Tag Archives: Sanofi

Tolebrutinib Receives FDA Breakthrough Therapy Designation for Progressive Multiple Sclerosis

(IN BRIEF) The FDA has granted Breakthrough Therapy designation to tolebrutinib for treating adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS), following positive results from the HERCULES phase 3 study. The study showed tolebrutinib delayed disability progression by 31% and … Read the full press release

EMA Approves Dupixent as First-Ever Treatment for Young Children with Eosinophilic Esophagitis in the EU

(IN BRIEF) The European Medicines Agency has approved Dupixent as the first treatment for eosinophilic esophagitis (EoE) in young children aged one to 11, marking a significant step in managing this condition in a critical developmental phase. The approval is … Read the full press release

Sanofi and CD&R Join Forces to Propel Opella’s Global Consumer Healthcare Expansion

(IN BRIEF) Sanofi and CD&R have entered exclusive negotiations for CD&R to acquire a 50% controlling stake in Opella, Sanofi’s consumer healthcare business, while Sanofi retains a significant share. The partnership aims to support Opella’s growth as a global leader … Read the full press release

Sanofi and Orano Med Partner to Drive Development of Advanced Radioligand Cancer Therapies

(IN BRIEF) Sanofi and Orano Med have partnered to accelerate the development of next-generation radioligand therapies (RLTs) for rare cancers. By combining their expertise, they aim to advance treatments using lead-212 (212Pb) alpha-emitting isotopes, which target and destroy cancer cells … Read the full press release

Sanofi’s Tolebrutinib Shows Breakthrough Potential in Slowing Disability Progression for Multiple Sclerosis Patients

(IN BRIEF) Sanofi’s phase 3 study for its drug tolebrutinib has shown promising results in treating non-relapsing secondary progressive multiple sclerosis (nrSPMS), a condition with no current approved therapies. The HERCULES study revealed that tolebrutinib successfully delayed disability progression in … Read the full press release

Sanofi’s Frexalimab Shows Promise in Phase 2 for Treating Multiple Sclerosis

(IN BRIEF) Sanofi’s experimental CD40L antibody, frexalimab, demonstrates encouraging results in a 48-week phase 2 study for relapsing multiple sclerosis (MS). Presented at the American Academy of Neurology Annual Meeting, the data reveals sustained reduction in disease activity and favorable … Read the full press release

AstraZeneca and Sanofi’s Beyfortus Receives Approval in Japan for Prophylaxis against Respiratory Syncytial Virus

(IN BRIEF) AstraZeneca and Sanofi celebrate the approval of Beyfortus (nirsevimab) in Japan by the Ministry of Health, Labour, and Welfare for preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in neonates, infants, and children entering … Read the full press release

Patients as Partners® Europe Announces the Launch of 8th Annual Meeting with 2024 Keynotes and Topics

(IN BRIEF) The Conference Forum announced the launch of the 8th annual Patients as Partners® Europe meeting, scheduled for May 14-15, 2024, at Plaisterers’ Hall in London, England. This event brings together pharma R&D and patient advocacy to discuss patient … Read the full press release

Breakthrough Study Shows Amlitelimab’s Long-lasting Effectiveness in Atopic Dermatitis Treatment

(IN BRIEF) In a groundbreaking Phase 2b study, amlitelimab demonstrates remarkable potential in maintaining treatment response for patients with moderate to severe atopic dermatitis (AD). Presented at the American Academy of Dermatology (AAD) 2024 Conference, the study reveals sustained improvement … Read the full press release

Dupixent® Receives Landmark Approval in Japan for Chronic Spontaneous Urticaria Treatment

(IN BRIEF) Japan’s Ministry of Health, Labor and Welfare (MHLW) has authorized the marketing and manufacturing of Dupixent® (dupilumab) for treating chronic spontaneous urticaria (CSU) in patients aged 12 years and older. This approval marks a significant milestone as Japan … Read the full press release

Sanofi’s Dupixent Receives FDA Approval for Pediatric Eosinophilic Esophagitis (EoE) Treatment

(IN BRIEF) The U.S. Food and Drug Administration (FDA) has granted approval for Dupixent® (dupilumab) to treat pediatric patients aged 1 to 11 years, weighing at least 15 kg, who suffer from eosinophilic esophagitis (EoE). Dupixent is now the first … Read the full press release

Sanofi Ceases Development of Tusamitamab Ravtansine for NSCLC after Trial Misses Primary Endpoint

(IN BRIEF) Sanofi has announced the discontinuation of the global clinical development program for tusamitamab ravtansine, following an interim analysis of the Phase 3 CARMEN-LC03 trial. The trial assessed tusamitamab ravtansine as a monotherapy in previously treated metastatic non-squamous non-small … Read the full press release

Sarclisa Combination Therapy Boosts Myeloma Remission Rates in Phase 3 Trial

(IN BRIEF) In the Phase 3 IsKia trial presented at the American Society of Hematology (ASH) Annual Meeting, Sarclisa® (isatuximab) combined with carfilzomib, lenalidomide, and dexamethasone (KRd) demonstrated a significant improvement in achieving minimal residual disease (MRD) negativity among newly … Read the full press release

Sanofi’s Robust Pipeline and Strategic Focus Aim to Lead Immunology Industry

(IN BRIEF) Sanofi is showcasing its ambitious pipeline transformation strategy, which includes a record 12 potential blockbuster opportunities currently under clinical evaluation. Among these, there are nine innovative medicines and vaccines with peak sales potential ranging from €2 to €5 … Read the full press release

Sarclisa Combination Treatment Shows Promise in Phase 3 Trial for Newly Diagnosed Multiple Myeloma Patients

(IN BRIEF) The Phase 3 IMROZ trial, assessing the use of Sarclisa® (isatuximab) in combination with standard-of-care bortezomib, lenalidomide, and dexamethasone (VRd), has achieved its primary efficacy endpoint at a planned interim analysis. The trial demonstrated a statistically significant improvement … Read the full press release

Sanofi’s CHC Launches Shared Care Collective with Global Experts to Advance Health and Sustainability Initiatives

(IN BRIEF) Sanofi’s Consumer Healthcare business unit (CHC) has introduced the Shared Care Collective, an advisory board consisting of experts from various fields, both internal and external, to bolster sustainability efforts within the CHC business. This initiative aims to foster … Read the full press release

Dupixent Shows Remarkable Efficacy in Reducing COPD Exacerbations in Second Phase 3 Trial

(IN BRIEF) In a significant development, the second investigational Phase 3 trial of Dupixent® (dupilumab) for chronic obstructive pulmonary disease (COPD), known as NOTUS, has demonstrated promising results. The trial found that Dupixent reduced COPD exacerbations by 34% compared to … Read the full press release

Sanofi and Teva Collaborate on Inflammatory Bowel Disease Treatment, TEV’574, in $1.5 Billion Deal

(IN BRIEF) Sanofi and Teva Pharmaceuticals have announced a collaboration to co-develop and co-commercialize TEV’574, a promising asset currently in Phase 2b clinical trials for the treatment of Ulcerative Colitis and Crohn’s Disease, both forms of inflammatory bowel disease (IBD). … Read the full press release

Sanofi Collaborates with Janssen on Vaccine for Extraintestinal Pathogenic E. coli

(IN BRIEF) Sanofi has entered into an agreement with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, to develop and commercialize a vaccine candidate for extraintestinal pathogenic E. coli (ExPEC) that is currently in Phase 3 of clinical trials. ExPEC … Read the full press release

Sanofi’s ALTUVIIIO Granted Marketing Authorization in Japan for Hemophilia A Treatment

(IN BRIEF) The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for ALTUVIIIO, a novel factor VIII replacement therapy used to control bleeding in patients with hemophilia A. ALTUVIIIO, also known as efanesoctocog alfa, stands out … Read the full press release