![[The Fix] Device Harmonisation Continues!](https://media.beehiiv.com/cdn-cgi/image/fit=scale-down,quality=80,format=auto,width=720,onerror=redirect/uploads/asset/file/1e8f0da5-07f4-473f-9984-e59b44764bd9/T_personal_shared_-_Frame_581__1_.jpg?t=1792545030)
Welcome to another exciting week from the Healthcare and Life Sciences ecosystem! We've got a packed newsletter full of insights, events, and inspiring stories from the heart of innovation.
Table of Contents
🖼️ International Reliance Routes
News:
Quick editor’s note to mention we have added a new section for M&A under funding news!
🧬 Biotech
🤝 Roche Inks $1.16B ALK7 RNAi Licensing Deal with Rona Therapeutics: Roche entered into a global development and commercialization pact with China’s Rona Therapeutics to advance an investigational RNAi therapeutic targeting ALK7 for metabolic diseases and obesity.
🤖 AstraZeneca Partners with insitro in $1.46B AI Drug Discovery Alliance: AstraZeneca and machine-learning pioneer insitro formed a multi-target collaboration to discover and develop novel medicines for severe liver and heart diseases.
📈 Sionna Therapeutics and Iambic Therapeutics Bank Combined $341M in IPO Debuts: Public biotech markets continued their late-year momentum as cystic fibrosis challenger Sionna raised $191 million and AI drug design specialist Iambic secured $150 million.
⚖️ Halozyme Prevails in High-Stakes Subcutaneous Formulation Patent Dispute with Merck: Halozyme announced a key legal victory upholding its foundational patent protections around recombinant human hyaluronidase enzyme delivery.
🧬 Legend Biotech Clears IND for In Vivo CAR-T Therapy LB2501: The FDA cleared Legend Biotech’s investigational new drug application to initiate human trials for an in vivo CAR-T candidate targeting CD19 and CD20 directly inside the patient
💻 Digital Health
🌍 eHealth Africa and Egypt’s Ministry of Health Ink Continental AI Protocol: eHealth Africa and the Egyptian Ministry of Health signed a strategic pact to deploy unified health information systems, teleradiology, and clinical AI surveillance across Africa.
☁️ GE HealthCare and Microsoft Expand Cloud-Native Precision Imaging: GE HealthCare integrated Azure AI infrastructure across regional radiology networks to automate multimodal diagnostic reporting and lower clinician administrative strain.
🇪🇺 European Commission Advances Cross-Border Federated EHR Framework: The EU finalized technical specifications under the European Health Data Space to enable real-time, interoperable patient record exchange across 12 member states.
📱 Teladoc Health Launches Global Chronic Care AI Navigation Engine: Teladoc deployed an upgraded predictive analytics engine to personalize real-time glycemic and cardiometabolic monitoring for employer-sponsored virtual care programs globally.
🇸🇬 Synapxe and Regional Health Clusters Pilot Edge-AI Inpatient Monitoring: Singapore’s national health tech agency commenced multi-center clinical validation of contactless, edge-computed sensor suites for inpatient fall and deterioration prevention.
⚖️ Regulatory Affairs
💊 FDA Accepts Formycon and Zydus Filing for Keytruda Biosimilar FYB206: The FDA formally accepted the 351(k) application for FYB206, advancing the first regulatory review challenger to Merck’s flagship blockbuster pembrolizumab.
🎗️ FDA Grants Accelerated Approval for Daiichi Sankyo’s Ifinatamab Deruxtecan: Regulators approved the B7-H3-directed antibody-drug conjugate for patients with extensive-stage small cell lung cancer progressing after platinum-based systemic therapy.
🇪🇺 EMA Validates Marketing Authorization Application for Inovio's INO-3107: European regulators accepted the regulatory submission for Inovio's DNA immunotherapy candidate indicated for adult recurrent respiratory papillomatosis under accelerated assessment.
👁️ FDA Clears Chugai & Roche’s Satralizumab for Thyroid Eye Disease: The FDA authorized subcutaneous satralizumab (anti-IL-6 receptor) to reduce orbital inflammation and proptosis in adult patients with active autoimmune thyroid eye disease.
🇬🇧 UK MHRA Launches Harmonized International Medical Device Reliance Route: The MHRA introduced streamlined approval protocols for diagnostic software and medical hardware holding verified clearances in the US, EU, or Singapore.FDA Proposes Major Rule Overhaul to Modernize Global Drug Manufacturing Registrations: Federal regulators introduced a sweeping framework intended to digitize, clean, and aggressively enforce automated reporting standards for both domestic and foreign commercial pharmaceutical manufacturing facilities
🛒 Funding & M/A roundup:
Funding
Company / Partnership | Funding Amount | Focus Area | Location | Investors / Partners |
Kailera Therapeutics | $600.0M (Series B) | Clinical-stage injectable & oral GLP-1/GIP agonists for obesity | Waltham, MA, US | Bain Capital Private Equity (Lead) |
OMass Therapeutics | $310.0M (Series C) | Native mass spectrometry platform for immunology & rare diseases | Oxford, UK | GV, Bain Capital Life Sciences, Forbion, Novo Holdings, Syncona, Sanofi Ventures |
Kardigan | $254.0M (Series B) | Small-molecule therapies for genetic & rare cardiovascular diseases | United States | T. Rowe Price, Fidelity, Sequoia Heritage, ARCH Venture Partners |
City Therapeutics | $200.0M (IPO) | Next-generation engineered RNAi therapeutics platform | Cambridge, MA, US | Public Markets (Nasdaq) |
Iambic Therapeutics | $150.0M (IPO) | AI-driven drug discovery for precision oncology | San Diego, CA, US | Public Markets (Nasdaq) |
VeraDermics | $150.0M (Series C) | Oral small-molecule therapies for hair regrowth & dermatology | New Haven, CT, US | SR One (Lead) |
Soufflé Therapeutics | $135.0M (Series B) | Small-molecule targeting for difficult-to-drug oncology targets | United States | Institutional biopharma growth syndicate |
Estuary Biotherapeutics | $93.0M (Series A) | Gene therapies for polycystic kidney disease (ADPKD) | Cambridge, MA, US | RA Capital, Deep Track, Biogen New Ventures, UPMC Enterprises, GV |
Peptilogics | $78.0M (Series B2) | Computational peptide therapeutics to prevent surgical device infections | Pittsburgh, PA, US | Presight Capital, Thiel Bio, Founders Fund |
MD Integrations | $77.0M (Growth) | White-label clinician network & asynchronous telehealth infrastructure | New York, US | Updata Partners, Denali Growth Partners |
Sirona Medical | $40.0M (Series D) | Cloud-native diagnostic radiology AI operating platform | San Francisco, CA, US | Healthcare IT & growth stage investors |
Archon Biosciences | $20.0M (Seed) | Generative protein design & geometric "antibody cages" (AbCs) | Seattle, WA, US | Madrona Ventures (Lead), Deep Tech Funds, Angel Syndicate |
Ikarovec | £5.0M (~$6.5M) (Seed) | Bicistronic gene therapies for geographic atrophy & dry AMD | Norwich, UK | LifeArc Ventures, Parkwalk Advisors |
Antiverse | £3.5M (~$4.6M) (Seed) | Generative AI antibody discovery for complex GPCRs & ion channels | Cardiff, UK | Early-stage European life sciences syndicate |
Undisclosed (Seed) | AI-driven oral cyclic peptide drug discovery | Shanghai, China | Early-stage Chinese biotech venture syndicate | |
Causa Prima | $20.0M (Seed) | AI agent platform for biomedical and scientific discovery | United States | Base10 Partners |
M&A
Acquiring Company | Target Company / Asset | Transaction Value | Deal Rationale & Focus Area |
Lundbeck | Longboard Pharmaceuticals | ~$2.6B ($60.00/share) | Adds clinical-stage 5-HT2C agonist bexicaserin for Dravet syndrome, Lennox-Gastaut syndrome, and rare epileptic encephalopathies. |
Galderma | ZO Skin Health | $1.5B Enterprise Value | Expands medical dermatology footprint into physician-dispensed and clinical skincare channels. |
Merck (MSD) | Modifi Biosciences | Up to $1.3B ($30M Upfront / Milestones) | Acquires pre-clinical direct DNA modification molecules targeting DNA repair defects (MGMT-deficient tumors such as glioblastoma). |
Altaris | Simulations Plus | Undisclosed (Buyout) | Sponsor-backed take-private combining computational biosimulation and AI-accelerated drug development software platforms. |
Merz Pharma | Windstar Medical | Undisclosed | Broadens European consumer healthcare, self-care, and over-the-counter wellness portfolio. |
Healthcare Services Group | NEXDINE Hospitality | $93.5M Upfront | Strategic expansion into outsourced food, clinical nutrition, and support operations for healthcare and senior living networks. |
🚀 Big news for MedTech and Digital Health in Great Britain
The UK MHRA is advancing its International Recognition & Reliance Route for medical devices and diagnostic software.
For MedTech manufacturers, this represents a major strategic shift:
Instead of navigating duplicative pre-market assessments post-Brexit, companies holding verified clearances from trusted regulators—including the US (FDA), European Union (MDR/IVDR), and Singapore (HSA)—can access a streamlined route into the GB market.
Key Takeaways for MedTech Founders & Regulatory Leaders:
🔹 Shorter Time-to-Market: Accelerated reliance pathways mean life-saving hardware and diagnostic software reach NHS clinicians and patients faster.
🔹 Resource Efficiency: Significantly cuts redundant review costs and audits for devices with established clinical safety records.
🔹 UK Sovereignty Maintained: Devices must still appoint a UK Responsible Person (UKRP), conform to UK Post-Market Surveillance (PMS) rules, and meet domestic labelling requirements.
As regulatory harmonization gains momentum globally, the UK is positioning itself as a fast, pragmatic launchpad for healthcare innovation.
🏢Job Opportunities
Listed chronological order (latest at the end!).
When you apply tell the company you heard about the role @ The Fix! (Click for link to listing)
🌎Americas
💡 Enterprise Business Development Representative, Heidi (US)
💡 Managing Director of New Ventures - Cedars-Sinai, Redesign Health (US)
💡 Founding Product Manager, Platform + Consumer + AI, Legion Health(US)
💡 Senior Product Manager, Healthcare, Whoop (US)
💡Senior Product Manager - Clinician Experience, K Health (US)
💡Client Success Manager, Doximity (US)
💡Information/ Data Scientist- Paradigm Health (US)
💡 Physician - Clinical AI Expert (Remote), Aptura (US)
💡 Member of Product Operations & Strategy Staff, Abridge (US)
💡 Member of Product Staff, AI/ML (Evals), Abridge (US)
💡 Member of Product Staff, Clinical Decision Support, Abridge (US)
💡 Member of Product Staff, Forward Deployed, Abridge (US)
💡 Member of Product Staff, Foundation Models & Post-Training, Abridge (US)
💡 Member of Product Staff, Nursing, Abridge (US)
💡 Member of Technical Staff, Research Science, Abridge (US)
💡 Implementation Director, Federal, Abridge (US)
💡 Finance & Strategy Lead, Abridge (US)
💡 AI Automation Manager, Florence Healthcare (US)
💡 Director of AI, Florence Healthcare (US)
💡 VP, Professional Services, Florence Healthcare (US)
💡 Customer Success Manager, Healthie (US)
💡 Clinical Product Marketing Manager, Healthie (US)
💡 Senior Product Designer, Healthie (US)
💡 Senior Product Manager, Billing & Payments, Healthie (US)
💡 Senior Product Manager, Revenue Cycle, Healthie (US)
💡 Clinical Account Executive, Healthie (US)
💡 Customer Success Operations Lead, Healthie (US)
💡 Advanced Practice Pharmacist, Akido (US)
💡 Physician Assistant (Physician Associate) RIPCMG, Akido (US)
💡 Primary Care Physician (Rhode Island Primary Care Medical Group), Akido (US)
💡 Clinical Pharmacist - Ambulatory Care / COPD Population Health Program, Akido (US)
💡 Clinical Review Nurse - Complex Case Management and Prior-Authorization, Akido (US)
💡 Director, Enterprise Partnerships (West), Pearl Health (US)
💡 Account Executive - Biopharma Clinical Research, Study Conduct, Paradigm Health (US)
💡 Manager, Academics Partnerships, Paradigm Health (US)
💡 Clinical Compliance Auditor - Remote, Guidehealth (US)
💡 Remote Clinical Pharmacist – HEDIS Medication Adherence, Guidehealth (US)
💡 Regional Vice President of Enterprise Sales, eHealth Technologies (US)
💡 Clinical Agent Lead (Product), Thesis Care (US)
💡 Clinical Strategy Lead, Thesis Care (US)
💡 Senior Product Manager - Growth, Harmonic (US)
💡 Senior Product Manager, Platform, Luminai (US)
💡 Executive Director, Strategic Partnerships, Luminai (US)
💡 Product Designer, Luminai (US)
💡 Deployment Strategist, Luminai (US)
💡 Strategy Lead, Luminai (US)
💡 Senior Product Manager, Applied AI, Luminai (US)
💡 Clinical AI Manager, Ambience Healthcare (US)
💡 Clinical AI Researcher, Ambience Healthcare (US)
💡 Product Lead, Inpatient, Ambience Healthcare (US)
💡 Head of National Strategic Accounts, Ambience Healthcare (US)
💡 National Strategic Account Executive, Ambience Healthcare (US)
💡 Physician, Virtual Care (Evenings/Weekends, IMLC Required), Counsel Health (US)
💡 Physician, Virtual Care (Full-Time, IMLC Required), Counsel Health (US)
💡 Physician AI Engineer, Counsel Health (US)
💡 Research Scientist, Counsel Health (US)
💡 Product Designer (Consumer), Counsel Health (US)
💡 Senior Clinical Context Engineer, Doctronic (US)
💡 Senior Product Manager, Consumer, Doctronic (US)
💡 Clinical Product Manager, Doctronic (US)
💡 Medical Director, Doctronic, Doctronic (US)
💡 Partnerships Operations Manager, Doctronic (US)
💡 Senior Director of Implementation, Doctronic (US)
💡 Agent Product Manager, Assort Health (US)
💡 Director of Agent Product Management, Enterprise & Strategic Accounts, Assort Health (US)
💡 Director of Agent Product Management, Health Systems, Assort Health (US)
💡 Director of Agent Product Management, Mid-Market Accounts, Assort Health (US)
💡 Principal Agent Strategy Manager, Assort Health (US)
💡 Principal Agent Strategy Manager, Health Systems, Assort Health (US)
💡 Senior Agent Product Manager, Assort Health (US)
💡 Senior Agent Strategy Manager, Assort Health (US)
💡 Senior Agent Strategy Manager, Health Systems, Assort Health (US)
💡 Research Engineer, Assort Health (US)
💡 Clinical Data Integration Engineer, Layer Health (US)
💡 Clinical Quality Data Abstraction Specialist - CathPCI (Contractor), Layer Health (US)
💡 Clinical Quality Data Abstraction Specialist - GWTG (Contractor), Layer Health (US)
💡 Customer Success Manager, Layer Health (US)
💡 Data Scientist, Layer Health (US)
💡 Forward Deployed Data Scientist, Layer Health (US)
💡 ML Research Engineer, Layer Health (US)
💡 ML Scientist, Layer Health (US)
💡 Physician Informatician (MD required), Layer Health (US)
💡 Senior Data Scientist - LLM Evaluation & Business Intelligence, Paradigm Health (US)
💡 Informatics Senior Data Scientist, Paradigm Health (US)
💡 Clinical Product Manager, AI, Doximity (US)
💡 Commercial Data Scientist, Doximity (US)
💡 Senior Data Scientist, Doximity (US)
💡 Client Success Manager, Pharma, Doximity (US)
💡 Senior Product Manager - Clinician Experience, K Health (US)
💡 Physician Associate (Physician Assistant) | Kern Street Medicine, Akido (US)
💡 AI Deployment Strategist, Telepatia (Brazil)
🌍Europe / Middle East
💡Co-founding CEO, Daya Ventures (Sweden)
💡Clinical Doctor, Zava (Ireland)
💡Senior Transformation Manager — Suvera Ltd – (UK)
💡Medical Advisor, Rare Disease — Novo Nordisk – (Denmark)
💡Clinical Safety Officer — Healthtech-1 – (UK)
💡Clinical Editor, BMJ Women's Health — BMJ Group –(UK)
💡Healthcare Strategic Lead, UK Public Sector Healthcare — BCG – (UK)
💡Clinical Safety Specialist — Assuric – (UK)
💡 Programme Director Cohort 3 — ARIA – (UK)
💡 Partnerships Manager, Medical Devices — Proximie – (UK)
💡 Chief Digital Information Officer — Great Ormond Street Hospital for Children NHS Foundation Trust – (UK)
💡 Clinical Associate in GTM [London] — Heidi – (UK)
💡 Clinical Specialist — Microsoft AI – (UK)
💡 Director, Partnerships & Enterprise International Growth — Ōura – (UK)
💡 Member of Product Staff – Health AI — Microsoft AI – (UK)
💡 CTO – Diagnuvo Health Ltd– (UK)
💡 Clinical Specialist, Youth Mental Health, Google (UK)
💡 Clinical AI Lead, Aptura AI (UK)
💡 Founding Implementation Lead (NHS), (UK)
💡 Medical Director, Lucis (France)
💡 Transformation Lead, Suvera (UK)
💡 Member of Technical Staff - Applied AI Lead, Health, Microsoft (UK)
💡 Associate Medical Director, Hesta Health (UK)
💡Physician - Clinical AI Expert, Aptura (UK)
💡 Clinical Specialist, Youth Mental Health, Google (UK)
💡 Clinical AI Lead, Aptura AI (UK)
💡 Founding Implementation Lead (NHS), Heim (UK)
💡 Solution Architect for Clinical Software Solutions (all genders), Avelios Medical (Germany)
💡 Clinical Change Manager (all genders) - Nursing or Medical Background, Avelios Medical (Germany)
💡 Clinical Consultant (all genders), Avelios Medical (Germany)
💡 Clinical Project Manager (all genders), Avelios Medical (Germany)
💡 Partnership Manager (all genders), Avelios Medical (Germany)
💡 (Senior) Product Designer (all genders), Avelios Medical (Germany)
💡 Medical Product Manager (all genders), Avelios Medical (Germany)
💡 Product Manager Pharmacy (all genders), Avelios Medical (Germany)
💡 Senior AI Product Designer (all genders), Avelios Medical (Germany)
💡 Senior Product Manager (all genders), Avelios Medical (Germany)
💡 Solution Consultant for Clinical Software (all genders), Avelios Medical (Germany)
💡 Strategic Account Development Representative (Pharma/Life Sciences), Florence Healthcare (Serbia)
💡 Customer Success Specialist - 6 month FTC (parental leave cover), Tandem Health (Netherlands)
💡 Customer Success Specialist - Netherlands, Tandem Health (Netherlands)
💡 Head of Customer Success, Tandem Health (Sweden)
💡 Medical Operations - DACH (m/f/d), Tandem Health (Germany)
💡 Medical Operations - Denmark, Tandem Health (Sweden / Denmark)
💡 Medical Operations - Finland, Tandem Health (Finland)
💡 Medical Operations - Global, Tandem Health (Sweden)
💡 Medical Operations - Greece, Tandem Health (Greece)
💡 Medical Operations - Milan, Tandem Health (Italy)
💡 Medical Operations - Stockholm, Tandem Health (Sweden)
💡 Medical Operations Dentistry - Finland, Tandem Health (Finland)
💡 Project Delivery Lead, Tandem Health (Netherlands)
💡 Project Delivery Specialist - Helsinki, Tandem Health (Finland)
💡 Project Delivery Specialist - Stockholm, Tandem Health (Sweden)
💡 Lead Clinical Researcher, Tandem Health (Sweden)
💡 Senior Product Designer, Tandem Health (Sweden)
💡 Technical Project Manager - Dach (m/f/d), Tandem Health (Germany)
💡 Technical Project Manager - France, Tandem Health (France)
💡 Technical Project Manager - UK, Tandem Health (UK)
💡 Quality & Regulatory Affairs Manager, Outcomes4Me (Germany)
🌏Asia
💡 Health Economics & Market Access Senior Manager / Deputy - SEA and Phamaging Countries, AEIRA (SG)
💡 QA Senior Manager, AEIRA (SG)
💡 Commercial Excellent Deputy, AEIRA (SG)
💡Founding Research Scientist, MenSC Labs (SG)
💡 Growth & Partnerships Lead, Lucence (SG)
💡 General Manager of Asia Pacific, Stellaromics (SG)
💡 Enterprise Account Executive, Heidi (SG)
💡 Product Lead, Synapxe (SG)
💡 Life Science Scientist, PatSnap (SG)
💡 Technical Program Manager, Integrations - Health Systems, Heidi (SG)
💡 Manager, APAC Business Development and Partnership, Dexcom (SG)
💡 General Manager, Neuromodulation APAC, Abbott (SG)
💡 Biotech Portfolio Lead, Thermo Fisher Scientific (SG)
💡Head of Engineering, Connect One (SG)
💡Digital Transformation Lead, MOHT (SG)
💡Care Professional Operation Manager, Homage (SG)
💡Head of Operations, For Youth (SG)
💡 Digital Transformation Lead, The Ministry of Health Office for Healthcare Transformation (MOHT) (SG)
🖥️Remote/ Various
💡 Head of Product - Integrations, PHIL (remote)
💡Product Manager- Trella Health (remote)
💡Vice President Sales and Strategic Accounts- Outcomes4Me (remote)
💡 Clinical Data Product Manager, Trella Health (Remote)
💡 Transformation Lead, Suvera (Remote)
💡 Senior Physician Executive, Abridge (Remote)
💡 Senior Nursing Executive, Abridge (Remote)
💡 Clinical Expert, Care Team Operations (NP), Thesis Care (Remote)
💡 Clinical Expert, Care Team Operations (RN), Thesis Care (Remote)
🌆Upcoming Events
🍵Upcoming Tech Brews meetings
Singapore
- Sat 24 Oct, 9:00AM "Networking"
- Fri 30 Oct, 3:00PM Tech Brews Roast Season 5India
-Sat 17 Oct, Virtual
Japan
- Sat 17 Oct, 9:00AM with Guest speaker Shohei IkomaLondon
- 15 Oct, 6pm Panel Event: Challenges in Healthcare expansion in UKBangkok
- 19 oct, 6:00PM with Guest Speaker: Ajeesh AshrafEdinburgh
- Thur 23 Oct, 5:30PM “Networking”Taipei
- Fri 20 Nov, 4:30PM Pop Up
🌏 Global MedTech & Health Summits
October 18–21, 2026 The MedTech Conference USA Leading global medtech gathering focused on regulation, investment, product innovation, and patient impact.
October 26, 2026 Global Health Exhibition Saudi Arabia Global Health Exhibition brings together healthcare innovators, global leaders, decision-makers and solution providers to accelerate digital transformation, advance new models of care, and build an integrated, technology-driven healthcare ecosystem. Topics include AI in clinical practice, digital health, workforce evolution and breakthrough medical technologies. https://www.globalhealthsaudi.com/en/home.html
November 3, 2026 Future of Health Europe UK Explores digital health, sustainable care models, health economics, inclusivity, and AI in European health systems.
November 4, 2026 AI in Health Summit by Economist Impact UK Explores how AI could shape the future of healthcare, uncovering opportunities and providing insights to drive change. https://events.economist.com/ai-health-summit/
November 8–11, 2026 ISPOR Europe 2026 Scotland Leading health economics and outcomes research conference focused on value measurement, pricing, reimbursement, and evidence-driven policy.
November 11–13, 2026 MedTech World Malta Held at the Mediterranean Conference Centre in Valletta, MedTech World brings together over 2,000 industry leaders, startups and investors. The event includes two stages of discussions, an exhibition floor, the MedTech World StartUp Pitch and the MedTech World Awards. https://med-tech.world/malta/
Get your event listed here! Simply fill in the form here
Editorial: Terence Tan
Events & Opportunities: Eugene Fang
Disclaimers- Views, thoughts, and opinions expressed in the text belong solely to the author, and not necessarily to the author's employer, organization, committee or other group or individual. The above analysis is also purely personal opinion and should not be taken as professional advice. All content intended for informational purposes.
Disclosures- At the time of this post, The Fix or the team have not received any sponsorship, whether financial or in-kind for this post. There is no equity or financial stake in any of the private companies mentioned above
