The FDA has approved Gazyva for patients aged two years and older with frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome who are in complete remission. Gazyva (obinutuzumab) reduced relapse risk in the Phase III INShore study, with 95% of treated patients experiencing no relapse after week eight and remaining in complete remission at one year. The approval introduces a B-cell-targeted therapy into a paediatric and adult nephrology setting where repeated relapses and prolonged immunosuppression can create substantial treatment burden. Field Content Article Type Approvals Drug Name Obinutuzumab Brand Name Gazyva Company Roche / Genentech Regulatory Authority U.S. Food and Drug Administration Approval Type New indication approval Indication Frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome in patients in complete remission Patient Population Adults and children aged two years and older Therapy Areas Nephrology; rare disease; paediatrics Technology/Modality Anti-CD20 monoclonal antibody Clinical Study Phase III INShore Key Result 95% of Gazyva-treated patients experienced no relapse after week eight and were in complete remission at one year, compared with 73% receiving mycophenolate mofetil Geography United States What Happened The FDA approved Gazyva to reduce relapse risk in eligible patients with childhood-onset idiopathic nephrotic syndrome. Why It Matters The approval provides a new B-cell-directed option for patients with frequently relapsing or steroid-dependent disease. Supporting Context Relapsing nephrotic syndrome can require repeated corticosteroid or immunosuppressive treatment, creating significant long-term treatment burden. Potential Impact Gazyva may help prolong remission and reduce relapse frequency in eligible patients. Key Takeaway Gazyva is now FDA approved for frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome from age two. What to Watch Treatment uptake, durability of remission and positioning relative to existing immunosuppressive strategies. Primary Source U.S. Food and Drug Administration Relevant Date 25 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 Camzyos approval to paediatric patients with symptomatic obstructive hypertrophic cardiomyopathy who weigh at least 30kg. Camzyos (mavacamten) is now approved to improve functional capacity and symptoms in both adults and eligible paediatric patients with obstructive hypertrophic cardiomyopathy. The expansion, supported by the Phase III SCOUT-HCM study, extends cardiac myosin inhibition into a younger patient population with this inherited heart condition. Field Content Article Type Approvals Drug Name Mavacamten Brand Name Camzyos Company Bristol Myers Squibb Regulatory Authority U.S. Food and Drug Administration Approval Type Indication expansion Indication Symptomatic obstructive hypertrophic cardiomyopathy Patient Population Adults and paediatric patients weighing at least 30kg Therapy Areas Cardiology; hypertrophic cardiomyopathy Technology/Modality Cardiac myosin inhibitor Clinical Study Phase III SCOUT-HCM Geography United States What Happened The FDA expanded Camzyos approval to eligible paediatric patients with symptomatic obstructive hypertrophic cardiomyopathy. Why It Matters The decision extends a disease-specific therapy for oHCM into a paediatric population with limited targeted treatment options. Supporting Context Bristol Myers Squibb describes Camzyos as the only FDA-approved therapy for oHCM in a paediatric population. Potential Impact The label expansion broadens access to cardiac myosin inhibition for younger patients meeting the weight and disease criteria. Key Takeaway Camzyos is now FDA approved for symptomatic oHCM in adults and eligible paediatric patients. What to Watch Paediatric uptake, guideline integration and longer-term safety and effectiveness data from younger patients. Primary Source Bristol Myers Squibb Relevant Date 30 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

ALK is investing approximately DKK 500 million to expand its long-term manufacturing partnership with Catalent and increase capacity for fast-dissolving allergy immunotherapy tablets. The three-year investment programme is expected to add around 300 million tablets of annual capacity, taking potential production to approximately 1.1 billion tablets from the early 2030s. The expanded partnership also secures long-term access to Catalent's Zydis technology and could support future peanut and tree-nut allergy tablet programmes. Field Content Article Type Deals Companies ALK; Catalent Deal Type Strategic manufacturing partnership expansion Investment Approximately DKK 500 million over three years Technology/Platform Catalent Zydis fast-dissolving tablet technology Therapy Areas Allergy; immunotherapy Manufacturing Scope Allergy immunotherapy tablets Additional Annual Capacity Approximately 300 million tablets Expected Total Annual Capacity Approximately 1.1 billion tablets from the early 2030s Potential Future Programmes Peanut and tree-nut allergy tablets What Happened ALK expanded its manufacturing partnership with Catalent through a DKK 500 million investment programme. Why It Matters The agreement materially increases production capacity for ALK's tablet-based allergy immunotherapy portfolio and secures long-term access to a specialised drug-delivery platform. Supporting Context Catalent's Zydis technology is used for rapidly dissolving oral tablets and forms part of ALK's existing allergy tablet manufacturing network. Strategic Rationale ALK is expanding capacity ahead of anticipated long-term demand and potential launches in additional allergy indications. Potential Impact Higher capacity could support wider global access to allergy immunotherapy tablets and future expansion into food-allergy treatment. Key Takeaway ALK is committing around DKK 500 million to increase annual allergy-tablet capacity to approximately 1.1 billion units. What to Watch Capacity build-out, future product launches and development of peanut and tree-nut allergy tablets. Primary Source ALK Relevant Date 30 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

Medscape's 2026 Canada physician compensation report shows average total physician compensation of C$394,000, while fewer than half of respondents say they feel fairly paid. Average base salary was reported at C$290,000, with the survey also highlighting unpaid work and continuing financial pressure across the Canadian medical workforce. The findings provide a current benchmark for physician earnings, perceived compensation fairness and the wider economics affecting medical practice in Canada. Field Content Article Type Compensation Report Medscape Canada Physician Compensation Report 2026 Geography Canada Average Total Compensation C$394,000 Average Base Salary C$290,000 Fairly Compensated 47% of respondents Topic Physician compensation and workforce economics What Happened Medscape published its 2026 Canadian physician compensation report with new data on earnings and perceptions of pay. Why It Matters The report provides a current benchmark for physician remuneration while highlighting ongoing dissatisfaction with compensation and the burden of unpaid work. Supporting Context Less than half of surveyed physicians said they felt fairly compensated despite average total compensation approaching C$400,000. Workforce Context The findings sit within broader concerns around physician workload, practice costs and recruitment and retention pressures. Potential Impact Compensation trends can influence specialty choice, workforce mobility, recruitment and long-term health-system staffing. Key Takeaway Canadian physicians reported average total compensation of C$394,000, but only 47% said they felt fairly compensated. What to Watch Specialty-level pay differences, gender gaps, changes in unpaid workload and future compensation trends. Primary Source Medscape Relevant Date 29 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

Novo Nordisk has secured rights outside Greater China to Hengrui Pharma's once-weekly oral GLP-1/GIP dual receptor agonist HRS-1596 in a deal worth up to $2.6bn. Hengrui will receive $300m upfront, with total potential consideration of up to $2.6bn plus royalties as Novo Nordisk adds the phase 1-ready candidate to its obesity and metabolic disease pipeline. The agreement gives Novo Nordisk global rights outside Greater China to develop, manufacture and commercialise HRS-1596. Field Content Alert Type Deals Companies Novo Nordisk; Hengrui Pharma Deal Type Exclusive licence Asset or Company HRS-1596 Therapy Area(s) Obesity and metabolic disease Technology or Modality Once-weekly oral GLP-1/GIP dual receptor agonist Deal Value $300m upfront; total potential consideration of up to $2.6bn plus royalties Development Stage Phase 1-ready Geography Global rights outside Greater China What Happened Novo Nordisk entered an exclusive licence agreement with Hengrui Pharma for HRS-1596, a once-weekly oral GLP-1/GIP dual receptor agonist. Why It Matters The agreement adds another oral incretin-based candidate to Novo Nordisk's metabolic disease pipeline as competition continues across next-generation obesity treatments. Supporting Context Hengrui will receive $300m upfront and is eligible for additional development, regulatory and commercial milestone payments, taking potential total consideration to up to $2.6bn, as well as royalties. Strategic Rationale Novo Nordisk gains access to a differentiated once-weekly oral GLP-1/GIP programme that complements its existing obesity and metabolic disease portfolio. Potential Impact Successful development could broaden the range of oral incretin-based treatment options available within the competitive obesity market. Key Takeaway Novo Nordisk is expanding its next-generation obesity pipeline through a potentially $2.6bn licensing agreement for Hengrui's once-weekly oral GLP-1/GIP candidate. What to Watch Clinical development of HRS-1596 and progression beyond its initial Phase I programme. Primary Source Novo Nordisk Relevant Date 29 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

AstraZeneca is investing $2bn in Summit Therapeutics alongside a clinical collaboration focused on combinations involving the PD-1/VEGF bispecific antibody ivonescimab. The companies plan to evaluate ivonescimab with AstraZeneca oncology medicines, beginning with the antibody-drug conjugate sonesitatug vedotin. The transaction combines a major equity investment with expanded clinical collaboration around one of the industry's closely watched PD-1/VEGF programmes. Field Content Alert Type Deals Companies AstraZeneca; Summit Therapeutics Deal Type Equity investment and clinical collaboration Asset or Company Ivonescimab Therapy Area(s) Oncology Technology or Modality PD-1/VEGF bispecific antibody Deal Value $2bn equity investment Development Stage Clinical development Geography Global collaboration What Happened AstraZeneca announced a $2bn equity investment in Summit Therapeutics alongside a clinical collaboration to evaluate combinations involving ivonescimab and AstraZeneca oncology medicines. Why It Matters The agreement expands AstraZeneca's exposure to the emerging PD-1/VEGF bispecific field while creating opportunities to evaluate ivonescimab alongside assets from its established oncology portfolio. Supporting Context The collaboration is expected to begin by evaluating ivonescimab in combination with AstraZeneca's antibody-drug conjugate sonesitatug vedotin. Strategic Rationale AstraZeneca gains strategic exposure to Summit and an opportunity to explore combinations between ivonescimab and its own oncology pipeline. Potential Impact The collaboration could generate new combination regimens involving PD-1/VEGF inhibition and AstraZeneca oncology therapies if clinical studies support their use. Key Takeaway AstraZeneca is making a $2bn strategic investment in Summit while expanding clinical work around ivonescimab combination therapies. What to Watch Initiation and results of combination studies involving ivonescimab and AstraZeneca oncology assets. Primary Source AstraZeneca Relevant Date 28 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

STADA and SBP Group have launched a strategic biosimilars partnership beginning with a proposed Keytruda biosimilar and providing a framework for up to three additional programmes. The initial programme covers TQB3570, a proposed pembrolizumab biosimilar, with CTTQ responsible for development, manufacturing and supply and STADA receiving exclusive commercial rights across multiple European and CIS markets. The agreement also gives the partners a framework for up to three additional oncology and immunology biosimilars, substantially broadening the potential scope of the collaboration. Field Content Article Type Deals Companies STADA; SBP Group; CTTQ Deal Type Strategic biosimilars partnership Initial Asset TQB3570 Reference Product Keytruda (pembrolizumab) Therapy Areas Oncology; immunology Technology/Modality Monoclonal antibody biosimilars Programme Scope TQB3570 plus framework for up to three additional biosimilar programmes Commercial Territories European Union; Switzerland; United Kingdom; CIS, with options covering additional territories What Happened STADA and SBP Group launched a strategic partnership initially covering TQB3570, a proposed pembrolizumab biosimilar, with a framework for up to three additional biosimilars. Why It Matters The partnership combines a major biosimilar opportunity around Keytruda with the potential creation of a broader oncology and immunology portfolio. Development Responsibilities CTTQ will develop, manufacture and supply the products while STADA receives exclusive commercial rights in agreed territories. Strategic Rationale The arrangement combines SBP Group and CTTQ's development and manufacturing capabilities with STADA's established European biosimilars commercial infrastructure. Potential Impact The collaboration could create multiple new biosimilar competitors across major oncology and immunology biologic markets. Key Takeaway STADA and SBP Group are building a multi-product biosimilars partnership starting with a proposed Keytruda biosimilar. What to Watch Development progress for TQB3570, regulatory filings and selection of the additional biosimilar programmes. Primary Source STADA Relevant Date 28 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 Teva's DEGEVMA as a biosimilar to Xgeva across all reference-product indications, expanding competition in denosumab treatment. DEGEVMA (denosumab-adet) is approved for indications including prevention of skeletal complications in adults with advanced cancer involving bone, giant cell tumour of bone and hypercalcaemia of malignancy. The approval marks Teva's second FDA-approved biosimilar of 2026 and adds another denosumab option to the US biologics market. Field Content Article Type Approvals Drug Name Denosumab-adet Brand Name DEGEVMA Company Teva Pharmaceuticals Reference Product Xgeva (denosumab) Regulatory Authority U.S. Food and Drug Administration Approval Type Biosimilar approval Indications All approved reference-product indications Therapy Areas Oncology; bone disease Technology/Modality Monoclonal antibody biosimilar Geography United States What Happened The FDA approved DEGEVMA as a biosimilar to Xgeva across all indications of the reference product. Why It Matters The approval expands biosimilar competition for denosumab and may increase treatment options for patients requiring Xgeva-class therapy. Supporting Context Indications include prevention of bone complications associated with advanced cancer, giant cell tumour of bone and hypercalcaemia of malignancy. Strategic Context DEGEVMA is Teva's second FDA-approved biosimilar of 2026. Potential Impact Additional biosimilar competition could broaden access to denosumab therapy in the United States. Key Takeaway DEGEVMA gives Teva an FDA-approved biosimilar to Xgeva across all reference-product indications. What to Watch US commercial launch, pricing, payer coverage and adoption relative to Xgeva and competing denosumab biosimilars. Primary Source Teva Pharmaceuticals Relevant Date 28 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 Emcitate as the first treatment for MCT8 deficiency, providing a therapy for the peripheral thyrotoxicosis associated with this ultra-rare genetic disorder. Emcitate (tiratricol) is approved for adults and paediatric patients with MCT8 deficiency, also known as Allan-Herndon-Dudley syndrome. The first-in-disease approval provides a treatment designed to act without relying on the defective MCT8 transporter responsible for the disorder. Field Content Article Type Approvals Drug Name Tiratricol Brand Name Emcitate Regulatory Authority U.S. Food and Drug Administration Approval Type First FDA-approved treatment for MCT8 deficiency Indication Peripheral thyrotoxicosis in adults and paediatric patients with MCT8 deficiency Therapy Areas Rare disease; endocrinology; neurology Disease MCT8 deficiency / Allan-Herndon-Dudley syndrome Technology/Modality Thyroid hormone analogue Geography United States What Happened The FDA approved Emcitate for peripheral thyrotoxicosis in adults and paediatric patients with MCT8 deficiency. Why It Matters Emcitate is the first FDA-approved treatment for MCT8 deficiency, addressing an ultra-rare genetic disorder with no previously approved therapy. Supporting Context MCT8 deficiency results from defects in the MCT8 thyroid hormone transporter and is also known as Allan-Herndon-Dudley syndrome. Potential Impact The approval establishes the first US pharmacological treatment option for patients with MCT8 deficiency. Key Takeaway Emcitate becomes the first FDA-approved treatment for MCT8 deficiency. What to Watch US launch, patient access and longer-term evidence from treatment in adults and children. Primary Source U.S. Food and Drug Administration Relevant Date 28 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

Merck has secured exclusive worldwide rights to SciBrunch Therapeutics' preclinical KRAS G12D inhibitor SPR2015 in an oncology licensing transaction worth up to $2.13 billion. SciBrunch will receive $400 million upfront, with additional development, commercial and other milestone payments potentially taking the total transaction value to $2.13 billion. The agreement gives Merck a preclinical oral KRAS G12D (ON) inhibitor targeting one of the most important oncogenic mutations across multiple tumour types. Field Content Article Type Deals Companies Merck; SciBrunch Therapeutics Deal Type Exclusive global licensing agreement Asset SPR2015 Therapy Areas Oncology Technology/Modality Oral KRAS G12D (ON) inhibitor Development Stage Preclinical Upfront Payment $400 million Potential Deal Value Up to $2.13 billion Geography Worldwide What Happened Merck secured exclusive worldwide rights to SciBrunch Therapeutics' investigational oral KRAS G12D (ON) inhibitor SPR2015. Why It Matters The transaction adds a targeted oncology programme directed at KRAS G12D, a major oncogenic driver across several difficult-to-treat cancers. Supporting Context SPR2015 is a preclinical small-molecule programme designed to inhibit the active ON state of KRAS G12D. Strategic Rationale Merck gains a potentially differentiated KRAS-targeted asset for its oncology pipeline while SciBrunch receives substantial upfront funding and downstream milestone opportunities. Potential Impact Successful development could expand targeted treatment options for patients with KRAS G12D-mutated cancers. Key Takeaway Merck is paying $400 million upfront for SPR2015 in a licensing transaction worth up to $2.13 billion. What to Watch IND-enabling development, entry into clinical trials and initial evidence of activity across KRAS G12D-mutated tumours. Primary Source Merck Relevant Date 28 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 Council has formally adopted its position on the EU pharmaceutical package, moving the bloc's largest overhaul of medicines legislation in decades toward its final legislative stages. The reform covers medicine authorisation, regulatory data and market protection, supply obligations, orphan-drug incentives, antimicrobial resistance and changes to the Bolar exemption. The regulation and directive still require adoption by the European Parliament before the new pharmaceutical framework can enter into force. Field Content Article Type Industry Updates Development EU pharmaceutical legislation reform Institution Council of the European Union Policy Area Pharmaceutical and medicines regulation Legislative Instruments EU pharmaceutical package regulation and directive Geography European Union What Happened The Council formally adopted its first-reading position on the regulation and directive forming the EU pharmaceutical package. Why It Matters The package represents the most extensive reform of EU pharmaceutical legislation in decades and will reshape important rules governing medicines development, authorisation, incentives and supply. Key Measures Changes cover regulatory and market-protection rules, medicine-supply obligations, orphan-drug incentives, the Bolar exemption and incentives addressing antimicrobial resistance. Legislative Status Council first-reading position formally adopted; European Parliament adoption remains required. Potential Impact Pharmaceutical and biotechnology companies operating in Europe will need to adapt regulatory, intellectual-property and market-access strategies to the revised framework. Key Takeaway The EU pharmaceutical reform has passed a major Council milestone and is moving toward completion of the legislative process. What to Watch European Parliament adoption, publication of the final legislation and implementation timelines for the new rules. Primary Source Council of the European Union Relevant Date 28 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 EU authorisation introduces a pharmacological treatment for eligible boys with cerebral adrenoleukodystrophy under exceptional circumstances. Nezglyal has received EU-wide marketing authorisation for boys aged 2 to 12 years with cerebral adrenoleukodystrophy who meet specified MRI and neurological criteria. The orphan medicine was authorised under exceptional circumstances and will be subject to additional monitoring as evidence continues to develop following approval. Field Content Alert Type Approvals Product Nezglyal Indication Cerebral adrenoleukodystrophy (cALD) Patient Population Boys aged 2 to 12 years meeting specified MRI and neurological criteria Regulator European Commission / European Medicines Agency Regulatory Status EU-wide marketing authorisation under exceptional circumstances Orphan Status Orphan medicine Monitoring Subject to additional monitoring What Happened Nezglyal received EU-wide marketing authorisation for eligible boys with cerebral adrenoleukodystrophy. Why It Matters The authorisation provides a pharmacological treatment option for a severe rare neurological manifestation of adrenoleukodystrophy. Regulatory Context The medicine was authorised under exceptional circumstances and is subject to additional monitoring. Potential Impact Eligible children with cALD gain a newly authorised treatment option across the European Union. Key Takeaway Nezglyal has secured EU authorisation for a defined paediatric cerebral adrenoleukodystrophy population. What to Watch European launch, country-level access decisions and collection of additional post-authorisation evidence. Primary Source European Medicines Agency Relevant Date 21 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