Jaguar LAA has acquired assets from Johnson & Johnson related to the Laminar left atrial appendage closure programme, creating a newly independent medical-device company focused on advancing the technology. The transaction transfers the Laminar programme and associated assets to Jaguar LAA, which has also brought key programme personnel into the new organisation to continue development of the left atrial appendage closure platform. Jaguar LAA plans to advance the programme through additional development and regulatory activity, positioning the company to continue work on a potential device-based approach to reducing stroke risk in patients with atrial fibrillation. Field Content Alert Type Deal Companies Jaguar LAA; Johnson & Johnson Deal Type Asset acquisition Asset or Company Laminar left atrial appendage closure programme Therapy Area(s) Cardiology; atrial fibrillation; structural heart Technology or Modality Left atrial appendage closure medical device Deal Value Financial terms were not disclosed Geography United States What Happened Jaguar LAA acquired Johnson & Johnson assets related to the Laminar left atrial appendage closure programme and brought key programme personnel into the newly formed independent company. Why It Matters The transaction preserves development of the Laminar technology outside Johnson & Johnson and creates a dedicated organisation focused on advancing the programme toward further regulatory and commercial milestones. Supporting Context Left atrial appendage closure devices are designed to reduce stroke risk in selected patients with atrial fibrillation by isolating the appendage, where blood clots can form. Strategic Rationale Jaguar LAA gains control of an established medtech programme, intellectual property and experienced personnel while creating a focused development organisation around the Laminar platform. Potential Impact Successful development and regulatory approval could add another device-based option for stroke prevention in patients with atrial fibrillation. Key Takeaway Jaguar LAA has acquired the Laminar left atrial appendage closure assets from Johnson & Johnson and will continue development of the programme independently. What to Watch Future clinical development, regulatory submissions and financing milestones for the Laminar programme. Primary Source PR Newswire Relevant Date 11 September 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

Proteomics International has begun the controlled commercial rollout of its PromarkerD and PromarkerEso blood tests in Western Australia and the Northern Territory through its exclusive pathology distribution agreement with Healius. The rollout expands clinical access to PromarkerD, which assesses diabetic kidney disease risk, and PromarkerEso, which supports detection of oesophageal adenocarcinoma, ahead of a planned broader national launch. The commercial milestone moves both tests further into routine pathology channels and represents an important step in Proteomics International's strategy to scale its diagnostic portfolio across Australia. Field Content Alert Type Industry Update Companies Proteomics International; Healius Development Type Commercial rollout Products PromarkerD; PromarkerEso Therapy Area(s) Diabetes; kidney disease; oncology; oesophageal cancer Technology or Modality Blood-based proteomic diagnostic tests Geography Western Australia; Northern Territory; Australia What Happened Proteomics International began the controlled market release of PromarkerD and PromarkerEso through Healius pathology services in Western Australia and the Northern Territory. Why It Matters The rollout moves the tests from development and validation into broader clinical use through a major pathology network and provides a pathway toward national commercialisation. Supporting Context PromarkerD is designed to assess risk of diabetic kidney disease progression, while PromarkerEso is a blood test intended to support detection of oesophageal adenocarcinoma. Strategic Rationale The Healius distribution agreement gives Proteomics International access to established pathology infrastructure and a scalable channel for introducing its diagnostic products to clinicians and patients. Potential Impact Wider clinical access could support earlier risk identification and diagnosis while generating real-world commercial and clinical evidence for both tests. Key Takeaway Proteomics International has started commercial deployment of PromarkerD and PromarkerEso in WA and the NT through Healius ahead of a planned national rollout. What to Watch Expansion into additional Australian states, clinician adoption and progress toward full national availability. Primary Source Proteomics International Relevant Date 14 September 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 FDA has approved Isembyld as the first spinal muscular atrophy treatment designed to directly target muscle loss, for patients aged 2 years and older receiving an SMN2-targeted therapy. Isembyld, also known as apitegromab-mstn, is a muscle-targeted monoclonal antibody that inhibits myostatin activation and is used alongside existing SMN2-targeted treatment for spinal muscular atrophy. The approval introduces a complementary treatment approach that acts directly on skeletal muscle rather than the underlying SMN pathway, providing a new option for eligible children and adults with SMA. Field Content Alert Type Approval Drug Name Apitegromab-mstn Brand Name Isembyld Company Scholar Rock Regulatory Authority U.S. Food and Drug Administration Approval Type New drug approval Indication Treatment of spinal muscular atrophy in adults and paediatric patients aged 2 years and older receiving an SMN2-targeted therapy Therapy Area(s) Neurology; rare disease; neuromuscular disease Technology or Modality Monoclonal antibody; myostatin inhibitor Geography United States What Happened The FDA approved Isembyld (apitegromab-mstn) for adults and children aged 2 years and older with spinal muscular atrophy who are receiving an SMN2-targeted treatment. Why It Matters Isembyld is the first approved SMA treatment designed to directly target muscle loss, providing a complementary mechanism to existing therapies that act on the underlying SMN pathway. Supporting Context Apitegromab-mstn is a monoclonal antibody designed to selectively inhibit activation of myostatin, a negative regulator of skeletal muscle growth. Key Takeaway Isembyld introduces the first FDA-approved muscle-targeted treatment for eligible patients with spinal muscular atrophy. What to Watch Clinical uptake alongside SMN2-targeted therapies and longer-term evidence on motor function and treatment outcomes across SMA populations. Primary Source U.S. Food and Drug Administration Relevant Date 11 September 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

Medicus Pharma has secured exclusive worldwide rights to Pfizer's CD228-targeted antibody-drug conjugate PF-08046031 in an oncology licensing agreement potentially worth more than $1 billion. Medicus will pay Pfizer $12 million upfront and a further $15 million after one year, with Pfizer eligible for more than $1 billion in development, regulatory and commercial milestone payments plus royalties on future sales. The transaction adds a potentially first-in-class CD228-targeted antibody-drug conjugate to Medicus' oncology pipeline and gives the company responsibility for its future development and commercialisation worldwide. Field Content Alert Type Deal Companies Medicus Pharma; Pfizer Deal Type Exclusive worldwide licensing agreement Asset or Company PF-08046031 / CD228V Therapy Area(s) Oncology; solid tumours Technology or Modality CD228-targeted antibody-drug conjugate Deal Value US$12 million upfront, US$15 million after one year, more than US$1 billion in potential development, regulatory and commercial milestones, plus royalties Geography Worldwide What Happened Medicus Pharma secured exclusive worldwide rights from Pfizer to develop and commercialise the CD228-targeted antibody-drug conjugate PF-08046031, also known as CD228V. Why It Matters The agreement gives Medicus control of a potentially differentiated oncology asset targeting CD228 and represents a substantial expansion of the company's therapeutic pipeline. Supporting Context PF-08046031 is an early-stage antibody-drug conjugate designed to target CD228, a cell-surface protein expressed across several tumour types. Strategic Rationale Medicus gains a global oncology development asset while Pfizer retains substantial economic participation through milestone payments and royalties. Potential Impact Successful development could establish a new targeted treatment approach for cancers expressing CD228 and materially broaden Medicus' oncology portfolio. Key Takeaway Medicus Pharma has licensed Pfizer's CD228V antibody-drug conjugate globally in a transaction carrying more than US$1 billion in potential milestone payments. What to Watch Medicus' development plans for PF-08046031, progression into further clinical evaluation and selection of priority tumour indications. Primary Source U.S. Securities and Exchange Commission Relevant Date 11 September 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 FDA has approved Telix's Pixclara as the first FET-PET imaging agent in the United States for evaluating glioma, providing a new tool to help distinguish tumour progression from treatment-related changes. Pixclara, or floretyrosine F 18, is a radioactive diagnostic imaging agent used with positron emission tomography to evaluate adults and paediatric patients with glioma. The approval addresses a significant diagnostic challenge in brain cancer care by providing amino-acid PET imaging that can help clinicians assess suspected recurrent or progressive disease when conventional imaging may be inconclusive. Field Content Alert Type Approval Drug Name Floretyrosine F 18 Brand Name Pixclara Company Telix Pharmaceuticals Regulatory Authority U.S. Food and Drug Administration Approval Type New diagnostic imaging drug approval Indication PET imaging of adults and paediatric patients with glioma Therapy Area(s) Oncology; neuro-oncology; diagnostic imaging Technology or Modality FET-PET; radioactive diagnostic imaging agent Geography United States What Happened The FDA approved Pixclara (floretyrosine F 18), Telix's FET-PET imaging agent for use in adults and paediatric patients with glioma. Why It Matters Pixclara is the first FDA-approved FET-PET imaging agent for glioma and provides clinicians with an additional tool for evaluating suspected recurrent or progressive brain cancer and distinguishing disease from treatment-related changes. Supporting Context Conventional MRI can have difficulty distinguishing recurrent tumour from treatment effects, creating a need for more specific molecular imaging approaches in glioma management. Key Takeaway Pixclara brings FDA-approved FET-PET imaging to the US for the first time, expanding diagnostic options for patients with glioma. What to Watch US commercial rollout, availability across PET imaging centres and integration of FET-PET into glioma diagnosis and follow-up pathways. Primary Source Telix Pharmaceuticals Relevant Date 14 September 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

CordenPharma is investing €80 million to expand aseptic fill-finish operations at its Caponago site in Italy, increasing projected sterile injectable capacity to up to 500 million units annually. The expansion will add new aseptic filling lines and strengthen CordenPharma's ability to manufacture and package sterile injectable medicines for pharmaceutical and biotechnology customers. The investment reflects growing demand for outsourced sterile manufacturing capacity and forms part of the company's broader strategy to scale high-value injectable drug production across its global network. Field Content Alert Type Industry Update Company CordenPharma Development Type Manufacturing capacity expansion Investment €80 million Facility Caponago manufacturing site Location Italy Manufacturing Area Aseptic fill-finish; sterile injectables Projected Capacity Up to 500 million sterile injectable units annually What Happened CordenPharma announced an €80 million investment to expand aseptic fill-finish capacity at its Caponago facility in Italy. Why It Matters The expansion substantially increases sterile injectable manufacturing capacity at a time of strong demand for outsourced aseptic production services. Supporting Context The programme includes additional aseptic filling infrastructure designed to support pharmaceutical and biotechnology customers across multiple injectable formats. Strategic Rationale CordenPharma is scaling high-value sterile manufacturing capabilities to strengthen its position as a global contract development and manufacturing partner. Potential Impact The added capacity could support greater commercial supply volumes and provide drug developers with additional European sterile manufacturing options. Key Takeaway CordenPharma is investing €80 million to scale its Italian sterile injectable operations toward 500 million units of annual capacity. What to Watch Completion of the new filling lines, customer onboarding and utilisation of the expanded Caponago capacity. Primary Source CordenPharma Relevant Date 10 September 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 FDA has expanded the accelerated approval of Hyrnuo to include first-line treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer harbouring HER2/ERBB2 tyrosine kinase domain activating mutations. Sevabertinib, marketed as Hyrnuo, can now be used in the first-line setting for eligible patients with HER2-mutated advanced non-small cell lung cancer, extending its previous indication beyond previously treated disease. The approval broadens access to a targeted oral therapy for a molecularly defined group of lung cancer patients and reinforces the growing role of biomarker testing in treatment selection. Field Content Alert Type Approval Drug Name Sevabertinib Brand Name Hyrnuo Company Bayer Regulatory Authority U.S. Food and Drug Administration Approval Type Accelerated approval expansion Indication First-line treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer harbouring HER2/ERBB2 tyrosine kinase domain activating mutations Therapy Area(s) Oncology; lung cancer Biomarker HER2/ERBB2 TKD activating mutation Geography United States What Happened The FDA expanded the accelerated approval of Hyrnuo (sevabertinib) to include first-line treatment of eligible adults with HER2/ERBB2-mutated advanced non-squamous NSCLC. Why It Matters The expanded indication moves Hyrnuo into the first-line setting for a molecularly selected lung cancer population that previously had more limited targeted treatment options. Supporting Context Hyrnuo had previously been approved for patients with HER2-mutated advanced NSCLC following prior systemic therapy. Key Takeaway Hyrnuo can now be used as a first-line targeted treatment for eligible patients with HER2-mutated advanced non-squamous NSCLC. What to Watch Adoption of HER2 mutation testing in first-line NSCLC and confirmatory evidence supporting the accelerated approval. Primary Source U.S. Food and Drug Administration Relevant Date 9 September 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

A UK national commission has proposed a new regulatory framework for artificial intelligence in healthcare designed to support faster adoption while maintaining safety, accountability and public trust. The recommendations call for a proportionate, lifecycle-based approach to AI regulation that considers clinical governance, transparency, oversight and post-market monitoring across healthcare systems. The blueprint is intended to reduce regulatory fragmentation and give developers, healthcare organisations and regulators a clearer framework for deploying AI-enabled technologies safely within the NHS. Field Content Alert Type Industry Update Organisation National Commission into the Regulation of AI in Healthcare Development Type Regulatory policy recommendations Topic Artificial intelligence regulation in healthcare Sector Digital health; healthcare technology Geography United Kingdom What Happened The National Commission into the Regulation of AI in Healthcare published recommendations for a future UK regulatory framework covering the development and use of AI-enabled healthcare technologies. Why It Matters The recommendations could shape how AI tools are evaluated, governed, monitored and adopted across the NHS and wider UK healthcare system. Key Recommendations Proportionate regulation; lifecycle oversight; clear accountability; transparency; clinical governance; post-market monitoring; coordinated regulation across the healthcare system Supporting Context The commission's work responds to rapid growth in healthcare AI and concerns that existing regulatory structures may not provide sufficient clarity for safe and scalable deployment. Potential Impact A clearer regulatory framework could accelerate adoption of beneficial AI technologies while establishing stronger safeguards for patients, clinicians and healthcare organisations. Key Takeaway The UK is moving toward a more coordinated and lifecycle-based regulatory model for healthcare AI. What to Watch Government response to the commission's recommendations and subsequent changes to UK healthcare AI regulation and NHS implementation guidance. Primary Source GOV.UK Relevant Date 10 September 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

Lupin has received Indian marketing approval for a pegfilgrastim biosimilar used to reduce the risk of chemotherapy-induced neutropenia. The approval expands Lupin's biosimilar portfolio in oncology supportive care and provides another locally manufactured treatment option for patients receiving myelosuppressive chemotherapy. Pegfilgrastim is a long-acting granulocyte colony-stimulating factor used to reduce the incidence and duration of neutropenia and related infection risk following cancer treatment. Field Content Alert Type Approval Drug Name Pegfilgrastim biosimilar Company Lupin Regulatory Authority Indian regulatory authorities Approval Type Marketing approval Indication Reduction of chemotherapy-induced neutropenia in patients receiving myelosuppressive anticancer treatment Therapy Area(s) Oncology; supportive care Technology or Modality Biosimilar; granulocyte colony-stimulating factor Geography India What Happened Lupin received marketing approval in India for its pegfilgrastim biosimilar. Why It Matters The approval adds another biosimilar option in oncology supportive care and expands access to long-acting neutropenia prevention for patients receiving chemotherapy. Supporting Context Pegfilgrastim is a long-acting granulocyte colony-stimulating factor used to stimulate neutrophil production following myelosuppressive chemotherapy. Key Takeaway Lupin has added an approved pegfilgrastim biosimilar to its Indian oncology supportive-care portfolio. What to Watch Commercial launch, physician uptake and pricing relative to existing pegfilgrastim products in India. Primary Source ETPharma.com Relevant Date 10 September 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

Sernova and Seraxis have entered a definitive merger agreement to create BetaNova Biotherapeutics, combining complementary cell-replacement technologies for type 1 diabetes. The transaction will bring together Sernova's Cell Pouch platform and Seraxis' stem-cell-derived pancreatic islet technology under a newly formed biotechnology company. Shareholders of Sernova and Seraxis are expected to each own approximately half of BetaNova, with the transaction accompanied by a US$10 million financing. Field Content Alert Type Definitive merger agreement Companies Sernova and Seraxis New Company BetaNova Biotherapeutics Therapy Area(s) Type 1 diabetes Technology Cell replacement and stem-cell-derived pancreatic islets Transaction Type Merger Financing US$10 million Expected Ownership Approximately 50% Sernova shareholders and 50% Seraxis shareholders What Happened Sernova and Seraxis entered a definitive merger agreement to form BetaNova Biotherapeutics. Why It Matters The merger combines complementary technologies intended to advance a potentially differentiated cell-replacement approach for type 1 diabetes. Supporting Context Sernova contributes its Cell Pouch platform while Seraxis contributes stem-cell-derived pancreatic islet technology. Key Takeaway The combination creates a new diabetes-focused biotechnology company with an integrated cell-therapy platform. What to Watch Transaction completion, financing close and development priorities for BetaNova's combined pipeline. Primary Source Sernova Relevant Date 8 September 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 FDA has granted accelerated approval to Hyrnuo for first-line treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer carrying activating HER2/ERBB2 tyrosine kinase domain mutations. The decision expands the use of sevabertinib into the first-line setting for eligible patients with HER2-mutant non-small cell lung cancer. The approval provides a new targeted treatment option for this molecularly defined patient group and further supports routine HER2 mutation testing in advanced disease. Field Content Alert Type FDA accelerated approval Company Bayer Drug / Asset Hyrnuo (sevabertinib) Regulator U.S. Food and Drug Administration Indication Locally advanced or metastatic non-squamous non-small cell lung cancer Biomarker Activating HER2/ERBB2 tyrosine kinase domain mutations Treatment Setting First-line What Happened The FDA granted accelerated approval to Hyrnuo as a first-line treatment option for adults with locally advanced or metastatic non-squamous NSCLC harbouring activating HER2/ERBB2 TKD mutations. Why It Matters The approval expands access to a biomarker-directed therapy earlier in the treatment pathway for patients with HER2-mutant NSCLC. Supporting Context Hyrnuo had previously been approved in patients who had received prior systemic therapy, making this an expansion into the first-line setting. Key Takeaway Sevabertinib is now available as a first-line targeted treatment for eligible adults with HER2-mutant non-squamous NSCLC. What to Watch Confirmatory clinical data and uptake of HER2 mutation testing in first-line advanced NSCLC. Primary Source U.S. Food and Drug Administration Relevant Date 9 September 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

Novartis reports that the Phase III HARBOR study of del-desiran did not meet its primary endpoint in patients with myotonic dystrophy type 1. The trial failed to demonstrate a statistically significant improvement on the primary vHOT functional endpoint, although Novartis reported activity across a number of secondary and exploratory measures. The setback is significant because del-desiran is a central asset from Novartis' acquisition of Avidity Biosciences and had been positioned as a potential disease-modifying treatment for DM1. Field Content Alert Type Phase III clinical trial results Company Novartis Drug / Asset Delpacibart etedesiran (del-desiran) Trial HARBOR Development Stage Phase III Therapy Area(s) Neuromuscular disease Indication Myotonic dystrophy type 1 Primary Endpoint vHOT functional endpoint What Happened The Phase III HARBOR study did not achieve a statistically significant improvement on its primary vHOT endpoint. Why It Matters Del-desiran is a strategically important asset for Novartis following its acquisition of Avidity, making the Phase III miss a significant pipeline setback. Supporting Context Novartis reported activity across a number of secondary and exploratory measures despite the primary endpoint miss. Key Takeaway HARBOR missed its primary Phase III endpoint, creating uncertainty around the development path for del-desiran in DM1. What to Watch Full HARBOR results, regulatory discussions and Novartis' next development steps for del-desiran. Primary Source Novartis Relevant Date September 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