Approval is based on positive results from the IMROZ phase 3 study, demonstrating Sarclisa in combination with standard-of-care treatment significantly improved PFS, compared to the standard of care alone in TI NDMMRepresents third indication in the EU, including two for the treatment of adult patients with R/R MM, and one in NDMMParis, January 22, 2025. Following the adoption of a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), the EU has approved Sarclisa in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT), based on data from the IMROZ phase 3 study. With the expanded marketing authorization, Sarclisa is the first anti-CD38 therapy in combination with VRd in this patient population in the EU.Olivier NatafGlobal Head of Oncology at Sanofi“While there have been many important advancements in multiple myeloma treatment over the past decade, there remains a significant unmet need in the front-line setting, particularly for transplant-ineligible patients. With today’s decision the 27 countries in the EU will have access to a potentially transformative new combination regimen, marking a significant step forward in our mission to make a meaningful difference in multiple myeloma treatment.”In September 2024, the US Food and Drug Administration (FDA) approved Sarclisa in combination with VRd for the treatment of adult patients with NDMM who are not eligible for ASCT, representing the first global approval for Sarclisa in the front-line setting. In addition, the FDA granted orphan drug exclusivity for Sarclisa in the approved indication. Beyond the US and the EU, regulatory submissions for Sarclisa in NDMM not eligible for ASCT are under review in Japan and in China.About SarclisaSarclisa (isatuximab) is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity

Sürdürülebilir sağlık için ortak hareket etme vizyonuyla çalışmalar yürüten TÜSAP Platformu, sağlık sektörünün mevcut durumundan yola çıkarak vizyon tartışmaları yapmak ve sektörün geleceğini etkileyecek nitelikli bilgiler üretmek amacıyla 40. Vizyon Toplantısı’nı, Sanofi’nin katkılarıyla düzenledi.Zirvede Sanofi’nin PharmUp Girişimci Destek Programı kapsamında hayata geçirilen, metabolik ve nadir bir hastalık grubu olan Lizozomal Depo Hastalıkları odağında çözüm geliştiren girişimcilere yönelik başlattığı Care4Rare projesinin Demoday etkinliği gerçekleştirildi.Care4Rare programı, Sanofi’nin Sağlık Bakanlığı Nadir Hastalıklar Sağlık Strateji Belgesi ve Eylem Planı’na uygun birçok dijital çözüm, yaklaşım, fikir ve paydaşlarla iş birliği fırsatları yaratmayı hedeflediği projesi. Lizozomal Depo Hastalıkları başta olmak üzere nadir hastalıklara sahip hastaların tanı, tedavi ve günlük yaşam süreçlerindeki öncelikli sorunlarına girişimci gözü ile bulunan çözümlerin hayata geçirilmesi için kapsamlı destekler sunuluyor.Care4Rare'in Demo Day'inde sunum yapan girişimler şu şekilde:Umaxlife: Biyomarkerlara entegre olarak veri toplayabilen, derin öğrenme ile akıl sağlığının insan bedenine etkisini ölçümleyen dijital terapötik platform.Inorare: Nadir hastalıklarla mücadele edenlerin en çok kullandığı medikal cihazlardan biri olan TAK kateterlerin ev ortamında kullanıcı tarafından en az 10 kez sterilize edilip tekrar kullanımını sağlayacak bir kişisel sterilizasyon sunuyor.Pons: Hastane dışında yapay zeka destekli mobil ultrason teknolojisi ile erken aşama yüksek riskli kanser vakalarının tespitini mümkün kılan teknolojiye sahip girişim.RareGlow: Hastalığın seyrine göre fizyoterapistin ailelere verdiği egzersiz programını 3 boyutlu bir modelle uygulamaya entegre ediyor.RareSum: Doktorların yüklediği anonim hasta profillerini inceleyen, bugüne kadar yayınlanmış vaka çalışmalarıyla eşleşme sağlayan, doktorun teşhis ve tedavisini bilimsel kanıtlarla desteklemesini sağlayan, yapay zeka tabanlı karar destek mekanizması

What You Should Know:– BrightInsight, Inc., a provider of regulated digital health solutions, has announced an expanded multi-year partnership with Sanofi, a global biopharmaceutical company. This expanded partnership builds on a successful collaboration that began in 2022 when Sanofi selected the BrightInsight Platform to accelerate the development of a SaMD for one of its specialty care medicines.– The goal of the collaboration aims to accelerate Sanofi’s drug development timeline and improve patient outcomes through innovative digital health solutions.Accelerating Time-to-Market for New TherapiesSanofi aims to cut its drug development timeline in half, and this partnership with BrightInsight will play a key role in achieving that goal. By leveraging BrightInsight’s platform and technology, Sanofi can streamline the development and deployment of digital health solutions that support clinical trials, enhance patient engagement, and improve medication adherence.Enhancing Patient Experience with “MyWay”Under the expanded partnership, Sanofi will utilize BrightInsight’s “MyWay” mobile application, a Software as a Medical Device (SaMD) solution designed to empower patients in managing their health conditions. MyWay offers several key features:Symptom Tracking: Allows patients to track their symptoms, such as flares or disease progression.Allows patients to track their symptoms, such as flares or disease progression. Medication Management: Helps patients manage their medications, including tracking injections and adherence.Helps patients manage their medications, including tracking injections and adherence. Financial Tracking: Enables patients to track medical expenses in select countries.Enables patients to track medical expenses in select countries