Flow Neuroscience has launched FL-100 in the United States, bringing an FDA-approved at-home transcranial direct-current stimulation treatment to adults with moderate-to-severe major depressive disorder. The prescription device delivers non-invasive electrical stimulation at home and is intended to provide a drug-free treatment option for eligible adults with depression. The US launch expands access to neuromodulation outside clinic-based settings and represents a significant commercial milestone for home-based digital and device-enabled mental healthcare. Field Content Alert Type Industry Update Product Name FL-100 Company Flow Neuroscience Development Type US commercial launch Indication Moderate-to-severe major depressive disorder in adults Therapy Area(s) Psychiatry; mental health; depression Technology or Modality Transcranial direct-current stimulation; neuromodulation Regulatory Status FDA-approved prescription medical device Geography United States What Happened Flow Neuroscience launched its FL-100 at-home tDCS treatment in the United States for adults with moderate-to-severe major depressive disorder. Why It Matters The launch broadens access to a non-pharmacological treatment that can be used at home under prescription rather than requiring repeated clinic-based neuromodulation sessions. Supporting Context Transcranial direct-current stimulation uses low-intensity electrical current applied through scalp electrodes to modulate activity in brain regions associated with depression. Potential Impact At-home treatment could improve convenience and expand the range of options available to patients who cannot tolerate, do not respond to or prefer alternatives to medication. Key Takeaway Flow Neuroscience has begun US commercialisation of an FDA-approved at-home tDCS treatment for depression. What to Watch Prescription uptake, payer coverage, patient adherence and real-world evidence on effectiveness outside controlled clinical settings. Primary Source Flow Neuroscience Relevant Date 16 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

UpFront Diagnostics has secured CE mark approval for LVOne, a rapid blood test designed to identify large-vessel-occlusion stroke in pre-hospital settings. LVOne is intended to support faster triage of suspected stroke patients by identifying biomarkers associated with large-vessel occlusion from a blood sample before hospital arrival. The CE mark enables European commercialisation and could support more rapid routing of eligible patients to specialist stroke centres for thrombectomy assessment. Field Content Alert Type Approval Product Name LVOne Company UpFront Diagnostics Regulatory Authority European CE marking framework Approval Type CE mark approval Intended Use Rapid blood-based identification of large-vessel-occlusion stroke in suspected stroke patients Therapy Area(s) Neurology; stroke; diagnostics Technology or Modality In-vitro diagnostic blood test Geography Europe What Happened UpFront Diagnostics secured CE mark approval for LVOne, enabling commercialisation of the rapid blood test in Europe. Why It Matters Large-vessel-occlusion stroke requires rapid specialist intervention, and an earlier blood-based indication could support faster patient triage and transfer decisions. Supporting Context LVOne is designed for use close to the patient, including pre-hospital settings, to help identify patients who may need assessment for mechanical thrombectomy. Key Takeaway LVOne has received CE mark approval, opening a European commercial pathway for rapid blood-based stroke triage. What to Watch Commercial rollout, adoption by emergency medical services and real-world evidence showing whether LVOne shortens time to specialist stroke treatment. Primary Source UpFront Diagnostics Relevant Date 16 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

Escugen Biotechnology and Sovran Biosciences have expanded their oncology collaboration with a co-development agreement for a pan-tumour bispecific antibody-drug conjugate. The programme will combine MICA/B targeting with a second tumour-associated target using an AND-gated design intended to improve tumour selectivity across multiple cancer types. The agreement advances the companies' relationship from research collaboration into joint development of a potentially first-in-class ADC programme, with financial terms undisclosed. Field Content Alert Type Deal Companies Escugen Biotechnology; Sovran Biosciences Deal Type Co-development agreement Asset or Company Pan-tumour bispecific antibody-drug conjugate programme Therapy Area(s) Oncology; solid tumours Technology or Modality Bispecific antibody-drug conjugate; AND-gated targeting Targets MICA/B plus a second tumour-associated target Deal Value Financial terms were not disclosed Geography Global What Happened Escugen and Sovran expanded their existing collaboration into a co-development agreement for a bispecific ADC intended to target multiple tumour types. Why It Matters The programme uses dual-target recognition designed to increase tumour selectivity, potentially improving therapeutic index compared with conventional single-target ADCs. Supporting Context The AND-gated strategy requires recognition of MICA/B and a second tumour-associated target to enhance preferential activity against cancer cells. Strategic Rationale Escugen and Sovran are combining complementary antibody-engineering and oncology-development capabilities to advance a differentiated ADC platform. Potential Impact If successful, the approach could support development of a broadly applicable ADC with improved specificity across multiple solid tumours. Key Takeaway Escugen and Sovran have moved into joint development of a pan-tumour bispecific ADC based on dual-target recognition. What to Watch Selection of the second tumour target, candidate nomination and progression into preclinical and clinical development. Primary Source Escugen Biotechnology / Sovran Biosciences Relevant Date 16 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

GSK has acquired full global rights to Chimagen Biosciences' trispecific T-cell engager programme for multiple myeloma in a transaction worth up to $750 million. The programme is designed to engage T cells against multiple myeloma through a trispecific antibody approach, adding another differentiated immuno-oncology asset to GSK's haematology pipeline. Chimagen is eligible for upfront and milestone payments worth up to $750 million, while GSK will assume responsibility for further global development and commercialisation of the programme. Field Content Alert Type Deal Companies GSK; Chimagen Biosciences Deal Type Global rights acquisition / licensing agreement Asset or Company Trispecific T-cell engager programme Therapy Area(s) Oncology; haematology; multiple myeloma Technology or Modality Trispecific T-cell engager Deal Value Up to US$750 million in upfront and milestone payments Geography Global What Happened GSK acquired full global rights to Chimagen Biosciences' trispecific T-cell engager programme for multiple myeloma. Why It Matters The deal adds a potentially differentiated next-generation immunotherapy to GSK's multiple myeloma pipeline and strengthens its position in haematologic oncology. Supporting Context The programme uses a trispecific antibody design intended to direct T cells against tumour targets associated with multiple myeloma. Strategic Rationale GSK gains control of an innovative early-stage oncology programme while Chimagen receives near- and long-term economics tied to development and commercial success. Potential Impact Successful development could provide a new treatment approach for patients with multiple myeloma and strengthen competition in the T-cell engager field. Key Takeaway GSK is committing up to US$750 million for global rights to Chimagen's trispecific T-cell engager programme in multiple myeloma. What to Watch Entry into clinical development, early safety and efficacy data and positioning against other T-cell engager and cell-therapy approaches in multiple myeloma. Primary Source GSK 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

Sanofi and Cheplapharm have agreed a major mature-medicines transaction covering 20 products and three manufacturing sites in France, Hungary and Singapore. Cheplapharm will take responsibility for the portfolio and manufacturing facilities, while Sanofi will receive a 26.4% equity stake in Cheplapharm as part of the strategic partnership. The transaction allows Sanofi to further concentrate resources on innovative medicines while transferring established products and manufacturing infrastructure to a company specialised in mature pharmaceutical brands. Field Content Alert Type Deal Companies Sanofi; Cheplapharm Deal Type Portfolio and manufacturing asset transfer; strategic partnership Asset or Company 20 mature medicines and three manufacturing sites Manufacturing Sites France; Hungary; Singapore Therapy Area(s) Multiple therapeutic areas Technology or Modality Mature pharmaceutical products and manufacturing operations Deal Value Sanofi to receive a 26.4% equity stake in Cheplapharm; additional financial terms not disclosed Geography Global What Happened Sanofi and Cheplapharm agreed to transfer 20 mature medicines and three manufacturing sites to Cheplapharm, with Sanofi receiving a 26.4% equity stake in the company. Why It Matters The transaction represents a substantial portfolio and manufacturing realignment and allows Sanofi to focus more resources on innovative medicines while maintaining economic participation through its Cheplapharm stake. Supporting Context Cheplapharm specialises in acquiring and managing established pharmaceutical brands and mature medicines. Strategic Rationale Sanofi is simplifying its portfolio and manufacturing footprint, while Cheplapharm gains a significant group of established products and production assets. Potential Impact The transaction could reshape supply and commercial management of the transferred medicines while strengthening Cheplapharm's manufacturing and product portfolio. Key Takeaway Sanofi is transferring 20 mature medicines and three manufacturing sites to Cheplapharm in exchange for a significant equity stake. What to Watch Regulatory approvals, completion of the transaction and integration of the medicines and manufacturing sites into Cheplapharm. Primary Source Sanofi 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 Curium's Bexlutry as the first radioligand equivalent to Lutathera for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours. Bexlutry, or lutetium Lu 177 dotatate, delivers targeted radiation to tumour cells expressing somatostatin receptors and provides a new radioligand treatment option for eligible patients with GEP-NETs. The approval introduces the first FDA-approved therapeutic equivalent to Novartis' Lutathera and could broaden access to radioligand therapy in neuroendocrine tumour care. Field Content Alert Type Approval Drug Name Lutetium Lu 177 dotatate Brand Name Bexlutry Company Curium Pharma Regulatory Authority U.S. Food and Drug Administration Approval Type New drug approval; radioligand therapeutic equivalent Indication Treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours Therapy Area(s) Oncology; neuroendocrine tumours Technology or Modality Radioligand therapy Reference Product Lutathera Geography United States What Happened The FDA approved Bexlutry (lutetium Lu 177 dotatate) for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours. Why It Matters Bexlutry is the first FDA-approved radioligand therapeutic equivalent to Lutathera, introducing another treatment option in an increasingly important precision-oncology modality. Supporting Context Lutetium Lu 177 dotatate targets somatostatin receptor-expressing tumour cells and delivers radioactive lutetium-177 directly to those cells. Key Takeaway Bexlutry becomes the first FDA-approved Lutathera equivalent for SSTR-positive GEP-NETs. What to Watch Commercial rollout, treatment-centre adoption and the effect of additional competition on access to radioligand therapy. Primary Source Curium Pharma 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 expanded the approved use of Ameluz with red-light photodynamic therapy to include treatment of superficial basal cell carcinoma in adults. The approval makes Ameluz with Biofrontera's RhodoLED system the first FDA-approved photodynamic therapy for a skin cancer and provides a non-surgical treatment option for eligible patients. The expanded indication builds on Ameluz's established use in actinic keratosis and extends the company's photodynamic therapy platform into superficial basal cell carcinoma. Field Content Alert Type Approval Drug Name Aminolevulinic acid hydrochloride gel Brand Name Ameluz Company Biofrontera Regulatory Authority U.S. Food and Drug Administration Approval Type Label expansion Indication Treatment of superficial basal cell carcinoma in adults using Ameluz with red-light photodynamic therapy Therapy Area(s) Dermatology; oncology; skin cancer Technology or Modality Photodynamic therapy Device RhodoLED red-light system Geography United States What Happened The FDA approved an expanded indication for Ameluz with red-light photodynamic therapy to treat superficial basal cell carcinoma in adults. Why It Matters The approval establishes the first FDA-approved photodynamic therapy for a skin cancer and introduces a non-surgical option for eligible patients with superficial basal cell carcinoma. Supporting Context Ameluz is already used with red-light photodynamic therapy for actinic keratosis and is activated by the RhodoLED treatment system. Key Takeaway Ameluz with RhodoLED becomes the first FDA-approved photodynamic therapy for superficial basal cell carcinoma. What to Watch Dermatology adoption, reimbursement and uptake relative to surgical and other non-surgical treatment options. Primary Source Biofrontera 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

Lilly and QurCan Therapeutics have entered a multi-programme collaboration to develop nucleic-acid medicines for central and peripheral nervous system diseases using QurCan's TERP delivery platform. QurCan's polymer-lipid nanoparticle technology is designed to deliver genetic medicines beyond the liver and will be applied to selected CNS and PNS targets under the collaboration. QurCan is eligible for up to $237 million per programme in development and commercial milestones, as well as royalties, giving the agreement potentially substantial value across multiple programmes. Field Content Alert Type Deal Companies Eli Lilly and Company; QurCan Therapeutics Deal Type Strategic research and licensing collaboration Asset or Company TERP polymer-lipid nanoparticle delivery platform Therapy Area(s) Neurology; central nervous system; peripheral nervous system Technology or Modality Nucleic-acid therapeutics; polymer-lipid nanoparticles; genetic medicine Deal Value Up to US$237 million per programme in milestone payments, plus royalties Geography Global What Happened Lilly and QurCan Therapeutics entered a multi-programme collaboration to develop CNS and PNS genetic medicines using QurCan's TERP delivery technology. Why It Matters Efficient delivery remains a major challenge for genetic medicines outside the liver, and the collaboration gives Lilly access to a platform designed for broader tissue targeting. Supporting Context QurCan's TERP technology uses polymer-lipid nanoparticles designed to deliver nucleic-acid therapeutics to tissues including the central and peripheral nervous systems. Strategic Rationale Lilly gains access to a specialised delivery platform while QurCan receives development funding and potential milestone and royalty economics across multiple programmes. Potential Impact Successful programmes could expand the range of neurological diseases addressable with nucleic-acid medicines. Key Takeaway Lilly is partnering with QurCan on multiple genetic-medicine programmes, with potential payments of up to US$237 million per programme. What to Watch Selection of programme targets, preclinical development and evidence that TERP can achieve effective delivery in CNS and PNS tissues. Primary Source QurCan Therapeutics 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

The European Medicines Agency has opened consultation on a draft guideline addressing the design and interpretation of studies assessing drug absorption interactions within the gastrointestinal tract. The draft guidance focuses on situations where medicines may alter the absorption of other drugs through mechanisms including changes in gastric pH, gastrointestinal motility, binding or complex formation. Comments are open until 31 December 2026, after which EMA may revise the guideline before final adoption and implementation across European medicines development. Field Content Alert Type Industry Update Organisation European Medicines Agency Development Type Draft regulatory guideline and public consultation Topic Drug absorption interactions in the gastrointestinal tract Sector Pharmaceutical regulation; clinical pharmacology Geography European Union What Happened EMA opened a public consultation on a draft guideline covering the design, conduct and interpretation of studies assessing drug absorption interactions in the gastrointestinal tract. Why It Matters The guideline could influence how pharmaceutical companies design interaction studies and demonstrate the safety and effectiveness of medicines whose absorption may be altered by other drugs. Key Areas Gastric pH changes; gastrointestinal motility; binding and complex formation; study design; data interpretation Supporting Context Gastrointestinal interactions can affect drug exposure without involving conventional metabolic or transporter-mediated drug-drug interaction pathways. Potential Impact Final guidance could standardise European expectations for evaluating these interactions during medicine development and regulatory submissions. Key Takeaway EMA is developing more specific regulatory expectations for assessing drug absorption interactions occurring within the gastrointestinal tract. What to Watch Stakeholder feedback before the 31 December 2026 consultation deadline and subsequent publication of the final guideline. Primary Source European Medicines Agency 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 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