BOEHRINGER INGELHEIM


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US FDA approves Jardiance® (empagliflozin) for the treatment of type 2 diabetes in children 10 years and older

Retrieved on: 
Wednesday, June 21, 2023
Hypersensitivity, Exercise, Insulin, Diet, Prevalence, Medicine, Type 2 diabetes, Diabetes, Diabetic ketoacidosis, Angioedema, Dialysis, Tablet, Boehringer Ingelheim, A1C, Excipient, LLY, Hypoglycemia, Lilly, Patient, Metformin, Risk, Eli Lilly and Company, Ageing, Regulatory affairs, FDA, Safety, III, NYSE, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Medical device, F.A.C.E

RIDGEFIELD, Conn. and INDIANAPOLIS, June 21, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.

Key Points: 
  • Jardiance is not recommended in patients with type 1 diabetes.
  • Jardiance is not recommended for use to improve glycemic control in patients with type 2 diabetes with an eGFR less than 30 mL/min/1.73 m2.
  • Type 2 diabetes represents a significant and growing health concern among young people in the U.S. Over the past two decades, the prevalence of type 2 diabetes in people aged 10-19 has nearly doubled.
  • New treatment options are critical to help address the over 5,700 new cases of type 2 diabetes in this population each year in the U.S.

US FDA approves the Cyltezo® Pen, a new autoinjector option, ahead of July 1 commercial launch

Retrieved on: 
Monday, May 22, 2023
Arthritis Foundation, Use, Interchangeability, Certification, Boehringer Ingelheim, Patient, Usability, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, News, Food, Pharmaceutical industry, Adalimumab

Initially approved as a pre-filled syringe, Cyltezo is indicated to treat multiple chronic inflammatory diseases.

Key Points: 
  • Initially approved as a pre-filled syringe, Cyltezo is indicated to treat multiple chronic inflammatory diseases.
  • The 40 mg/0.8 mL pre-filled Cyltezo Pen will be available in two-, four- and six-pack options on July 1, 2023.
  • "We're excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo's launch on July 1."
  • The patient-centered design of the pen features a one-button, three-step activation, with 100% drug visibility and a protected needle.

Healthy.io Announces Collaboration with Boehringer Ingelheim to Increase Access to Testing for Kidney Disease

Retrieved on: 
Wednesday, May 10, 2023
Kidney disease, ACR, ESRD, Kidney failure, Senior, Chronic kidney disease, Diabetes, Smartphone, Boehringer Ingelheim, Dialysis, Hypertension, Kidney, Patient, Risk, National Kidney Foundation, UACR, Diagnosis, FDA, CKD, Healthy.io, African Americans, Medicine, Pharmaceutical industry, Four-minute warning

Through this collaboration, Boehringer Ingelheim will work with Healthy.io's Minuteful Kidney™ test kit to explore the operational aspects of an at-home UACR (urine albumin-to-creatinine ratio) test kit – the first and only FDA-cleared, smartphone powered at-home ACR test – to at-risk, previously untested patients.

Key Points: 
  • Through this collaboration, Boehringer Ingelheim will work with Healthy.io's Minuteful Kidney™ test kit to explore the operational aspects of an at-home UACR (urine albumin-to-creatinine ratio) test kit – the first and only FDA-cleared, smartphone powered at-home ACR test – to at-risk, previously untested patients.
  • This will help engage these patients in their kidney health by conducting a smartphone-powered test at the time and place of their choosing as a step-in screening for earlier identification of CKD.
  • "Minuteful Kidney is a catalyst to increase ACR testing at scale and support early detection of CKD," said Paula LeClair, U.S. General Manager at Healthy.io.
  • Yet most don't know they have the condition until it progresses to end-stage renal disease (ESRD), eventually requiring dialysis and/or a kidney transplant.

Boehringer Ingelheim and Zealand Pharma announce phase II trial showed 14.9% weight loss in people living with obesity or overweight

Retrieved on: 
Wednesday, May 10, 2023
Research, Diabetes, Fitness & Nutrition, Clinical Trials, Cardiology, Biotechnology, Pharmaceutical, Health, Science, Other Science, Ingelheim am Rhein, Maintenance, Obesity, Therapy, Heart failure, Chronic kidney disease, Prevalence, Hepatology, Liver disease, Weight loss, Multimedia, Boehringer Ingelheim, Patient, American Diabetes Association, CRM, Overweight, Zealand Pharma, Pharmaceutical industry

Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) today announced that patients treated with BI 456906 achieved up to 14.9% weight loss after 46 weeks, using the planned maintenance dose.

Key Points: 
  • Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) today announced that patients treated with BI 456906 achieved up to 14.9% weight loss after 46 weeks, using the planned maintenance dose.
  • The phase II clinical trial evaluating the effect of different doses of the novel glucagon/GLP-1 receptor dual agonist BI 456906 in people living with obesity or overweight without type 2 diabetes (NCT04667377) met its primary endpoint.
  • Obesity is a major global health challenge, and the worldwide prevalence has more than doubled over the past four decades11.
  • The World Obesity Federation predicts that by 2025, 2.7 billion adults could be living with obesity or overweight, placing a high burden on individuals, healthcare systems and society11.

Boehringer Ingelheim and Zealand Pharma announce phase II trial showed 14.9% weight loss in people living with obesity or overweight

Retrieved on: 
Wednesday, May 10, 2023
Maintenance, Obesity, Boehringer, Therapy, Heart failure, Chronic kidney disease, Prevalence, Hepatology, Liver disease, Weight loss, Boehringer Ingelheim, Patient, American Diabetes Association, CRM, Overweight, Zealand Pharma, Pharmaceutical industry

The phase II clinical trial evaluating the effect of different doses of the novel glucagon/GLP-1 receptor dual agonist BI 456906 in people living with obesity or overweight without type 2 diabetes (NCT04667377) met its primary endpoint.

Key Points: 
  • The phase II clinical trial evaluating the effect of different doses of the novel glucagon/GLP-1 receptor dual agonist BI 456906 in people living with obesity or overweight without type 2 diabetes (NCT04667377) met its primary endpoint.
  • “Obesity is one of many cardio-renal-metabolic diseases, which together represent one of the fastest growing health challenges worldwide.
  • Obesity is a major global health challenge, and the worldwide prevalence has more than doubled over the past four decades11.
  • The World Obesity Federation predicts that by 2025, 2.7 billion adults could be living with obesity or overweight, placing a high burden on individuals, healthcare systems and society11.

Boehringer Ingelheim Begins Clinical Development of First-In-Class Treatment for Fibrotic Diseases

Retrieved on: 
Tuesday, May 9, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Tissue, Graft-versus-host disease, Heart, SingHealth, Partnership, Boehringer, Doctor of Philosophy, Neoplasm, Infection, Survival, Pharmacokinetics, Quality of life, Scar, PDE4B, Inflammation, DSM-IV codes, Lung, Pulmonary fibrosis, Boehringer Ingelheim, Duke–NUS Medical School, Fibrosis, Death, Discovery, Patient, Vicki Belo, Circulatory system, Biology, Liver, IPF, Safety, Pharmaceutical industry

Boehringer Ingelheim is already a global leader in the treatment of pulmonary fibrosis, and the initiation of clinical development of the anti-IL-11 treatment reflects the company’s long-term commitment to combat fibrotic disease across therapeutic areas.

Key Points: 
  • Boehringer Ingelheim is already a global leader in the treatment of pulmonary fibrosis, and the initiation of clinical development of the anti-IL-11 treatment reflects the company’s long-term commitment to combat fibrotic disease across therapeutic areas.
  • The IL-11 inhibitor antibody is the first of its kind to reach clinical development stage and is based on a partnership between the Company and Enleofen Bio Pte.
  • ‘Fibrotic disease’ is a term that covers a range of diseases characterized by uncontrolled and progressive fibrosis, or scarring, of various organs and tissues.
  • Some examples of fibrotic diseases are, systemic sclerosis, graft-versus-host disease as well as heart, lung, liver, and kidney fibrosis.

Click Therapeutics and Boehringer Ingelheim Initiate Pivotal Clinical Trial of Prescription Digital Therapeutics for the Treatment of Negative Symptoms in Schizophrenia

Retrieved on: 
Thursday, May 4, 2023
Software, Biotechnology, Pharmaceutical, General Health, Health, FDA, Technology, Clinical Trials, Consensus, Consensus decision-making, Hallucination, Partnership, Therapy, Motivation, Disability, Perception, Clinical trial, Psychopharmacology, Mental health, DSM-IV codes, NIMH, Doctor of Philosophy, CNS, Boehringer Ingelheim, MD, Patient, Risk, Diagnosis, Digital, National Institute of Mental Health, FAAN, Behavior, Disease, Pharmaceutical industry, Nursing, Schizophrenia

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced the initiation of the CONVOKE Study , a registrational clinical trial to investigate the use of prescription digital therapeutics as an adjunct treatment to standard of care antipsychotic therapy to treat the negative symptoms of schizophrenia in patients 18 years and older.

Key Points: 
  • Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced the initiation of the CONVOKE Study , a registrational clinical trial to investigate the use of prescription digital therapeutics as an adjunct treatment to standard of care antipsychotic therapy to treat the negative symptoms of schizophrenia in patients 18 years and older.
  • The study intervention period will be 16 weeks and efficacy will be assessed by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure scale (CAINS-MAP).
  • The CAINS-MAP measures experiential negative symptoms, the clinical target of interest in the evaluation of efficacy in this study.
  • “Our partnership with Click Therapeutics, who share a like-minded goal through our approach to prescription digital therapeutics, has the potential to address significant unmet needs in schizophrenia.

SPEVIGO® granted Breakthrough Therapy Designation in the U.S. for the prevention of generalized pustular psoriasis flares

Retrieved on: 
Tuesday, May 2, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Flare, Executive officer, Safety, Dermatology, Breakthrough therapy, BTD, Multimedia, Boehringer Ingelheim, Congress, National Medical Products Administration, CDE, GPP, FDA, Center for Drug Evaluation and Research, Regulation of tobacco by the U.S. Food and Drug Administration, NMPA, Food, Pharmaceutical industry

Boehringer Ingelheim announced today that spesolimab (marketed as SPEVIGO®) received Breakthrough Therapy Designation (BTD) as an investigational treatment for the prevention of flares in adolescents and adults with generalized pustular psoriasis (GPP) from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • Boehringer Ingelheim announced today that spesolimab (marketed as SPEVIGO®) received Breakthrough Therapy Designation (BTD) as an investigational treatment for the prevention of flares in adolescents and adults with generalized pustular psoriasis (GPP) from the U.S. Food and Drug Administration (FDA).
  • This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20230502005731/en/
    “GPP flares may appear suddenly, intensify quickly, and can be life-threatening if left untreated, leaving those affected feeling anxious and uncertain about their future” said Carinne Brouillon, Member of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim.
  • Data from the trial will be presented at the 25th World Congress of Dermatology 2023 in early July.

U.S. FDA Grants Breakthrough Therapy Designation for Spesolimab for the Prevention of Flares in Adults with Generalized Pustular Psoriasis (GPP)

Retrieved on: 
Tuesday, May 2, 2023
Infection, Flare, Heart failure, Hospital, TB, Kidney, Medicine, History, Marketing, Sepsis, Boehringer Ingelheim, Breakthrough therapy, Patient, Tuberculosis, Risk, Immune system, Torosyan v. Boehringer Ingelheim Pharmaceuticals, Inc., GPP, FDA, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mental health, Food, Safety, Birth control, Pharmaceutical industry, Dermatology

GPP is a rare and potentially life-threatening chronic neutrophilic skin disease characterized by flares of widespread eruptions of painful, sterile pustules across the body.

Key Points: 
  • GPP is a rare and potentially life-threatening chronic neutrophilic skin disease characterized by flares of widespread eruptions of painful, sterile pustules across the body.
  • Flares greatly affect a person's quality of life and can lead to hospitalization with serious complications, including heart failure, renal failure, sepsis, and death.
  • "The FDA's action reinforces the potential of spesolimab and represents a critical step in bringing this treatment to patients who need it most.
  • Spesolimab is marketed as SPEVIGO (spesolimab-sbzo) injection, for intravenous use by Boehringer Ingelheim
    Pharmaceuticals, Inc. (BIPI) and is indicated for the treatment of GPP flares in adults.

BioMed X Launches XSeed Labs in the US with Boehringer Ingelheim - a New Model for Building an External Innovation Ecosystem on an Industry Campus

Retrieved on: 
Thursday, April 27, 2023
Yale University, NASH, Boehringer Ingelheim, Biomedical Research, Research, Fibrosis, Crohn's disease, Patient, BioMed Central, Fatty liver disease, Ecosystem, Scleroderma, Wound healing, Medical imaging

RIDGEFIELD, CT, Apr 27, 2023 - (ACN Newswire) - BioMed X announced today the expansion of its collaboration with Boehringer Ingelheim with the launch of a new model for biomedical research: XSeed Labs.

Key Points: 
  • RIDGEFIELD, CT, Apr 27, 2023 - (ACN Newswire) - BioMed X announced today the expansion of its collaboration with Boehringer Ingelheim with the launch of a new model for biomedical research: XSeed Labs.
  • The first research project of the new lab will focus on fibrotic disease processes, a key focus area of Boehringer Ingelheim.
  • The goal of this new collaboration is to bring BioMed X's successful innovation model to Boehringer Ingelheim's main US research and development campus and serve as a nucleus for a vibrant external innovation ecosystem.
  • Dr. Christian Tidona, Founder and Managing Director of BioMed X, explains: "The principle behind BioMed X has always been to combine the best of both worlds - academia and industry.