NASDAQ:SNY

Dupixent® (dupilumab) FDA Approved as First and Only Treatment Indicated for Children Aged 1 Year and Older with Eosinophilic Esophagitis (EoE)

Retrieved on: 
Thursday, January 25, 2024
Ageing, Regeneron Pharmaceuticals, Patient, Histology, Failure, Diagnosis, Medicine, Heartburn, Risk, Lower respiratory tract infection, Food, Arthralgia, Chronic pain, Safety, Disease, Esophagus, Inflammation, Helminthiasis, Priority review, FDA, Eosinophilic esophagitis, Prevalence, Vomiting, International development, Growth, Pharmaceutical industry

TARRYTOWN, N.Y. and PARIS, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE). Dupixent is now the first and only medicine approved in the U.S. specifically indicated to treat these patients. This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40 kg. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.

Key Points: 
  • Dupixent is now the first and only medicine approved in the U.S. specifically indicated to treat these patients.
  • This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40 kg.
  • Approximately 21,000 children under the age of 12 in the U.S. are currently being treated for EoE with unapproved therapies.
  • “With this approval, Dupixent becomes the first and only treatment option for EoE patients aged 1 and older, weighing at least 15 kg.

Dupixent® (dupilumab) Significantly Reduced COPD Exacerbations in Second Positive Phase 3 Trial, Accelerating FDA Submission and Confirming Potential to Become First Approved Biologic for This Serious Disease

Retrieved on: 
Monday, November 27, 2023
Patient, Regeneron Pharmaceuticals, Food, Smoker, Aes, Breakthrough therapy, Death, Upper respiratory tract infection, Diarrhea, FDA, Hypertension, Headache, Common, Inflammation, COVID-19, European Medicines Agency, Doctor of Philosophy, International development, Back pain, Phenotype, Safety, History, Pharmaceutical industry

TARRYTOWN, N.Y. and PARIS, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the second Dupixent® (dupilumab) investigational Phase 3 chronic obstructive pulmonary disease (COPD) trial (NOTUS) showed that Dupixent significantly reduced (34%) exacerbations, confirming positive results from the landmark Phase 3 BOREAS trial. The NOTUS trial also confirmed that treatment with Dupixent led to rapid and significant improvements in lung function by 12 weeks and were sustained at 52 weeks.

Key Points: 
  • “These results demonstrate the important role of type 2 inflammation in yet another chronic and debilitating disease, and the ability of Dupixent to address this inflammation.
  • Patients receiving Dupixent compared to placebo experienced:
    34% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p=0.0002), the primary endpoint.
  • BOREAS results showed:
    30% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p=0.0005), the primary endpoint.
  • The safety and efficacy of Dupixent in COPD are currently under clinical investigation and have not been evaluated by any regulatory authority.

Teva Completes Closing of Exclusive Collaboration Deal to Deliver Inflammatory Bowel Disease Treatment

Retrieved on: 
Thursday, November 30, 2023
Health, Other Science, General Health, Research, Science, Pharmaceutical, Biotechnology, NYSE, SAN, Teva Pharmaceuticals, Weight loss, Abdominal pain, Teva, Fatigue, TEVA, Ulcerative colitis, Crohn's disease, Inflammation, GI, IBD, Diarrhea, TEV, Inflammatory bowel disease, TASE, Medication, Sanofi

Inflammatory bowel disease (IBD) is the term for two conditions -- Crohn’s disease and ulcerative colitis – characterized by chronic inflammation of the gastrointestinal (GI) tract. Prolonged inflammation results in damage to the GI tract. The common symptoms for both conditions are persistent diarrhea, rectal bleeding, abdominal pain, fatigue, and weight loss. An estimated ~10 million people worldwide live with IBD.

Key Points: 
  • Teva Pharmaceuticals, a U.S. subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today closing of its collaboration deal to co-develop and co-commercialize asset TEV ‘574 with Sanofi (EURONEXT: SAN and NASDAQ: SNY).
  • TEV '574 is currently in Phase 2b clinical trials for the treatment of ulcerative colitis and Crohn's disease, two types of inflammatory bowel disease.
  • As announced on October 4th, 2023, under the terms of the agreement, Teva will receive an upfront payment of $500 million shortly after closing and up to $1 billion in development and launch milestones.
  • Inflammatory bowel disease (IBD) is the term for two conditions -- Crohn’s disease and ulcerative colitis – characterized by chronic inflammation of the gastrointestinal (GI) tract.

Sanofi honors 10 advocacy organizations promoting health equity solutions in underserved U.S. communities

Retrieved on: 
Thursday, November 2, 2023
RSV, Historically black colleges and universities, Social media, Black, Sickle cell disease, Physician, PASD, Equity, Navigation, Trust, Quality of life, Vaccination, Caregiver, Clinical trial, Partnership, African Americans, Nursing, Patient, Diagnosis, Coagulopathy, MS, Birth control, Vaccine, BMT, University

KO Flu and Covid will engage and communicate with seniors about influenza risks and the benefits of vaccination by utilizing boxing events in historically disadvantaged communities.

Key Points: 
  • KO Flu and Covid will engage and communicate with seniors about influenza risks and the benefits of vaccination by utilizing boxing events in historically disadvantaged communities.
  • This service will assist patients and caregivers by clarifying treatment options, providing biomarker testing education, and identifying clinical trial options.
  • Transplant Equity and Awareness for Sickle Cell Disease will address low stem cell donation and the underutilization of Bone Marrow Transplant (BMT) treatment.
  • This multi-organization partnership strives to lead an educational awareness program targeting Black and Hispanic communities in the US.

Sanofi launches "The 1 Pledge" movement to drive early screening for type 1 diabetes in the U.S.

Retrieved on: 
Wednesday, November 1, 2023
Patient, Fitness, Child, Social media, Education, Pledge, Family, Hope, Pancreas, Autoantibody, Diabetes, Times Square, Learning, Disease, Caregiver, Risk, Robin, Go for Your Life (fitness program), Autoimmune disease, Sanofi, Movement, Diagnosis, Entertainment, Pharmaceutical industry

Had we detected my child's type 1 diabetes before their diagnosis it could have given us valuable time to prepare.

Key Points: 
  • Had we detected my child's type 1 diabetes before their diagnosis it could have given us valuable time to prepare.
  • We have been advocating for awareness around type 1 diabetes for nearly as many years as she has been living with diabetes.
  • By using personal stories, these celebrities aim to share the importance of screening, education and preparation for type 1 diabetes.
  • Sanofi encourages people interested in learning more about screening or type 1 diabetes to speak to their doctor.

Dupixent® (dupilumab) Phase 3 Results Show Sustained Efficacy for Up to One Year in Children 1 to 11 Years of Age with Eosinophilic Esophagitis (EoE)

Retrieved on: 
Sunday, October 22, 2023
Abdominal pain, FDA, Adolescence, Headache, American College, Ageing, Icahn School of Medicine at Mount Sinai, Aes, Food, Injection site reaction, ACG, Priority, American College of Gastroenterology, Regeneron Pharmaceuticals, Inflammation, Eating, Priority review, Cough, PESQ, COVID-19, Mount Sinai, Eosinophilic esophagitis, Biopsy, Safety, Patient, Food and Drug Administration, Failure, Pharmaceutical industry, Vaccine, MPH, Medicine, Part, Sanofi, Dupilumab

PARIS and TARRYTOWN, N.Y., Oct. 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that positive results from a Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) showed consistent efficacy and safety for up to one year (52 weeks) in children aged 1 to 11 years with eosinophilic esophagitis (EoE). These results represent the first analysis of longer-term data in this age group and will be featured in a late-breaking session on October 25 at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting.

Key Points: 
  • “Dupilumab is the first and only therapeutic approved for adults and certain adolescents with EoE.
  • Some children with EoE may have sub-optimal response to currently unapproved standard of care therapies, underscoring the need for treatments targeting key pathways driving inflammation in EoE.
  • All children in Part B were treated with higher or lower dose Dupixent for an additional 36 weeks, providing up to 52 weeks of data.
  • In Part B, there were 37 patients who continued on higher dose Dupixent and 18 who switched from placebo to higher dose Dupixent.

Sanofi Bridging the Gap between the Homeless and Society via Futsal

Retrieved on: 
Tuesday, October 17, 2023
Soccer, Philanthropy, Health, Sports, Other Philanthropy, Pharmaceutical, Sport, Association of Indonesia Futsal Club, Culture, Sanofi Pasteur, Grocery store, Tourism, Sanofi

Sanofi in Korea[1], the Korean subsidiaries of the global healthcare company Sanofi, hosted the founding ceremony of the homeless futsal club ‘Dream’ together with Dalpengyee, a nonprofit organization, to promote self-sufficiency among the homeless.

Key Points: 
  • Sanofi in Korea[1], the Korean subsidiaries of the global healthcare company Sanofi, hosted the founding ceremony of the homeless futsal club ‘Dream’ together with Dalpengyee, a nonprofit organization, to promote self-sufficiency among the homeless.
  • Sanofi sponsored the foundation of the ‘Dream’ as part of its decade-long homeless program Helping Hands, wishing to go beyond protecting rights to health, and highlight the cultural and sports rights of the homeless.
  • Helping Hands is Korea’s largest homeless free flu vaccination program operated by targeting the homeless and housing-vulnerable groups in medical service blind spots.
  • Sanofi has operated this program since 2011, contributing to preventing social disconnection of the homeless in addition to promoting the right to health of the homeless.

Stagwell's (STGW) The Harris Poll Unveils First-of-its-kind Global Hemophilia Survey on the Daily Challenges for Patients, Caregivers, and Providers

Retrieved on: 
Tuesday, October 10, 2023
Haemophilia, Probability, Stagwell, MBA, Communication, Anxiety, Human, Caregiver, MPH, Medical Affairs Bureau, Health, Rare, Disease, Patient, Data, Research, Depression, Friends, The Harris Poll, Child, Hematology, Life, Face, Nursing, Pharmaceutical industry, Residential care, MD, Sanofi

NEW YORK, Oct. 10, 2023 /PRNewswire/ -- The Harris Poll, a Stagwell (NASDAQ: STGW) agency, announced today the findings from a first-of-its-kind global hemophilia survey – 'Hemophilia Life Stages and Changes Global Survey' – sponsored by Sanofi. The findings deliver critical insights from patients, caregivers, and hematologists on challenges they face in their daily lives as they live or care for those with hemophilia across important life stages. The Harris Poll and Sanofi conducted the survey of more than 2,700 participants across four continents and 11 countries to gain a greater understanding of the current state of hemophilia care globally, the evolving needs of this community over their lifetime, and the areas that require improvement. 

Key Points: 
  • NEW YORK, Oct. 10, 2023 /PRNewswire/ -- The Harris Poll , a Stagwell (NASDAQ: STGW) agency, announced today the findings from a first-of-its-kind global hemophilia survey – 'Hemophilia Life Stages and Changes Global Survey' – sponsored by Sanofi.
  • The findings deliver critical insights from patients, caregivers, and hematologists on challenges they face in their daily lives as they live or care for those with hemophilia across important life stages.
  • The goal is to drive action and dialogue that leads to improved care for people with hemophilia.
  • The results of the survey provide valuable insights for caregivers, patients living with hemophilia, healthcare professionals, policymakers, and patient organizations worldwide.

Sanofi and Teva Announce Exclusive Collaboration to Deliver Inflammatory Bowel Disease Treatment

Retrieved on: 
Wednesday, October 4, 2023
Biotechnology, Pharmaceutical, Health, Teva Pharmaceuticals, TEVA, Teva, Crohn's disease, Diarrhea, IBD, Disease, TEV, Weight loss, Inflammation, Abdominal pain, Ulcerative colitis, Science, Pivot, Inflammatory bowel disease, SAN, TASE, SNY, GI, NYSE, Fatigue, Pharmaceutical industry, Fine chemical, Sanofi

Inflammatory bowel disease (IBD) is the term for two conditions -- Crohn’s disease and ulcerative colitis – characterized by chronic inflammation of the gastrointestinal (GI) tract. Prolonged inflammation results in damage to the GI tract. The common symptoms for both conditions are persistent diarrhea, rectal bleeding, abdominal pain, fatigue, and weight loss. An estimated ~10 million people worldwide live with IBD.

Key Points: 
  • Sanofi (EURONEXT: SAN and NASDAQ: SNY) and Teva Pharmaceuticals, a U.S. subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announce today a collaboration to co-develop and co-commercialize asset TEV ‘574, currently in Phase 2b clinical trials for the treatment of Ulcerative Colitis and Crohn's Disease, two types of inflammatory bowel disease.
  • This collaboration further validates the great science that Teva has to offer with our internally developed anti-TL1A.
  • Inflammatory bowel disease (IBD) is the term for two conditions -- Crohn’s disease and ulcerative colitis – characterized by chronic inflammation of the gastrointestinal (GI) tract.
  • Teva will hold an investor call and live webcast today (Wednesday, October 4, 2023) at 8:00 a.m.

Dupixent® (dupilumab) sBLA for Treatment of Eosinophilic Esophagitis (EoE) in Children Aged 1 to 11 Accepted for FDA Priority Review

Retrieved on: 
Tuesday, September 26, 2023
Priority review, Eosinophilic esophagitis, Diarrhea, COVID-19, Rash, Regeneron Pharmaceuticals, Gastroenteritis, Patient, Nausea, Diagnosis, Priority, Ageing, FDA, Headache, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Human, Food, Safety, Disease, Pharmaceutical industry, Vaccine, Dupilumab, Sanofi

TARRYTOWN, N.Y. and PARIS, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat children aged 1 to 11 years with eosinophilic esophagitis (EoE). The target action date for the FDA decision is January 31, 2024. Dupixent is the first and only treatment in the U.S. approved for children and adults aged 12 years and older with EoE, weighing at least 40kg.

Key Points: 
  • The target action date for the FDA decision is January 31, 2024.
  • Dupixent is the first and only treatment in the U.S. approved for children and adults aged 12 years and older with EoE, weighing at least 40kg.
  • The sBLA is supported by data from the Phase 3 EoE KIDS trial (Parts A and B) evaluating the efficacy and safety of Dupixent in children aged 1 to 11 with EoE.
  • Priority review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.