Sanofi
🇫🇷France
- Country
- 🇫🇷France
- Ownership
- Public
- Employees
- 87.9K
- Market Cap
- $141.3B
- Website
- http://www.sanofi.com
- Introduction
Sanofi engages in the research, production, and distribution of pharmaceutical products. It operates through the following business segments: Pharmaceuticals, Consumer Healthcare, and Vaccines. The Pharmaceuticals segment comprises the commercial operations of the following global franchises: specialty care, diabetes and cardiovascular, established prescription products and generics, and research, development, and production activities. The Consumer Healthcare segment includes the commercial operations for its Consumer Healthcare products. The Vaccines segment consists commercial operations of Sanofi Pasteur. The company was founded in 1973 and is headquartered in Paris, France.
Isatuximab Plus VRd Earns CHMP Recommendation for Newly Diagnosed, Transplant Ineligible Multiple Myeloma Patients
The CHMP recommended isatuximab (Sarclisa) combined with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients ineligible for autologous stem cell transplant. Data from the phase 3 IMROZ trial showed isatuximab plus VRd reduced disease progression or death risk by 40.4% compared to VRd alone, with a median progression-free survival not reached in the isatuximab group and 54.34 months in the VRd group.
Where are they now? 4 biotechs that soared then crashed during the pandemic
Many biotechs that rose during the pandemic have faced challenges as their COVID-19 candidates faltered. CureVac, after its mRNA vaccine's low efficacy, restructured and partnered with GSK. Novavax, despite FDA approval, struggled with uptake and faced a clinical hold on its flu/COVID shot. Inovio Pharmaceuticals, once a frontrunner with DNA-based tech, faced controversy and delayed its FDA application. Veru's antiviral sabizabulin was denied EUA and now focuses on GLP-1 related treatments.
FDA Accepts Resubmission of Supplemental Biologics License Application for Dupixent for Treating CSU in Patients Aged 12+ with Inadequate H1 Antihistamine Control
The FDA accepted Sanofi and Regeneron's resubmitted sBLA for Dupixent in treating CSU in patients aged 12+ with inadequate H1 antihistamine control, supported by LIBERTY-CUPID Phase III data. Study C results showed Dupixent reduced itch severity and urticaria activity scores, with safety consistent with known profiles. The FDA decision target date is April 18, 2025.
FDA Accepts sBLA Review for Dupilumab in Treatment of CSU in Adult and Pediatric Patients
The FDA is reviewing dupilumab's sBLA for chronic spontaneous urticaria (CSU) in patients 12+ not controlled by H1 antihistamines, with a decision target date of April 18, 2025. Dupilumab, a monoclonal antibody inhibiting IL-4 and IL-13 pathways, has shown significant reductions in itch and hive activity in phase 3 trials, meeting primary and secondary endpoints. Safety results were consistent with known profiles, though AEs were more common with dupilumab.
FDA to review Sanofi, Regeneron's Dupixent sBLA for CSU
FDA reviews Sanofi and Regeneron’s Dupixent for chronic spontaneous urticaria (CSU) in adults and children aged 12+ despite H1 antihistamine treatment, with a decision target date of 18 April 2025. Based on LIBERTY-CUPID Phase III clinical programme, Dupixent showed significant itch and urticaria activity reduction, with a consistent safety profile. Dupixent is approved in over 60 countries for various conditions and is under review in the EU for CSU.
FDA accepts application for dupilumab to treat chronic spontaneous urticaria
FDA accepts dupilumab's sBLA for chronic spontaneous urticaria treatment, targeting April 18, 2025 for approval. Dupilumab, an IL-4 and IL-13 inhibitor, aims to treat CSU not controlled by H1 antihistamines. Studies A, B, and C in the LIBERTY-CUPID program support the application, showing dupilumab's efficacy in reducing itch and urticaria activity.
EMA's CHMP recommends Sanofi's Sarclisa approval for multiple myeloma
EMA’s CHMP recommends Sanofi’s Sarclisa with VRd for newly diagnosed MM in transplant-ineligible patients, based on Phase III IMROZ trial results. Sarclisa, approved in over 50 countries for relapsed or refractory MM, shows no new safety concerns when combined with VRd. Sanofi aims to establish a new standard-of-care in the EU.
Halozyme Makes Unsolicited €2B Takeover Bid for Drug R&D Services Firm Evotec
Halozyme proposes €2 billion acquisition of Evotec, offering €11.00 per share in cash, a 109% premium to Evotec's Oct. 15 stock price. Evotec, with 4,000 employees, faces recent setbacks including a cyberattack and restructuring. Halozyme, with 373 employees, offers Enhanze drug delivery tech used by Roche, Takeda, Eli Lilly, Pfizer, and AbbVie.
Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic
FDA accepts Regeneron and Sanofi's resubmission of Dupixent for chronic spontaneous urticaria (CSU) review, with a decision expected by April 18, 2025. Dupixent, if approved, would be the first targeted therapy for CSU in a decade, supported by pivotal data showing significant itch and hive activity reduction.
FDA reviews Sanofi and Regeneron's Dupixent label expansion for urticaria
FDA reviews Sanofi and Regeneron’s Dupixent for chronic spontaneous urticaria, targeting decision by April 2025. Dupixent, a monoclonal antibody, inhibits IL-4 and IL-13 pathways, showing significant itch and urticaria reduction in Study C. Already approved in Japan and UAE, Dupixent seeks EU approval and has potential revenue of $23.6bn by 2030.
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