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Sanofi (SNY), a global leader in pharmaceuticals and vaccines, provides critical health solutions through its innovative drug development and strategic partnerships. This dedicated news hub offers investors and industry professionals centralized access to official updates and analysis.
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Sanofi and the National Institute for Health and Care Research announced the enrollment of the first patient in the Hospitalised RSV Monoclonal Antiody Prevention (HARMONIE) study, targeting the prevention of Respiratory Syncytial Virus (RSV) in infants. This extensive clinical study will evaluate nirsevimab across over 20,000 infants in the UK, France, and Germany, with a focus on reducing RSV hospitalizations. The study commenced with the first patient visit on August 8, 2022, and aims to improve understanding of RSV protection through a single injection.
Sanofi has appointed three new leaders for its U.S. General Medicines and North American Vaccines and Consumer Healthcare divisions. Olivier Bogillot will lead U.S. General Medicines from September 1, moving from his role as President of Sanofi France. Deborah Glasser is the new Head of Vaccines for North America, having previously worked at Biogen. Andrew Loucks will take charge of North America Consumer Healthcare effective August 8, joining from Sensory Cloud. These appointments aim to strengthen leadership and enhance commercial operations.
Sanofi has partnered with Howard University College of Pharmacy to launch a two-year Doctorate in Pharmacy fellowship program aimed at addressing disparities in underrepresented communities. Set to begin in the latter half of 2022, the program will select ten PharmD graduates for practical experiences across diverse fields like oncology and neurology. This initiative marks a significant commitment, being the first industry partnership from Howard University to promise post-fellowship employment. The fellowship aligns with Sanofi's Diversity, Equity & Inclusion strategy, which aims to enhance representation by 2025.
Sanofi has received FDA approval for its Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluzone Quadrivalent vaccines for the 2022-2023 flu season. This follows a CDC recommendation favoring these vaccines for adults 65 and older, who are at a higher risk of severe flu complications. Notably, Fluzone High-Dose offers superior protection against flu-related hospitalizations and is the only vaccine with a decade of proven efficacy in this demographic. Sanofi aims to enhance vaccination rates among vulnerable populations to mitigate flu-related health risks.
Dupixent has received FDA approval as the first biologic medicine for children aged 6 months to 5 years diagnosed with moderate-to-severe atopic dermatitis. A Phase 3 trial showed that children treated with Dupixent alongside topical corticosteroids achieved 28% clear skin, compared to 4% with corticosteroids alone. The treatment significantly reduced disease severity and itch. Long-term safety data reaffirmed Dupixent's established safety profile. Regeneron and Sanofi aim to address the significant unmet needs of young children suffering from this debilitating condition.
Sanofi has officially opened a new 900,000 square-foot campus at Cambridge Crossing, Massachusetts. This facility, housing 2,500 employees, aims to enhance collaboration among R&D, Medical, and Specialty Care divisions, facilitating the development of innovative treatments. The campus features state-of-the-art environmental designs, including CO2 sensors and rainwater harvesting systems for efficiency. The opening aligns with Sanofi's Play to Win strategy to drive growth and innovation, supported by local government leaders highlighting its role in enhancing Massachusetts' health and life sciences ecosystem.
The FDA has accepted Dupixent (dupilumab) for Priority Review to treat prurigo nodularis, a chronic skin disease. If approved, Dupixent will be the first medicine specifically indicated for this condition in the U.S. The target decision date is September 30, 2022. This application is backed by two Phase 3 trials demonstrating significant improvements in symptoms compared to placebo. The most commonly observed adverse event was conjunctivitis. Approximately 75,000 U.S. patients struggle with this disease, highlighting the potential market need for Dupixent.
The FDA has approved Dupixent (dupilumab) 300 mg weekly as the first and only treatment for eosinophilic esophagitis (EoE) in the U.S., benefiting approximately 160,000 patients. In a Phase 3 trial, Dupixent demonstrated a 69% and 64% reduction in symptoms compared to placebo, with a significant histological remission rate of 60% and 59% versus 5% and 6%. This approval marks Dupixent's fourth indication and supports its role in addressing type 2 inflammation-related conditions. Regulatory filings in Europe and other regions are planned in 2022.
Sanofi (Nasdaq: SNY) announced successful outcomes from its collaboration with Sempre Health on April 13, 2022. Their partnership improved medication adherence by 25% for patients on medications like Lantus and Toujeo. Patients using Sempre's platform refilled, on average, three more prescriptions than those not using it. The innovative program significantly reduced out-of-pocket costs for patients by up to 60%. This collaboration aims to enhance access to diabetes treatments for over 34 million Americans and is crucial for managing chronic conditions effectively.
Regeneron Pharmaceuticals and Sanofi have announced that the European Commission expanded the marketing authorization for Dupixent (dupilumab) to include children aged 6 to 11 with severe asthma characterized by type 2 inflammation. Supported by Phase 3 trial data, Dupixent significantly reduced severe asthma attacks by up to 65% compared to placebo, improved lung function, and quality of life. The treatment also reduced reliance on systemic corticosteroids by 66%. The approval highlights Dupixent's established safety profile and its commitment to addressing severe asthma in pediatric patients.