(IN BRIEF) Roche has introduced the cobas HDV test, the first high-throughput, fully automated assay for detecting and quantifying Hepatitis D Virus RNA. The test runs on the cobas 5800, 6800 and 8800 systems and is available in countries accepting … Read the full press release
Posted in Business, Healthcare, Pharma & Biotech, Science, Switzerland, Technology
Tagged automated assay, Basel, CE Mark, chronic hepatitis, co-infection, cobas 5800, cobas 8800, cobas HDV test, cobas HDV Test Aims to Improve Access to Reliable Hepatitis D Testing, cobas® 6800, diagnostic testing, HBV, HDV, HDV RNA, hepatitis B virus, Hepatitis D Virus, high-throughput testing, laboratory workflow, liver cancer, liver disease, liver failure, Matt Sause, Molecular Diagnostics, patient care, Roche, Roche Diagnostics, Roche Expands cobas Diagnostics Portfolio With New Hepatitis D Virus Assay, Roche Introduces First High-Throughput Automated Test for Hepatitis D Virus RNA, super-infection, Switzerland, treatment monitoring, viral hepatitis
(IN BRIEF) The US Food and Drug Administration has accepted and granted Priority Review to Roche’s supplemental Biologics License Application for Enspryng, or satralizumab, in thyroid eye disease. The application is supported by data from the Phase 3 SatraGO-1 and … Read the full press release
Posted in Healthcare, Pharma & Biotech, Science, Switzerland, Technology
Tagged at-home treatment, autoimmune disease, Chugai, clinical activity score, clinical development, diplopia, Enspryng, Enspryng Could Become At-Home Subcutaneous Treatment Option for Thyroid Eye Disease, Enspryng Phase 3 Programme Shows Improvements in Key Thyroid Eye Disease Measures, FDA, FDA Priority Review Supports Roche’s Planned Expansion of Enspryng Into Thyroid Eye Disease, Graves’ ophthalmopathy, IL-6 receptor, Levi Garraway, neuromyelitis optica spectrum disorder, NMOSD, ophthalmology, Phase 3 clinical trial, Priority Review, proptosis, rare disease, regulatory submission, Roche, SatraGO-1, SatraGO-2, satralizumab, sBLA, subcutaneous treatment, supplemental Biologics License Application, TED, thyroid eye disease, US Food and Drug Administration
(IN BRIEF) Sanofi has appointed Paulo Fontoura as Executive Vice President and Global Head of Research & Development Pharma, effective September 1, 2026. Based in Paris and reporting to CEO Belén Garijo, Fontoura will join Sanofi’s Executive Committee and lead … Read the full press release
Posted in Artificial Intelligence (AI), Business, France, Healthcare, Management, Pharma & Biotech, Science
Tagged American Academy of Neurology, artificial intelligence, Belén Garijo, biopharma, breakthrough therapies, clinical development, clinical scientists, drug discovery, EMA approvals, FDA approvals, generative AI, Global Head of R&D Pharma, Houman Ashrafian, immunology, infectious diseases, neuroimmunology, Neurology, neuroscience, new molecular entities, New University of Lisbon, ophthalmology, Paulo Fontoura, Paulo Fontoura to Lead Sanofi’s Global R&D Organisation from September 2026, pharmaceutical innovation, pharmaceutical research and development, physician-scientist, pipeline development, R&D transformation, rare diseases, regulatory affairs, Roche, Sanofi, Sanofi Appoints Paulo Fontoura as Global Head of Pharmaceutical Research and Development, Sanofi Executive Committee, Sanofi Selects Paulo Fontoura to Advance Global Pipeline and AI-Enabled R&D Strategy, Sanofi Strengthens Research and Development Leadership with Paulo Fontoura Appointment, Stanford University, translational medicine, Xaira Therapeutics
(IN BRIEF) Roche has announced that the US FDA has accepted its supplemental Biologics License Application for Lunsumio VELO, a subcutaneous formulation of mosunetuzumab, in combination with Polivy for adults with relapsed or refractory large B-cell lymphoma, including diffuse large … Read the full press release
Posted in Business, European Union, Healthcare, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged antibody-drug conjugate, ASCO Annual Meeting, Basel, CD20xCD3 bispecific antibody, CD79b, CELESTIMO, chemotherapy-free regimen, community oncology, crs, cytokine release syndrome, diffuse large B-cell lymphoma, DLBCL, European Hematology Association Congress, FDA, FDA Filing Acceptance Brings Roche’s Chemotherapy-Free Lymphoma Combination Closer to Potential Approval, follicular lymphoma, gemcitabine, haematology, LBCL, Levi Garraway, Lunsumio, Lunsumio VELO, Lunsumio VELO and Polivy Combination Shows 59 Percent Risk Reduction in Roche’s FDA Filing for LBCL, lymphoma care, Lymphoma Research Foundation, MabThera®, Meghan Gutierrez, Mission Cancer and Blood, MorningLyte, mosunetuzumab, Non-Hodgkin lymphoma, outpatient-ready treatment, oxaliplatin, PFS, Phase III Trial, polatuzumab vedotin, Polivy, progression-free survival, R-GemOx, relapsed or refractory large B-cell lymphoma, Rituxan, rituximab, Roche, Roche Reports FDA Acceptance of sBLA Based on SUNMO Study Results in Relapsed or Refractory Large B-Cell Lymphoma, sBLA, SUNMO study, supplemental Biologics License Application, Switzerland, T-cell engaging bispecific antibody, Tara M Graff
(IN BRIEF) Roche and Nurix Therapeutics have entered into an exclusive global licensing and collaboration agreement to co-develop and co-commercialise bexobrutideg, also known as NX-5948, an investigational oral BTK degrader with potential applications across malignant haematology, immunology and neurology. The … Read the full press release
Posted in Business, European Union, Financial, Government, Healthcare, Industrial, Investment, Law, Management, Marketing, Pharma & Biotech, Science, Switzerland, Technology
Tagged Arthur T Sands, B-cell malignancies, bexobrutideg, brain-penetrant therapy, Bruton’s tyrosine kinase, BTK, BTK degrader, BTK inhibitors, chronic lymphocytic leukaemia, chronic spontaneous urticaria, CLL, co-commercialisation, co-development, CSU, Hart-Scott-Rodino Antitrust Improvements Act, immunology, Immunology and Neurology Pipeline with Global Bexobrutideg Collaboration, kinase activity, Levi Garraway, licensing agreement, malignant haematology, MS, multiple sclerosis, Neurology, NHL, Non-Hodgkin lymphoma, Nurix Therapeutics, NX-5948, oncology pipeline, oral therapy, Phase 3 clinical trial, relapsed or refractory B-cell malignancies, Roche, Roche and Nurix Announce Up to USD 2.3 Billion Collaboration to Develop and Commercialise Bexobrutideg, Roche and Nurix Therapeutics Partner on Potential Best-in-Class Targeted Protein Degrader for B-Cell Malignancies, Roche oncology, Roche Strengthens Oncology, scaffolding function, Switzerland, targeted protein degradation, targeted protein degrader, treatment resistance, United States, USD 2.3 billion deal value, USD 700 million upfront payment
(IN BRIEF) Roche has received FDA acceptance under Priority Review for its New Drug Application for giredestrant as an adjuvant treatment for adults with ER-positive, HER2-negative stage I-III breast cancer. The FDA is expected to decide on the application by … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged adjuvant treatment, American Society of Clinical Oncology Congress, ASCO 2026, Basel, breast cancer research, CDK4/6 inhibitor, early stage breast cancer, endocrine therapy, ER-positive breast cancer, ESR1-mutated breast cancer, evERA Breast Cancer, everolimus, FDA, FDA Accepts Roche’s Giredestrant Application as Potential New Adjuvant Treatment for Early-Stage Breast Cancer, FDA Sets November 2026 Decision Date for Roche’s Giredestrant in Early-Stage ER-Positive Breast Cancer, giredestrant, HER2-negative breast cancer, hyaluronidase, iDFS, invasive disease-free survival, Levi Garraway, lidERA Breast Cancer, NDA, New Drug Application, oncology, overall survival, Palbociclib, PDUFA, pertuzumab, Phesgo, Prescription Drug User Fee Act, Priority Review, Roche, Roche Moves Forward With Giredestrant Filing in Curative-Intent Breast Cancer Treatment Setting, Roche Secures FDA Priority Review for Giredestrant in Early-Stage ER-Positive Breast Cancer, selective oestrogen receptor degrader, SERD, stage I breast cancer, stage II breast cancer, stage III breast cancer, targeted therapy, trastuzumab, United States Food and Drug Administration
(IN BRIEF) Roche has agreed to acquire PathAI to strengthen its digital pathology and AI-powered diagnostics capabilities. The deal builds on an existing partnership between the companies focused on AI-enabled companion diagnostics and pathology solutions. Roche said the acquisition will … Read the full press release
Posted in Artificial Intelligence (AI), Business, Financial, Industrial, Infrastructure & Utilities, Investment, Management, Marketing, Pharma & Biotech, Science, Switzerland, Technology
Tagged AI diagnostics, AI-powered pathology, AISight, Andy Beck, artificial intelligence, Biomarker Development, biomarker discovery, Biopharma Industry, cancer diagnosis, clinical trials, companion diagnostics, Diagnostic Tools, diagnostics division, digital pathology, Healthcare Innovation, healthcare technology, image management system, laboratory automation, Matt Sause, medical AI, medical imaging, oncology diagnostics, PathAI, pathology laboratories, pathology software, personalized healthcare, pharmaceutical industry, precision medicine, Roche, Roche and PathAI Combination Aims to Accelerate Personalized Cancer Diagnostics and Biomarker Discovery, Roche Deepens Investment in Artificial Intelligence Through Planned PathAI Acquisition, translational research
(IN BRIEF) Roche has reached a key regulatory milestone with the FDA’s acceptance of its application for Gazyva/Gazyvaro as a treatment for systemic lupus erythematosus. The submission is based on strong phase III trial data showing significant improvements in disease … Read the full press release
Posted in Healthcare, Industrial, Pharma & Biotech, Science, Switzerland, Technology
Tagged Albert T. Roy, ALLEGORY study, anti-CD20 therapy, autoimmune disease, B cells, biologics, clinical research, disease activity, FDA, FDA Filing Acceptance Marks Significant Step for Roche in Developing Targeted Therapy for Lupus Patients, Gazyva, Gazyvaro, Healthcare Innovation, immunology, Levi Garraway, lupus nephritis, Lupus Research Alliance, obinutuzumab, Phase III Trial, remission, Roche, Roche Advances New Treatment Option for Lupus as FDA Accepts Filing for Gazyva Based on Phase III Data, SLE, systemic lupus erythematosus, U.S. Food and Drug Administration
(IN BRIEF) Roche has obtained CE mark approval for its Elecsys Neurofilament Light Chain blood test, which detects neuroinflammation in patients with relapsing-remitting multiple sclerosis. The minimally invasive test measures biomarkers of nerve damage, offering an alternative to traditional monitoring … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged biomarkers, blood test, CE Mark, cobas instruments, diagnostics, Elecsys NfL, Elecsys NfL Approval Expands Access to Advanced MS Monitoring with Simple Blood Based Testing, Healthcare Innovation, Matt Sause, multiple sclerosis, neurofilament light chain, neuroinflammation, neurological disease, patient monitoring, relapsing remitting MS, Roche
(IN BRIEF) Roche has launched the cobas MPX-E assay, a multiplex molecular diagnostic test capable of detecting HIV, Hepatitis B, Hepatitis C, and Hepatitis E simultaneously in a single workflow. Available in CE mark–accepting markets, the assay is designed to … Read the full press release
Posted in Healthcare, Industrial, Pharma & Biotech, Science, Switzerland, Technology
Tagged blood donor screening, CE Mark, cobas 5800, cobas 8800, cobas MPX-E, cobas x800 systems, cobas® 6800, HBV, HCV, Healthcare Innovation, Hepatitis B, hepatitis C, Hepatitis E, HEV, HIV, In Vitro Diagnostics, laboratory automation, Matt Sause, Molecular Diagnostics, NAT blood screening, PCR testing, Roche, Roche Diagnostics, Roche Introduces cobas MPX-E Test to Enhance Laboratory Efficiency and Strengthen Global Blood Safety Standards, Roche Launches High-Throughput Multiplex Diagnostic Assay to Streamline Detection of HIV and Hepatitis Viruses, viral detection
(IN BRIEF) Roche reported that its phase III MAJESTY trial met its primary endpoint, showing that treatment with Gazyva/Gazyvaro enabled significantly more patients with primary membranous nephropathy to achieve complete remission at two years compared with tacrolimus. The study also … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Security & Safety, Switzerland, Technology
Tagged anti-CD20 monoclonal antibody, autoimmune kidney disease, B cell depletion therapy, clinical trial phase III, European Medicines Agency, FDA, Gazyva, Gazyvaro, idiopathic nephrotic syndrome, immunology pipeline, kidney function preservation, lupus nephritis, MAJESTY study, MAJESTY Trial Success Positions Gazyva for Possible First Approval in Primary Membranous Nephropathy Treatment, obinutuzumab, primary membranous nephropathy, remission outcomes, renal disease research, Roche, systemic lupus erythematosus
(IN BRIEF) Nokia has appointed Kristen Pressner as Chief People Officer and member of the Group Leadership Team, effective May 2026. With over 30 years of HR and leadership experience at Roche and Texas Instruments, Pressner will lead Nokia’s global … Read the full press release
Posted in Business, Finland, Management, News, Technology, Telecom
Tagged 5G, AI, AI empowerment, Chief People Officer, connectivity, Finland, global technology, HR transformation, Justin Hotard, Kristen Pressner, leadership appointment, next-generation networks, Nokia, Nokia appoints Kristen Pressner as Chief People Officer to drive global culture and AI-era transformation, organizational culture, Roche, Texas Instruments, workforce innovation
(IN BRIEF) Roche announced that its Phase III INShore trial evaluating Gazyva/Gazyvaro (obinutuzumab) in children and young adults with idiopathic nephrotic syndrome met its primary endpoint, showing superior sustained remission rates at one year compared to mycophenolate mofetil (MMF). The … Read the full press release
Posted in Business, Healthcare, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged B cell targeting, Basel, Chronic kidney disease, corticosteroids, EMA, FDA, Gazyva, Gazyva/Gazyvaro Demonstrates Superior Sustained Remission in Children and Young Adults With Idiopathic Nephrotic Syndrome, Gazyvaro, idiopathic nephrotic syndrome, immune-mediated kidney diseases, INS, INShore study, Levi Garraway, lupus nephritis, NOBILITY study, obinutuzumab, pediatric nephrology, phase III clinical trial, proteinuria, REGENCY study, renal disease, Roche, Roche Announces Positive Phase III INShore Results for Gazyva/Gazyvaro in Children and Young Adults With Idiopathic Nephrotic Syndrome, sustained remission, targeted therapy
(IN BRIEF) Roche reported groundbreaking phase III IMvigor011 results showing that Tecentriq (atezolizumab) significantly improved overall and disease-free survival in muscle-invasive bladder cancer using a ctDNA-guided treatment approach. Patients receiving Tecentriq experienced a 41% lower risk of death and a … Read the full press release
Posted in Business, Healthcare, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged adjuvant therapy, atezolizumab, bladder cancer, Cancer Immunotherapy, ctDNA, disease-free survival, ESMO Congress 2025, IMvigor011, Levi Garraway, molecular residual disease, MRD testing, muscle-invasive bladder cancer, Natera, oncology research, precision oncology, Roche, Roche Advances Personalized Oncology with Positive Phase III Tecentriq Results in ctDNA-Directed Bladder Cancer Treatment, Roche’s Tecentriq Shows 41% Survival Benefit in Landmark ctDNA-Guided Bladder Cancer Study, Signatera, survival benefit, TECENTRIQ, Thomas Powles
(IN BRIEF) Roche has received FDA approval for Gazyva/Gazyvaro (obinutuzumab) as a treatment for adult patients with active lupus nephritis, supported by data from the NOBILITY and REGENCY trials that showed significantly improved renal response compared with standard therapy. The … Read the full press release
Posted in Business, Healthcare, Industrial, Management, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged anti-CD20 monoclonal antibody, autoimmune disease, autoimmune therapy, biopharmaceuticals, CHMP, European Medicines Agency, FDA approval, Gazyva, Gazyva/Gazyvaro Approved by FDA as First Anti-CD20 Therapy to Achieve Complete Renal Response in Lupus Nephritis, Gazyvaro, kidney disease, Levi Garraway, Louise Vetter, Lupus Foundation of America, lupus nephritis, nephrology, NOBILITY trial, obinutuzumab, REGENCY trial, renal response, Roche, Roche Basel, Roche Strengthens Autoimmune Portfolio with FDA Approval of Gazyva/Gazyvaro for Lupus Nephritis Treatment, systemic lupus erythematosus
(IN BRIEF) Roche presented new data at ECTRIMS 2025 confirming that OCREVUS provides sustained protection against disability progression and maintains a consistent safety profile across multiple MS populations, including adults with advanced PPMS, children with RRMS, and women who are … Read the full press release
Posted in Healthcare, Management, Marketing, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged BTK inhibitor, disability progression, ECTRIMS 2025, fenebrutinib, FENhance, FENopta, FENtrepid, infant immunity, Levi Garraway, MINORE, MS, multiple sclerosis, neurofilament light chain, OCARINA II, ocrelizumab, OCREVUS, OPERETTA, ORATORIO-HAND, paediatric MS, PPMS, pregnancy outcomes, RMS, Roche, Roche presents late-breaking MS data including OCREVUS impact in pregnancy and two-year fenebrutinib Phase II outcomes, Roche showcases new OCREVUS and fenebrutinib data at ECTRIMS 2025 highlighting long-term efficacy and safety in MS, RRMS, SOPRANINO, Stephen L Hauser
(IN BRIEF) Roche has announced new data at the Euretina Congress in Paris from its AVONELLE-X and SALWEEN studies of Vabysmo (faricimab), confirming the therapy’s strong long-term outcomes for patients with retinal diseases. The AVONELLE-X study, the largest long-term extension … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged AVONELLE-X, bispecific antibody, diabetic macular edema, DME, durability, Euretina Congress, extended dosing, faricimab, Levi Garraway, long-term efficacy, LUCERNE, nAMD, neovascular age-related macular degeneration, ophthalmology, PCV, polypoidal choroidal vasculopathy, retinal vein occlusion, Roche, RVO, SALWEEN, TENAYA, Vabysmo, vision loss
(IN BRIEF) Roche’s ongoing Phase Ib/IIa Brainshuttle™ AD study of trontinemab shows that 91 percent of participants reach amyloid PET negativity, with ARIA‑E rates under 5 percent. The company has outlined Phase III TRONTIER 1 and 2 trials in early symptomatic Alzheimer’s for 2025, plus a planned … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged Alzheimer’s Association International Conference, amyloid plaques, amyloid‑beta monoclonal antibody, ARIA‑E, blood‑based biomarker, blood‑brain barrier, Brainshuttle, centiloids, clinical dementia rating sum of boxes, cognitive decline, diagnostics, early diagnosis, Elecsys pTau217, Levi Garraway, Matt Sause, PET negativity, Phase Ib/IIa, Phase III TRONTIER 1, Phase III TRONTIER 2, preclinical Alzheimer’s, pTau181, pTau217/Ab42 ratio, Roche, sustainability of clinical trials, TRAVELLER, trontinemab
(IN BRIEF) Roche has revealed that Dr. Hans Clevers, Head of Pharma Research and Early Development and board member since 2019, will retire from his pRED role at the end of August, though he will continue leading the Institute of … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged appointment, Barbara Schädler, Board of Directors, corporate executive committee, COVID-19, Group Communications, Hans Clevers, Institute of Human Biology, Johannes Clevers, ledership, Pharma Research and Early Development, pRED, retirement, Roche, succession planning, Thomas Schinecker
(IN BRIEF) Roche presented positive phase I/II data for NXT007, its Chugai-engineered bispecific antibody for haemophilia A, at the 2025 ISTH Congress. In the NXTAGE study’s highest-dose cohorts (B-3 and B-4), none of the 30 participants experienced bleeds requiring treatment, … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged bispecific antibody, Chugai, clinical development, emicizumab, global supply chain, Haemophilia A, haemostatic normalisation, Hemlibra, ISTH Congress 2025, Levi Garraway, NXT007, NXTAGE study, phase I/II data, Roche, subcutaneous dosing, thromboembolic events
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