FDA approves Sanofi’s Sarclisa to treat relapsed multiple myeloma
The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone (Kd), for the…
Pharmaceuticals, Biotechnology and Life Sciences
The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone (Kd), for the…
Sanofi and Regeneron posted positive results with an overall survival (OS) benefit from the Phase 3 trial investigating its PD-1 inhibitor Libtayo (cemiplimab) monotherapy compared to chemotherapy in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic.
Sanofi on Tuesday detailed plans investing in France to increase its vaccines research and production capacities, and contribute in responding to future pandemic risks, aligned with its corporate strategy presented last December, Sanofi will invest €610 million to create a new production site and research center in France with both dedicated to vaccines.
Denali Therapeutics and Sanofi have paused clinical studies with small molecule RIPK1 inhibitor DNL747 in Alzheimer’s disease and ALS, due to emerging evidence that higher levels of target inhibition may be required for maximizing efficacy, and certain challenges.
Regeneron Pharmaceuticals and Sanofi have shared positive results from Part A of the pivotal Phase 3 trial evaluating Dupixent in patients 12 years and older with eosinophilic esophagitis (EoE), in which the trial met both co-primary endpoints.
Sanofi said Friday that Libtayo (cemiplimab-rwlc) longer-term results in advanced cutaneous squamous cell carcinoma presented at ASCO 2020 show durable responses that deepen over time.
Mylan said on Friday that the U.S. Patent and Trademark Appeal Board (PTAB) has ruled in favor of Mylan in inter partes review (IPR) proceedings finding all challenged claims of Sanofi’s Lantus® SoloSTAR® device patents, U.S. Patent Nos. 8,603,044, 8,992,486, and 9,526,844 unpatentable.
Dupixent in patients 12 years and older with eosinophilic esophagitis (EoE) trial met both of its co-primary endpoints.
“When Sarclisa was added to standard-of-care treatment carfilzomib and dexamethasone in this phase 3 trial, results clearly demonstrated a significant reduction in risk of disease progression or death, ” said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi.
Schreiner MediPharm has developed a compact Booklet-Label for a needle protection system used in an international phase III clinical trial conducted by pharmaceutical corporation Sanofi.