(IN BRIEF) Sanofi has received Breakthrough Therapy designation from the US FDA for venglustat, an investigational oral drug targeting neurological symptoms of type 3 Gaucher disease, a rare genetic disorder with no approved treatments for its neurological manifestations. The designation … Read the full press release
Posted in European Union, France, Healthcare, Marketing, Pharma & Biotech
Tagged biotechnology, clinical trials, enzyme replacement therapy, Fast Track Designation, FDA, Gaucher disease type 3, GD3, imiglucerase, Karin Knobe, LEAP2MONO, lysosomal storage disorder, orphan drug, rare disease, Sanofi, Sanofi Strengthens Pipeline with Venglustat Following FDA Breakthrough Designation for Rare Neurological Disorder, US Food and Drug Administration, venglustat
(IN BRIEF) Sanofi announced that its Board of Directors will propose the appointment of Orange CEO Christel Heydemann as an independent director during the company’s Annual General Meeting scheduled for April 29, 2026. At the same meeting, shareholders will also … Read the full press release
Posted in Business, Financial, France, Industrial, Investment, Management, Pharma & Biotech, Science, Technology
Tagged Alcatel, Alcatel-Lucent, Annual General Meeting April 2026, Belén Garijo, board leadership diversity, Christel Heydemann, Christophe Babule, corporate governance, digital transformation leadership, diversity in science and technology, Ecole Nationale des Ponts et Chaussées, École polytechnique, executive leadership Europe, Frédéric Oudéa, French National Order of Merit, global pharmaceutical company governance, independent director appointment, Industrial Transformation, Jean-Paul Kress, Legion of Honor France, Nomination Governance and CSR Committee, Orange Group, Patrick Kron, Sanofi, Sanofi Board Announces Governance Updates Including Proposed Appointment of Christel Heydemann and Departure of Patrick Kron, Sanofi Board of Directors, Sanofi Moves to Strengthen Board Expertise with Proposed Addition of Orange CEO Christel Heydemann, Sanofi Prepares Governance Changes Ahead of April 2026 Annual General Meeting with Proposed Board Appointment, Schneider Electric
(IN BRIEF) Sanofi has obtained orphan drug designation in Japan for rilzabrutinib as a treatment for IgG4-related disease, a rare immune-mediated condition with limited treatment options. The designation from Japan’s Ministry of Health, Labour and Welfare is supported by positive … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Technology
Tagged Bruton tyrosine kinase inhibitor, BTK inhibitor, IgG4-RD, IgG4-related disease, immune thrombocytopenia, immune-mediated diseases, ITP, MHLW, Ministry of Health Labour and Welfare Japan, orphan drug designation, phase 2 clinical trial NCT04520451, rare disease treatment, rare diseases, rheumatology, RILIEF phase 3 study NCT07190196, rilzabrutinib, Sanofi, Sanofi Expands Global Regulatory Recognition of Rilzabrutinib for Rare Immune Mediated Diseases, Sanofi Secures Japanese Orphan Drug Status for Rilzabrutinib Following Positive Clinical Study Results, SCD, sickle cell disease, wAIHA, warm autoimmune hemolytic anemia
(IN BRIEF) Sanofi reported new real-world evidence showing that immunization with Beyfortus can significantly reduce RSV-related hospitalizations not only during an infant’s first RSV season but also into the second year of life. The NIRSE-GAL study in Galicia, Spain, demonstrated … Read the full press release
Posted in Business, Financial, France, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Retail, Science, Security & Safety, Technology
Tagged Beyfortus, early lung protection, Federico Martinón Torres, Galicia Spain, hospitalization reduction, infant immunization, infant respiratory health, lower respiratory tract infection, monoclonal antibody, New Published Data Reinforce Value of Universal Infant RSV Immunization in Reducing Hospital Burden, NIRSE GAL study, nirsevimab, pediatric prevention, public health strategy, real-world evidence, RSV respiratory syncytial virus, RSVVW 26 Rome, Sanofi, The Lancet Infectious Diseases, Thomas Triomphe
(IN BRIEF) Sanofi has received Breakthrough Therapy designation from the U.S. FDA and orphan drug designation from Japan’s Ministry of Health, Labour and Welfare for rilzabrutinib (Wayrilz) in warm autoimmune hemolytic anemia, based on data from the ongoing LUMINA 2 … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Retail, Science, Security & Safety, Technology
Tagged Breakthrough Therapy, BTK inhibitor, clinical trials, FDA, FDA Grants Breakthrough Status to Sanofi’s Rilzabrutinib for Rare Blood Disorder, IgG4-related disease, immune thrombocytopenia, Japanese Ministry of Health Labour and Welfare, Karin Knobe, LUMINA 2, LUMINA 3, orphan drug, rare diseases, rilzabrutinib, Sanofi, Sanofi Advances Rilzabrutinib with Breakthrough and Orphan Designations in wAIHA, sickle cell disease, Tailored Covalency®, wAIHA, warm autoimmune hemolytic anemia, Wayrilz
(IN BRIEF) Sanofi has received a positive recommendation from the European Medicines Agency’s CHMP for the conditional approval of Rezurock to treat late-line chronic graft-versus-host disease in adults and adolescents aged 12 and older. The opinion, based on clinical trial … Read the full press release
Posted in European Union, France, Healthcare, Marketing, Pharma & Biotech
Tagged belumosudil, CHMP, CHMP Recommends Conditional EU Authorisation for Sanofi’s Rezurock to Treat Late-Line Chronic GVHD, chronic graft-versus-host disease, clinical trials, conditional marketing authorisation, EU regulatory approval, European Medicines Agency, GVHD, haematology, rare diseases, Rezurock™, ROCK2 inhibitor, ROCKstar study, Sanofi, stem cell transplant
(IN BRIEF) Sanofi has secured regulatory approval in China for two innovative medicines, Myqorzo for obstructive hypertrophic cardiomyopathy and Redemplo for familial chylomicronemia syndrome. The approvals expand treatment options for patients with serious cardiovascular and rare metabolic diseases and underscore … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Security & Safety, Technology
Tagged aficamten, cardiovascular disease, China NMPA, clinical phase 3 trials, familial chylomicronemia syndrome, FCS, Greater China, innovative medicines, Myqorzo, obstructive hypertrophic cardiomyopathy, oHCM, Olivier Charmeil, plozasiran, rare diseases, Redemplo, Sanofi, Sanofi Strengthens China Portfolio with Approval of Two Innovative Therapies for oHCM and FCS, siRNA therapy
(IN BRIEF) The European Commission has approved Sanofi’s Teizeild as the first disease-modifying therapy in the EU to delay the onset of stage 3 type 1 diabetes in adults and children with stage 2 T1D. Supported by TN-10 phase 2 … Read the full press release
Posted in Business, European Union, Financial, France, Government, Healthcare, Industrial, Investment, Management, Pharma & Biotech, Science, Security & Safety, Technology
Tagged autoimmune disease, beta cell function, CHMP, clinical approval, disease modifying therapy, EMA, European Commission, Sanofi, Sanofi’s Teizeild Becomes First EU-Approved Therapy to Delay Type 1 Diabetes Progression, T1D, Teizeild, teplizumab, TN-10 study, type 1 diabetes
(IN BRIEF) Sanofi’s Tzield has been accepted for priority review by the U.S. Food and Drug Administration to expand its use to children aged one year and older with stage 2 type 1 diabetes. The submission is supported by interim … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged autoimmune disease, beta cell protection, Christopher Corsico, clinical development, disease modifying therapy, FDA priority review, pediatric diabetes, pediatric endocrinology, PETITE T1D study, regulatory review, Sanofi, Sanofi’s Tzield Receives FDA Priority Review for Use in Young Children with Stage 2 Type 1 Diabetes, stage 2 T1D, teplizumab mzwv, type 1 diabetes, TZIELD
(IN BRIEF) The Institute of Cancer Research has led a study showing that chromosomal instability in circulating tumour cells can predict resistance to cabazitaxel in men with advanced prostate cancer. Using blood samples from more than 200 patients enrolled in … Read the full press release
Posted in Healthcare, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged Blood test developed by ICR researchers may guide treatment decisions in advanced prostate cancer, cabazitaxel, CARD trial, chemotherapy resistance, chromosomal instability, circulating tumour cells, JCI Insight, liquid biopsy, mCRPC, metastatic castration-resistant prostate cancer, oncology biomarkers, personalised cancer treatment, Prostate Cancer Research, Sanofi, The Institute of Cancer Research London
(IN BRIEF) Siemens and Capgemini have deepened their collaboration to develop AI-native digital solutions that integrate artificial intelligence directly into the foundation of product engineering, manufacturing, and operations. The partnership will deliver industry-specific applications that combine Siemens’ industrial software and … Read the full press release
Posted in Artificial Intelligence (AI), Energy, Gas & Oil, Environment, France, Germany, Industrial, Infrastructure & Utilities, News, Technology
Tagged AI agents, AI-native, Aiman Ezzat, Airbus, artificial intelligence, automation, Capgemini, Cedrik Neike, Cloud, digital transformation, Digital Twins, energy transition, engineering, Europe, GravitHy, hydrogen, industrial AI, industrial software, Industry 4.0, Manufacturing, operations, Sanofi, Siemens, Siemens and Capgemini Deepen Global Partnership to Deliver Intelligent and Sustainable Industrial Innovation, smart manufacturing, sustainability, technology partnership
Pertussis cases surge: Over 60,000 reported in Europe; infants most at risk. Maternal vaccination expands: Finland, Norway, and UK updated pregnancy vaccine strategies. BioNet advances: Submitted recombinant pertussis vaccine to EMA; secured EU-GMP approval. Nasal vaccine progresses: ILiAD’s BPZE1 granted … Read the full press release
Posted in Denmark, European Union, Finland, France, Germany, Healthcare, Ireland, News, Norway, Pharma & Biotech, Science, United Kingdom
Tagged acellular pertussis vaccine, Adacel, antibody avidity, antigen dose, ASEAN, Bio Farma, BioNet, biotechnology, booster dose, Boostrix-IPV, BPZE1, certification, Chulalongkorn University, clinical trial, compliance, Dario Cresci, dTap, ECDC, EMA, EU-GMP, EU-GMP certification, EU/EEA, Europe Confronts Pertussis Resurgence as Infant Cases Rise Amid Falling Immunity and Vaccination Gaps, Europe Faces Pertussis Resurgence Amid Waning Immunity and Falling Maternal Vaccination Rates, European Medicines Agency, European Union, European Union Good Manufacturing Practice, Europe’s Pertussis Vaccine Market Opens to New Entrants as Demand Rises, From EU-GMP Certification to ASEAN Partnerships BioNet Broadens Its Global Vaccine Strategy, GMP production facilities, GSK, Hanna Nohynek, health policy, HPRA, human challenge trial, hVIVO, ILiAD Biotechnologies, immunization strategy, infant protection, Innovation Passport, Institut Pasteur, intranasal vaccine, Ireland Health Products Regulatory Authority, Lancet Infectious Diseases, maternal vaccination, MHRA, mucosal immunity, outbreak, pandemic recovery, Pertagen®, pertussis, pertussis vaccine, Pertussis Vaccine Manufacturing, pharmaceutical quality, Phase 3, Philippe Guillot-Chêne, pregnancy immunization, public health, recombinant pertussis vaccine, recombinant pertussis vaccines, regulatory approval, Sanofi, Tdap, TdaP combination vaccine, V, vaccine, vaccine blunting, vaccine development, Vaccine Hesitancy, vaccine pipeline, vaccine rollout, vaccine shortage, vaccine supply, vaccine uptake, VacPertagen, whooping cough
(IN BRIEF) Sanofi’s investigational therapy efdoralprin alfa met all primary and key secondary endpoints in the Phase 2 ElevAATe study for alpha-1 antitrypsin deficiency emphysema, demonstrating superior efficacy compared to standard plasma-derived therapy. The results highlight its potential as the … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged AATD emphysema, alpha-1 antitrypsin deficiency, biotechnology, Christopher Corsico, clinical research, David Geffen School of Medicine, efdoralprin alfa, ElevAATe OLE, ElevAATe study, FDA Fast Track, functional AAT, Igor Barjaktarevic, orphan drug designation, phase 2 trial, protein replacement therapy, pulmonary medicine, rare disease, recombinant therapy, respiratory health, respiratory innovation, Sanofi, Sanofi’s Efdoralprin Alfa Shows Superior Results in Phase 2 AATD Emphysema Trial, SAR447537, UCLA
(IN BRIEF) Sanofi has boosted its venture capital arm, Sanofi Ventures, with a new $625 million multi-year commitment, raising the fund’s assets under management to more than $1.4 billion. Since 2012, Sanofi Ventures has invested over $800 million in more … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged AI in healthcare, Biotech, digital health, early-stage funding, Healthcare Innovation, immunology, IPOs, Jason P Hafler, medical breakthroughs, Neurology, Paul Hudson, rare diseases, Sanofi, Sanofi boosts its venture arm with fresh $625 million funding to support biotech and digital health startups, Sanofi expands Sanofi Ventures with $625 million to drive biotech and digital health breakthroughs, Sanofi Ventures, scientific progress, vaccines, venture capital
(IN BRIEF) Sanofi has finalized its takeover of Vigil Neuroscience for roughly $470 million, acquiring all outstanding shares at $8 each and issuing a $2-per-share CVR tied to VG-3927’s first commercial sale. This deal, following Sanofi’s June 2024 strategic investment, … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Technology
Tagged acquisition, Alzheimer’s disease, contingent value right, CVR, neurodegenerative research, Neurology, partnership, Phase 2 clinical study, preclinical pipeline, Sanofi, strategic investment, TREM2 agonist, VG-3927, VGL101, Vigil Neuroscience
(IN BRIEF) Sanofi has secured European Commission approval for Sarclisa in combination with VRd as an induction treatment for newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant. The decision was based on part one of the GMMG-HD7 … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged autologous stem cell transplant, bortezomib, cancer treatment, clinical trials, dexamethasone, EU approval, front-line therapy, German-speaking Myeloma Multicenter Group, GMMG-HD7, hematologic malignancies, ICARIA-MM, IKEMA, IMROZ, isatuximab, lenalidomide, MRD negativity, Multiple Myeloma, Olivier Nataf, oncology, progression-free survival, Sanofi, Sarclisa, transplant-eligible, VRd
(IN BRIEF) Sanofi has completed its purchase of Blueprint Medicines, acquiring the approved systemic mastocytosis therapy Ayvakit/Ayvakyt (avapritinib), along with two pipeline candidates: elenestinib (a KIT D816V inhibitor in Phase 2/3 HARBOR, NCT04910685) and BLU‑808 (a wild‑type KIT inhibitor). The $129.00‑per‑share … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged $129.00 per share, avapritinib, Ayvakit, Ayvakyt, Blueprint Medicines, BLU‑808, contingent rights, elenestinib, GIST, HARBOR, KIT inhibitor, MERGER, NASDAQ delisting, NCT04910685, partnership, PDGFRA D842V, Sanofi, SM, sustainability, systemic mastocytosis, tender offer
(IN BRIEF) The FDA has awarded orphan drug designation to Sanofi’s riliprubart for the treatment of antibody-mediated rejection in solid organ transplants, highlighting the therapy’s potential in an area lacking approved options. Riliprubart, a humanized IgG4 antibody targeting activated C1s … Read the full press release
Posted in Business, Financial, France, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Security & Safety, Technology
Tagged Alyssa Johnsen, AMR, antibody-mediated rejection, C1s inhibition, chronic inflammatory demyelinating polyneuropathy, CIDP, ClinicalTrials.gov, complement pathway, FDA, Global Therapeutic Area Development Head, immunology, MOBILIZE, NCT05156710, NCT06290128, NCT06290141, orphan drug designation, Phase 2 study, riliprubart, Sanofi, SAR445088, solid organ transplantation, VITALIZE
(IN BRIEF) The CHMP has recommended EU approval of Sarclisa alongside VRd for transplant-eligible NDMM, based on GMMG-HD7 trial results showing superior MRD negativity and PFS compared to VRd alone. This potential label extension would mark Sarclisa’s fourth EU approval … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged ASH 2024, autologous stem cell transplant, bortezomib, CHMP, dexamethasone, European Medicines Agency, GMMG-HD7, isatuximab, Journal of Clinical Oncology, lenalidomide, MRD negativity, Multiple Myeloma, NDMM, phase 3 study, progression-free survival, Sanofi, Sarclisa, transplant-eligible, VRd
(IN BRIEF) Sanofi has launched early global shipments of Beyfortus (nirsevimab) in anticipation of the 2025–2026 RSV season, enabling healthcare providers to begin immunizations well before the typical onset of infections in November. In collaboration with AstraZeneca, Sanofi has significantly … Read the full press release
Posted in Business, Financial, France, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged AstraZeneca, Beyfortus, EU label, extended protection, global distribution, hospitalizations, infant immunization, lower respiratory tract disease, monoclonal antibody, newborn care, nirsevimab, pediatric health, public health, real-world studies, respiratory syncytial virus, RSV, RSV season, Sanofi, Thomas Triomphe, Vaccine Innovation, vaccine supply chain
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