The FDA has approved Inluriyo in combination with Verzenio for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer following progression on endocrine therapy. The combination pairs Lilly's oral selective estrogen receptor degrader imlunestrant with the CDK4/6 inhibitor abemaciclib for patients whose tumours carry an ESR1 mutation. The approval also includes Guardant360 CDx as a companion diagnostic, reinforcing the role of circulating tumour DNA testing in identifying patients for biomarker-directed breast cancer treatment. Field Content Alert Type Approval Drug Name Imlunestrant Brand Name Inluriyo Combination Therapy Verzenio (abemaciclib) Company Eli Lilly and Company Regulatory Authority U.S. Food and Drug Administration Approval Type Combination therapy approval Indication Adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer following progression on at least one line of endocrine therapy Therapy Area(s) Oncology; breast cancer Biomarker ESR1 mutation Companion Diagnostic Guardant360 CDx Technology or Modality Oral selective estrogen receptor degrader plus CDK4/6 inhibitor Geography United States What Happened The FDA approved Inluriyo in combination with Verzenio for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression on endocrine therapy. Why It Matters The approval introduces another biomarker-driven treatment option for patients whose cancers develop ESR1-mediated resistance to endocrine therapy. Supporting Context ESR1 mutations are a recognised mechanism of acquired resistance in hormone receptor-positive breast cancer and can be detected using circulating tumour DNA testing. Key Takeaway Inluriyo plus Verzenio is now an FDA-approved treatment option for ESR1-mutated advanced ER-positive, HER2-negative breast cancer. What to Watch Clinical adoption of ESR1 testing, use of Guardant360 CDx and positioning of the combination within later-line endocrine treatment pathways. Primary Source U.S. Food and Drug Administration Relevant Date 18 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 and Amneal has launched a 120 mg/0.5 mL lanreotide injection referencing Somatuline Depot, expanding competition in the US complex-injectables market. The product received Competitive Generic Therapy designation and is used in indications including acromegaly and gastroenteropancreatic neuroendocrine tumours. The immediate commercial launch gives clinicians and patients another lanreotide treatment option and supports Amneal's strategy of expanding its portfolio of complex generic and specialty injectable products. Field Content Alert Type Approval Drug Name Lanreotide injection Company Amneal Pharmaceuticals Regulatory Authority U.S. Food and Drug Administration Approval Type Generic drug approval and commercial launch Reference Product Somatuline Depot Strength 120 mg/0.5 mL Regulatory Designation Competitive Generic Therapy Indication Approved lanreotide indications including acromegaly and gastroenteropancreatic neuroendocrine tumours Therapy Area(s) Endocrinology; oncology; neuroendocrine tumours Technology or Modality Complex injectable generic Geography United States What Happened The FDA approved Amneal's lanreotide 120 mg/0.5 mL injection referencing Somatuline Depot, and the company launched the product immediately. Why It Matters The approval introduces additional competition in a complex injectable medicine used across endocrine and neuroendocrine tumour care. Supporting Context Lanreotide is a long-acting somatostatin analogue used in acromegaly and for management of certain gastroenteropancreatic neuroendocrine tumours. Potential Impact Additional competition may improve treatment availability and create greater pricing choice for healthcare providers and patients. Key Takeaway Amneal has secured FDA approval and launched a complex injectable lanreotide product referencing Somatuline Depot. What to Watch Commercial uptake, pricing and market share within the US lanreotide market. Primary Source Amneal Pharmaceuticals Relevant Date 18 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

Telix Pharmaceuticals has agreed to acquire ITM in a major radiopharmaceutical transaction valued at $1.65 billion upfront, with up to a further $700 million linked to regulatory and commercial milestones. The combination brings together Telix's oncology-focused radiopharmaceutical portfolio with ITM's isotope production infrastructure and therapeutic development capabilities. The transaction is intended to create a larger vertically integrated radiopharmaceutical company with capabilities spanning isotope supply, drug development, manufacturing and commercialisation. Field Content Alert Type Deal Companies Telix Pharmaceuticals; ITM Deal Type Acquisition Asset or Company ITM Therapy Area(s) Oncology; nuclear medicine Technology or Modality Radiopharmaceuticals; radioligand therapy; medical isotopes Deal Value US$1.65 billion upfront on a cash-free/debt-free basis, plus up to US$700 million in contingent regulatory and commercial milestone payments Geography Global What Happened Telix agreed to acquire 100% of ITM in a transaction valued at US$1.65 billion upfront, with additional contingent payments linked to ITM-11. Why It Matters The transaction combines a commercial and clinical radiopharmaceutical portfolio with major isotope-production capabilities, increasing scale across the radiopharma value chain. Supporting Context ITM has established isotope-production infrastructure and a pipeline of radiopharmaceutical therapies, while Telix has built a growing portfolio of diagnostic and therapeutic nuclear-medicine products. Strategic Rationale Telix gains greater control over isotope supply, manufacturing and therapeutic development while expanding its oncology pipeline and global radiopharmaceutical infrastructure. Potential Impact The combined business could improve isotope security, accelerate development of new radioligand therapies and strengthen competition in the rapidly expanding radiopharmaceutical market. Key Takeaway Telix is acquiring ITM for US$1.65 billion upfront in a major transaction designed to create a vertically integrated global radiopharmaceutical company. What to Watch Regulatory approvals, transaction completion, integration of isotope-production operations and progress of ITM-11 against its contingent milestones. Primary Source Telix Pharmaceuticals 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

Novo Nordisk and Orbis Medicines have entered a multi-target drug-discovery partnership worth up to $1.4 billion to develop orally bioavailable macrocycle medicines for cardiometabolic disease. The collaboration will use Orbis' AI-enabled nGen platform to identify macrocyclic drug candidates against targets that have historically been difficult to address with conventional small molecules. Orbis is eligible for upfront and milestone payments of up to $1.4 billion plus royalties, while Novo Nordisk will also make a strategic investment in the company. Field Content Alert Type Deal Companies Novo Nordisk; Orbis Medicines Deal Type Multi-target drug discovery and licensing partnership Asset or Company nGen macrocycle discovery platform Therapy Area(s) Cardiometabolic disease Technology or Modality Orally bioavailable macrocycles; AI-enabled drug discovery Deal Value Up to US$1.4 billion in upfront and milestone payments, plus royalties and a strategic equity investment Geography Global What Happened Novo Nordisk and Orbis Medicines entered a multi-target partnership to discover and develop orally bioavailable macrocycle medicines for cardiometabolic diseases. Why It Matters The deal gives Novo access to a platform designed to create oral medicines against targets that are difficult to address using conventional small-molecule approaches. Supporting Context Orbis' nGen platform combines high-throughput macrocycle synthesis and artificial intelligence to identify orally bioavailable compounds with properties traditionally associated with larger biologic drugs. Strategic Rationale Novo Nordisk gains access to a differentiated discovery technology while Orbis secures substantial development economics and validation of its macrocycle platform. Potential Impact Successful programmes could expand the range of cardiometabolic targets that can be treated with convenient oral medicines. Key Takeaway Novo Nordisk is committing up to US$1.4 billion to an Orbis Medicines macrocycle discovery partnership focused on cardiometabolic disease. What to Watch Target selection, candidate nomination and progression of the first nGen-derived programmes into preclinical development. Primary Source Orbis Medicines Relevant Date 17 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

Viatris has received Japanese approval for Wakix to treat narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnoea. Wakix, or pitolisant, is the first histamine H3 receptor antagonist and inverse agonist approved in Japan for these indications and provides a non-stimulant approach to improving wakefulness. The approval expands the international reach of Wakix and introduces a new mechanism of action for patients in Japan with disabling excessive daytime sleepiness. Field Content Alert Type Approval Drug Name Pitolisant Brand Name Wakix Company Viatris Regulatory Authority Japanese regulatory authorities Approval Type Marketing approval Indication Narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnoea Therapy Area(s) Neurology; sleep medicine Technology or Modality Histamine H3 receptor antagonist/inverse agonist Geography Japan What Happened Viatris received Japanese approval for Wakix for narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnoea. Why It Matters Wakix introduces a first-in-class, non-stimulant wake-promoting mechanism to the Japanese market for patients affected by significant daytime sleepiness. Supporting Context Pitolisant enhances histaminergic activity in the brain through H3 receptor antagonism and inverse agonism and is already used in other international markets. Key Takeaway Wakix becomes Japan's first approved H3 receptor antagonist/inverse agonist for narcolepsy and excessive daytime sleepiness associated with OSA. What to Watch Japanese commercial launch, reimbursement, prescribing patterns and adoption across sleep-medicine centres. Primary Source Viatris 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

New SullivanCotter data show physician compensation continuing to rise faster than productivity across major US specialty groups. Median total cash compensation increased across all major specialty categories, with adult medical specialties recording a 7.2% year-on-year increase while productivity growth remained comparatively modest. The findings highlight ongoing pressure on healthcare organisations as physician labour costs rise faster than output, with particularly strong compensation growth also reported in specialties including anesthesiology and radiology. Field Content Alert Type Compensation Organisation SullivanCotter Report 2026 Physician Compensation and Productivity Survey Geography United States Metric Median total cash compensation Overall Trend Physician compensation growth continued to outpace productivity growth across major specialty groups Adult Medical Specialties Median total cash compensation increased 7.2% year-on-year Highlighted Specialties Anesthesiology; radiology What Happened SullivanCotter reported continued physician compensation growth across all major specialty groups while corresponding productivity increases remained smaller. Why It Matters Compensation rising faster than productivity increases financial pressure on hospitals and medical groups and may affect recruitment strategy, service-line economics and physician workforce planning. Supporting Context Healthcare organisations continue to compete for physicians amid workforce shortages, increasing demand and specialty-specific recruiting pressure. Potential Impact Persistent divergence between pay and productivity could increase operating costs and force employers to reconsider compensation models, staffing structures and service delivery. Key Takeaway US physician pay continues to rise faster than productivity, with adult medical specialties showing particularly strong year-on-year compensation growth. What to Watch Whether compensation growth moderates, how productivity trends respond and which specialties experience the greatest future recruitment pressure. Primary Source SullivanCotter Relevant Date 17 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 Fayuvi as the first gene therapy for children with Sanfilippo syndrome type A, introducing the first treatment designed to address the underlying cause of the rare neurodegenerative disorder. Fayuvi, or rebisufligene etisparvovec-hopf, is approved for paediatric patients with mucopolysaccharidosis type IIIA and delivers a functional copy of the SGSH gene to support production of the deficient enzyme. The approval marks a major milestone for families affected by Sanfilippo syndrome type A, a progressive inherited condition that previously had no approved disease-modifying treatment. Field Content Alert Type Approval Drug Name Rebisufligene etisparvovec-hopf Brand Name Fayuvi Company Ultragenyx Pharmaceutical Regulatory Authority U.S. Food and Drug Administration Approval Type Gene therapy approval Indication Paediatric patients with mucopolysaccharidosis type IIIA, also known as Sanfilippo syndrome type A Therapy Area(s) Rare disease; neurology; genetic disease Technology or Modality AAV-based gene therapy Target SGSH gene / heparan N-sulfatase deficiency Geography United States What Happened The FDA approved Fayuvi as the first gene therapy and first approved treatment for paediatric patients with Sanfilippo syndrome type A. Why It Matters The approval introduces the first disease-modifying option for a progressive neurodegenerative disorder that previously had no approved treatment targeting the underlying genetic cause. Supporting Context Sanfilippo syndrome type A is caused by pathogenic variants in the SGSH gene, resulting in deficiency of the heparan N-sulfatase enzyme and progressive accumulation of heparan sulfate. Key Takeaway Fayuvi becomes the first approved therapy for Sanfilippo syndrome type A and a major new milestone in paediatric gene therapy. What to Watch Commercial rollout, treatment-centre readiness, long-term follow-up and real-world evidence on neurological and developmental outcomes. Primary Source U.S. Food and Drug Administration Relevant Date 17 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 Kerendia to adults with chronic kidney disease associated with type 1 diabetes, introducing a new treatment option for this high-risk population. Kerendia, or finerenone, is a non-steroidal mineralocorticoid receptor antagonist already used in chronic kidney disease associated with type 2 diabetes and can now also be prescribed for eligible adults with type 1 diabetes. The expanded indication addresses an area with limited therapeutic innovation and gives clinicians another option for reducing kidney and cardiovascular risks associated with diabetic kidney disease. Field Content Alert Type Approval Drug Name Finerenone Brand Name Kerendia Company Bayer Regulatory Authority U.S. Food and Drug Administration Approval Type Indication expansion Indication Chronic kidney disease associated with type 1 diabetes in adults Therapy Area(s) Nephrology; diabetes; cardiometabolic disease Technology or Modality Non-steroidal mineralocorticoid receptor antagonist Geography United States What Happened The FDA approved Kerendia for adults with chronic kidney disease associated with type 1 diabetes. Why It Matters The approval creates a new treatment option for a population with substantial kidney and cardiovascular risk and historically limited disease-specific pharmacological choices. Supporting Context Finerenone is already approved for chronic kidney disease associated with type 2 diabetes and acts by selectively blocking mineralocorticoid receptor overactivation. Key Takeaway Kerendia's FDA label now includes adults with chronic kidney disease associated with type 1 diabetes. What to Watch Clinical adoption, incorporation into kidney-disease treatment pathways and real-world outcomes in people with type 1 diabetes. Primary Source Bayer Relevant Date 17 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

Roche and Dualitas Therapeutics have entered a large-scale bispecific antibody discovery collaboration potentially worth more than $1 billion across immunology and inflammation programmes. Roche will pay Dualitas $36.5 million upfront to screen more than 300,000 bispecific antibody combinations using Dualitas' discovery platform against selected therapeutic targets. The collaboration combines Roche's development capabilities with high-throughput bispecific screening and gives Dualitas potential milestone and commercial payments exceeding $1 billion. Field Content Alert Type Deal Companies Roche; Dualitas Therapeutics Deal Type Discovery and licensing collaboration Asset or Company Bispecific antibody discovery platform Therapy Area(s) Immunology; inflammation Technology or Modality Bispecific antibodies; high-throughput antibody screening Deal Value US$36.5 million upfront with total potential economics exceeding US$1 billion Screening Scale More than 300,000 bispecific combinations Geography Global What Happened Roche entered a discovery collaboration with Dualitas to identify bispecific antibody candidates for selected immunology and inflammation targets. Why It Matters The agreement applies high-throughput screening to a very large bispecific design space, potentially accelerating identification of differentiated therapeutic combinations. Supporting Context Dualitas' platform is designed to generate and screen large libraries of bispecific antibodies to identify combinations with desirable biological activity and drug properties. Strategic Rationale Roche gains access to a scalable bispecific discovery engine while Dualitas receives upfront funding and substantial milestone-based economics. Potential Impact Successful programmes could generate new biologic therapies for inflammatory and immune-mediated diseases. Key Takeaway Roche is paying US$36.5 million upfront in a bispecific discovery collaboration with Dualitas carrying more than US$1 billion in potential total value. What to Watch Selection of development candidates, advancement into preclinical studies and disclosure of specific disease targets. Primary Source Fierce Biotech Relevant Date 17 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

Medovate and JEB Technologies are combining into a single medical-device company under the Medovate name, integrating product development, manufacturing, regulatory and commercial capabilities. The combined organisation will bring together Medovate's international commercial platform and medical-device portfolio with JEB Technologies' engineering and manufacturing capabilities. The consolidation is intended to create a vertically integrated medtech business able to take devices from concept through regulatory approval, manufacturing and global commercialisation. Field Content Alert Type Deal Companies Medovate; JEB Technologies Deal Type Corporate combination / merger Asset or Company Combined business operating under the Medovate name Sector Medical devices; medtech Technology or Modality Medical-device development and manufacturing Deal Value Financial terms were not disclosed Geography United Kingdom; international What Happened Medovate and JEB Technologies agreed to combine into one medical-device company operating under the Medovate brand. Why It Matters The transaction creates a more integrated medtech organisation spanning design, engineering, manufacturing, regulatory approval and international commercialisation. Supporting Context Medovate specialises in developing and commercialising clinician-led medical technologies, while JEB Technologies provides product-development and manufacturing capabilities. Strategic Rationale Combining the businesses creates an end-to-end platform capable of supporting medical devices from initial concept through commercial-scale production and market launch. Potential Impact The integrated model could shorten development timelines and give external innovators a single partner for design, regulatory, manufacturing and commercialisation services. Key Takeaway Medovate and JEB Technologies are consolidating into one vertically integrated medical-device company. What to Watch Formal launch of the combined company on 21 September and subsequent portfolio, customer and international expansion plans. Primary Source Medovate / JEB Technologies 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

Henlius has received approval in Pakistan for HANDAYUAN, its adalimumab biosimilar, marking the product's first regulatory approval outside China. The biosimilar, marketed locally as Adaliget, has been approved by Pakistan's Drug Regulatory Authority across the indications authorised for the reference adalimumab product in the country. The approval advances Henlius' international biosimilar strategy and expands access to an established TNF inhibitor used across multiple inflammatory and autoimmune diseases. Field Content Alert Type Approval Drug Name Adalimumab biosimilar Brand Name HANDAYUAN / Adaliget Company Henlius Regulatory Authority Drug Regulatory Authority of Pakistan Approval Type Marketing approval Reference Product Adalimumab reference biologic Indication All indications of the reference adalimumab product approved in Pakistan Therapy Area(s) Immunology; inflammatory disease; autoimmune disease Technology or Modality Biosimilar monoclonal antibody; TNF inhibitor Geography Pakistan What Happened Pakistan's Drug Regulatory Authority approved Henlius' adalimumab biosimilar HANDAYUAN, marketed locally as Adaliget. Why It Matters The decision is HANDAYUAN's first approval outside China and expands Henlius' international commercial footprint in biosimilars. Supporting Context Adalimumab is a TNF-targeting monoclonal antibody used across a wide range of inflammatory and autoimmune diseases. Key Takeaway Henlius has secured the first overseas approval for HANDAYUAN with regulatory clearance in Pakistan. What to Watch Commercial launch in Pakistan and additional international regulatory filings and approvals for HANDAYUAN. Primary Source Henlius 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

Zealand Pharma has licensed its GLP-1/gastrin dual-agonist peptide platform to Elvinix for development as a potentially regenerative treatment for type 1 diabetes. Elvinix receives rights to Zealand's preclinical peptide platform and associated data package, which is intended to stimulate pancreatic beta-cell regeneration while supporting metabolic control. The deal transfers a non-core early-stage programme to a dedicated development company while preserving the potential for a disease-modifying approach to type 1 diabetes. Field Content Alert Type Deal Companies Zealand Pharma; Elvinix Deal Type Exclusive licensing agreement Asset or Company GLP-1/gastrin dual-agonist peptide platform Therapy Area(s) Type 1 diabetes; metabolic disease; regenerative medicine Technology or Modality Peptide therapeutics; GLP-1/gastrin dual agonism Development Stage Preclinical Deal Value Financial terms were not disclosed Geography Global What Happened Zealand Pharma licensed its GLP-1/gastrin dual-agonist peptide platform and associated preclinical package to Elvinix for development in type 1 diabetes. Why It Matters The programme is intended to support pancreatic beta-cell regeneration, offering a potentially disease-modifying approach rather than solely replacing insulin or managing glucose. Supporting Context Combining GLP-1 and gastrin activity has been investigated as a strategy for promoting beta-cell growth and improving pancreatic function. Strategic Rationale Elvinix gains control of an early regenerative diabetes platform while Zealand can focus resources on its core pipeline and retain potential value from future development. Potential Impact Successful development could introduce a regenerative therapeutic strategy aimed at restoring insulin-producing capacity in type 1 diabetes. Key Takeaway Zealand has out-licensed a regenerative GLP-1/gastrin peptide platform to Elvinix for type 1 diabetes development. What to Watch Preclinical validation, progression toward first-in-human studies and disclosure of development milestones under the licence. Primary Source Zealand Pharma / Elvinix 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