If authorised, Icotyde would become the first oral treatment targeting the interleukin-23 receptor available to eligible adults and adolescents in the EU. The European Medicines Agency’s human medicines committee has recommended granting EU marketing authorisation to Janssen-Cilag’s Icotyde (icotrokinra) for moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older weighing at least 40 kg. The positive opinion introduces the prospect of an oral interleukin-23 receptor-targeted treatment, but a European Commission decision and national pricing and reimbursement assessments are still required before patient access. Field Content Alert Type Industry Update Topic Regulatory recommendation and psoriasis treatment Organisation(s) European Medicines Agency; Committee for Medicinal Products for Human Use; Janssen-Cilag International N.V. Affected Stakeholders Dermatologists, eligible adults and adolescents with plaque psoriasis, Janssen-Cilag, payers and national reimbursement authorities Therapy Area(s) Dermatology; plaque psoriasis Geography European Union What Happened On 23 July 2026, EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending EU marketing authorisation for Icotyde for moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older weighing at least 40 kg. The recommendation is not a marketing authorisation: it will be referred to the European Commission for a final decision. Why It Matters Icotyde blocks the interleukin-23 receptor and would be the first authorised oral medicine targeting the interleukin-23 pathway in the EU. This could provide an additional treatment format for eligible patients alongside existing injectable medicines targeting the pathway. Supporting Context EMA assessed four Phase 3 trials involving approximately 2,500 patients. Across three studies, 50% to 57% of patients receiving Icotyde achieved PASI 90 after 16 weeks, compared with 1% to 4% receiving placebo; a fourth study included psoriasis affecting difficult-to-treat areas. Who Is Most Affected Dermatologists and eligible patients would be most directly affected by the potential addition of an oral interleukin-23 receptor-targeted treatment. Payers and national health authorities will subsequently determine pricing and reimbursement if the European Commission grants authorisation. Industry Impact If authorised, Icotyde could increase competition in the moderate-to-severe psoriasis market and broaden treatment choice for patients who may prefer an oral medicine. Its practical impact will depend on the final authorised indication, national reimbursement decisions and adoption in clinical practice. Key Takeaway The positive CHMP opinion moves the first oral interleukin-23 receptor-targeted psoriasis treatment closer to EU authorisation, but it is not yet approved. What to Watch The European Commission’s marketing-authorisation decision, followed by pricing and reimbursement decisions in individual EU Member States. Primary Source European Medicines Agency announcement Relevant Date 23 July 2026 — positive CHMP opinion 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 provides adults and children aged 12 years and older with a single over-the-counter combination option that delivers both rapid and prolonged pain relief without requiring separate analgesic products. The US Food and Drug Administration (FDA) has approved Tylenol with Naproxen (acetaminophen/naproxen sodium) for the temporary relief of pain, making it the first non-prescription fixed-dose combination of acetaminophen and naproxen sodium available in the United States. The approval offers an additional over-the-counter pain management option for patients aged 12 years and older while providing a single-tablet formulation that combines two established non-opioid analgesics. Field Content Alert Type Drug Approval Drug Name Tylenol with Naproxen Indication Temporary relief of pain in adults and children aged 12 years and older. Therapy Area(s) Pain Management Geography US (FDA) What Happened On 24 July 2026, the FDA approved Tylenol with Naproxen (acetaminophen 325 mg/naproxen sodium 110 mg tablets) for over-the-counter temporary pain relief in adults and children aged 12 years and older. The approval establishes the product as the first non-prescription fixed-dose combination of acetaminophen and naproxen sodium, providing up to 12 hours of pain relief in a single tablet formulation. Why It Matters The approval introduces a new over-the-counter treatment option that combines two well-established non-opioid analgesics in a fixed-dose product, potentially simplifying pain management for patients who would otherwise use separate acetaminophen and naproxen products. It expands the range of non-prescription analgesic options but does not alter existing safety precautions associated with acetaminophen- or NSAID-containing medicines. Supporting Context While other over-the-counter products combine acetaminophen with a non-steroidal anti-inflammatory drug, this is the first to combine acetaminophen specifically with naproxen sodium. FDA-approved labelling includes standard warnings for both acetaminophen- and NSAID-containing products, including liver toxicity and pregnancy-related precautions. Key Takeaway FDA approval adds the first fixed-dose acetaminophen and naproxen sodium combination to the US over-the-counter pain relief market, expanding non-prescription treatment choices for eligible patients. What to Watch Monitor commercial availability following the FDA approval and how the product is incorporated into over-the-counter pain management recommendations and consumer use. Primary Source https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-nonprescription-fixed-dose-combination-acetaminophen-and-naproxen-sodium-12-hour Relevant Date 24 July 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

If authorised, the combination would add an antibody-drug conjugate-based first-line option for eligible European patients with unresectable locally advanced or metastatic triple-negative breast cancer. The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended extending Trodelvy’s marketing authorisation to include its use with Keytruda in adults with previously untreated, PD-L1-positive, unresectable locally advanced or metastatic triple-negative breast cancer. The positive opinion could expand first-line treatment choice for this population, but a European Commission decision is still required before the indication is authorised in the EU. Field Content Alert Type Industry Update Topic Regulatory recommendation and first-line breast cancer treatment Organisation(s) European Medicines Agency; Committee for Medicinal Products for Human Use; Gilead Sciences Affected Stakeholders Medical oncologists, eligible patients with metastatic triple-negative breast cancer, Gilead Sciences, Merck, payers and national reimbursement authorities Therapy Area(s) Oncology; breast cancer Geography European Union What Happened On 24 July 2026, the CHMP adopted a positive opinion recommending Trodelvy (sacituzumab govitecan) in combination with Keytruda (pembrolizumab) for adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumours express PD-L1 with a combined positive score of at least 10 and who have not received systemic treatment for metastatic disease. The opinion is a regulatory recommendation rather than a marketing authorisation and will now be considered by the European Commission. Why It Matters If authorised, the regimen would provide an antibody-drug conjugate plus immunotherapy option in the first-line PD-L1-positive setting. The recommendation also extends Trodelvy’s potential role across first-line metastatic triple-negative breast cancer, following EU authorisation of Trodelvy monotherapy for patients who are not candidates for PD-1 or PD-L1 inhibitor treatment. Supporting Context The recommendation is based on the Phase 3 ASCENT-04/KEYNOTE-D19 study, in which Trodelvy plus Keytruda reduced the risk of disease progression or death by 35% compared with standard chemotherapy plus Keytruda in patients with PD-L1-positive metastatic triple-negative breast cancer. Who Is Most Affected Oncologists and eligible patients would be most directly affected by the possible addition of a new first-line regimen. Payers and health technology assessment bodies would subsequently assess pricing, reimbursement and positioning within European treatment pathways. Industry Impact Authorisation could increase competition in the first-line metastatic triple-negative breast cancer market and support wider use of antibody-drug conjugates earlier in treatment. The practical impact would depend on the final European Commission decision, national reimbursement and clinical adoption. Key Takeaway The CHMP opinion moves Trodelvy plus Keytruda closer to becoming a first-line European treatment option for PD-L1-positive metastatic triple-negative breast cancer, but the combination is not yet authorised for this indication. What to Watch The European Commission’s final decision, the authorised label and subsequent pricing and reimbursement decisions across individual EU Member States. Primary Source European Medicines Agency opinion on the Trodelvy variation Relevant Date 24 July 2026 — CHMP positive opinion 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

If authorised by the European Commission, Icotyde would provide eligible adults and adolescents with an oral alternative to existing injectable treatments targeting the IL-23 pathway. The European Medicines Agency’s human medicines committee has recommended EU marketing authorisation for Janssen-Cilag’s Icotyde (icotrokinra) to treat moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older weighing at least 40 kg who are candidates for systemic therapy. The positive opinion moves the first oral medicine targeting the interleukin-23 receptor closer to European availability, although final authorisation and national pricing and reimbursement decisions are still required. Field Content Alert Type Industry Update Topic Regulatory recommendation and oral plaque psoriasis treatment Organisation(s) European Medicines Agency; Committee for Medicinal Products for Human Use; Janssen-Cilag International N.V. Affected Stakeholders Dermatologists, eligible adults and adolescents with plaque psoriasis, Janssen-Cilag, payers and national reimbursement authorities Therapy Area(s) Dermatology; plaque psoriasis Geography European Union What Happened On 23 July 2026, the Committee for Medicinal Products for Human Use adopted a positive opinion recommending marketing authorisation for Icotyde. The proposed indication covers moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older weighing at least 40 kg who are candidates for systemic therapy. The recommendation is not yet an EU marketing authorisation and will be referred to the European Commission for a final decision. Why It Matters Icotyde is an oral synthetic peptide that selectively targets the interleukin-23 receptor. If authorised, it would become the first oral medicine targeting the IL-23 pathway in the EU, potentially broadening treatment choice for patients who currently receive injectable medicines acting on the same pathway. Supporting Context The CHMP assessment included four Phase 3 studies involving nearly 2,500 adults and adolescents. EMA reported that the treatment reduced disease severity and skin involvement; fungal infections were the most commonly reported adverse effect. Who Is Most Affected Dermatologists and eligible patients would be most directly affected by the potential availability of an oral IL-23 receptor-targeted treatment. National payers and health technology assessment bodies would determine pricing, reimbursement and positioning within local treatment pathways following any European Commission authorisation. Industry Impact Authorisation could increase competition within the moderate-to-severe psoriasis market and expand the use of IL-23-targeted treatment beyond injectable products. Its practical effect would depend on the final label, comparative clinical positioning, national reimbursement and adoption in practice. Key Takeaway The CHMP opinion moves the first oral IL-23 receptor-targeted psoriasis medicine closer to EU authorisation, but Icotyde is not yet approved. What to Watch The European Commission’s final marketing-authorisation decision, publication of the approved product information and subsequent pricing and reimbursement decisions across EU Member States. Primary Source European Medicines Agency: Icotyde Relevant Date 23 July 2026 — positive CHMP opinion 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

This article provides a structured interpretation of the NHS Employers summary of the Doctors’ and Dentists’ Pay Review Body (DDRB) 2026 pay award announcement. It is based on the published employer evidence and associated workforce data, focusing on what the reported figures show about current trends in NHS primary care staffing. The DDRB 2026 announcement confirms a 3.5% pay uplift for doctors, dentists and salaried GPs, and a 3.75% uplift for salaried dentists in community services from April 2026. Alongside the pay decision, the employer evidence provides context on workforce composition, recruitment, retention, and operational pressures across general practice and dentistry. Dentistry: Workforce and Service Pressures in Community and Public Provision Community Dental Services (CDS) and Public Dental Services (PDS) provide care for patients with complex needs who may not be able to access general dental services. The employer evidence highlights several consistent trends across these services. Demand pressures linked to access in general dentistry The evidence indicates that pressures in general dental access are contributing to increased demand within CDS and PDS settings. This includes: Higher volumes of complex patient presentations Increased reliance on CDS and PDS provision Concentration of patients with higher treatment needs within these services Workforce trends in community and public dentistry The data shows reductions in workforce levels over time in parts of the UK: CDS dentist headcount in England has reduced over the past decade PDS workforce in Scotland has declined from 438 in 2015 to 336 in 2025 These figures indicate a downward trend in staffing levels within these services over the period reported. Recruitment and vacancy filling The employer evidence reports ongoing recruitment challenges in salaried dental roles, particularly in entry-level positions and in certain geographic areas. Examples include: Difficulty filling Band A salaried dental posts Extended recruitment processes for some vacancies Reduced applicant availability in rural and coastal regions One example cited involved 81 recruitment campaigns undertaken to fill 17 posts. Workforce pressures and workplace experience The evidence also references reports of increasing incidents of verbal and physical aggression towards dental staff, often associated with patient frustration linked to waiting times and access constraints. General Practice: Workforce Composition and Employment Structure The employer evidence describes changes in the composition of the GP workforce over recent years, alongside overall growth in qualified GP numbers. Changes in GP workforce structure In England, the reported trends include: Qualified permanent GP full-time equivalent growth of 2.1% in the most recent year GP partners decreasing by 2.9% in the same period (12.7% over five years) Salaried GPs increasing by 8.8% in the same period (35.0% over five years) These figures show a shift in the balance between partner and salaried roles within general practice. Differences in working patterns The evidence indicates differences in average participation rates between GP partners and salaried GPs: GP partners: approximately 0.85 full-time equivalent participation Salaried GPs: approximately 0.62 full-time equivalent participation This indicates variation in average clinical time worked per individual across contract types. Recruitment and early-career employment The employer evidence highlights ongoing recruitment and retention challenges within general practice. It also references situations where newly qualified GPs may experience difficulties securing employment opportunities, alongside reports of practices using alternative workforce funding routes such as ARRS to support staffing. Pay and Financial Context The DDRB 2026 evidence includes information on GP earnings and practice financial pressures. GP partner earnings Reported median pre-tax incomes for GP partners vary by nation: England: £141,700 Northern Ireland: £108,100 These figures show variation in contractor GP earnings across the UK. Salaried GP pay Salaried GP pay is reported as broadly aligned with or below comparator roles when adjusted for full-time equivalent, with variation depending on contract terms and local arrangements. The employer's evidence also notes that pay award implementation may vary depending on practice-level financial constraints. Practice cost pressures The evidence reports increases in operating costs across primary care: 17% increase in expenses in England (2023–24) 15% increase in Wales over the same period increased borrowing and financing costs, including a reported 68% rise in interest and mortgage-related expenses for some practices These cost increases are presented alongside broader inflationary and staffing pressures affecting practice finances. Summary of Reported Trends Across the DDRB 2026 employer evidence, several consistent patterns are reported: Dentistry Increased demand within CDS and PDS linked to access pressures in general dentistry Declining workforce levels in some regions over time Ongoing recruitment difficulties in salaried and entry-level roles Reports of increased workplace pressure and patient-related incidents General Practice Growth in total qualified GP numbers alongside a shift from partner to salaried roles Differences in average participation rates between contract types Ongoing recruitment and retention challenges Variation in pay and financial conditions across nations and practices Rising operational costs within general practice Conclusion The DDRB 2026 employer evidence and associated pay award data show changes in both workforce composition and operational pressures across dentistry and general practice. The reported figures highlight shifts in employment structure, variation in workforce distribution, and ongoing recruitment and financial constraints within primary care services. Source NHS Employers - Doctors’ and dentists’ pay award announcement 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

Jazz Pharmaceuticals has expanded its oncology pipeline through a new collaboration with AbCellera, signing a deal worth more than $2.4 billion focused on developing next-generation multispecific antibodies for gastrointestinal (GI) cancers and other solid tumours. The agreement strengthens Jazz’s position in oncology while providing access to AbCellera’s advanced antibody discovery platform, which is designed to generate novel T-cell engaging therapies capable of tackling some of the most difficult-to-treat cancer types. Targeting the Next Wave of T-Cell Engagers The partnership centres on the discovery of multispecific antibodies that can direct a patient’s own T cells to recognise and destroy cancer cells. AbCellera will deploy its proprietary technology stack, which combines CD3-binding antibody libraries, costimulatory targeting approaches, multispecific protein engineering and high-throughput functional screening tools. Together, these capabilities are designed to overcome some of the limitations that have historically restricted T-cell engager therapies in solid tumours, where treatment success has lagged behind achievements seen in blood cancers. Under the agreement, AbCellera will lead discovery and early-stage development for two initial T-cell engager programmes and has committed to initiating a third programme within the next 12 months. Jazz will retain exclusive options to advance each candidate into clinical development and global commercialisation. The companies also have the flexibility to expand the collaboration with up to two additional programmes in the future. A Heavily Back-Loaded Deal Structure Financially, the deal follows a familiar biotech partnership model, with relatively modest upfront payments balanced by substantial downstream incentives. AbCellera will receive $56 million upfront covering the first two programmes, alongside a further $28 million payment when the third programme is launched. The larger value lies in future milestones. Should Jazz choose to exercise its development options, AbCellera could receive up to $792 million per programme through a combination of option fees, development milestones, regulatory achievements and commercial sales targets. In addition, the Canadian biotech will be eligible for tiered royalties ranging from the mid-single digits to low-double digits on future product sales. The structure allows Jazz to access multiple early-stage assets while limiting upfront risk, while giving AbCellera significant upside if the programmes progress successfully. Building on Jazz’s GI Oncology Strategy The collaboration aligns closely with Jazz’s growing focus on gastrointestinal cancers. The company’s current GI oncology franchise is led by zanidatamab, a HER2-targeted bispecific antibody marketed as Ziihera. The therapy received accelerated FDA approval in 2024 for previously treated biliary tract cancer and has become a cornerstone of Jazz’s oncology growth strategy. Momentum around zanidatamab continues to build. The drug recently outperformed Roche’s Herceptin in a Phase III study involving first-line gastroesophageal adenocarcinoma and is currently under FDA priority review for a potential label expansion, with a regulatory decision expected later this year. By adding multiple T-cell engager programmes focused on GI cancers and solid tumours, Jazz is broadening its oncology portfolio beyond a single lead asset while increasing exposure to one of the industry's most active areas of cancer research. Why the Deal Matters The Jazz–AbCellera agreement reflects several wider trends shaping oncology drug development: Multispecific antibodies continue to attract significant investment as companies search for more effective immune-based therapies. T-cell engager technologies are increasingly being adapted for solid tumours, an area with substantial unmet clinical need. Pharmaceutical companies are favouring platform-based partnerships that generate multiple assets rather than pursuing individual licensing deals. Discovery-stage biotech companies are increasingly monetising proprietary AI, screening and engineering platforms through large milestone-driven collaborations. For Jazz, the deal represents another step in its evolution into a larger oncology player. For AbCellera, it provides validation of its antibody discovery capabilities while creating a potentially lucrative long-term development partnership. Summary Jazz Pharmaceuticals has signed a collaboration worth more than $2.4 billion with AbCellera to develop multispecific antibody therapies targeting GI cancers and other solid tumours. The partnership gives Jazz access to a pipeline of next-generation T-cell engager candidates while leveraging AbCellera’s antibody discovery and engineering platform. With multiple programmes planned and significant milestone potential, the deal highlights the growing industry focus on multispecific antibodies and immune-engaging approaches in solid tumour oncology. 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

What $500,000+ average cardiology pay actually means for your position in the specialty. The Medscape Cardiologist Compensation Report 2026 shows cardiology sitting firmly at the top end of physician earnings, with average total compensation just over $500,000. This includes base salary, bonus, and additional income such as productivity-linked and profit-sharing components. What matters is not just the figure itself, but how your own compensation compares to it. Cardiologist compensation sits just above $500,000 on average The Medscape 2026 data confirms cardiologists are firmly in the top tier of physician earnings, with average total compensation just over $500,000. What this means in real terms: This is now the baseline reference point for the specialty Anything significantly below this figure places you under the reported cardiology average Anything meaningfully above it places you in the upper-earning segment of the specialty So the key question becomes: Are you above or below the $500,000 cardiology anchor point? Because that is now the effective centre of gravity for the specialty. A meaningful share of cardiologists sit below the average Despite the high average figure, the report shows that not all cardiologists are clustered around it. A substantial portion sits below the $500,000 level, while others sit above it and pull the average upward. If you are earning noticeably below $500,000: You are not outside cardiology norms But you are below the reported central earnings anchor for the specialty If you are around $500,000: You are aligned with the typical cardiology outcome in 2026 If you are above it: You are in the higher output segment of cardiology economics, where procedural volume and system structure start to dominate earnings Only 52% of cardiologists feel fairly compensated Just 52% of cardiologists say they feel fairly compensated despite the $500,000+ average. That creates an important disconnect. Being above a very high absolute income level does not guarantee perceived fairness. What this means for you: Two cardiologists on similar earnings can feel very differently about their compensation depending on workload, administrative burden, and system structure. So even at this level, income and satisfaction are not tightly aligned. 42% expect further pay increases, 44% expect flat pay, 14% expect decline The report shows the following expectations: 42% expect pay increases 44% expect flat compensation 14% expect a decrease What this means in real terms: The majority of cardiologists are no longer expecting strong upward movement beyond the current level. So even in a specialty anchored above $500,000, future earnings progression is becoming uneven and increasingly uncertain. What this means for you by experience level If you are an early career (0–3 years post-consultant) At this stage, the $500,000+ figure is not where most cardiologists start. What matters is positioning relative to it. If you are: Significantly below $500,000, you are in the early development phase of cardiology earnings Approaching $500,000, you are already reaching full specialty earning potential earlier than typical Above $500,000, you are already in a high-output cardiology role very early in your consultant career Key point: The distance to the $500,000 anchor is the most important signal at this stage. If you are mid-career (4–9 years) This is where cardiology earnings stabilise around the $500,000 anchor. What the report implies: This is the phase where most cardiologists converge around the average divergence begins depending on procedural intensity and system structure If you are: Below $500,000, you are under the cardiology centre of gravity Around $500,000, you are tracking the typical specialty outcome Above $500,000, you are in the higher output segment of the distribution Key insight: This is where earnings stop being about experience and start being about structure. If you are established (10–19 years) At this stage, $500,000 becomes a dividing line rather than a benchmark. What the report shows: Many cardiologists remain clustered near the average Others pull above it based on productivity and procedural volume If you are: Below $500,000, you are under the current cardiology earnings anchor Around $500,000, you are aligned with the main distribution of the speciality Above $500,000, you are in the group capturing a disproportionate share of cardiology earnings Key point: The gap between below and above average becomes financially meaningful at this stage. If you are a senior (20+ years) At the senior level, the $500,000 figure becomes a split point. Two outcomes emerge: Stabilised earnings around the $500,000 anchor Or continued progression above it driven by procedural scale and practice structure The difference is no longer experience-based. It is system-based. The core message of the 2026 report The Medscape 2026 cardiology data can be reduced to three hard anchors: Cardiology average sits just above $500,000 52% feel fairly compensated 44% expect flat pay, 42% expect increases Taken together, they show a clear structure: Cardiology is a high-paying speciality where $500,000 is the central reference point, but not everyone sits at it, and not everyone moves beyond it. Summary If you are a cardiologist reading this report, the key question is not whether the specialty pays well. It clearly does, anchored just above $500,000. The real question is: Am I below, around, or above the $500,000 cardiology benchmark And is my position moving with the specialty or stagnating beneath it Because the report makes one thing very clear: $500,000 is the centre of cardiology earnings, but your position relative to it defines your real income outcome. Source Medscape Cardiologist Compensation Report 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

A new biotech focused exclusively on migraine treatment has emerged with significant financial backing and a leadership team responsible for some of the most important advances in migraine medicine over the last decade. Vedana Therapeutics has launched with $46 million in Series A funding and a clear ambition: to become what its leadership describes as "the migraine company." The company is targeting patients who continue to experience debilitating migraines despite the arrival of CGRP inhibitors, one of the most important therapeutic breakthroughs in neurology in recent years. Building Beyond the CGRP Revolution The approval of the first CGRP inhibitor in 2018 transformed migraine treatment, creating the first therapies specifically designed to prevent migraines rather than repurposing medicines developed for other conditions. However, despite the success of drugs such as Aimovig and Ajovy, a substantial proportion of patients continue to experience significant disease burden. Vedana believes the next major opportunity lies in targeting a separate biological pathway involving pituitary adenylate cyclase-activating polypeptide (PACAP). Research has shown that PACAP can trigger migraine-like symptoms even when CGRP pathways are fully blocked, suggesting it may represent an important complementary mechanism involved in migraine development. By targeting PACAP, Vedana hopes to provide meaningful relief for patients who do not achieve sufficient benefit from current therapies. Two Lead Programmes Targeting Unmet Need The company's pipeline is centred around two investigational programmes: A next-generation anti-PACAP monoclonal antibody A dual-targeting PACAP/CGRP bispecific antibody The dual-targeting approach is particularly notable because it seeks to address multiple migraine pathways simultaneously, potentially improving outcomes for patients with difficult-to-treat disease. Vedana plans to use its newly secured funding to advance both programmes into clinical development next year. Entering an Increasingly Competitive Space Vedana is not alone in pursuing PACAP-based therapies. Several companies are now targeting the pathway, with Lundbeck currently leading the field through its investigational PACAP antibody bocunebart, which recently delivered positive Phase IIb migraine data. Other emerging players are also building PACAP-focused pipelines, reflecting growing industry confidence that the pathway could represent the next major wave of migraine innovation. Despite the increasing competition, Vedana believes its differentiation will come from developing therapies that are: More potent Longer acting Suitable for at-home administration Delivered through convenient autoinjector devices The company hopes these characteristics will improve both patient outcomes and treatment accessibility. A Leadership Team with Proven Migraine Expertise One of Vedana's most significant advantages may be its leadership team. The company has assembled executives and scientists who played central roles in developing some of today's leading migraine therapies. Key members include: Co-founder and Chief Scientist Leon Garcia, who previously helped develop both anti-CGRP and anti-PACAP antibodies at Alder BioPharmaceuticals Chief Medical Officer Ernesto Aycardi, who led pivotal and post-marketing studies for Ajovy Executive Chairman Rob Lenz, who previously oversaw the development of Aimovig during his time at Amgen This concentration of migraine-specific expertise gives Vedana experience across the entire drug development lifecycle, from discovery through to commercial launch. Why the Launch Matters Vedana's emergence highlights several important trends within neurology and biotech innovation: Migraine remains a major area of unmet medical need despite recent therapeutic advances. Companies are increasingly exploring alternative biological pathways beyond CGRP. PACAP is emerging as one of the most closely watched targets in migraine research. Investors continue to back specialist biotech companies built around focused disease expertise. Next-generation migraine therapies are increasingly aiming to improve both efficacy and patient convenience. The company's launch also demonstrates continued confidence that meaningful improvements can still be made beyond today's market-leading migraine treatments. Summary Vedana Therapeutics has launched with $46 million in funding and a leadership team drawn from some of the most successful migraine drug development programmes in recent history. Focused on the PACAP pathway, the company is developing both a next-generation anti-PACAP antibody and a dual-targeting PACAP/CGRP therapy designed to address patients who continue to experience migraines despite existing treatments. As competition around PACAP intensifies, Vedana is positioning itself to become a specialist leader in the next phase of migraine innovation. Discover how nuaxia can support your next medical education initiative: Find out more about our specialist services - Moore's Outcome Assessments, Educational Needs Assessments and Patient Impact Studies for the Medical Education sector Contact us on: support@nuaxia.com

Merck & Co. has strengthened its commitment to AI-driven drug discovery through a new multi-year partnership with Protillion Biosciences, signing a deal worth up to $510 million focused on identifying and engineering novel therapeutic candidates. The agreement will combine Merck's drug development capabilities with Protillion's AI-powered protein engineering platform, highlighting the growing role artificial intelligence is playing in the search for next-generation medicines. Using AI to Solve Complex Protein Engineering Challenges At the centre of the collaboration is Protillion's proprietary Prot-MaP platform, a lab-in-the-loop AI system designed to generate and analyse vast amounts of protein data. Unlike traditional protein engineering approaches, Prot-MaP can characterise millions of protein variants in a single run, creating large-scale training datasets that help AI models understand how subtle protein changes influence therapeutic performance. The platform is specifically designed to overcome one of the biggest challenges in AI drug discovery: model overfitting, where algorithms perform well on training data but struggle to predict outcomes in real-world development programmes. By generating high-quality experimental data at scale, Protillion aims to improve the reliability and predictive power of AI-driven protein design. The technology could enable the development of increasingly sophisticated biologic medicines featuring characteristics such as multi-target specificity and pH-dependent activity profiles. A Growing Focus on AI-Enabled Discovery For Merck, the partnership represents another step in a broader strategy to integrate artificial intelligence into early-stage research and development. AI is increasingly being deployed across the pharmaceutical industry to accelerate target identification, optimise molecule design and improve candidate selection before entering costly clinical development programmes. The ability to rapidly explore complex protein landscapes has become particularly attractive as biologic medicines continue to grow in importance across oncology, immunology and rare diseases. By combining machine learning with experimental validation, companies hope to reduce development timelines while improving the likelihood of identifying successful therapeutic candidates. A Milestone-Driven Collaboration Financial details of the agreement follow a familiar biotech partnership structure. Protillion will receive an undisclosed upfront payment and becomes eligible for additional research, development and commercial milestone payments tied to the successful advancement of multiple therapeutic programmes. The total potential value of the agreement exceeds $510 million. The structure allows Merck to access cutting-edge AI capabilities while limiting upfront financial risk, while providing Protillion with significant long-term upside if the collaboration generates successful drug candidates. Momentum Continues for Protillion The deal marks another significant milestone for Protillion as it expands both its technology platform and industry partnerships. The company recently appointed Bob Hollingsworth as Chief Scientific Officer. Hollingsworth brings extensive pharmaceutical experience, having previously held senior scientific leadership positions at Pfizer, GSK, MedImmune and Shoreline Therapeutics. Protillion has also attracted strong investor support since its launch, raising $18 million in Series A financing in 2022 from ARCH Venture Partners and Illumina Ventures. The Merck agreement provides further validation of the company's platform and its approach to AI-enabled protein engineering. Why the Deal Matters The Merck-Protillion collaboration reflects several broader trends shaping pharmaceutical R&D: AI is increasingly moving from experimental research into core drug discovery workflows. Protein engineering remains one of the most promising applications for machine learning in biotech. Pharmaceutical companies are seeking platform partnerships rather than individual asset acquisitions. Lab-in-the-loop AI models are gaining traction as companies seek better quality training data. Biologics continue to drive demand for advanced computational discovery tools. As competition intensifies around AI-enabled drug development, access to proprietary datasets and experimental validation capabilities is becoming an increasingly important differentiator. Summary Merck & Co. has signed a partnership worth up to $510 million with Protillion Biosciences to discover and engineer new therapeutic candidates using AI-powered protein design. The collaboration centres on Protillion's Prot-MaP platform, which combines large-scale experimental data generation with machine learning to optimise biologic drug discovery. The deal highlights the pharmaceutical industry's growing reliance on AI-driven platforms to accelerate innovation, improve candidate selection and unlock increasingly complex therapeutic opportunities. 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

Dermatology earnings flatten: positioning now defines outcomes, not progression

Swiss medical device company Distalmotion has secured additional US Food and Drug Administration (FDA) 510(k) clearance for its DEXTER robotic surgery system, further expanding its role in minimally invasive gynaecological procedures. The latest authorisation covers sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and endometriosis resection, marking the system’s second FDA clearance specifically within gynaecology and its fourth overall indication in the US. Expanding the Scope of Robotic Gynaecological Surgery With this new clearance, DEXTER now supports a broader range of gynaecological procedures beyond its existing approvals for hysterectomy and salpingo-oophorectomy. The system is also cleared for select general surgery procedures, including inguinal hernia repair and cholecystectomy, reinforcing its positioning as a multi-specialty soft tissue robotic platform. The expanded indication set is expected to increase adoption in ambulatory surgery centres (ASCs), where efficiency, throughput, and same-day discharge capabilities are increasingly important. By enabling a wider range of procedures to be performed robotically in outpatient environments, Distalmotion aims to support the continued shift of surgical care away from inpatient hospital settings. Supporting Outpatient Care Models Ambulatory surgery centres are under growing pressure to expand service lines while maintaining high procedural efficiency. DEXTER’s compact design and focus on streamlined robotic assistance are positioned to support this need, allowing care teams to treat a broader range of women’s health conditions without increasing procedural complexity. The system is designed for laparoscopic procedures across urology, general surgery, and gynaecology, combining robotic precision with workflows tailored to outpatient settings. Company Perspective on the Clearance Distalmotion CEO Greg Roche described the clearance as an important step in expanding the system’s clinical footprint in gynaecology. He said the additional indications help enable a more comprehensive GYN service line, supporting care teams in delivering robotic-assisted procedures alongside same-day discharge pathways. According to the company, this combination of robotics and outpatient care is central to improving both efficiency and patient access. Continued Clinical and Commercial Progress Alongside regulatory expansion, Distalmotion is advancing its US investigational device exemption (IDE) study evaluating DEXTER in myomectomy, further broadening its clinical evidence base in gynaecological surgery. The company reports that more than 4,000 patients have already been treated using the system across approved indications. DEXTER is a soft tissue robotic platform designed with single-use instruments and a compact footprint to facilitate integration into operating rooms with varying levels of infrastructure. Positioning in the Surgical Robotics Landscape The expansion of FDA clearances reflects broader momentum in surgical robotics, where manufacturers are increasingly focusing on: Expanding indications across multiple surgical specialties Supporting outpatient and ambulatory care settings Improving procedural efficiency and workflow integration Increasing adoption of minimally invasive techniques Distalmotion’s strategy aligns with this shift, targeting broader clinical applicability rather than single-procedure robotic systems. Summary Distalmotion has secured additional FDA clearance for its DEXTER robotic surgery system, expanding its approved use in gynaecological procedures including prolapse repair and endometriosis treatment. The move strengthens the system’s position in outpatient surgical care and supports its broader ambition to become a multi-specialty robotic platform across gynaecology, general surgery, and urology. With continued clinical studies underway and increasing procedural adoption, DEXTER is steadily broadening its footprint in the evolving surgical robotics market. 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 US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have announced a new formal collaboration initiative designed to deepen regulatory alignment across medical devices, artificial intelligence, and innovative medicines. The initiative aims to improve the speed and consistency of regulatory decision-making while preserving the independence of both agencies. It reflects a broader effort to keep pace with rapid scientific and technological advances shaping global healthcare development. A More Structured Model for Regulatory Cooperation At the centre of the programme is a new liaison framework, with reciprocal officer roles established within both agencies. These dedicated positions are intended to support ongoing scientific exchange, streamline communication, and improve coordination on emerging regulatory challenges. By embedding collaboration into day-to-day operations, the FDA and MHRA aim to reduce friction for developers operating across both markets, particularly in high-growth areas such as AI-enabled healthcare technologies and next-generation medical devices. The programme was formally introduced at the DIA Global Annual Meeting in Philadelphia, held from 14 to 18 June. MHRA CEO Lawrence Tallon said the initiative represents a step change in collaboration between the two regulators, particularly in how they share expertise and respond to technological change. He noted that improved alignment could help companies bring products to market more efficiently in both the UK and the US, reducing duplication in regulatory processes. FDA deputy commissioner Grace Graham also emphasised the benefits of closer cooperation, highlighting faster access to medical products and improved regulatory efficiency for patients and innovators. Industry Welcomes Reduced Friction Across Markets The announcement has been broadly welcomed by industry stakeholders. Scott Whitaker, CEO of the Advanced Medical Technology Association (AdvaMed), said closer alignment between the agencies could help reduce regulatory burden and accelerate patient access to medical technologies on both sides of the Atlantic. The initiative also builds on earlier commitments made in April to strengthen UK-US cooperation in medical device regulation. It comes at a time when governments and regulators are increasingly focused on balancing innovation with safety in fast-moving sectors such as AI-driven diagnostics and software-based medical devices. Linking Regulatory Alignment to Broader UK-US Policy Shifts The collaboration follows recent developments in UK-US pharmaceutical policy, including a trade and pricing agreement implemented in April 2026. That deal removed tariffs on UK pharmaceutical exports to the US and adjusted NHS pricing frameworks for new branded medicines. Commenting on the broader context, Duncan Edwards, CEO of BritishAmerican Business, said the initiative sends a positive signal for cross-border investment and innovation, highlighting the importance of regulatory certainty for industry planning and growth. Advancing AI Regulation in Healthcare The MHRA’s involvement in the programme also coincides with its ongoing work to develop a new regulatory framework for artificial intelligence in healthcare. This framework is expected to replace the UK’s current medical device regulation system as it applies to AI technologies. As part of this process, the MHRA established the National Commission on the Regulation of AI in Healthcare to gather evidence and stakeholder input. Recent consultation findings, published on 11 June, highlighted strong demand for reform. Of 761 responses from NHS organisations, industry, and academia, half of respondents called for substantial revision of the existing framework, while a further 21% supported a complete overhaul. A Step Toward Global Regulatory Convergence The FDA–MHRA liaison programme reflects a wider trend toward international regulatory convergence in healthcare. As medical technologies become increasingly global in development and deployment, regulators are under growing pressure to coordinate standards, share expertise, and reduce duplication without compromising safety. While both agencies retain full autonomy in decision-making, the initiative signals a more structured and collaborative approach to managing innovation across borders. 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