Sanofi provides healthcare solutions through its pharmaceutical and biotechnology products, focusing on treatments and vaccines for various medical needs. The company conducts extensive research and development to create new therapies and improve existing ones, particularly in areas like immunology, oncology, and rare diseases. Sanofi's products include prescription medicines, over-the-counter items, and vaccines, which are distributed to patients, healthcare professionals, and governments. What sets Sanofi apart from its competitors is its strong emphasis on scientific innovation and strategic partnerships, allowing it to maintain a diverse product pipeline. The company's goal is to enhance health outcomes and improve the quality of life for people globally.

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Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS)Tolebrutinib is the first and only brain-penetrant BTK inhibitor in MS to be designated Breakthrough Therapy by the FDAParis, December 13, 2024. The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). This is based on positive results from the HERCULES phase 3 study, demonstrating that tolebrutinib delayed the time to onset of 6-month confirmed disability progression (CDP), by 31% compared to placebo (HR 0.69; 95% CI 0.55-0.88; p=0.0026), with further analysis of secondary endpoints demonstrating that the number of participants who experienced confirmed disability improvement was nearly double with tolebrutinib (10%) compared to those on placebo (5%) (HR 1.88; 95% CI 1.10 to 3.21; nominal p=0.021).FDA Breakthrough Therapy designation is designed to expedite the development and review of medicines in the US that target serious or life-threatening conditions. Medicines qualifying for this designation must show preliminary clinical evidence that the drug may demonstrate substantial improvement on clinically significant endpoints over available medicines.Erik Wallström, MD, PhDGlobal Head of Neurology Development, Sanofi“This Breakthrough Therapy designation demonstrates the potential for tolebrutinib to delay disability progression, a critical unmet need for people living with multiple sclerosis. We look forward to working with the FDA during the regulatory review of this first of its kind medicine in non-relapsing secondary progressive multiple sclerosis where there are currently no approved treatments available.”Liver enzyme elevations (>3xULN) were observed in 4.1% of participants receiving tolebrutinib compared with 1.6% in the placebo group. A small (0.5%) proportion of participants in the tolebrutinib group experienced peak ALT increases of >20xULN, all occurring within the first 90 days of treatment

Tolebrutinib Designated Breakthrough Therapy By The Fda For Non-Relapsing Secondary Progressive Multiple Sclerosis

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Availability Of The Revised Financial Statements For Sanofi Excluding Opella

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the US suffer from chronic spontaneous urticaria (CSU) that is inadequately controlled by antihistaminesFDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decadeParis and Tarrytown, NY, November 15, 2024. The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is April 18, 2025.The resubmitted sBLA is supported by data from the multi-study LIBERTY-CUPID phase 3 clinical program (Study A, Study B, and Study C) for Dupixent in CSU. The sBLA adds results from Study C, which was conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines. Study C, the second LIBERTY-CUPID pivotal study in biologic-naïve patients, met its primary and key secondary endpoints, confirming results seen in the previous Study A. Results showed Dupixent significantly reduced itch and urticaria activity (itch and hives).Safety results in all LIBERTY-CUPID phase 3 studies were generally consistent with the known safety profile of Dupixent in its approved indications

Dupixent Sbla Accepted For Fda Review For The Treatment Of Chronic Spontaneous Urticaria

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

Brightinsight, Sanofi To Build Drug Companion Apps For Its Major Specialty Therapies

New analysis from the IMROZ phase 3 study of Sarclisa-VRd demonstrated higher and sustained MRD negativity rates in transplant-ineligible NDMM patients versus VRd aloneNew detailed results from the GMMG-HD7 phase 3 study of Sarclisa-RVd induction therapy resulted in a significant and clinically meaningful PFS benefit with deeper MRD negativity in transplant-eligible NDMM patientsResults support the benefit of Sarclisa-based combinations to patients in the front-line setting and the ongoing use of MRD negativity as a potential surrogate endpoint for PFS in MM researchParis, December 9, 2024. New data from three oral presentations, which demonstrated significant clinical benefit with Sarclisa-based quadruplets in newly diagnosed multiple myeloma (NDMM) patients were featured at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, CA, US. The presentations, including results from the IMROZ and German-speaking Myeloma Multicenter Group (GMMG)-HD7 phase 3 studies, showcased deep and durable responses and improved long-term outcomes with Sarclisa when added to current standard-of-care NDMM regimens.Dietmar Berger, MD, PhDChief Medical Officer, Global Head of Development at Sanofi“An important part of our approach to scientific innovation in oncology is identifying synergistic combinations, which may allow us to impact numerous unmet needs with a single therapy and expand the pool of patients who could one day benefit from our medicines. Results from key studies evaluating Sarclisa combinations further reinforce our confidence in this strategy and speak to the potential benefit of Sarclisa as a backbone therapy for newly diagnosed multiple myeloma, regardless of transplant eligibility.”Additional IMROZ phase 3 study analysis evaluating MRD in transplant-ineligible (TI) NDMM patientsThe IMROZ phase 3 study demonstrated that Sarclisa in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd), followed by Sarclisa-Rd, improved progression-free survival (PFS) and led to a rapid and greater depth of response compared to VRd alone, as shown by minimal residual disease (MRD) negativity rate over time, in TI NDMM patients. MRD negativity represents a measure of malignant cells left in the bone marrow after treatment and has been increasingly used as a surrogate endpoint for PFS in MM research. Numerous independent studies have shown a correlation between MRD negativity, deeper treatment responses and improved long-term outcomes.Sarclisa-VRd demonstrated a consistent benefit at every time point up to 60 months and led to the highest MRD negativity rate of a NDMM regimen with a VRd backbone, when evaluating exclusively TI patients.Higher MRD negativity rates were observed at both the end of initiation and during maintenance, with 58.1% of patients in the intention-to-treat (ITT) population treated with Sarclisa-VRd achieving MRD negativity versus 43.6% of patients in the control arm (OR 1.79; 95% CI: 1.22 to 2.63; p=0.0014).versus 43.6% of patients in the control arm (OR 1.79; 95% CI: 1.22 to 2.63; p=0.0014)

Ash: Sarclisa Combinations Demonstrated Significant Benefits In Newly Diagnosed Multiple Myeloma Patients

Approval based on phase 3 data showing significantly more children aged one to 11 years on Dupixent achieved histological disease remission at 16 weeks compared to placebo, which was sustained up to one yearDupixent is the first-ever medicine in the EU indicated to treat these young patients, who persistently struggle to eat at a critical stage in life where growth is crucialParis and Tarrytown, NY, November 6, 2024. The European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. Specifically, the approval covers children aged one to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy. This expands the initial approval in the European Union (EU) for EoE in adults and adolescents and makes Dupixent the first and only medicine indicated to treat these young patients. Dupixent is also approved in this young age group in the US and Canada.Roberta GiodicePresident, ESEO Italia“Young children with eosinophilic esophagitis are at the beginning of their life-long journey with a disease that challenges their ability to eat. Parents of these children have often relied on restrictive diets that do not specifically address the disease and can stunt their growth at a critical time in development that could impact them for years to come

Dupixent Approved In The Eu As The First And Only Medicine For Young Children With Eosinophilic Esophagitis

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

Sarclisa Approved In The Eu As The First Anti-Cd38 Therapy In Combination With Standard-Of-Care Vrd To Treat Transplant-Ineligible Newly Diagnosed Multiple Myeloma

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

Sanofi’Nin Girişimcilik Programı Care4Rare'In Demo Day'Inde Sunum Yapan Girişimler

Pivotal phase 3 data show rapid and durable platelet response, reduced bleeding and need for rescue response, and improved physical fatigue and quality of life measures in patients with persistent or chronic ITP. Results underscore the safety and efficacy of rilzabrutinib and its potential as the first BTK inhibitor in ITP. Rilzabrutinib is currently under regulatory review in the US and the EUParis, December 7, 2024. Positive results from the pivotal LUNA 3 phase 3 study of rilzabrutinib in adults with persistent or chronic immune thrombocytopenia (ITP), a rare immune-mediated disease, reinforce the efficacy and safety of rilzabrutinib, an oral, reversible, covalent Bruton’s tyrosine kinase (BTK) inhibitor, and further support its potential as a first-in-class treatment for ITP. Platelet response was achieved in 65% (n=86) of patients receiving rilzabrutinib compared to 33% (n=23) of patients on placebo. The primary endpoint was met, with rilzabrutinib demonstrating durable platelet response in 23% of ITP adult patients compared to 0% on the placebo arm (p0.0001), as well as key secondary endpoints including reduced bleeding, number of weeks with platelet response, the need for rescue therapy use, and improved physical fatigue and quality of life measures

Ash: Rilzabrutinib Demonstrated Significant Patient Benefit In The First Positive Phase 3 Study Of A Btk Inhibitor In Itp

PARIS and NEW YORK and SAN FRANCISCO, Nov. 12, 2024 /PRNewswire/ -- Today, Formation Bio, together with OpenAI and Sanofi, introduced Muse, an advanced AI-powered tool developed to accelerate and improve drug development by optimizing patient recruitment for clinical trials. Muse is the first outcome of the collaboration between the three companies, which aims to combine their pharma expertise and AI models to accelerate drug development and ultimately speed up breakthrough therapies to patients. Patient recruitment is a critical yet often slow and costly aspect of clinical development. It is estimated that less than 10% of patients participate in clinical trials for different reasons, including the fact that they are never invited or informed about the opportunity. This low participation rate causes delays that directly impact how quickly new medicine can reach patients

Formation Bio Collaborates With Sanofi And Openai To Introduce Muse, A First Of Its Kind Ai Tool To Accelerate Patient Recruitment In Drug Development

Zucara Therapeutics, a Toronto-based diabetes life sciences company, raised $20 million in Series B funding. The round was led by Sanofi, which gained an exclusive right of first negotiation, and The Perceptive Xontogeny Venture Fund. The funds will support the ongoing Phase 2a trial of ZT-01 for nocturnal hypoglycemia in Type 1 diabetes and nonclinical activities for a once-weekly version of ZT-01.

Zucara Therapeutics Secures $20M Series B Funding

Develops pharmaceuticals and life-saving vaccines

Sanofi

Develops pharmaceuticals and life-saving vaccines

Sanofi

Develops pharmaceuticals and life-saving vaccines

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