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The collaboration will connect ChemoMetec’s XcytoMatic 30 cell counter with Roche’s Cedex Bio Analyzer and establish a joint go-to-market strategy for the combined bioprocess monitoring solution. ChemoMetec and Roche Diagnostics have entered a collaboration agreement to develop a connectivity solution linking ChemoMetec’s XcytoMatic 30 (XM30) cell counting analyser with Roche’s Cedex Bio Analyzer, following a letter of intent signed in February 2026. The partnership aims to integrate complementary cell-counting and bioprocess-analysis technologies while allowing both companies to continue selling their respective instruments independently. Field Content Alert Type Deal Companies ChemoMetec; Roche Diagnostics Deal Type Technology development and commercial collaboration Asset or Company Connectivity solution linking ChemoMetec’s XcytoMatic 30 (XM30) cell counting analyser with Roche’s Cedex Bio Analyzer Technology or Modality Cell counting and bioprocess monitoring technology Deal Value Financial terms have not been disclosed. Geography Global What Happened On 10 August 2026, ChemoMetec and Roche Diagnostics entered a collaboration agreement covering development and subsequent commercialisation of a connection kit between Roche’s Cedex Bio Analyzer and ChemoMetec’s XcytoMatic 30 cell counting analyser. Roche will design the connection kit and undertake verification and validation, with the planned hardware and software connectivity intended to integrate the two systems. The companies will jointly promote the combined solution, while each will remain the sole seller of its own instrument. The agreement follows a letter of intent announced on 4 February 2026. (GlobeNewswire) Why It Matters The agreement brings together two complementary measurements used in bioprocess monitoring: ChemoMetec’s automated cell-counting technology and Roche’s bioprocess analyser. Successful integration could provide pharmaceutical and biotechnology customers with a more connected workflow for monitoring cell cultures during biopharmaceutical development and manufacturing, although the companies have not disclosed commercial targets or a launch timetable. (GlobeNewswire) Supporting Context ChemoMetec and Roche first announced their intention to explore the collaboration in February 2026, identifying connectivity between the XM30 and Cedex Bio Analyzer as the initial project. The new agreement moves that relationship from an exploratory letter of intent to a defined development and commercial collaboration. (Chemometec) Strategic Rationale ChemoMetec gains a route to integrate its cell-counting technology with an established Roche bioprocess platform and jointly promote the combined solution, while Roche adds automated cell-counting connectivity to the Cedex Bio Analyzer workflow without either company transferring ownership of its underlying instrument. (GlobeNewswire) Potential Impact If successfully developed and validated, the connectivity solution could support more integrated bioprocess monitoring workflows for pharmaceutical and biotechnology manufacturers. Its commercial impact will depend on completion of development, validation and customer adoption. Key Takeaway The agreement converts ChemoMetec and Roche’s February 2026 exploratory partnership into a formal collaboration to develop and jointly promote an integrated bioprocess monitoring solution. What to Watch Completion of Roche’s development, verification and validation work, details of commercial availability and implementation of the companies’ joint go-to-market strategy. (GlobeNewswire) Primary Source https://www.globenewswire.com/news-release/2026/08/10/3341652/0/en/chemometec-enters-collaboration-agreement-with-roche-diagnostics.html 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 EU Health Technology Assessment Regulation now requires eligible oncology medicines and advanced therapies to undergo a single European clinical assessment, increasing the importance of early evidence planning alongside EMA regulatory development. The European Union’s Joint Clinical Assessment (JCA) framework has been operating since 12 January 2025 for new oncology medicines and advanced therapy medicinal products, requiring developers to submit evidence for a common EU-level assessment alongside the marketing authorisation process. The system is changing market-access planning because developers must anticipate evidence requirements across Member States earlier, while national authorities retain responsibility for pricing, reimbursement, economic evaluation and other country-specific decisions. Field Content Alert Type Industry Update Topic Health technology assessment; market access; evidence generation Organisation(s) European Commission; Member State Coordination Group on Health Technology Assessment (HTACG); European Medicines Agency (EMA); national HTA bodies Affected Stakeholders Pharmaceutical and biotechnology companies developing oncology medicines and advanced therapies; market-access, HEOR, medical affairs and clinical-development teams; national HTA authorities Therapy Area(s) Oncology; Advanced therapies Geography European Union What Happened The EU Health Technology Assessment Regulation has applied since 12 January 2025, initially requiring JCAs for new cancer medicines containing new active substances and advanced therapy medicinal products submitted through the centralised EMA procedure. Developers must provide clinical evidence for an EU-level assessment of the relative effects of their technology, with the resulting JCA report subsequently considered by Member States in their national HTA processes. In 2026, these product groups remain in scope, while selected medical devices are also expected to enter JCA. (Public Health) Why It Matters JCA introduces a common European clinical evidence assessment but does not create a single EU reimbursement decision. Developers therefore need evidence packages capable of addressing the EU-level assessment while still preparing for national requirements covering issues such as cost-effectiveness, pricing and reimbursement. This increases the importance of coordinating regulatory, clinical-development, HEOR and market-access planning earlier in a product’s development. (Public Health) Supporting Context JCA reports focus on clinical domains and do not make value judgements or reimbursement recommendations. National authorities must consider the JCA report but may supplement it with additional analyses required for their own decision-making. The framework is being introduced progressively: orphan medicines enter scope from 13 January 2028, followed by all other new centrally authorised medicines from 13 January 2030. (EUR-Lex) Who Is Most Affected Developers of new oncology medicines and advanced therapies currently face the most immediate requirements, particularly teams responsible for clinical evidence generation, market access and HTA submissions. The impact will broaden substantially as orphan medicines and ultimately all new centrally authorised medicines enter the framework. (EUR-Lex) Industry Impact JCA could reduce duplication of clinical assessments across European markets, but it also concentrates evidence requirements into an earlier and more coordinated process. For pharmaceutical companies, this makes early identification of relevant patient populations, comparators, endpoints and evidence gaps increasingly important when designing development programmes intended to support both regulatory approval and European market access. Key Takeaway JCA is shifting European market-access planning upstream, requiring developers to consider EU-wide clinical evidence needs earlier while continuing to prepare for country-specific reimbursement assessments. What to Watch The HTACG expects around 50 medicinal-product JCAs in 2026, providing a larger test of the framework’s operational capacity. Further experience with published assessments, the introduction of selected medical devices and preparations for orphan medicines entering scope in 2028 will show how the system develops beyond its initial implementation phase. (Public Health) Primary Source https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-clinical-assessments_en Relevant Date 12 January 2025 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 acquisition would add a clinical-stage KCNT1 inhibitor for a rare genetic epilepsy with no FDA-approved treatments, while Actio’s remaining programmes will be transferred into a separate privately held company. Jazz Pharmaceuticals has agreed to acquire Actio Biosciences for $820 million upfront, with Actio shareholders eligible for up to a further $500 million in regulatory and sales milestones, giving the transaction a potential value of up to $1.32 billion. The acquisition centres on ABS-1230, a clinical-stage precision therapy targeting the KCNT1 ion channel in patients with KCNT1-related epilepsy, and would expand Jazz’s established epilepsy portfolio into a genetically defined disease population. Field Content Alert Type Deal Companies Jazz Pharmaceuticals; Actio Biosciences Deal Type Acquisition Asset or Company Actio Biosciences, principally ABS-1230 Therapy Area(s) Neurology; Epilepsy; Rare genetic diseases Technology or Modality Oral small-molecule KCNT1 ion-channel inhibitor Deal Value $820 million upfront, plus up to $500 million in contingent regulatory approval and sales milestone payments. The maximum potential consideration is approximately $1.32 billion, but the additional $500 million is not guaranteed. Development Stage Phase Ib/IIa Geography Global What Happened On 10 August 2026, Jazz Pharmaceuticals agreed to acquire Actio Biosciences for $820 million upfront plus up to $500 million in contingent regulatory and sales milestones. The principal programme included in the acquisition is ABS-1230, an oral small-molecule KCNT1 inhibitor currently being evaluated in the Phase Ib/IIa KYRON study for KCNT1-related epilepsy. Before closing, certain Actio employees and assets unrelated to ABS-1230 will be transferred into a new privately held company, in which Jazz will receive a minority interest and certain rights. The acquisition remains subject to customary closing conditions. Why It Matters ABS-1230 gives Jazz a clinical-stage precision medicine programme targeting the ion-channel dysfunction underlying KCNT1-related epilepsy, a rare developmental and epileptic encephalopathy with no FDA-approved treatment specifically for the condition. The programme complements Jazz’s existing epilepsy franchise while giving the company exposure to a genetically targeted therapeutic approach, although its clinical value remains to be established in ongoing trials. Supporting Context KCNT1-related epilepsy is a rare genetic disorder associated with severe, frequently treatment-resistant seizures that often begin in infancy. ABS-1230 is designed to selectively inhibit overactive KCNT1 potassium channels caused by disease-associated variants and has entered the FDA’s Rare Disease Evidence Principles process. Strategic Rationale Jazz gains a clinical-stage precision epilepsy programme that complements its existing neuroscience portfolio without acquiring all of Actio’s pipeline. Actio’s remaining programmes, including the TRPV4 inhibitor ABS-0871 for Charcot-Marie-Tooth disease type 2C, are expected to continue within the new spinout company. Potential Impact If ABS-1230 demonstrates sufficient safety and efficacy and secures regulatory approval, Jazz could add a genetically targeted therapy for a small epilepsy population with substantial unmet need. The programme’s eventual clinical and commercial contribution remains dependent on successful development and regulatory review. Key Takeaway The acquisition gives Jazz a clinical-stage precision therapy targeting the underlying channel dysfunction in KCNT1-related epilepsy, extending its epilepsy portfolio into a genetically defined rare disease. What to Watch Completion of the acquisition, results from the ongoing KYRON Phase Ib/IIa study and subsequent FDA discussions on the evidence and registration pathway for ABS-1230. Primary Source Jazz Pharmaceuticals acquisition announcement 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 completed transaction combines Kashiv’s biologics R&D and manufacturing capabilities with Amneal’s commercial infrastructure, giving the company end-to-end control across biosimilar development, production and commercialisation. Amneal Pharmaceuticals has completed its acquisition of 100% of Kashiv BioSciences, following an agreement providing for $375 million in cash and $375 million in equity at closing, plus up to $350 million in contingent regulatory milestone payments and potential commercial royalties. The combination gives Amneal an integrated global biosimilars platform spanning research, development, manufacturing and commercialisation, with a portfolio intended to support multiple future biosimilar launches. Field Content Alert Type Deal Companies Amneal Pharmaceuticals; Kashiv BioSciences Deal Type Acquisition Asset or Company 100% of Kashiv BioSciences Therapy Area(s) Multiple Technology or Modality Biosimilars; biologics development and manufacturing Deal Value The April 2026 acquisition agreement provided for $375 million in cash and $375 million in equity payable at closing, plus up to $350 million in potential regulatory milestone payments, potential royalties based on commercial milestones and funding of operations through closing. The additional $350 million and royalties are contingent and should not be treated as guaranteed consideration. (Amneal Pharmaceuticals) Development Stage Commercial and development-stage biosimilar portfolio Geography Global, with significant US operations and development and manufacturing capabilities in the US and India What Happened On 10 August 2026, Amneal announced completion of its acquisition of Kashiv BioSciences, following the definitive agreement announced on 22 April 2026. The transaction gives Amneal ownership of Kashiv’s biosimilar R&D, clinical, manufacturing, regulatory and intellectual-property capabilities, combining these operations with Amneal’s existing commercial infrastructure. Integration activities are now underway, focused on combining development and manufacturing capabilities and advancing the biosimilar pipeline. (BioSpace) Why It Matters The acquisition changes Amneal’s position in biosimilars from relying on partnerships and commercial capabilities to controlling a more vertically integrated platform spanning product development through manufacturing and commercialisation. Kashiv brings established biologics infrastructure, multiple commercial and advanced clinical-stage assets and experience obtaining marketing authorisations for biosimilars, potentially allowing Amneal to coordinate development and launches internally across a larger pipeline. (BioSpace) Supporting Context Amneal and Kashiv have worked together for more than a decade. At the time the transaction was announced, Amneal said the combined business was expected to have more than 12 commercial biosimilars and over 20 additional products in its pipeline by 2030, against a backdrop of more than $300 billion in projected global biologic loss of exclusivity over the coming decade. (Amneal Pharmaceuticals) Strategic Rationale Amneal gains Kashiv’s R&D and manufacturing infrastructure to complement its existing commercial scale, creating an end-to-end biosimilars operation. The integration is intended to support parallel development and commercialisation and a more consistent cadence of future biosimilar launches. (BioSpace) Potential Impact Successful integration could increase Amneal’s capacity to develop and launch biosimilars as major biologic products lose exclusivity. The extent of that impact will depend on successful pipeline development, regulatory approvals, manufacturing execution and commercial competition in individual biosimilar markets. Key Takeaway Completing the Kashiv acquisition gives Amneal an integrated biosimilars platform spanning R&D, manufacturing and commercialisation rather than simply adding individual biosimilar assets. What to Watch Integration of Kashiv’s development and manufacturing operations, progress of the combined biosimilar pipeline and whether Amneal achieves its planned cadence of multiple biosimilar launches each year. (BioSpace) Primary Source Amneal Pharmaceuticals completion announcement, 10 August 2026 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 next-generation sequencing companion diagnostic identifies BRAF V600E and V600K variants, helping clinicians determine which melanoma patients may be eligible for FDA-approved BRAF or BRAF/MEK targeted therapies. The US Food and Drug Administration (FDA) has approved Labcorp’s PGDx elio tissue complete CDx as a companion diagnostic to identify melanoma patients with BRAF V600E or V600K variants who may benefit from FDA-approved BRAF inhibitors or BRAF/MEK inhibitor combinations. The approval provides hospitals and clinical laboratories with a kit-based next-generation sequencing option for identifying patients whose tumours carry actionable BRAF variants and informing targeted treatment selection. Field Content Alert Type Drug Approval Drug Name PGDx elio tissue complete CDx Indication Companion diagnostic for identifying melanoma patients with BRAF V600E or BRAF V600K variants who may benefit from FDA-approved BRAF inhibitors or BRAF/MEK inhibitor combinations, in accordance with the approved therapeutic product labelling. (PR Newswire) Therapy Area(s) Oncology; Melanoma; Precision medicine Geography United States (FDA) What Happened On 10 August 2026, Labcorp announced FDA approval of PGDx elio tissue complete CDx as a companion diagnostic for melanoma patients with BRAF V600E or V600K variants. The tissue-based next-generation sequencing assay detects genomic alterations from formalin-fixed, paraffin-embedded tumour samples and can now be used to identify melanoma patients who may benefit from FDA-approved BRAF inhibitors or BRAF/MEK inhibitor combinations. (PR Newswire) Why It Matters BRAF status is clinically relevant when selecting targeted treatment for patients with advanced melanoma. The approval gives qualified healthcare professionals another FDA-approved method for identifying BRAF V600E/K-positive patients who may be eligible for established targeted therapies, supporting biomarker-directed treatment decisions. (PR Newswire) Supporting Context PGDx elio tissue complete CDx is a qualitative next-generation sequencing in vitro diagnostic capable of detecting single nucleotide variants, small insertions and deletions, copy-number amplifications and translocations. As a kit-based assay, it can be implemented within hospitals and clinical laboratories rather than requiring samples to be sent exclusively to a central laboratory. (PR Newswire) Key Takeaway FDA approval expands access to companion diagnostic testing that can identify BRAF V600E/K-positive melanoma patients for whom BRAF-targeted treatment may be appropriate. Primary Source https://www.prnewswire.com/news-releases/labcorp-announces-fda-approval-of-companion-diagnostic-supporting-patients-with-advanced-melanoma-302846587.html 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 transaction would give Sobi full ownership of a specialist commercialisation platform spanning seven Latin American markets, building on its $105 million investment in Pint Pharma in 2025. Swedish Orphan Biovitrum (Sobi) is seeking to acquire the remaining shares of Pharma Investments, the parent company of Pint Pharma, giving it full ownership of the Latin American specialist pharmaceutical business following its $105 million investment for 19.9% of voting rights and 60% of economic rights in 2025. The transaction would give Sobi direct control of a regional platform covering regulatory approval, market access and distribution of specialist medicines across seven Latin American markets, supporting its expansion in rare diseases, haematology and oncology. Field Content Alert Type Deal Companies Swedish Orphan Biovitrum (Sobi); Pint Pharma / Pharma Investments Deal Type Acquisition of remaining ownership interest Asset or Company Pharma Investments, parent company of Pint Pharma Therapy Area(s) Rare diseases; Haematology; Oncology Deal Value Consideration for the acquisition of the remaining shares has not been disclosed. In November 2025, Sobi paid $105 million for 19.9% of the voting rights and 60% of the economic rights in Pint Pharma; that amount relates to the earlier investment and is not the consideration for the current transaction. (Dealroom.co) Geography Latin America, including Brazil, Mexico, Argentina and Colombia What Happened Sobi is moving to acquire all remaining shares of Pharma Investments, the parent company of Pint Pharma, according to a transaction submitted to Brazil's competition authority Cade. The proposed acquisition builds on Sobi's 2025 investment, when it acquired 19.9% of the voting rights and 60% of the economic rights for $105 million. Completion would give Sobi full control of Pint Pharma, which operates across seven Latin American markets. The transaction remains subject to the relevant review and has not yet been presented as completed. (Dealroom.co) Why It Matters Full ownership would give Sobi direct control of an established Latin American platform for regulatory approval, market access and distribution of specialist medicines. This could provide Sobi with greater control over launches and commercialisation across markets where navigating country-specific regulatory and access requirements can be important for rare disease and speciality medicines. (Dealroom.co) Supporting Context Sobi and Pint Pharma have maintained a commercial relationship since 2021. The companies expanded that relationship in 2025 when Sobi invested $105 million in Pint Pharma, describing the business as a launch platform for Sobi medicines in Brazil and the wider Latin American region. (Sobi) Strategic Rationale Sobi would move from holding a majority economic interest but minority voting position to full ownership, giving it direct control of Pint Pharma's regional infrastructure and expertise. The transaction therefore deepens an existing partnership rather than representing Sobi's entry into an entirely new commercial relationship. (Dealroom.co) Potential Impact Full ownership could allow Sobi to use Pint Pharma more extensively as a regional launch and commercialisation platform for its specialist portfolio. The eventual impact will depend on transaction completion and Sobi's subsequent decisions regarding which products are introduced through the platform. Key Takeaway Full ownership of Pint Pharma would give Sobi direct control of a seven-market Latin American platform for launching and commercialising rare disease and speciality medicines. What to Watch Review by Brazil's Cade, completion of the acquisition, disclosure of the purchase consideration and Sobi's plans for integrating Pint Pharma into its Latin American commercial operations. (Dealroom.co) Primary Source Brazilian competition filing (Cade); transaction details reported by Dealroom.co based on InvestNews Relevant Date 7 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 partnership gives Sobi potential global commercial and development rights to the first-in-class anti-KIR3DL2 antibody while funding Innate’s Phase III programme in cutaneous T-cell lymphoma. Sobi and Innate Pharma have entered a strategic licensing partnership for lacutamab, with Sobi paying $75 million at closing and Innate eligible for up to a further $505 million in development, regulatory and commercial milestones, plus tiered double-digit royalties. The agreement enables Innate to initiate the confirmatory Phase III TELLOMAK-3 study while giving Sobi exclusive global commercialisation rights following potential accelerated approval and an option to assume full global development rights after positive Phase III results. Field Content Alert Type Deal Companies Swedish Orphan Biovitrum (Sobi); Innate Pharma Deal Type Strategic licensing and development partnership Asset or Company Lacutamab Therapy Area(s) Haematology; Oncology; Cutaneous T-cell lymphoma Technology or Modality First-in-class anti-KIR3DL2 monoclonal antibody Deal Value $75 million payable at closing, plus up to $40 million in near-term development milestones related to Sézary syndrome and up to a further $465 million associated with Sobi obtaining full development rights and future regulatory and commercial milestones. Innate is also eligible for tiered double-digit royalties on net sales. The total potential value of up to $580 million is contingent and should not be treated as guaranteed consideration. (PR Newswire) Development Stage Phase III-ready; TELLOMAK-3 confirmatory Phase III study planned Geography Global What Happened On 10 August 2026, Sobi and Innate Pharma announced a strategic partnership covering lacutamab, Innate’s anti-KIR3DL2 antibody for cutaneous T-cell lymphoma (CTCL). Innate will conduct the confirmatory Phase III TELLOMAK-3 trial, which is intended to support a potential accelerated approval filing in Sézary syndrome and subsequent full approvals in Sézary syndrome and mycosis fungoides. Sobi will receive exclusive global commercialisation rights following potential accelerated approval and may assume full global development rights after positive Phase III results. The transaction remains subject to closing conditions, including antitrust clearance. (PR Newswire) Why It Matters The agreement provides the financing and commercial partnership needed to move lacutamab into its pivotal Phase III programme while giving Sobi access to a late-stage rare haematological cancer asset. Lacutamab has already received FDA Breakthrough Therapy and Fast Track designations and EMA PRIME designation for relevant CTCL settings, but its future regulatory and commercial potential remains dependent on successful Phase III development and regulatory review. (PR Newswire) Supporting Context Lacutamab is being developed for CTCL, a group of rare non-Hodgkin lymphomas that includes Sézary syndrome and mycosis fungoides. TELLOMAK-3 will enrol patients with these diseases who have failed at least one previous systemic therapy, with progression-free survival as the primary endpoint. (PR Newswire) Strategic Rationale Sobi gains potential global rights to a differentiated late-stage therapy that fits its rare-disease strategy and commercial infrastructure. Innate secures funding to initiate TELLOMAK-3 while retaining responsibility for the trial and potential future economics through milestones and double-digit royalties. (PR Newswire) Potential Impact Positive TELLOMAK-3 results could allow Sobi to assume full development rights and support regulatory filings across major markets, potentially establishing lacutamab as a new targeted treatment for CTCL. This depends on successful Phase III results and subsequent regulatory approvals. Key Takeaway The partnership provides a route to fund lacutamab’s pivotal Phase III development while giving Sobi potential global rights to a differentiated late-stage therapy for rare T-cell lymphomas. What to Watch Transaction closing and antitrust clearance, initiation of TELLOMAK-3, progress towards a potential accelerated approval filing in Sézary syndrome and whether positive Phase III results trigger Sobi’s option to assume full global development rights. (PR Newswire) Primary Source https://www.prnewswire.com/news-releases/sobi-enters-strategic-partnership-with-innate-pharma-to-license-lacutamab-in-t-cell-lymphoma-302846936.html 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 long-term manufacturing agreement covers 55 oncology and non-oncology products across three Gland Pharma sites, with commercial revenue expected to begin in 2029. Gland Pharma has entered a strategic manufacturing and supply agreement with an undisclosed global pharmaceutical company covering technology transfer, development and commercial manufacturing of 55 sterile injectable products for global markets, with annualised revenue potential of approximately $90–100 million once fully commercialised. The agreement significantly expands Gland Pharma’s CDMO portfolio and provides a long-term manufacturing programme spanning complex and conventional injectables across multiple delivery formats. Field Content Alert Type Deal Companies Gland Pharma; undisclosed global pharmaceutical company Deal Type Strategic manufacturing and supply agreement / CDMO partnership Asset or Company Portfolio of 55 sterile injectable SKUs Therapy Area(s) Oncology; multiple non-oncology therapy areas Technology or Modality Sterile injectable manufacturing, including vials, lyophilised products, ampoules and pre-filled syringes Deal Value Financial consideration was not disclosed. Gland Pharma estimates the programme could generate approximately $90–100 million in annualised revenue once the portfolio is fully commercialised; this is projected future revenue rather than a guaranteed transaction value. (The Economic Times) Development Stage Portfolio includes both commercially marketed products and pipeline products under development. Geography Global What Happened Gland Pharma announced on 9 August 2026 that it had entered a strategic Manufacturing and Supply Agreement with an undisclosed global pharmaceutical company covering 55 sterile injectable SKUs across three Gland Pharma manufacturing sites. Under the full-service CDMO arrangement, Gland Pharma will undertake technology transfer, process development, scale-up, validation, commercial manufacturing and long-term supply, alongside quality and regulatory support. Technology transfer is expected to be completed within two years, with revenue generation planned to begin in calendar year 2029. (The Economic Times) Why It Matters The agreement provides Gland Pharma with a sizeable long-term CDMO programme covering a diversified portfolio rather than an individual product, increasing utilisation of its sterile manufacturing infrastructure and providing potential future revenue visibility. It also broadens the company’s role from manufacturing towards an integrated development, technology-transfer and supply partner, although the projected $90–100 million annual revenue depends on successful technology transfer and portfolio commercialisation. (The Economic Times) Supporting Context The portfolio spans complex and conventional injectable formulations across oncology and non-oncology products. CDMO is already an important part of Gland Pharma’s business, accounting for approximately 46% of FY26 revenue and growing 28% year on year. (The Economic Times) 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 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