The FDA has approved shorter monitoring requirements following the first two doses of Amgen's Imdelltra, reducing observation time from 22–24 hours to 6–8 hours. The prescribing-information update applies to the initial step-up doses of Imdelltra and could make administration of the bispecific T-cell engager more practical in community oncology settings. The change may reduce the logistical burden associated with treatment while maintaining required monitoring for cytokine release syndrome and other early treatment-related risks. Field Content Alert Type Approval Drug Name Tarlatamab-dlle Brand Name Imdelltra Company Amgen Regulatory Authority U.S. Food and Drug Administration Approval Type Prescribing-information / monitoring requirement update Indication Extensive-stage small cell lung cancer under the existing approved indication Therapy Area(s) Oncology; lung cancer Technology or Modality Bispecific T-cell engager Monitoring Change Post-dose monitoring for the first two doses reduced from 22–24 hours to 6–8 hours Geography United States What Happened The FDA approved an update to Imdelltra's prescribing information reducing monitoring time after the first two doses from 22–24 hours to 6–8 hours. Why It Matters Shorter observation requirements could make Imdelltra easier to administer outside large specialist centres and reduce the logistical burden on patients and oncology providers. Supporting Context Imdelltra is a bispecific T-cell engager used in extensive-stage small cell lung cancer and requires monitoring for cytokine release syndrome during early dosing. Key Takeaway FDA-approved shorter monitoring requirements could broaden practical access to Imdelltra treatment. What to Watch Changes in community-oncology adoption, outpatient administration patterns and real-world safety following the reduced monitoring requirement. Primary Source Amgen 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

Ori Biotech has entered a 10-year commercial partnership worth up to $120 million to integrate its IRO automated manufacturing platform into production of an autologous cell therapy. The agreement will deploy Ori's automated cell-therapy manufacturing technology across an undisclosed partner's commercial production process, supporting greater standardisation and manufacturing scalability. The long-term contract represents a significant commercial validation of Ori's platform as cell-therapy developers seek to reduce labour, variability and production complexity in advanced-therapy manufacturing. Field Content Alert Type Deal Companies Ori Biotech; undisclosed cell-therapy partner Deal Type Long-term commercial manufacturing technology partnership Asset or Company IRO automated cell-therapy manufacturing platform Therapy Area(s) Cell therapy; advanced therapies Technology or Modality Automated autologous cell-therapy manufacturing Deal Value Up to US$120 million over 10 years Geography Global What Happened Ori Biotech entered a 10-year agreement to integrate its IRO automated manufacturing platform into an undisclosed partner's commercial autologous cell-therapy manufacturing process. Why It Matters Commercial-scale manufacturing remains a major constraint in cell therapy, and the agreement provides significant validation of Ori's approach to automation and standardisation. Supporting Context Ori's IRO platform is designed to automate and digitally manage cell-therapy manufacturing processes with the aim of reducing labour requirements, variability and manufacturing cost. Strategic Rationale The partner gains access to an automated production platform, while Ori secures a long-term commercial deployment of its technology. Potential Impact Broader automation could improve consistency, scalability and economics for commercial cell-therapy production. Key Takeaway Ori Biotech has secured a 10-year cell-therapy manufacturing partnership worth up to US$120 million. What to Watch Commercial deployment of IRO, expansion to additional manufacturing sites and evidence of improved production efficiency. Primary Source Ori Biotech Relevant Date 15 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

Cardiff Oncology and Nerviano have resolved their licensing dispute and amended the global onvansertib licence agreement, updating exclusivity, economics and termination provisions. The companies have settled litigation relating to Cardiff's rights to onvansertib and revised the terms of their 2017 exclusive worldwide licence agreement without either party making a settlement payment. The amended agreement provides a clearer commercial framework for continued development of onvansertib, Cardiff's PLK1 inhibitor being evaluated across multiple oncology indications. Field Content Alert Type Deal Companies Cardiff Oncology; Nerviano Medical Sciences Deal Type Licence amendment and dispute settlement Asset or Company Onvansertib Therapy Area(s) Oncology Technology or Modality PLK1 inhibitor; small-molecule targeted therapy Deal Value No settlement payment; revised licence economics and contractual terms Geography Worldwide What Happened Cardiff Oncology and Nerviano resolved litigation over the global rights to onvansertib and amended their 2017 exclusive worldwide licence agreement. Why It Matters The settlement removes legal uncertainty around Cardiff's principal oncology asset and establishes updated commercial and contractual terms for its continued development. Supporting Context Onvansertib is an oral small-molecule inhibitor of polo-like kinase 1, or PLK1, being developed by Cardiff Oncology in multiple cancer settings. Strategic Rationale The revised agreement gives both companies greater clarity around exclusivity, economics and termination rights while allowing Cardiff to continue advancing onvansertib. Potential Impact Resolution of the dispute reduces a potential development and financing overhang for Cardiff's oncology pipeline. Key Takeaway Cardiff Oncology and Nerviano have settled their onvansertib licensing dispute and agreed revised terms governing the global programme. What to Watch Further clinical development of onvansertib and the practical impact of the revised licence economics on Cardiff's commercial strategy. Primary Source Cardiff Oncology 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

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