Search Results

The collaboration combines Biocytogen’s fully human antibody discovery platform with Whitehawk’s ADC expertise to develop novel cancer therapies with enhanced targeting potential. Biocytogen and Whitehawk Therapeutics have entered into a global partnership to develop bispecific antibody-drug conjugates (BsADCs), combining antibody engineering and targeted cancer drug delivery technologies. The collaboration aims to identify new ADC candidates by pairing Biocytogen’s bispecific antibody capabilities with Whitehawk’s proprietary antibody-drug conjugate (ADC) linker-payload platform. Combining Antibody Engineering with ADC Innovation Under the agreement, Biocytogen will provide access to up to five bispecific antibodies generated through its RenLite platform. Whitehawk will evaluate these antibody candidates alongside its own ADC technologies to identify potential BsADC programmes with differentiated therapeutic profiles. Following evaluation, Whitehawk will have the option to advance selected candidates into its development pipeline. If Whitehawk chooses to proceed with any resulting BsADC programmes, it will retain global rights and full control over further development activities. Targeting the Next Generation of Cancer Therapies Bispecific ADCs represent an emerging approach in oncology by combining two targeted antibody binding sites with the cancer-killing capabilities of ADC technology. Traditional ADCs use antibodies to deliver cytotoxic payloads directly to tumour cells, while bispecific antibodies are designed to recognise multiple targets or improve tumour selectivity. By combining these approaches, companies hope to improve precision, overcome treatment resistance and expand the number of cancers that can be effectively targeted. RenLite Platform Supports Bispecific Antibody Development Biocytogen’s RenLite platform uses a common light-chain antibody design to support the discovery and optimisation of fully human bispecific antibodies. The approach is intended to reduce the risk of light-chain mispairing, a technical challenge that can affect the development and manufacturing of bispecific antibody therapies. Through the partnership, Biocytogen will contribute its antibody discovery capabilities, while Whitehawk will apply its expertise in ADC development and oncology drug discovery. Deal Structure and Commercial Terms Financial terms include an upfront payment to Biocytogen, with the company also eligible for additional payments linked to development, regulatory and commercial milestones. Biocytogen will additionally receive low single-digit royalties on net sales of any commercial products resulting from the collaboration. Further financial details were not disclosed. Expanding Interest in ADC Platforms The partnership reflects continued industry investment in ADC technologies, which have become one of the fastest-growing areas of oncology drug development. Pharmaceutical companies are increasingly pursuing next-generation ADC approaches designed to improve tumour targeting, increase efficacy and address resistance to existing therapies. For Biocytogen, the collaboration expands the potential applications of its bispecific antibody platform beyond standalone antibody therapeutics. For Whitehawk, the partnership provides access to additional antibody candidates that could strengthen its ADC pipeline. Why the Partnership Matters The collaboration highlights several important trends in oncology innovation: Bispecific antibodies and ADCs are increasingly being combined to create more targeted cancer therapies. Biotech partnerships are accelerating access to specialised discovery platforms. Companies are seeking differentiated approaches to overcome limitations of existing oncology treatments. ADC technology remains a major focus for investment across the pharmaceutical industry. Summary Biocytogen and Whitehawk Therapeutics have partnered to develop bispecific antibody-drug conjugates by combining Biocytogen’s RenLite antibody platform with Whitehawk’s ADC expertise. The collaboration aims to generate differentiated cancer therapies with improved targeting capabilities, adding to the growing momentum behind next-generation oncology platforms. 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 non-binding recommendation could create a regulated US compounding route for BPC-157, KPV, TB-500 and MOTS-c, but it does not approve the substances as drugs or establish their safety or effectiveness. The FDA’s Pharmacy Compounding Advisory Committee has recommended that BPC-157-, KPV-, TB-500- and MOTS-c-related bulk substances be added to the Section 503A Bulks List after reviewing proposed uses including ulcerative colitis, wound healing, inflammatory conditions, obesity and osteoporosis. The recommendation concerns compounding eligibility only and remains subject to an FDA decision; none of the peptides has received FDA marketing approval through this process. Field Content Alert Type Regulatory Recommendation – Compounding Drug Name BPC-157, KPV, TB-500 and MOTS-c, including the free-base and acetate forms considered by the committee Indication Uses evaluated by the FDA included ulcerative colitis for BPC-157; wound healing and inflammatory conditions for KPV; wound healing for TB-500; and obesity and osteoporosis for MOTS-c. Therapy Area(s) Gastroenterology; inflammation and wound care; metabolic disease; bone health Geography US (FDA) What Happened On 23 July 2026, the FDA’s Pharmacy Compounding Advisory Committee recommended adding four groups of peptide-related bulk substances to the Section 503A Bulks List. The recommendation is advisory and non-binding: the FDA retains responsibility for the final decision, and the vote did not approve the peptides as medicines. Why It Matters Inclusion on the Section 503A Bulks List could allow qualifying licensed pharmacists and physicians to use these bulk substances in individually compounded prescriptions, subject to statutory compounding requirements. It would not provide the safety, efficacy, manufacturing or labelling findings associated with FDA approval of a new drug. Supporting Context FDA briefing materials had proposed that the free-base and acetate forms of all four peptides should not be included on the Section 503A Bulks List. The committee therefore reached a different recommendation after reviewing the available characterisation, safety, effectiveness and historical-use evidence. Key Takeaway The recommendation moves the four peptides closer to possible eligibility for pharmacy compounding but does not make them FDA-approved treatments. What to Watch The FDA’s final decision, any formal rulemaking required to amend the Section 503A Bulks List and any conditions or limitations placed on future inclusion. Primary Source FDA Pharmacy Compounding Advisory Committee meeting materials Relevant Date 23 July 2026 — advisory committee recommendation 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

The acquisition adds functional electrical stimulation technology to Ottobock’s neuro-orthotics offering, strengthening its position in the growing neurological devices market. German medical device company Ottobock has agreed to acquire Spanish medtech firm Fesia Technology, expanding its neuro-orthotics portfolio with a range of functional electrical stimulation (FES) products designed to support mobility and rehabilitation. The transaction, which is expected to close within six months, will see Ottobock take ownership of Fesia’s portfolio of wearable FES devices used to support patients recovering from neurological conditions including stroke, multiple sclerosis (MS) and cerebral palsy. Financial terms of the acquisition were not disclosed. Expanding Access to Functional Electrical Stimulation Fesia Technology develops wearable FES orthoses that use electrical pulses to stimulate weakened muscles, helping patients restore movement by encouraging the formation of new neural pathways. The company’s technology is designed to support people living with movement impairments caused by neurological disorders and injuries. Fesia’s product portfolio includes: Fesia Walk – a device designed to address foot drop by stimulating muscles involved in walking. Fesia Grasp – an upper limb orthosis designed to support hand function by targeting multiple muscle groups. The systems are controlled through the Fesia Pro smartphone application, allowing clinicians to customise stimulation parameters based on individual patient requirements. Strengthening Ottobock’s Neuro-Orthotics Strategy The acquisition complements Ottobock’s existing neurorehabilitation portfolio, which includes the Exopulse Mollii Suit, a full-body neuromodulation system designed to reduce muscle spasticity and pain through electrical stimulation. By integrating Fesia’s FES platform, Ottobock aims to broaden its ability to support patients across different stages of neurological rehabilitation. Fesia CEO Haritz Zabaleta said the partnership would allow the company to scale its technology globally and accelerate innovation in neurorehabilitation and human mobility. Growing Demand for Neurological Technologies The acquisition comes as demand for neurological devices continues to increase worldwide. Neurological disorders are currently the leading cause of disability globally and represent one of the largest healthcare challenges facing health systems. Industry analysis projects that the global neurology devices market will exceed $25 billion by 2034, driven by rising disease prevalence and increasing demand for advanced rehabilitation technologies. A 2024 World Health Organization report found that the overall health burden associated with neurological conditions has increased significantly since 1990, with access to specialist care remaining a challenge in many regions. Supporting Future Mobility Solutions Ottobock CEO Oliver Jakobi highlighted the growing number of people affected by neurological conditions and said improving care pathways for these patients remains a core focus for the company. The acquisition provides Ottobock with an established FES technology platform that can be integrated into its wider mobility ecosystem. By combining assistive devices, rehabilitation technologies and digital tools, Ottobock is positioning itself to play a larger role in the evolving neurological care market. Why the Acquisition Matters The deal reflects several broader trends shaping medical device innovation: Neurorehabilitation technologies are becoming increasingly important as neurological disease burden rises. Functional electrical stimulation is gaining traction as a non-invasive approach to restoring mobility. Medtech companies are expanding beyond traditional devices into integrated rehabilitation platforms. Demand is increasing for personalised solutions that support long-term patient recovery. Summary Ottobock has agreed to acquire Fesia Technology, adding wearable functional electrical stimulation devices to its neuro-orthotics portfolio. The acquisition strengthens Ottobock’s position in neurological rehabilitation and supports its broader strategy of developing technologies aimed at improving mobility and independence for patients living with neurological conditions.

The agreement adds advanced imaging capabilities to the xvision Spine System platform, supporting broader adoption of augmented reality navigation in spinal procedures. US-based medical technology company VB Spine has signed an agreement with Augmedics to acquire exclusive rights to its computed tomography-to-fluoroscopy (CT-Fluoro) technology for spinal applications. The transaction builds on VB Spine’s earlier acquisition of exclusive rights to the Augmedics xvision Spine System, further expanding its portfolio of image-guided surgical technologies. Financial terms of the agreement were not disclosed, with completion subject to customary closing conditions and regulatory approvals. Reducing Barriers to Spine Navigation Augmedics’ CT-Fluoro technology is designed to allow surgeons to register a patient’s preoperative CT scan using standard fluoroscopic imaging during spinal procedures. By reducing dependence on intraoperative CT or advanced 3D imaging systems, the technology could provide hospitals and surgical centres with greater flexibility when implementing navigation workflows. VB Spine believes the platform could help make augmented reality (AR)-based spine navigation more accessible across a wider range of healthcare settings. Building on the xvision Spine System The acquisition complements VB Spine’s existing focus on the xvision Spine System, an augmented reality navigation platform designed to provide surgeons with real-time guidance during spinal procedures. The system uses AR technology to display surgical navigation information directly within the surgeon’s field of view, helping support implant placement and procedural accuracy. VB Spine said integrating CT-Fluoro capabilities into its portfolio will provide surgeons with additional options for how navigation technology is used during operations. Supporting Technology-Enabled Spine Care VB Spine co-CEO Marc Viscogliosi said the company’s goal is to remove barriers that limit access to technologies designed to improve surgical efficiency and patient care. The addition of CT-Fluoro technology is expected to strengthen the xvision platform by expanding workflow flexibility for surgeons and healthcare facilities. Following completion of the deal, VB Spine plans to make the technology available as part of its broader spine procedure portfolio. Expanding Medical Technology Footprint The agreement represents another step in VB Spine’s strategy to develop a broader ecosystem of digital and image-guided solutions for spinal surgery. Earlier in 2026, the company agreed to acquire the SpineHawk intraoperative spinal visualisation platform from Robotron Surgical Technologies. That acquisition was aimed at expanding VB Spine’s capabilities in intraoperative imaging and advancing a software-focused roadmap for technology-enabled spine care. Why the Deal Matters The partnership reflects several wider trends in surgical technology: Augmented reality navigation is becoming increasingly important in complex procedures. Medical device companies are combining imaging, software and navigation technologies to improve surgical workflows. Reducing reliance on expensive imaging infrastructure could increase access to advanced surgical tools. Spine surgery continues to be a major focus area for digital health and medtech innovation. Summary VB Spine has agreed to acquire exclusive rights to Augmedics’ CT-Fluoro technology for spine applications, expanding its augmented reality navigation capabilities. The deal strengthens the xvision Spine System platform and supports VB Spine’s broader ambition to improve access to advanced image-guided technologies across spinal surgery. 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

EndoSure and Ziwig Endotest will be introduced as complementary diagnostic options, aiming to reduce delays in diagnosis for millions of women affected by endometriosis. The UK’s National Institute for Health and Care Excellence (NICE) has recommended the use of two non-invasive diagnostic technologies for endometriosis within the National Health Service (NHS), marking a significant step towards improving diagnosis of the condition. The draft early use healthtech guidance recommends EndoSure and Ziwig Endotest as complementary tools alongside existing clinical practice for an initial three-year period, during which further evidence will be collected to assess their long-term effectiveness. The move comes as patients in the UK continue to face lengthy delays before receiving an endometriosis diagnosis, with average waiting times exceeding nine years. New Approaches to Endometriosis Diagnosis Endometriosis occurs when tissue similar to the lining of the uterus grows outside its normal location, leading to inflammation, pain and, in some cases, infertility. The condition affects around 10% of women of reproductive age, but diagnosis can often be challenging and historically has relied on invasive procedures such as keyhole surgery. NICE said the introduction of new diagnostic approaches could provide a faster and less invasive pathway for patients while reducing reliance on specialist imaging expertise. How the New Tests Work The two recommended technologies use different approaches to identify biological signals associated with endometriosis. EndoSure Developed by EndoSure, the diagnostic uses abdominal sensor pads to detect electrical signals in the gut during a 45-minute procedure. The company says the test identifies patterns associated with the release of pro-inflammatory prostaglandins from endometriosis tissue, with results available immediately after testing. Ziwig Endotest Ziwig Endotest uses next-generation sequencing (NGS) technology to analyse saliva samples for 109 microRNAs (miRNAs) linked to endometriosis. Samples are analysed in a laboratory, with results typically returned within two to three weeks. Both tests are intended to support clinical decision-making rather than replace existing diagnostic assessments. Addressing Delays in Diagnosis The recommendation follows growing concerns over the time required for many patients to receive confirmation of endometriosis. A survey of more than 10,000 women found that half had visited their GP more than 10 times before receiving a diagnosis. NICE said the introduction of non-invasive diagnostics could support earlier identification of the condition, enabling patients to access appropriate treatment sooner. Dr Anastasia Chalkidou, healthtech programme director at NICE, highlighted the potential impact of faster diagnosis on patient outcomes and treatment decisions. A Step Forward for Women’s Health Innovation The NHS adoption of EndoSure and Ziwig Endotest reflects broader efforts to improve access to faster, less invasive diagnostic technologies. While NICE has not recommended either test as a standalone diagnostic solution, the guidance represents a move towards integrating emerging technologies into routine care pathways. The three-year evidence collection period will allow researchers and healthcare providers to assess how effectively the tools perform in real-world NHS settings. Why the Recommendation Matters The introduction of these technologies highlights several wider trends in healthcare innovation: Non-invasive diagnostics are increasingly being developed to replace or reduce reliance on invasive procedures. Earlier diagnosis is becoming a priority in conditions historically associated with long delays. Digital and molecular technologies are expanding diagnostic options across women’s health. Real-world evidence generation is becoming central to NHS adoption decisions. Summary NICE has recommended the NHS introduce EndoSure and Ziwig Endotest as complementary tools for diagnosing endometriosis. The technologies aim to reduce diagnostic delays by offering faster, less invasive alternatives to traditional pathways, potentially improving access to care for millions of women affected by the condition. 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 deal gives Vertex access to a commercial acromegaly therapy and a late-stage rare disease pipeline as the company diversifies beyond cystic fibrosis. Vertex Pharmaceuticals has agreed to acquire Crinetics Pharmaceuticals in a transaction valued at approximately $10 billion, marking the company’s largest acquisition to date. Under the terms of the agreement, Vertex will acquire Crinetics for $85 per share, with the transaction expected to close in the third quarter of 2026. The acquisition strengthens Vertex’s position in rare diseases by adding an established endocrinology portfolio, including Palsonify (paltusotine), an oral therapy approved in the US and EU for adults with acromegaly. Expanding Beyond Cystic Fibrosis Vertex built its commercial success around cystic fibrosis, with its franchise generating more than $11 billion in revenue in 2025. The company has used that financial strength to expand into additional therapeutic areas, including gene therapy, pain management and kidney disease. However, some newer growth areas have faced challenges. The company’s non-opioid pain medicine Journavx (suzetrigine) gained approval as the first new non-opioid pain treatment in more than two decades. Still, expectations for broader chronic pain adoption have remained limited. Meanwhile, uptake of Vertex’s gene therapy, Casgevy (exagamglogene autotemcel), has been affected by challenges common to cell and gene therapies, including high costs, reimbursement barriers, and complex treatment pathways. The Crinetics acquisition provides Vertex with a commercial product and a pipeline focused on rare endocrine disorders. Palsonify Provides Immediate Commercial Opportunity The centrepiece of the deal is Palsonify (paltusotine), an oral non-peptide somatostatin receptor type 2 (SST2) agonist designed to treat acromegaly. The therapy was approved in the US and EU as a first-line treatment for adults with acromegaly, a rare hormonal disorder caused by excess growth hormone production. Since launching in the US in late 2025, Palsonify has generated approximately $15.7 million in net product revenue. Vertex said early performance reflects strong demand, expanding prescribing activity and increasing reimbursement coverage. Vertex CEO Reshma Kewalramani said the company’s experience commercialising rare disease medicines would help accelerate the drug’s growth following the acquisition. Building a Rare Endocrinology Pipeline Beyond Palsonify, the acquisition adds Crinetics’ clinical pipeline, led by atumelnant, an oral adrenocorticotropic hormone (ACTH) receptor antagonist currently being studied in Phase III trials for congenital adrenal hyperplasia (CAH). CAH is a rare genetic disorder characterised by impaired cortisol production and excess androgen levels. In Phase II studies, atumelnant demonstrated reductions in androgen biomarkers, including androstenedione and 17-hydroxyprogesterone, while allowing patients to maintain physiologic glucocorticoid replacement therapy. The candidate is also being evaluated in Cushing’s syndrome, another rare endocrine condition. Crinetics’ wider pipeline includes: CRN09682, a Phase I/II programme for neuroendocrine tumours Preclinical programmes targeting Graves’ disease Thyroid eye disease Polycystic kidney disease Obesity Diabetes Vertex expects Palsonify and atumelnant together could generate peak annual revenue exceeding $5 billion. Strengthening Vertex’s M&A Strategy The Crinetics acquisition follows Vertex’s previous major acquisition of Alpine Immune Sciences for $4.9 billion in 2024, which provided the company with povetacicept. Povetacicept, a dual APRIL/BAFF inhibitor, is currently under FDA review for immunoglobulin A nephropathy (IgAN). Vertex has previously highlighted renal disease as a potential future growth driver, with the company suggesting its kidney portfolio could eventually surpass its cystic fibrosis business. Why the Deal Matters The acquisition highlights several important trends across the biopharmaceutical sector: Large pharmaceutical companies continue to use M&A to secure late-stage and commercial assets. Rare diseases remain a major focus for pipeline diversification. Oral therapies are attracting interest as alternatives to injectable treatments. Endocrinology is becoming an increasingly attractive market due to significant unmet medical needs. Summary Vertex Pharmaceuticals has agreed to acquire Crinetics Pharmaceuticals for approximately $10 billion, gaining access to Palsonify and a broader endocrinology pipeline. The deal strengthens Vertex’s strategy of expanding beyond cystic fibrosis while adding commercial and late-stage rare disease assets across acromegaly, congenital adrenal hyperplasia and other endocrine disorders. 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 setback clouds expansion plans for the RNA-targeted therapy after a pivotal cardiovascular outcomes study failed to demonstrate a significant benefit in patients with transthyretin amyloid cardiomyopathy. AstraZeneca and Ionis Pharmaceuticals have reported disappointing results from the Phase III CARDIO-TTRansform trial, with their investigational therapy eplontersen failing to meet its primary endpoint in patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). The announcement dealt a significant blow to the programme, with AstraZeneca's share price falling sharply following the news. The outcome also raises questions over the therapy's commercial expansion beyond its current approved indication. A Key Growth Opportunity Falls Short Eplontersen is already approved in the US and Europe for adults with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN), where it is marketed as Wainua in the US and Wainzua in Europe. Success in ATTR-CM was widely viewed as the next major commercial opportunity for the RNA-targeted medicine, placing it in direct competition with therapies including Alnylam's Amvuttra (vutrisiran) and Pfizer's Vyndaqel/Vyndamax (tafamidis). The programme also formed part of AstraZeneca's longer-term growth strategy as it works towards its ambition of generating $80 billion in annual revenue by 2030. Phase III Trial Misses Primary Endpoint The global CARDIO-TTRansform study enrolled 1,432 patients with either hereditary or wild-type ATTR-CM. Participants received either eplontersen or placebo alongside standard-of-care treatment, with the primary endpoint measuring a composite of cardiovascular death and recurrent cardiovascular events over 140 weeks. The study failed to demonstrate a statistically significant improvement in the overall patient population. However, a pre-specified subgroup analysis suggested patients receiving eplontersen as monotherapy experienced a nominally significant reduction in cardiovascular events compared with placebo. No meaningful treatment benefit was observed among patients already receiving transthyretin stabiliser therapy. Changing Treatment Landscape May Have Influenced Results According to the companies, the widespread use of stabiliser therapies during the study may have affected the trial outcome. More than 57% of participants were receiving stabiliser treatment when they entered the study, while an additional 24% began stabiliser therapy during the trial. Ionis CEO Brett Monia said the findings reflected the rapidly evolving treatment landscape, where stabiliser therapies have become increasingly common in routine clinical practice. Encouraging Secondary Findings Although the primary endpoint was missed, the companies highlighted several positive secondary outcomes. Multiple imaging and biomarker analyses favoured eplontersen over placebo, while the therapy produced large and sustained reductions in transthyretin protein levels. The safety profile also remained consistent with previous studies, with no new safety concerns identified. AstraZeneca and Ionis plan to conduct further analyses of the full dataset before presenting detailed results at the upcoming European Society of Cardiology (ESC) Congress. Competitive Pressure Continues The setback arrives as competition within ATTR-CM continues to intensify. RNA-targeted medicines and transthyretin stabilisers are increasingly competing to improve outcomes for patients with this progressive and often fatal cardiac disease. The trial outcome may strengthen the positions of existing therapies while prompting AstraZeneca and Ionis to reassess eplontersen's future role within the evolving treatment landscape. Why the Results Matter The study highlights several important trends across cardiovascular drug development: Demonstrating additional benefit on top of existing standard-of-care therapies is becoming increasingly challenging. ATTR-CM is rapidly evolving as new treatments become integrated into routine clinical practice. RNA-targeted medicines continue to show strong biological activity, but translating biomarker improvements into clinical outcomes remains critical. Large cardiovascular outcome trials remain one of the highest hurdles in late-stage drug development. Summary AstraZeneca and Ionis have reported that the Phase III CARDIO-TTRansform trial of eplontersen failed to meet its primary endpoint in transthyretin-mediated amyloid cardiomyopathy. While secondary analyses and biomarker data remained encouraging, the results represent a setback for the therapy's expansion into ATTR-CM and underline the increasing complexity of developing new treatments in an evolving standard-of-care environment. 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 expands Accord BioPharma's oncology supportive care portfolio, making it the only US company to offer two pegfilgrastim biosimilars alongside a filgrastim biosimilar. Accord BioPharma has received US Food and Drug Administration (FDA) approval for ENNUMO (pegfilgrastim-pccg), a biosimilar to Neulasta (pegfilgrastim), strengthening the company's position in the growing biosimilars market. The approval gives Accord BioPharma what it describes as the most comprehensive granulocyte colony-stimulating factor (G-CSF) biosimilar portfolio in the United States, adding ENNUMO alongside its existing pegfilgrastim biosimilar UDENYCA and short-acting filgrastim biosimilar FILKRI. Expanding Supportive Care Options in Oncology ENNUMO has been approved for the same indications as the reference product, Neulasta. The biosimilar is indicated to reduce the incidence of febrile neutropenia in adults and children receiving myelosuppressive chemotherapy for non-myeloid cancers, as well as to improve survival following exposure to myelosuppressive doses of radiation associated with Hematopoietic Subsyndrome of Acute Radiation Syndrome. Febrile neutropenia is one of the most common and serious complications associated with cancer treatment, often leading to hospitalisation, treatment delays and chemotherapy dose reductions. G-CSF therapies help stimulate white blood cell production, reducing the risk of infection in patients undergoing chemotherapy. Building a Broader Biosimilar Portfolio With ENNUMO's approval, Accord BioPharma now offers: ENNUMO (pegfilgrastim-pccg) – long-acting G-CSF biosimilar UDENYCA (pegfilgrastim-cbqv) – long-acting G-CSF biosimilar FILKRI (filgrastim-laha) – short-acting G-CSF biosimilar The company says the expanded portfolio allows healthcare providers greater flexibility when selecting supportive care options for oncology patients across different clinical settings. Long-Term Biosimilar Growth Strategy The approval represents another milestone in Accord BioPharma's broader expansion strategy. The company aims to launch 20 biosimilars in the US by 2030, building its presence across oncology, immunology and, eventually, central nervous system (CNS) therapies. Accord BioPharma is the US specialty division of Intas Pharmaceuticals, one of the world's largest biosimilar developers. Company executives said expanding access to high-quality, lower-cost biologic medicines remains central to its long-term strategy. Why the Approval Matters The approval reflects several broader trends across the healthcare market: Biosimilars continue to increase competition within oncology supportive care. Larger biosimilar portfolios are giving healthcare providers greater treatment flexibility. Expanding biosimilar availability could improve patient access while helping reduce healthcare costs. Oncology supportive care remains a key area for biosimilar adoption as chemotherapy use continues to grow. Summary The FDA has approved Accord BioPharma's ENNUMO, a biosimilar to Neulasta, for the prevention of febrile neutropenia and treatment following radiation exposure. The approval strengthens Accord BioPharma's oncology portfolio, making it the only company in the US to offer two pegfilgrastim biosimilars alongside a filgrastim biosimilar as it pursues its goal of launching 20 biosimilars by 2030. 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 AI-powered software analyses retinal images captured by the widely used iCare DRSplus camera, supporting earlier detection of diabetic retinopathy in primary care and community healthcare settings. iHealthScreen has received US Food and Drug Administration (FDA) clearance for iPredict-DR, an artificial intelligence (AI)-powered screening software designed to detect diabetic retinopathy in adults with diabetes. The software analyses colour retinal fundus images captured using the iCare DRSplus camera to identify more than mild diabetic retinopathy (mtmDR), one of the leading causes of preventable blindness worldwide. AI Supports Earlier Disease Detection iPredict-DR has been developed as a Software as a Medical Device (SaMD) and uses AI algorithms to analyse retinal images without requiring manual interpretation during the initial screening process. The software is intended to help healthcare professionals identify patients who require further ophthalmic assessment, enabling earlier referral and intervention. The FDA clearance was supported by a clinical validation study evaluating the software's diagnostic performance, safety and usability. Addressing a Growing Healthcare Challenge Diabetic retinopathy is a common complication of diabetes caused by prolonged high blood sugar levels damaging blood vessels in the retina. If left undiagnosed and untreated, the condition can lead to progressive vision loss and blindness. According to the International Diabetes Federation, the global number of people living with diabetes is expected to reach 700 million by 2045, increasing demand for scalable screening solutions. Despite recommendations for annual eye examinations, studies from the American Academy of Ophthalmology suggest that approximately 60% of people with diabetes miss their yearly retinal screening appointments, creating opportunities for disease progression before diagnosis. Expanding the AI Eye Screening Platform Following the FDA clearance, iHealthScreen plans to expand its AI platform into additional ophthalmic and systemic diseases. The company is pursuing further regulatory clearances for software designed to detect: Age-related macular degeneration (AMD) Glaucoma Hypertensive retinopathy Cardiovascular disease risk CEO Dr Alauddin Bhuiyan said the approval supports the company's goal of making AI-powered retinal screening more widely available in primary care and community healthcare settings to enable earlier diagnosis and referral. AI Continues to Transform Medical Imaging The clearance reflects the growing adoption of artificial intelligence across medical imaging and diagnostic workflows. AI technologies are increasingly being used to improve disease detection, reduce diagnostic workloads and expand access to specialist screening services. Market forecasts suggest the global AI in healthcare sector will continue to grow rapidly over the coming years, while researchers are also exploring additional ophthalmic AI applications, including software capable of identifying dementia risk through routine eye examinations. Why the Clearance Matters The FDA decision highlights several broader trends shaping digital healthcare: AI-powered screening tools are becoming increasingly integrated into routine clinical practice. Earlier detection of diabetic retinopathy could help reduce preventable vision loss. Software as a Medical Device continues to expand across ophthalmology and diagnostic imaging. Retinal imaging is emerging as a valuable platform for identifying both eye disease and wider systemic health conditions. Summary The FDA has cleared iHealthScreen's AI-powered iPredict-DR software to screen adults with diabetes for more than mild diabetic retinopathy using retinal images captured by the iCare DRSplus camera. The approval expands the use of AI in ophthalmology and supports earlier detection of one of the leading causes of preventable blindness, while laying the groundwork for future AI-based screening tools targeting additional eye and systemic diseases. 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 Elecsys IGRA TB test delivers results in under 24 hours and brings automated latent tuberculosis screening to Roche's cobas immunoassay platforms. Roche has received CE Mark approval for its Elecsys Interferon Gamma Release Assay (IGRA) TB test, a blood-based diagnostic designed to detect latent tuberculosis infection (TBI) in routine laboratory settings. The automated assay is designed to improve testing efficiency by running on Roche's cobas immunoassay systems, helping laboratories increase throughput while reducing manual workflows. Faster, Automated TB Screening The Elecsys IGRA TB test delivers results in less than 24 hours, with each assay requiring approximately 19 minutes to process. By integrating automated sample handling and digital workflows, the system is intended to support growing demand for latent tuberculosis screening while improving laboratory efficiency. Roche says the platform offers faster turnaround times and greater testing capacity compared with traditional manual testing methods. Supporting Global Tuberculosis Control Latent tuberculosis occurs when individuals are infected with Mycobacterium tuberculosis but do not show symptoms of active disease. Without diagnosis and treatment, latent infection can later progress to active tuberculosis, contributing to ongoing disease transmission and mortality. The World Health Organization (WHO) has identified improved diagnosis and treatment of latent TB as a key component of its strategy to reduce tuberculosis deaths by 90% and new cases by 80% by 2030. Roche believes wider access to automated diagnostics could help support these global elimination efforts. Clinical Study Demonstrates Strong Performance The CE Mark approval was supported by a global multi-centre clinical evaluation conducted across regions with both high and low tuberculosis incidence, including Europe, Africa, the Western Pacific and the Americas. Compared with existing standard testing methods, the Elecsys IGRA TB assay demonstrated: 91.12% positive percent agreement 94.57% negative percent agreement 100% relative sensitivity in patients with bacteriologically confirmed tuberculosis 95.32% specificity in a low-risk patient cohort The findings indicate the assay can accurately identify latent tuberculosis infection while maintaining strong diagnostic performance across diverse populations. Expanding Roche's Diagnostics Portfolio The approval further strengthens Roche's diagnostics business as the company continues to invest in laboratory automation and molecular testing technologies. It follows the recent launch of Axelios 1, Roche's next-generation sequencing platform for research applications, reflecting the company's continued focus on expanding its diagnostic capabilities. Why the CE Mark Matters The approval highlights several important trends across diagnostic medicine: Automated laboratory testing is helping improve efficiency and scalability for infectious disease screening. Early identification of latent tuberculosis remains central to global disease elimination strategies. Blood-based diagnostics are increasingly replacing more labour-intensive testing workflows. Integrated laboratory platforms continue to play a growing role in public health screening programmes. Summary Roche has secured CE Mark approval for its Elecsys IGRA TB blood test, providing laboratories with an automated solution for detecting latent tuberculosis infection. Designed for use on Roche's cobas immunoassay systems, the assay delivers rapid, high-throughput testing and supports global efforts to improve tuberculosis screening and reduce the burden of one of the world's leading infectious diseases. 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 DE STSF platform combines radiofrequency and pulsed field ablation in a single catheter, expanding treatment options for electrophysiologists managing complex cardiac arrhythmias. Johnson & Johnson has received US Food and Drug Administration (FDA) approval for its Dual Energy Thermocool Smarttouch SF (DE STSF) platform, a catheter ablation system that enables physicians to deliver both radiofrequency (RF) and pulsed field (PF) energy using a single device. The approval expands the company's electrophysiology portfolio by giving clinicians greater flexibility to tailor ablation strategies based on individual patient anatomy and procedural requirements. Dual-Energy Approach to Catheter Ablation The DE STSF platform builds on Johnson & Johnson's established Thermocool Smarttouch SF technology, which the company says has been used to treat more than one million patients in the United States. The addition of pulsed field ablation allows physicians to choose between two different energy sources during procedures: Radiofrequency (RF) ablation, which uses heat to destroy abnormal cardiac tissue. Pulsed field (PF) ablation, a newer, non-thermal technology that selectively targets cardiac cells using electrical pulses. Providing both options through a single catheter is intended to simplify workflows while allowing clinicians to adapt treatment to different clinical scenarios. Integrated with the CARTO Platform The DE STSF system is fully integrated with Johnson & Johnson's CARTO mapping ecosystem. The platform combines advanced cardiac mapping, imaging capabilities and PF Index guidance to help physicians visualise anatomy and accurately deliver ablation therapy. According to the company, the integrated system is designed to support precise catheter contact, predictable energy delivery and more consistent procedural workflows. Commercial Rollout Planned for Later This Year Following FDA approval, Johnson & Johnson expects the first US procedures using the DE STSF platform to take place later this year as part of a phased commercial launch. The approval follows the technology's earlier introduction in Europe, where the platform has already entered clinical use. Company executives said the launch represents another milestone during a period of significant innovation within the electrophysiology market. Growing Innovation in Cardiac Electrophysiology Demand for advanced catheter ablation technologies continues to increase as physicians seek safer, more effective treatments for cardiac arrhythmias such as atrial fibrillation. Pulsed field ablation has emerged as one of the fastest-growing technologies in electrophysiology due to its potential to reduce damage to surrounding tissue while maintaining procedural effectiveness. Johnson & Johnson continues to expand its cardiovascular device portfolio, having recently initiated enrolment in its SKYWARD investigational device exemption study evaluating the Shockwave SkyRunner Carotid intravascular lithotripsy system. Why the Approval Matters The FDA approval reflects several key trends across cardiovascular medical technology: Dual-energy ablation systems are providing physicians with greater procedural flexibility. Pulsed field ablation continues to gain momentum as a next-generation treatment approach. Integration of mapping, imaging and navigation technologies is improving procedural precision. Competition within the electrophysiology market is accelerating as manufacturers expand their cardiac device portfolios. Summary Johnson & Johnson has secured FDA approval for its Dual Energy Thermocool Smarttouch SF platform, enabling physicians to perform both radiofrequency and pulsed field catheter ablation using a single system. Integrated with the CARTO ecosystem, the platform offers greater flexibility for treating complex cardiac arrhythmias and further strengthens Johnson & Johnson's position in the rapidly evolving electrophysiology market. 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 new funding will accelerate manufacturing and commercial deployment of the FDA-cleared Marie system, which reimagines proton therapy by rotating the patient instead of the treatment machine. Leo Cancer Care has secured $65 million in Series D financing to expand manufacturing and commercial deployment of its Marie upright radiotherapy platform, following growing interest in the company's patient-centred approach to cancer treatment. The oversubscribed funding round was led by Yu Galaxy and included participation from new investor Eventide Asset Management, alongside existing shareholders. Funding to Accelerate Commercial Growth The latest investment follows Leo Cancer Care's $40 million fundraising completed in September 2025. According to the company, the new capital will be used to: Expand manufacturing capacity. Accelerate commercial deployment of the Marie platform. Support ongoing clinical research and product development. Advance its broader upright radiotherapy strategy across proton therapy, photon therapy and medical imaging. Rethinking Radiotherapy Delivery At the centre of Leo's technology is Marie, an integrated upright patient positioning system and CT scanner designed for proton therapy. Unlike conventional radiotherapy systems, where a large gantry rotates around a patient lying flat, Marie keeps the treatment equipment fixed while rotating the patient into the required treatment position. The company believes this upright approach can improve anatomical consistency and organ stability during treatment, potentially enhancing treatment precision while simplifying system design. Building Momentum Following FDA Clearance Marie received US Food and Drug Administration (FDA) 510(k) clearance in July 2025. Since then, the platform has attracted growing interest from leading cancer centres. In June, the system was used during the world's first compact upright proton therapy treatment at Stanford Medicine Cancer Center, demonstrating the clinical feasibility of the company's novel treatment approach. The milestone marked an important step towards broader adoption of upright proton therapy in clinical practice. Expanding Access to Advanced Cancer Care Leo Cancer Care says its long-term strategy is to redesign radiotherapy around the patient rather than the treatment machine. The company believes upright treatment systems could make advanced cancer therapies more accessible by reducing infrastructure requirements while maintaining treatment quality. Alongside the financing announcement, Leo also revealed it is preparing to announce a strategic partnership with a major international healthcare company, with further details expected in the coming weeks. Why the Funding Matters The investment reflects several important trends across radiation oncology: Companies are exploring new treatment workflows that improve both patient experience and operational efficiency. Proton therapy continues to expand beyond specialist centres through more compact technologies. Innovation is increasingly focused on improving access to advanced radiotherapy rather than simply reducing equipment costs. Investors remain supportive of technologies that could reshape cancer treatment delivery. Summary Leo Cancer Care has raised $65 million to accelerate commercial rollout of its FDA-cleared Marie upright radiotherapy platform. The funding will support manufacturing expansion, clinical development and broader deployment of a system designed to transform proton therapy by rotating the patient rather than the treatment machine, as interest in upright cancer treatment continues to grow. 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