BTK degrader targeting B-cell malignancies, immunology, and neurology. The move signals a deeper strategic shift in the BTK space — from inhibition to degradation — as pharma companies look to overcome resistance mechanisms and expand therapeutic durability in complex blood cancers. Moving Beyond BTK Inhibition BTK has long been a validated target in haematology and immune-mediated diseases, with multiple oral inhibitors already on the market or in late-stage development. But degraders represent a step change. Rather than simply blocking BTK activity, bexobrutideg is designed to eliminate the protein entirely, offering a potentially more complete and durable therapeutic effect. Early clinical data has shown promising single-agent activity in diseases such as: Chronic lymphocytic leukaemia (CLL) Waldenström macroglobulinaemia A Phase III study in relapsed/refractory CLL is expected to begin this summer, where the drug will be evaluated against Eli Lilly’s BTK inhibitor Jaypirca (pirtobrutinib), setting up a key head-to-head benchmark in the class. A Multi-Asset, Shared-Risk Structure The Roche–Nurix collaboration is structured as a fully integrated co-development and co-commercialisation agreement: $700m upfront payment to Nurix Up to $2.3bn total deal value including milestones 60/40 cost sharing on development (Roche/Nurix) 50/50 split of US profits and losses Roche leads commercialisation outside the US Nurix eligible for tiered royalties in international markets This model reflects a broader industry trend: pharma is increasingly willing to share both risk and upside in exchange for earlier access to differentiated science. Why Roche Is Moving Now Roche already has a BTK franchise strategy in motion, including fenebrutinib, an oral BTK inhibitor in development for multiple sclerosis. But the competitive landscape is intensifying: New-generation BTK inhibitors are already on the market Multiple competitors are advancing next-gen molecules BTK degraders are emerging as a potential next wave of innovation By partnering early in the degrader space, Roche is effectively hedging its BTK future while expanding optionality across haematology, immunology, and neurology. From Blocking to Degrading: A Platform Shift What makes this deal notable is not just the asset, but the modality. BTK degraders represent part of a wider movement in drug discovery: Moving from inhibition → degradation From reversible binding → targeted protein elimination From single-pathway modulation → broader biological control If successful, this approach could reshape how a range of disease-driving proteins are targeted beyond BTK. A Strategic Inflection Point for Nurix For Nurix, the deal validates its emerging position in targeted protein degradation — one of the most closely watched modalities in biotech. The company has signalled ambitions to evolve beyond a single-asset story into a commercial-stage player, and the Roche partnership provides: Global development scale Late-stage clinical acceleration Commercial infrastructure beyond the US Combination potential with Roche’s B-cell franchise Summary The $2.3bn Roche–Nurix collaboration marks a significant escalation in the BTK space, as the industry begins shifting from inhibition-based therapies toward next-generation protein degraders. With Phase III development imminent and head-to-head competition already emerging, Bexobrutideg is positioned at the centre of what could become a defining class evolution in haematology and immunology. More broadly, the deal reinforces a clear trend in pharma strategy: platform science + shared risk + modality innovation = the new blueprint for late-stage pipeline building. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

GSK has agreed to acquire Nuvalent in a $10.6bn all-cash transaction, bringing a trio of late-stage lung cancer assets into its oncology portfolio and marking one of the company’s largest strategic moves in over a decade. The acquisition centres on Nuvalent’s targeted therapies for genetically defined non–small-cell lung cancer (NSCLC), including ROS1 inhibitor zidesamtinib (NVL-520) and ALK inhibitor neladalkib (NVL-655), both of which are already in late-stage development and under FDA review. The deal signals a decisive pivot back toward larger, near-commercial oncology assets — a contrast to GSK’s recent preference for smaller bolt-on acquisitions in the $2–4bn range. A Multi-Asset Late-Stage Oncology Expansion Rather than a single-asset bet, the Nuvalent acquisition effectively brings a bundled late-stage pipeline into GSK’s oncology franchise. The key assets include: Zidesamtinib (ROS1 inhibitor), targeting TKI-pretreated ROS1-positive NSCLC Neladalkib (ALK inhibitor), targeting ALK-positive NSCLC NVL-330, a brain-penetrant HER2-selective TKI in early clinical development Both lead programmes are already supported by Phase I/II data and have FDA decisions pending later this year, with potential launches depending on regulatory outcomes. Zidesamtinib has shown objective response rates in the mid-40% range in heavily pre-treated populations, with higher efficacy in patients exposed to fewer prior therapies. Neladalkib has demonstrated response rates in the low 30% range in similar settings. Together, these assets strengthen GSK’s position in molecularly defined lung cancers where sequential resistance to existing tyrosine kinase inhibitors continues to create unmet clinical need. A Strategic Shift in Capital Deployment GSK CEO Luke Miels described the transaction as a “multi-product deal” targeting clinically validated mechanisms that address both efficacy and tolerability gaps in lung cancer treatment. While the company had previously signalled a preference for smaller, modular acquisitions, Miels noted that Nuvalent represented a “three-in-one” opportunity that justified a larger upfront commitment. The $124 per share cash offer represents a 40% premium to Nuvalent’s closing price on June 8, with the transaction expected to close in Q3, pending regulatory approval. Why This Deal Matters Now The acquisition highlights several broader trends shaping oncology M&A: Pharma is increasingly prioritising late-stage, de-risked oncology assets over early discovery platforms Molecularly targeted lung cancer therapies remain one of the most competitive and commercially attractive areas in oncology Large-cap pharma is re-accelerating deal size after a period of capital discipline Multi-asset acquisitions are re-emerging as a way to compress pipeline risk and time-to-market Importantly, timing also matters. With FDA decisions for both lead assets expected imminently, GSK is positioning itself not just for pipeline expansion, but for potential near-term commercial launches. A Platform for Broader Lung Cancer Growth Beyond the acquired assets, GSK expects the deal to reinforce its broader oncology strategy, including internal development of its B7-H3 antibody-drug conjugate programme risvutatug rezetecan in small-cell lung cancer. Analysts have suggested the acquisition could also help offset longer-term revenue pressures from upcoming patent expirations in other therapeutic areas by strengthening GSK’s oncology revenue base. Summary The $10.6bn acquisition of Nuvalent represents a significant escalation in GSK’s oncology strategy, bringing multiple late-stage lung cancer therapies into its pipeline at a pivotal moment for regulatory and commercialisation timelines. More broadly, the deal reflects a renewed industry preference for late-stage, multi-asset acquisitions designed to accelerate near-term revenue generation while reinforcing long-term therapeutic platforms in high-value oncology markets. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

Eli Lilly has signed a licensing deal worth up to $1bn with Swedish biotech AlzeCure Pharma for ACD680, a preclinical Alzheimer’s programme targeting amyloid-beta production via gamma-secretase modulation. The move extends Lilly’s growing presence in Alzheimer’s disease and adds a complementary approach to its existing anti-amyloid therapy Kisunla (donanemab), shifting part of its focus further upstream in disease biology. A Shift From Removal To Modulation ACD680 is a small molecule gamma-secretase modulator designed to alter how amyloid precursor proteins are processed. Instead of directly clearing amyloid plaques, it aims to reduce production of Aβ42, a peptide associated with plaque formation, while increasing shorter amyloid-beta fragments such as Aβ37 and Aβ38, which are considered less toxic. The concept sits within a long-standing but still active hypothesis in Alzheimer’s research: that changing amyloid production early in the disease cascade may offer a more durable disease-modifying effect. Deal Structure The agreement includes: $10m upfront payment Up to ~$990m in development and commercial milestones Mid-single digit royalties on future sales Lilly secures global rights to ACD680, while AlzeCure retains upside through milestone and royalty participation. Why This Matters For Lilly The deal strengthens Lilly’s Alzheimer’s strategy at a time when the field remains both commercially important and scientifically contested. Kisunla positioned Lilly in the anti-amyloid antibody space, but outcomes across the class continue to generate debate around the magnitude of clinical benefit in real-world settings. Despite this, amyloid remains the dominant biological target in Alzheimer’s drug development, with dozens of active programmes continuing to pursue variations of the same pathway. ACD680 represents a complementary angle rather than a replacement strategy, broadening Lilly’s exposure across multiple points in amyloid biology. Part Of A Broader Dealmaking Wave The Alzheimer’s agreement is one of several major transactions Lilly has signed in 2026, reflecting a sustained external innovation strategy across multiple therapeutic areas. Recent deals include: A $1.9bn RNA exon editing partnership with Ascidian Therapeutics A $1.26bn GLP-2 licensing deal with Hanmi Pharmaceutical A $3bn collaboration with Haisco Pharmaceutical Group $3.83bn in vaccine-related acquisitions across multiple biotech companies The pattern reflects a clear shift towards building breadth across modalities through structured, milestone-driven partnerships. Summary The $1bn AlzeCure deal reinforces Lilly’s continued commitment to Alzheimer’s disease while expanding its strategy from antibody-based plaque targeting into earlier-stage modulation of amyloid production. More broadly, it underscores how large pharma is increasingly building pipelines through layered, multi-modal external innovation rather than single-platform dependence. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

Subtle Medical has received FDA clearance for SubtleHD(CT), an AI-powered software platform designed to improve computed tomography (CT) image quality by reducing noise and enhancing low-contrast detectability. The clearance marks the company's expansion beyond PET and MRI imaging enhancement, extending its AI imaging platform into one of the most widely used diagnostic modalities in healthcare. The announcement follows closely behind the company's $33m Series C financing round and highlights growing momentum behind AI-driven workflow optimisation in medical imaging. Bringing AI Enhancement to Existing CT Infrastructure SubtleHD(CT) has been developed as a software-as-a-medical-device (SaMD) that integrates directly into existing radiology workflows. Rather than requiring new imaging hardware, the platform is designed to improve image quality across a broad range of scanner fleets, including older CT systems that remain heavily utilised in hospitals and imaging centres. This approach reflects a growing trend across healthcare technology: using software to extend the useful life and performance of existing infrastructure rather than relying solely on capital-intensive equipment upgrades. For providers facing budget pressures and increasing imaging demand, AI enhancement tools offer a potential route to improving diagnostic quality without large-scale hardware replacement programmes. AI's Growing Role in Radiology Workflows SubtleHD(CT) joins a broader portfolio of AI imaging products already commercialised by Subtle Medical. The company's platform now includes: SubtlePET for PET image enhancement and workflow acceleration SubtleHD(MR) for MRI image quality improvement SubtleALIGN for automated MRI positioning and alignment SubtleSYNTH for generating MRI contrasts from existing image sequences Together, these products form part of Subtle's vendor-neutral AI Imaging Hub, designed to operate across multiple scanner manufacturers and healthcare environments. The strategy positions AI not as a standalone diagnostic tool, but as a workflow layer capable of improving image acquisition, standardisation and efficiency across the imaging pathway. Addressing Capacity Challenges in Medical Imaging The clearance also arrives against a backdrop of growing workforce pressure in radiology. Healthcare systems globally continue to face rising imaging demand while struggling to recruit sufficient numbers of radiologists and imaging specialists. According to projections from the Association of American Medical Colleges (AAMC), the United States could face a radiologist shortfall approaching 42,000 professionals by 2036. As a result, AI tools that reduce repeat scans, improve image consistency and streamline workflow efficiency are increasingly being viewed as operational necessities rather than experimental technologies. Funding and Leadership Momentum The FDA clearance follows Subtle Medical's recently completed $33m Series C financing round, which the company plans to use to accelerate product development and global commercial expansion. The financing also coincided with the appointment of new CEO Ohad Arazi, an experienced healthcare technology executive whose previous leadership roles have included positions at Change Healthcare, Zebra Medical Vision and Clarius Mobile Health. The combination of fresh capital, new leadership and regulatory momentum positions the company for broader adoption across imaging markets. Why This Matters SubtleHD(CT) reflects a broader shift in healthcare AI adoption. Rather than replacing clinicians, many of the most commercially successful AI applications are focused on improving workflow efficiency, image quality and operational capacity within existing clinical environments. Medical imaging has emerged as one of the clearest examples of this trend, where AI can help healthcare systems manage growing demand while maximising the value of existing infrastructure and workforce resources. Summary The FDA clearance of SubtleHD(CT) expands Subtle Medical's AI imaging platform into CT diagnostics, adding image enhancement capabilities to one of healthcare's most widely used imaging modalities. More broadly, the approval highlights how AI adoption in medical imaging is increasingly centred on workflow optimisation, infrastructure efficiency and clinician support as healthcare systems confront rising demand and growing workforce shortages. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

KARL STORZ has received US Food and Drug Administration (FDA) clearance for its RUBINA Lens exoscope, enabling the company to bring its near-infrared (NIR) fluorescence imaging technology into open surgical procedures. The approval extends the reach of KARL STORZ’s imaging ecosystem beyond minimally invasive surgery, allowing surgeons to access real-time fluorescence visualisation during a wider range of operations without requiring major changes to existing operating room infrastructure. Bringing Advanced Visualisation to Open Surgery The RUBINA Lens is a digital, camera-based exoscope that provides surgeons with a magnified 4K view of the surgical field displayed on a monitor. The system allows clinicians to switch between standard white-light imaging and near-infrared fluorescence imaging using indocyanine green (ICG), a fluorescent dye commonly used to assess blood flow and tissue perfusion during surgery. By combining these imaging modes, the device can reveal anatomical and physiological information that may not be visible to the naked eye, potentially supporting more informed intraoperative decision-making. The FDA clearance covers use cases including: Real-time tissue perfusion assessment Lymphatic mapping procedures Breast surgery applications Other open surgical procedures where NIR imaging with ICG may provide clinical value Expanding Existing Surgical Imaging Infrastructure One of the key advantages of the RUBINA Lens is its ability to integrate with existing KARL STORZ imaging platforms. The exoscope connects directly to the company's IMAGE1 S RUBINA systems, allowing hospitals already using KARL STORZ equipment to expand fluorescence-guided surgery capabilities without purchasing entirely new imaging infrastructure. This reflects a broader trend across surgical technology, where manufacturers are increasingly focused on extending the functionality of existing platforms rather than requiring complete equipment replacement. According to KARL STORZ, the system has been designed to fit naturally into existing operating room workflows while minimising procedural complexity. Designed for Surgical Flexibility The RUBINA Lens can be operated either as a handheld device or mounted to a holding arm, providing flexibility across different surgical environments and procedural requirements. Additional features include: High-resolution 4K imaging Wide working distance to reduce frequent refocusing Large 16:9 field of view Manual horizon control for image orientation Compatibility with standard sterilisation processes Multiple fluorescence viewing modes similar to those available in the company's endoscopic systems These capabilities are intended to support surgeon comfort while maintaining visual consistency across both open and minimally invasive procedures. Why Fluorescence-Guided Surgery Matters Fluorescence imaging has become an increasingly important tool across a growing range of surgical specialties. By using dyes such as indocyanine green, surgeons can visualise blood flow, tissue perfusion and lymphatic structures in real time, helping to identify critical anatomy and assess tissue viability during procedures. The technology has gained traction because it provides functional information beyond traditional visual inspection, offering an additional layer of data during surgery without significantly disrupting workflow. As healthcare systems continue to prioritise precision surgery and improved patient outcomes, fluorescence-guided imaging is becoming an increasingly common component of modern operating rooms. What This Means for the Industry The FDA clearance of the RUBINA Lens highlights several broader trends in surgical technology: Advanced imaging capabilities are increasingly moving beyond minimally invasive procedures into open surgery Hospitals are seeking technologies that integrate with existing operating room infrastructure Fluorescence-guided surgery continues to expand across multiple clinical specialties Digital visualisation platforms are becoming central to modern surgical workflows The approval also reinforces the growing importance of real-time imaging technologies that provide surgeons with enhanced visibility and decision support during procedures. Summary KARL STORZ has secured FDA clearance for the RUBINA Lens exoscope, extending its near-infrared fluorescence imaging capabilities into open surgery. By combining 4K visualisation with real-time fluorescence imaging and compatibility with existing KARL STORZ platforms, the device supports a growing industry shift towards image-guided surgical procedures that enhance intraoperative decision-making while fitting seamlessly into established operating room workflows. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The US Food and Drug Administration (FDA) has approved a combination regimen of Merck & Co.’s Keytruda (pembrolizumab) and Welireg (belzutifan) for the adjuvant treatment of adults with clear cell renal cell carcinoma (ccRCC) at risk of recurrence following surgery. The decision also extends to Keytruda Qlex, a subcutaneous formulation of the anti–PD-1 therapy (pembrolizumab/berahyaluronidase alfa-pmph), marking another step in Merck’s strategy to broaden Keytruda’s delivery formats and lifecycle. Phase III data underpinning approval The approval follows a priority review and is based on the Phase III LITESPARK-022 trial, which enrolled 1,841 patients who had undergone nephrectomy and were classified as intermediate-high or high risk of recurrence, or had resected metastatic disease with no evidence of active cancer. Patients were randomised to receive either Welireg plus Keytruda or Keytruda plus placebo in the adjuvant setting. At a prespecified interim analysis, the combination demonstrated a 28% improvement in disease-free survival (DFS), defined as time to recurrence, metastasis or death. There were 186 DFS events in the combination arm compared with 246 in the control group. Median DFS was not reached in either arm, and overall survival data remain immature. Expanding Welireg’s role in renal cell carcinoma Welireg (belzutifan), a HIF-2α inhibitor, already carries an indication in kidney cancer following its 2023 approval for previously treated advanced renal cell carcinoma patients who had received PD-(L)1 and VEGF-targeted therapies. The latest approval moves the therapy further upstream into the post-surgical adjuvant setting, reinforcing Merck’s intent to build a multi-line renal cancer franchise spanning both immunotherapy and targeted hypoxia pathways. Keytruda’s growing footprint in kidney cancer This marks Keytruda’s fourth approved indication in renal cell carcinoma. Earlier approvals include first-line advanced settings in combination with Pfizer’s Inlyta (axitinib) and Eisai’s Lenvima (lenvatinib), as well as a post-nephrectomy indication based on the KEYNOTE-564 study, where Keytruda demonstrated a 38% improvement in overall survival in high-risk patients. Taken together, these approvals consolidate Keytruda as a central backbone therapy across multiple stages of kidney cancer treatment. Competitive backdrop remains unresolved Despite the expanding evidence base for Keytruda-based combinations, treatment selection in renal cell carcinoma remains highly competitive. Some clinical experts continue to favour Bristol Myers Squibb’s Opdivo (nivolumab)-based combinations, citing ongoing uncertainty around optimal sequencing and long-term comparative outcomes across immuno-oncology regimens. This leaves the field open, with multiple checkpoint inhibitor combinations still competing for long-term dominance in both advanced and adjuvant kidney cancer settings. Outlook The Welireg–Keytruda approval strengthens Merck’s position in renal oncology by combining immunotherapy with targeted hypoxia biology in a high-risk post-surgical population. While the immediate clinical impact will depend on uptake and sequencing preferences, the broader strategic signal is clear: Merck is continuing to build depth across multiple mechanisms in kidney cancer rather than relying on single-agent dominance. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The approval provides adults aged 45 years and older at average risk of colorectal cancer with an additional blood-based screening option, expanding access for individuals who are overdue for screening. The US Food and Drug Administration (FDA) has approved SimpleScreen™ CRC, Freenome's blood-based colorectal cancer screening test, for adults aged 45 years and older who are at average risk of the disease, marking the company's first commercial product. The approval expands the range of screening options available for eligible patients and may help increase screening uptake among individuals who are reluctant to undergo stool-based testing or colonoscopy, while not replacing established diagnostic pathways. Field Content Alert Type Drug Approval Drug Name SimpleScreen™ CRC Indication Blood-based screening for colorectal cancer in adults aged 45 years and older who are at average risk of colorectal cancer. Therapy Area(s) Oncology; Gastroenterology Geography US (FDA) What Happened The FDA approved SimpleScreen™ CRC on 27 July 2026 for colorectal cancer screening in adults aged 45 years and older who are at average risk of the disease. The approval gives Freenome its first FDA-approved commercial product and authorises Abbott, which holds exclusive US commercialisation rights, to launch the blood-based screening test in the US. The approval expands the range of FDA-authorised blood-based colorectal cancer screening options available for average-risk adults. Why It Matters The approval provides clinicians and eligible patients with an additional non-invasive colorectal cancer screening option. While blood-based testing does not replace colonoscopy or other recommended diagnostic pathways, it may improve participation among people who remain unscreened, helping to broaden access to recommended colorectal cancer screening. Supporting Context Colorectal cancer is the second leading cause of cancer-related death in the United States. Freenome estimates that up to 60 million eligible Americans are overdue for colorectal cancer screening, highlighting the need for additional screening options. Key Takeaway FDA approval of SimpleScreen™ CRC expands the range of blood-based colorectal cancer screening options available for average-risk adults aged 45 years and older. What to Watch Abbott plans to commercially launch SimpleScreen™ CRC in the United States during autumn 2026. Uptake, reimbursement and future updates to clinical screening recommendations will be important to monitor. Primary Source https://investors.freenome.com/news-releases/news-release-details/fda-approves-freenomes-simplescreentm-crc-blood-based-screening Relevant Date 27 July 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The acquisition gives argenx full ownership of FB102, expanding its immunology pipeline with a first-in-class anti-CD122 antibody that has shown early clinical proof of concept in autoimmune disease. argenx has entered into a definitive agreement to acquire Forte Biosciences in an all-cash transaction valued at approximately $2.2 billion, or $77 per share, securing ownership of its lead asset, FB102, a first-in-class anti-CD122 antibody currently in Phase I development. The acquisition expands argenx's immunology portfolio with a clinically validated programme in vitiligo and coeliac disease and provides a platform for potential development in additional autoimmune conditions. Field Content Alert Type Deal Companies argenx; Forte Biosciences Deal Type Acquisition Asset or Company Forte Biosciences, including lead asset FB102 Therapy Area(s) Immunology; Autoimmune diseases; Dermatology; Gastroenterology Technology or Modality First-in-class anti-CD122 monoclonal antibody Deal Value Approximately $2.2 billion equity value. argenx will acquire all outstanding Forte Biosciences shares through a cash tender offer at $77 per share. No contingent milestone payments were disclosed. Development Stage Phase I (FB102) Geography Global What Happened argenx announced on 27 July 2026 that it had entered into a definitive agreement to acquire Forte Biosciences through a wholly owned subsidiary. The all-cash tender offer values Forte at approximately $2.2 billion ($77 per share). The transaction remains subject to customary closing conditions, including shareholder tender requirements and US antitrust clearance under the Hart-Scott-Rodino Act, and is expected to close in the third quarter of 2026. Following completion, argenx will obtain full ownership of FB102 and Forte's assets. Why It Matters The acquisition gives argenx direct access to a differentiated anti-CD122 programme with early clinical proof of concept in vitiligo and coeliac disease, broadening its immunology pipeline beyond its existing portfolio. It also adds a mechanism that targets pathogenic T-cell and NK-cell activity, potentially supporting future development across multiple autoimmune diseases, although further clinical development will determine its ultimate role. Supporting Context argenx stated that the acquisition builds on its previous strategic investment in Forte Biosciences. FB102 has reported positive Phase Ib data in vitiligo and previously demonstrated clinical activity in coeliac disease, forming the basis for the acquisition. Strategic Rationale argenx gains full control of a clinically validated immunology asset and associated intellectual property, while Forte shareholders receive cash consideration for their shares. The transaction also enables argenx to integrate FB102 into its existing antibody-based immunology portfolio. Potential Impact If clinical development is successful, FB102 could broaden argenx's autoimmune pipeline and support development in additional immune-mediated diseases beyond its current indications. Any future commercial impact will depend on subsequent clinical, regulatory and development milestones. Key Takeaway The acquisition gives argenx full ownership of an early-stage, first-in-class immunology asset that complements its existing autoimmune disease portfolio. What to Watch Completion of the tender offer, satisfaction of regulatory closing conditions, and further clinical development of FB102 in vitiligo, coeliac disease and other autoimmune indications. Primary Source https://argenx.com/news/2026/press-release-3333257.html Relevant Date 27 July 2026 Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

The once-daily treatment introduces the first approved norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD, with US availability dependent on DEA scheduling. The FDA has approved Otsuka’s Simtriyo (centanafadine) extended-release capsules for attention-deficit/hyperactivity disorder in adults and paediatric patients aged 6 years and older who weigh at least 20 kg. The approval expands ADHD treatment options across childhood, adolescence and adulthood, although the central nervous system stimulant carries boxed warnings and will not become commercially available until controlled-substance scheduling is completed. Field Content Alert Type Drug Approval Drug Name Simtriyo (centanafadine) Indication Treatment of attention-deficit/hyperactivity disorder in adults and paediatric patients aged 6 years and older weighing at least 20 kg Therapy Area(s) Psychiatry; paediatrics; neurodevelopmental disorders Geography US (FDA) What Happened Otsuka announced on 24 July 2026 that the FDA had approved Simtriyo, a once-daily extended-release capsule, for ADHD in adults and paediatric patients aged 6 years and older weighing at least 20 kg. The approval was supported by four randomised, double-blind, placebo-controlled Phase 3 studies conducted in children, adolescents and adults. Why It Matters Simtriyo is the first approved treatment described as inhibiting the reuptake of norepinephrine, dopamine and serotonin, providing an additional pharmacological option for patients across multiple age groups. The higher doses evaluated in the pivotal paediatric and adolescent studies produced statistically significant improvements in ADHD symptom scores compared with placebo. Supporting Context Simtriyo is classified as a central nervous system stimulant. Its prescribing information includes boxed warnings concerning suicidal ideation and behaviours in paediatric patients and the potential for abuse, misuse and addiction; it is not recommended for children younger than 6 years or those weighing under 20 kg. Key Takeaway The approval adds a once-daily treatment with a distinct triple-reuptake mechanism to the US ADHD market for eligible children, adolescents and adults. What to Watch DEA controlled-substance scheduling, commercial availability later in 2026 and the presentation of findings from Otsuka’s Phase 3b study in adults with ADHD and comorbid anxiety. Primary Source Otsuka’s official FDA approval announcement Relevant Date 24 July 2026 — FDA approval announcement date Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

If authorised, Icotyde would become the first oral treatment targeting the interleukin-23 receptor available to eligible adults and adolescents in the EU. The European Medicines Agency’s human medicines committee has recommended granting EU marketing authorisation to Janssen-Cilag’s Icotyde (icotrokinra) for moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older weighing at least 40 kg. The positive opinion introduces the prospect of an oral interleukin-23 receptor-targeted treatment, but a European Commission decision and national pricing and reimbursement assessments are still required before patient access. Field Content Alert Type Industry Update Topic Regulatory recommendation and psoriasis treatment Organisation(s) European Medicines Agency; Committee for Medicinal Products for Human Use; Janssen-Cilag International N.V. Affected Stakeholders Dermatologists, eligible adults and adolescents with plaque psoriasis, Janssen-Cilag, payers and national reimbursement authorities Therapy Area(s) Dermatology; plaque psoriasis Geography European Union What Happened On 23 July 2026, EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending EU marketing authorisation for Icotyde for moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older weighing at least 40 kg. The recommendation is not a marketing authorisation: it will be referred to the European Commission for a final decision. Why It Matters Icotyde blocks the interleukin-23 receptor and would be the first authorised oral medicine targeting the interleukin-23 pathway in the EU. This could provide an additional treatment format for eligible patients alongside existing injectable medicines targeting the pathway. Supporting Context EMA assessed four Phase 3 trials involving approximately 2,500 patients. Across three studies, 50% to 57% of patients receiving Icotyde achieved PASI 90 after 16 weeks, compared with 1% to 4% receiving placebo; a fourth study included psoriasis affecting difficult-to-treat areas. Who Is Most Affected Dermatologists and eligible patients would be most directly affected by the potential addition of an oral interleukin-23 receptor-targeted treatment. Payers and national health authorities will subsequently determine pricing and reimbursement if the European Commission grants authorisation. Industry Impact If authorised, Icotyde could increase competition in the moderate-to-severe psoriasis market and broaden treatment choice for patients who may prefer an oral medicine. Its practical impact will depend on the final authorised indication, national reimbursement decisions and adoption in clinical practice. Key Takeaway The positive CHMP opinion moves the first oral interleukin-23 receptor-targeted psoriasis treatment closer to EU authorisation, but it is not yet approved. What to Watch The European Commission’s marketing-authorisation decision, followed by pricing and reimbursement decisions in individual EU Member States. Primary Source European Medicines Agency announcement Relevant Date 23 July 2026 — positive CHMP opinion Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com