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The proposed acquisition gives Wise Equity control of a specialist oral solid-dose manufacturer with established capabilities in effervescent, soluble, orally disintegrating and sublingual formulations. Italian private equity firm Wise Equity has agreed to acquire 100% of E-Pharma Trento, a contract development and manufacturing organisation specialising in oral solid dosage forms, from healthcare distribution group Unifarm. The transaction gives Wise Equity a pharmaceutical CDMO with development, manufacturing and licensing capabilities and approximately €55 million in revenue, providing a platform for further growth in Italy and international markets. Field Content Alert Type Deal Companies Wise Equity; E-Pharma Trento; Unifarm Deal Type Acquisition Asset or Company 100% of E-Pharma Trento Therapy Area(s) Multiple Technology or Modality Pharmaceutical CDMO specialising in oral solid dosage forms, including effervescent, soluble, orally disintegrating and sublingual formulations Deal Value Financial terms have not been disclosed. Geography Italy; international markets What Happened Wise Equity has signed an agreement to acquire 100% of E-Pharma Trento from Unifarm through its Wisequity VII fund. E-Pharma is an Italian CDMO specialising in oral solid dosage forms and provides services spanning product development, commercial manufacturing and out-licensing of registration dossiers. The transaction has been announced but remains subject to completion; financial terms have not been disclosed. E-Pharma currently identifies Unifarm as its sole shareholder. (epharmatrento.it) Why It Matters The acquisition gives Wise Equity an established pharmaceutical manufacturing platform with specialist formulation technologies and both domestic and international business. E-Pharma reports approximately €55 million in revenue, with pharmaceuticals accounting for 65% of its business and international markets representing 35%, providing a base from which the new owner could pursue further CDMO growth. (e-pharma.com) Supporting Context Founded in 1993, E-Pharma operates two plants in Trento and reports 276 employees, production of more than 611 million dosage units and approximately 240 manufactured SKUs. Its capabilities include contract development, manufacturing and regulatory support, alongside patented technologies covering areas including orally disintegrating formulations and packaging. (e-pharma.com) Strategic Rationale Wise Equity gains a specialised pharmaceutical CDMO with established manufacturing infrastructure, proprietary formulation technologies and international customers. The acquisition provides a platform from which the investor could support organic expansion or additional acquisitions, although specific future investment plans have not been disclosed. Key Takeaway The acquisition gives Wise Equity control of a €55 million-revenue specialist CDMO with established oral solid-dose development and manufacturing capabilities. What to Watch Completion of the transaction and Wise Equity's subsequent plans for investment, capacity expansion, international growth or further CDMO acquisitions around E-Pharma. Primary Source https://www.pehub.com/wise-equity-inks-agreement-to-acquire-e-pharma-trento/ Relevant Date 10 August 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 draft guidance could reduce reliance on animal studies for some oncology products while increasing the importance of analytical characterisation and weight-of-evidence approaches during development. The US Food and Drug Administration (FDA) has issued draft guidance recommending streamlined approaches to general toxicology studies for certain oncology biologics and conjugated products, including antibody-drug conjugates (ADCs), as part of its programme to reduce unnecessary animal testing. The proposals could alter nonclinical development strategies by allowing some studies to use fewer animal species or be replaced by evidence-based approaches, while requiring sponsors to establish that the alternative evidence adequately addresses product safety. Field Content Alert Type Industry Update Topic Nonclinical safety; regulatory guidance; animal testing Organisation(s) US Food and Drug Administration (FDA) Affected Stakeholders Developers of oncology biologics and conjugated products, including ADC manufacturers; nonclinical safety scientists; regulatory affairs teams Therapy Area(s) Oncology Geography United States What Happened On 29 May 2026, the FDA issued draft guidance titled Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products. The guidance describes circumstances in which general toxicology programmes for certain oncology products could be reduced, including situations where studies may not be necessary, where testing in one relevant species may be sufficient, or where some longer-duration non-human primate studies could be replaced by a weight-of-evidence risk assessment. The recommendations remain draft guidance and are not currently binding requirements. Why It Matters Traditional nonclinical toxicology programmes can require extensive animal studies before and during clinical development. For ADC and oncology biologic developers, the FDA's proposed framework could allow more product-specific safety programmes that reduce unnecessary studies where existing pharmacological, analytical or toxicological evidence adequately characterises risk, potentially changing how companies plan nonclinical development. Supporting Context The guidance forms part of the FDA's broader effort to reduce reliance on animal testing in drug development and follows analysis of whether conventional toxicology studies consistently provide information needed for oncology development. ADCs present particular nonclinical considerations because their safety profiles can reflect the antibody, linker, cytotoxic payload and conjugated product. Who Is Most Affected Oncology companies developing ADCs, monoclonal antibodies and other conjugated products are most directly affected, particularly nonclinical and regulatory teams deciding which studies are necessary to support first-in-human and subsequent clinical development. Industry Impact If finalised, the guidance could shift some oncology nonclinical programmes away from standardised animal-study packages towards scientifically justified, weight-of-evidence strategies. Any reduction in studies would remain product-specific, meaning the guidance should not be interpreted as removing the need for nonclinical safety assessment across ADC development generally. Key Takeaway The FDA's draft framework gives oncology developers a potential route to reduce unnecessary animal toxicology studies where existing evidence provides an adequate scientific basis for a streamlined approach. What to Watch The FDA's response to stakeholder comments and publication of final guidance will determine whether the proposed approaches become part of the agency's formal recommendations for oncology biologic and ADC development. Primary Source https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-pharmaceuticals-streamlined-nonclinical-safety-studies-biologics-and-conjugated-products Relevant Date 29 May 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

Healthcare organisations and technology developers face an expanding mix of state laws, sector-specific FDA expectations and federal policy initiatives rather than a single nationwide AI regulatory framework. A new analysis argues that declining public trust, cybersecurity risks, commercial pressure and state-level legislative activity are increasing the likelihood of further US artificial intelligence oversight, although Congress has not enacted a comprehensive federal AI law. For healthcare stakeholders, the immediate challenge is managing existing state requirements and FDA expectations while preparing for possible national standards that could affect clinical AI development, procurement, transparency and ongoing performance monitoring. Field Content Alert Type Industry Update Topic Artificial intelligence regulation and healthcare technology Organisation(s) US federal government; US Food and Drug Administration; state legislatures Affected Stakeholders Healthcare AI developers, medical-device manufacturers, health systems, clinicians procuring or using AI tools, and organisations deploying automated decision systems Therapy Area(s) Industry-wide Geography United States What Happened An analysis published on 1 August 2026 identified public concern, cybersecurity threats, commercial pressure, political momentum and US competition for global AI leadership as factors that could drive further federal oversight. No comprehensive federal AI statute has been enacted: current governance instead consists of federal executive policy, sector-specific agency activity and an expanding patchwork of state laws. In healthcare, the FDA has already issued draft lifecycle guidance for AI-enabled medical devices and maintains a regularly updated list of authorised AI-enabled products, while the White House’s AI Action Plan prioritises innovation and the removal of regulatory barriers alongside monitoring emerging risks. (Forbes) Why It Matters Healthcare organisations cannot wait for a single federal AI Act before addressing compliance. Developers and providers may already need to consider medical-device regulation, validation, bias, transparency, cybersecurity and post-market performance, while also accounting for differing state requirements. Any future national framework could reduce regulatory fragmentation, but its obligations and relationship with state law remain uncertain. (U.S. Food and Drug Administration) Supporting Context The White House’s July 2025 AI Action Plan promotes private-sector innovation, AI infrastructure and US leadership while opposing regulation considered unnecessarily burdensome. At the same time, state lawmakers have continued to pursue rules covering areas such as high-risk automated decisions, transparency, employment and healthcare, creating practical compliance duties despite the lack of an overarching federal law. (The White House) Who Is Most Affected Medical-device companies and digital-health developers face the clearest immediate exposure because AI functions that meet the definition of a medical device remain subject to FDA premarket requirements and lifecycle expectations. Health systems and clinicians are also affected when evaluating whether tools are authorised, appropriately validated and suitable for specific patient populations and clinical workflows. (U.S. Food and Drug Administration) Industry Impact The evolving framework could increase demand for formal AI governance, product documentation, risk assessment, bias evaluation, human oversight and post-deployment monitoring across healthcare organisations. However, the eventual extent of federal intervention remains unclear, particularly given the administration’s stated preference for innovation-led and minimally burdensome regulation. (The White House) Key Takeaway US healthcare AI oversight is already developing through agency guidance and state legislation, even though a comprehensive federal regulatory framework has not been adopted. 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

Recent legal and regulatory developments could influence how innovative medicines are protected in Europe by changing the interaction between regulatory exclusivity, patent rights and generic market entry. The EU General Court has annulled a European Commission decision that granted Biogen an additional year of market protection for Tecfidera, while policymakers continue to advance the EU Pharmaceutical Package, which would reform regulatory exclusivity and broaden Bolar exemptions. Together, these developments highlight the growing interaction between regulatory protection and intellectual property strategy for pharmaceutical companies developing and commercialising medicines in Europe. Field Content Alert Type Industry Update Topic Pharmaceutical regulation and intellectual property Organisation(s) EU General Court; European Commission; Council of the European Union Affected Stakeholders Originator pharmaceutical companies, generic and biosimilar manufacturers, biotechnology companies and intellectual property professionals Geography European Union What Happened The EU General Court confirmed that the conditions for obtaining an additional year of market protection under Article 14(11) of Regulation (EC) No 726/2004 must be applied strictly by annulling the European Commission's decision granting Biogen extended protection for Tecfidera. Separately, the EU's proposed Pharmaceutical Package continues to progress through the legislative process, introducing reforms to regulatory exclusivity, market protection and the scope of the Bolar exemption, although the legislation has not yet been formally adopted and will be subject to a transitional implementation period. (Osborne Clarke) Why It Matters These developments reinforce that regulatory exclusivity and patent protection operate together but under separate legal frameworks. Pharmaceutical companies may need to reassess lifecycle management, market-entry planning, patent enforcement and generic launch strategies as the regulatory environment evolves. (Osborne Clarke) Supporting Context The Tecfidera judgment illustrates how decisions affecting regulatory exclusivity can directly influence commercial timelines for innovative medicines. At the same time, the proposed Pharmaceutical Package would shorten and condition certain exclusivity periods while expanding activities permitted under the Bolar exemption before generic or biosimilar launch. (Osborne Clarke) Who Is Most Affected Pharmaceutical companies managing European product lifecycles, together with generic and biosimilar developers planning market entry, are likely to experience the greatest impact because both regulatory protection and patent strategy influence launch timing and competitive positioning. (Osborne Clarke) Industry Impact If adopted in its current form, the pharmaceutical reforms could alter how companies balance regulatory incentives with patent portfolios, requiring earlier planning for lifecycle management, intellectual property strategy and competition from generic and biosimilar medicines. The practical impact will depend on the final legislative text and national implementation. (Osborne Clarke) Key Takeaway Regulatory exclusivity and patent protection are becoming increasingly interconnected strategic considerations for companies operating in the European pharmaceutical market. (Osborne Clarke) What to Watch Formal adoption of the EU Pharmaceutical Package, publication in the Official Journal, the subsequent two-year transition period and future case law interpreting both the revised exclusivity framework and UPC pharmaceutical patent disputes. (Osborne Clarke) 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 biomarker-selected regimen adds an AKT inhibitor to abiraterone and prednisone for adults with newly diagnosed metastatic disease whose tumours show PTEN deficiency. The US Food and Drug Administration has approved Truqap (capivasertib) with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer. The expanded indication provides a new targeted combination for a molecularly defined patient group, although treatment requires FDA-authorised PTEN testing and monitoring for toxicities including hyperglycaemia, diarrhoea and cutaneous reactions. Field Content Alert Type Drug Approval Drug Name Truqap (capivasertib) Indication In combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer that is PTEN-deficient, as detected by an FDA-authorised test. Therapy Area(s) Oncology; Prostate cancer Geography United States (FDA) What Happened On 12 June 2026, the FDA expanded Truqap’s approval to include capivasertib with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. The agency also approved the VENTANA PTEN (SP218) RxDx Assay as a companion diagnostic for identifying eligible patients. Truqap was previously approved in combination with fulvestrant for a biomarker-defined population with advanced breast cancer. (U.S. Food and Drug Administration) Why It Matters PTEN deficiency is used to identify patients whose disease may be appropriate for this AKT-targeted combination, introducing a biomarker-directed option earlier in the metastatic prostate cancer pathway. In CAPItello-281, the regimen improved radiographic progression-free survival compared with abiraterone and placebo, but overall survival data were immature at the time of the analysis and the additional toxicity burden requires active clinical management. (U.S. Food and Drug Administration) Supporting Context CAPItello-281 enrolled 1,012 adults with newly diagnosed PTEN-deficient disease. Median radiographic progression-free survival was 33.2 months with capivasertib and abiraterone versus 25.7 months with placebo and abiraterone, corresponding to a hazard ratio of 0.81. (U.S. Food and Drug Administration) Key Takeaway The approval adds a PTEN-selected targeted regimen for metastatic hormone-sensitive prostate cancer, with eligibility dependent on companion diagnostic testing. What to Watch Mature overall survival findings from CAPItello-281 and how routinely PTEN testing is incorporated into treatment selection for newly diagnosed metastatic disease. Primary Source https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation Relevant Date 12 June 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 approval adds another US biosimilar option for rituximab-treated conditions, including non-Hodgkin lymphoma and chronic lymphocytic leukaemia, although commercial availability and pricing have not yet been confirmed. The US Food and Drug Administration has approved Reditux, Dr. Reddy’s Laboratories’ rituximab biosimilar referencing Rituxan, for the reference product’s eligible haematological malignancy and autoimmune disease indications. The approval expands the number of rituximab biosimilars available to US clinicians and patients, with Fresenius Kabi holding exclusive US commercialisation rights. Field Content Alert Type Drug Approval Drug Name Reditux (rituximab biosimilar) Indication Eligible indications of the reference product Rituxan, including CD20-positive non-Hodgkin lymphoma, CD20-positive chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris. Therapy Area(s) Haematology; Oncology; Rheumatology; Immunology Geography United States (FDA) What Happened On 1 August 2026, the FDA approved Reditux, Dr. Reddy's Laboratories' rituximab biosimilar referencing Rituxan. The approval was supported by analytical, non-clinical and clinical evidence demonstrating no clinically meaningful differences from the reference product in terms of safety, purity and potency. Fresenius Kabi holds exclusive commercialisation rights for the product in the United States. Why It Matters The approval provides healthcare providers with another rituximab biosimilar across multiple oncology and autoimmune indications, potentially increasing treatment choice and supporting biosimilar competition. However, FDA approval alone does not determine pricing, reimbursement, formulary inclusion or uptake in clinical practice. Supporting Context Rituximab is a CD20-directed monoclonal antibody widely used in B-cell malignancies and several autoimmune diseases. Reditux has previously been marketed in India and approved in numerous international markets before receiving FDA approval. Key Takeaway FDA approval adds another rituximab biosimilar to the US market, expanding treatment options across approved oncology and autoimmune indications. What to Watch Commercial launch timing, payer coverage, formulary adoption and pricing will determine how quickly Reditux becomes available to US clinicians and patients. Primary Source https://www.drreddys.com/cms/sites/default/files/2026-08/20260801_PressRelease_rituximab_SE.pdf Relevant Date 1 August 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

Pathos AI licenses first-in-class bispecific ADC JSKN016 from Alphamab Oncology in deal worth up to $4.8 billion Pathos AI has entered a global licensing agreement with Alphamab Oncology for JSKN016, a first-in-class TROP2/HER3 bispecific antibody-drug conjugate (ADC), paying $200 million upfront in a deal that could be worth up to $4.8 billion if development, regulatory and commercial milestones are achieved. The transaction adds a differentiated clinical-stage oncology asset to Pathos AI's pipeline while enabling Alphamab Oncology to retain Greater China rights and participate in the programme's long-term commercial success through milestone payments and royalties. Field Content Alert Type Deal Companies Pathos AI; Alphamab Oncology Deal Type Global licensing agreement Asset or Company JSKN016, a first-in-class TROP2/HER3 bispecific antibody-drug conjugate (ADC) Therapy Area(s) Oncology; Solid tumours Technology or Modality Bispecific antibody-drug conjugate (ADC) Deal Value $200 million upfront, with potential development, regulatory and commercial milestone payments bringing the total value to up to $4.8 billion, plus tiered royalties on future net sales. Development Stage Phase I/II Geography Global excluding Greater China (Alphamab Oncology retains Greater China rights) What Happened On 5 August 2026, Pathos AI announced a global licensing agreement with Alphamab Oncology for exclusive rights outside Greater China to develop, manufacture and commercialise JSKN016. Pathos AI will pay $200 million upfront and may make additional milestone payments of up to $4.6 billion, together with tiered royalties on net sales. Alphamab Oncology retains rights in Greater China while both companies will collaborate on technology transfer and ongoing development activities. Why It Matters The agreement provides Pathos AI with a clinical-stage bispecific ADC targeting both TROP2 and HER3, expanding its precision oncology portfolio with a novel modality that could have potential across multiple solid tumours. For Alphamab Oncology, the partnership provides significant non-dilutive capital while retaining regional commercial rights and future economic participation outside Greater China. Supporting Context JSKN016 is designed to target both TROP2 and HER3, two proteins frequently expressed across a range of epithelial cancers. Early clinical studies are evaluating the candidate in patients with advanced solid tumours, where bispecific ADCs are being explored as a strategy to improve tumour targeting while broadening therapeutic activity. 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 all-stock transaction combines complementary central nervous system portfolios spanning neuroscience and addiction medicine, creating a larger commercial-stage company with a broader product portfolio and pipeline. Supernus Pharmaceuticals and Indivior have agreed to merge in an all-stock transaction that will create a combined central nervous system (CNS) biopharmaceutical company with approximately $2.2 billion in annual revenue, with Indivior shareholders also receiving a $1 billion special dividend before closing. The merger brings together complementary commercial portfolios and development pipelines in neuroscience and addiction medicine while aiming to strengthen long-term growth through greater scale and operational efficiencies. Field Content Alert Type Deal Companies Supernus Pharmaceuticals; Indivior Pharmaceuticals Deal Type Merger (all-stock transaction) Asset or Company Combined CNS biopharmaceutical businesses and product portfolios Therapy Area(s) Neuroscience; Psychiatry; Addiction medicine Deal Value All-stock merger creating a company with approximately $2.2 billion in annual revenue. Indivior shareholders are expected to receive a $1 billion special dividend before closing. (Reddit) Geography Global What Happened On 3 August 2026, Supernus Pharmaceuticals and Indivior announced an agreement to merge in an all-stock transaction. Under the terms announced, Supernus shareholders will receive 1.5401 Indivior shares for each Supernus share, while Indivior shareholders will receive a $1 billion special dividend before completion. The combined company will continue to focus on CNS disorders, bringing together commercial products and development programmes across neuroscience and addiction medicine. (Reddit) Why It Matters The merger creates a larger CNS-focused pharmaceutical company with a broader commercial portfolio, increased revenue base and a more diversified pipeline. Combining complementary expertise across neurology, psychiatry and addiction medicine could support future product development and commercial execution, although the anticipated benefits will depend on successful integration. (Reddit) Supporting Context Supernus has an established portfolio in neurological disorders including ADHD and Parkinson's disease, while Indivior specialises in treatments for opioid use disorder and addiction. The transaction combines businesses with different but complementary CNS therapeutic focuses. (Supernus Pharmaceuticals) Strategic Rationale Supernus gains greater commercial scale and access to Indivior's addiction medicine franchise, while Indivior broadens its CNS portfolio through Supernus' neuroscience products and development capabilities. (Reddit) Potential Impact If completed, the merger could strengthen the combined company's competitive position within the CNS market through a broader portfolio and increased financial scale. Realisation of these benefits will depend on shareholder approvals, regulatory clearances and successful integration. 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 orexin receptor agonist provides adults with a treatment that targets the underlying loss of orexin signalling rather than managing individual symptoms separately. The US Food and Drug Administration (FDA) has approved Orzeyful (oveporexton) for the treatment of adults with narcolepsy type 1, making it the first medicine approved to address the condition as a complete disorder by restoring orexin signalling. The approval introduces a new therapeutic approach for patients experiencing excessive daytime sleepiness, cataplexy and other symptoms, although commercial launch must await scheduling by the US Drug Enforcement Administration (DEA). Field Content Alert Type Drug Approval Drug Name Orzeyful (oveporexton) Indication Treatment of narcolepsy type 1 in adults. Therapy Area(s) Neurology; Sleep Medicine Geography United States (FDA) What Happened On 5 August 2026, the FDA approved Orzeyful (oveporexton) for the treatment of adults with narcolepsy type 1. The twice-daily oral therapy is the first approved medicine to directly activate the orexin receptor and treat the disorder by addressing the underlying loss of orexin signalling rather than targeting individual symptoms. Marketing cannot begin until the DEA completes scheduling under the Controlled Substances Act. Why It Matters Existing treatments generally focus on individual symptoms such as excessive daytime sleepiness or cataplexy. Orzeyful introduces a disease-targeted approach that demonstrated improvements across multiple symptoms of narcolepsy type 1, providing clinicians with a new treatment option that addresses the condition more broadly. Supporting Context Narcolepsy type 1 is caused by the loss of orexin-producing neurons, leading to excessive daytime sleepiness, cataplexy, sleep paralysis, hallucinations and disrupted night-time sleep. FDA approval was supported by two Phase III clinical trials involving 273 adults with narcolepsy type 1. Key Takeaway FDA approval makes Orzeyful the first therapy to target the underlying orexin deficiency responsible for narcolepsy type 1 while addressing the full spectrum of the condition's symptoms. What to Watch The DEA's scheduling decision will determine when Orzeyful becomes commercially available in the United States, followed by reimbursement decisions and clinical adoption. Primary Source https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-full-range-narcolepsy-type-1-symptoms Relevant Date 5 August 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 approval introduces the first messenger RNA influenza vaccine into the US market, expanding vaccine technology options for seasonal influenza prevention in older adults. The US Food and Drug Administration (FDA) has approved mFlusiva (mRNA-1010), Moderna's seasonal influenza vaccine, for the prevention of influenza in adults aged 50 years and older, making it the first mRNA-based influenza vaccine approved in the United States. The approval expands the use of mRNA technology beyond COVID-19 and respiratory syncytial virus vaccines, although commercial availability for the 2026–2027 influenza season will depend on existing supply contracts and distribution timelines. Field Content Alert Type Drug Approval Drug Name mFlusiva (mRNA-1010) Indication Active immunisation for the prevention of influenza in adults aged 50 years and older. (The Wall Street Journal) Therapy Area(s) Infectious Diseases; Vaccines Geography United States (FDA) What Happened On 5 August 2026, the FDA approved mFlusiva (mRNA-1010) for the prevention of seasonal influenza in adults aged 50 years and older. The decision makes mFlusiva the first mRNA-based influenza vaccine licensed in the United States following a positive recommendation from the FDA's Vaccines and Related Biological Products Advisory Committee. The approval follows additional regulatory review after Moderna amended its application in response to earlier FDA concerns regarding trial design. (The Wall Street Journal) Why It Matters The approval introduces mRNA technology to seasonal influenza vaccination, providing an alternative manufacturing platform that could support future vaccine development and updates. It also represents an important regulatory milestone for Moderna as the company broadens its respiratory vaccine portfolio beyond COVID-19 and RSV, although real-world uptake will depend on procurement, reimbursement and clinician adoption. (Barron's) Supporting Context In a Phase III study involving more than 40,000 adults aged 50 years and older, mFlusiva demonstrated approximately 26.6% greater efficacy against influenza than a standard-dose comparator vaccine and reduced severe influenza requiring hospitalisation or urgent care by 47.9%. A post-marketing study in older adults is planned as part of the approval. (The Wall Street Journal) Key Takeaway FDA approval establishes mFlusiva as the first licensed mRNA seasonal influenza vaccine in the United States, expanding vaccine technology options for older adults. What to Watch Commercial rollout during the 2026–2027 influenza season, completion of the required post-marketing study and continued development of Moderna's combined influenza/COVID-19 vaccine programme. (Barron's) Primary Source https://www.fda.gov/news-events (FDA approval announcement); https://investors.modernatx.com (Moderna press release) Relevant Date 5 August 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 engineered oncolytic viral therapy, used with nivolumab, provides a new treatment option for adults with unresectable cutaneous melanoma that has progressed despite prior PD-1-based immunotherapy. The US Food and Drug Administration (FDA) has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease has progressed on a PD-1-blocking antibody-based regimen. The approval introduces an engineered oncolytic viral immunotherapy for this treatment-resistant population, with continued approval dependent on confirmation of clinical benefit in post-approval trials. Field Content Alert Type Drug Approval Drug Name Tudriqev (vusolimogene oderparepvec-wtpg) Indication In combination with nivolumab for adults with unresectable advanced cutaneous melanoma who experienced disease progression with a PD-1-blocking antibody-based regimen. (U.S. Food and Drug Administration) Therapy Area(s) Oncology; Melanoma Geography United States (FDA) What Happened On 6 August 2026, the FDA granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), Replimune's genetically modified oncolytic viral therapy, in combination with nivolumab for adults with unresectable advanced cutaneous melanoma that has progressed following PD-1-based therapy. Tudriqev is a modified herpes simplex virus type 1 (HSV-1) injected directly into tumours and engineered to destroy cancer cells while stimulating an anti-tumour immune response. The application received Breakthrough Therapy and Priority Review designations. (U.S. Food and Drug Administration) Why It Matters Patients whose advanced melanoma progresses despite PD-1-based immunotherapy have a need for additional effective treatment options. Tudriqev provides a new approach combining direct tumour injection with systemic nivolumab and is intended to stimulate an immune response in disease that has stopped responding to previous immunotherapy; however, the approval is based on response data rather than confirmed survival benefit. (U.S. Food and Drug Administration) Supporting Context In an open-label, single-arm trial enrolling 140 adults with Stage IIIB, IIIC or IV unresectable melanoma that had progressed following prior anti-PD-1-based therapy, 91 patients were evaluable for efficacy. The objective response rate was 24%, with a median duration of response of 14.1 months. Important safety warnings include possible herpes infection or reactivation, accidental transmission of herpes infection to close contacts and complications associated with the injection procedure. (U.S. Food and Drug Administration) Key Takeaway Tudriqev provides a new FDA-approved viral immunotherapy option for adults with unresectable advanced melanoma whose disease has progressed despite PD-1-based treatment. What to Watch Replimune must conduct post-approval trial or trials to verify Tudriqev's clinical benefit, and continued approval may depend on the results of this confirmatory evidence. (U.S. Food and Drug Administration) Primary Source https://www.fda.gov/news-events/press-announcements/fda-approves-new-engineered-viral-immunotherapy-patients-treatment-resistant-advanced-melanoma Relevant Date 6 August 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 proposed acquisition would add Xycota’s preclinical CNS pipeline and exosome-based delivery platform to NexTel Medical, including lead programme XYCO-01 for frontotemporal dementia. NexTel Medical Corp. has signed a letter of intent to acquire 100% of Xycota Biosciences, an early-stage biotechnology company developing exosome-delivered neuroplasticity therapeutics for neurodegenerative conditions. If completed, the transaction would give NexTel access to Xycota’s preclinical pipeline and delivery technology, led by XYCO-01, an exosome-formulated psilocin candidate being developed initially for frontotemporal dementia (FTD). Field Content Alert Type Deal Companies NexTel Medical Corp.; Xycota Biosciences Deal Type Proposed acquisition under letter of intent Asset or Company 100% of Xycota Biosciences, including its neuroplasticity therapeutic pipeline and exosome delivery platform Therapy Area(s) Neurology; Neurodegenerative diseases Technology or Modality Exosome-delivered neuroplasticity therapeutics Deal Value Financial consideration for the proposed acquisition has not been disclosed. Development Stage Preclinical Geography United States What Happened NexTel Medical Corp. announced that it has executed a letter of intent to acquire 100% of Xycota Biosciences. The proposed transaction would give NexTel ownership of Xycota’s CNS drug-development platform and preclinical programmes. Xycota’s lead asset, XYCO-01, is an exosome-formulated psilocin candidate initially targeting FTD, with additional programmes or potential applications in mild traumatic brain injury, ALS and other neurodegenerative conditions. The announcement represents a proposed transaction rather than a completed acquisition, and completion remains dependent on definitive documentation and other agreed conditions. (Xycota Biosciences) Why It Matters The proposed acquisition would extend NexTel’s biotechnology portfolio into CNS drug development and give it access to a differentiated approach combining neuroplasticity pharmacology with exosome-based delivery. Xycota is attempting to exploit the BDNF-TrkB neuroplasticity pathway while reducing or avoiding the hallucinogenic effects associated with conventional psychedelic administration, but these delivery and therapeutic hypotheses remain to be validated clinically. (Xycota Biosciences) Supporting Context Xycota describes XYCO-01 as an exosome-formulated psilocin programme intended initially for FTD. Its strategy is supported by preclinical research investigating the role of BDNF-TrkB signalling in psilocybin-associated neuroplasticity, but Xycota states that its programmes remain preclinical and that clinical trials have not begun. (Xycota Biosciences) Strategic Rationale NexTel would gain ownership of an early-stage CNS platform and pipeline that could broaden its biotechnology activities into neurodegeneration. For Xycota, the proposed transaction could provide access to NexTel’s public-company infrastructure and resources as its lead programme moves towards regulatory and clinical development. Potential Impact If completed and successfully developed, the acquisition could give NexTel a platform spanning several neurodegenerative indications. Any clinical or commercial impact remains highly uncertain because the programmes are preclinical and their safety and efficacy have not been established in patients. (Xycota Biosciences) Key Takeaway The proposed acquisition would give NexTel ownership of Xycota’s preclinical neuroplasticity platform, but its strategic value will depend on completion of the transaction and subsequent clinical validation. What to Watch Execution of a definitive acquisition agreement, disclosure of the transaction consideration and closing conditions, and Xycota’s progress towards regulatory clearance and first-in-human development of XYCO-01. Primary Source Morningstar/Accesswire announcement supplied: https://www.morningstar.com/news/accesswire/1201772msn/nextel-medical-corp-executes-letter-of-intent-to-acquire-100-of-xycota-biosciences-llc Relevant Date August 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