Autoantibody

Type 1 Diabetes Market to Accelerate Substantially During the Study Period (2019-2032), Predicts DelveInsight | Leading Companies Developing Therapies - Eli Lilly, Vertex, Bayer, Novo Nordisk, Rise, Tolerion, BioKier, Dompé Farmaceutici

Retrieved on: 
Wednesday, November 15, 2023
Meal, Novo Nordisk, T1D, Prevalence, Therapy, Insulin, Weight loss, Abdominal pain, Eating, Disease, International Diabetes Federation, IDF, Fatigue, Autoantibody, Pancreas, Random glucose test, Finerenone, Urination, Health, Eli Lilly, Eli Lilly and Company, Diabetes, Gestational diabetes, Hunger, Hyperglycemia, Xerostomia, Type 1, Glycated hemoglobin, Glucose, LAS, Overalls, Vertex Pharmaceuticals, Type 2 diabetes, Hypoglycemia, Pharmaceutical industry, Dietary supplement, Bayer

LAS VEGAS, Nov. 15, 2023 /PRNewswire/ -- DelveInsight's Type 1 Diabetes Market Insights report includes a comprehensive understanding of current treatment practices, type 1 diabetes emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].

Key Points: 
  • According to the International Diabetes Federation (IDF), Type 1 diabetes may affect anybody at any age, although it impacts children and adolescents the most commonly.
  • Over 1 million children and adolescents under the age of 20 have type 1 diabetes.
  • Diabetes is medically categorized into three primary types, with Type 1 diabetes, Type 2 diabetes, and gestational diabetes being the main classifications.
  • To know more about type 1 diabetes treatment, visit @ Type 1 Diabetes Treatment Drugs

Type 1 Diabetes Market to Accelerate Substantially During the Study Period (2019-2032), Predicts DelveInsight | Leading Companies Developing Therapies - Eli Lilly, Vertex, Bayer, Novo Nordisk, Rise, Tolerion, BioKier, Dompé Farmaceutici

Retrieved on: 
Wednesday, November 15, 2023
Meal, Novo Nordisk, T1D, Prevalence, Therapy, Insulin, Weight loss, Abdominal pain, Eating, Disease, International Diabetes Federation, IDF, Fatigue, Autoantibody, Pancreas, Random glucose test, Finerenone, Urination, Health, Eli Lilly, Eli Lilly and Company, Diabetes, Gestational diabetes, Hunger, Hyperglycemia, Xerostomia, Type 1, Glycated hemoglobin, Glucose, LAS, Overalls, Vertex Pharmaceuticals, Type 2 diabetes, Hypoglycemia, Pharmaceutical industry, Dietary supplement, Bayer

LAS VEGAS, Nov. 15, 2023 /PRNewswire/ -- DelveInsight's Type 1 Diabetes Market Insights report includes a comprehensive understanding of current treatment practices, type 1 diabetes emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].

Key Points: 
  • According to the International Diabetes Federation (IDF), Type 1 diabetes may affect anybody at any age, although it impacts children and adolescents the most commonly.
  • Over 1 million children and adolescents under the age of 20 have type 1 diabetes.
  • Diabetes is medically categorized into three primary types, with Type 1 diabetes, Type 2 diabetes, and gestational diabetes being the main classifications.
  • To know more about type 1 diabetes treatment, visit @ Type 1 Diabetes Treatment Drugs

Cabaletta Bio Receives FDA Clearance of CABA-201 IND Application for Treatment of Generalized Myasthenia Gravis

Retrieved on: 
Monday, November 6, 2023
GMG, Steroid, FDA, IND, Respiratory failure, Food, Enzyme inhibitor, Myositis, MG, Lupus, Autoantibody, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Protein, Disease, Clinical trial, Acetylcholine receptor, Risk, Neurology, Neuromuscular junction, Autoimmune disease, Scleroderma, NMJ, Patient, Investigational New Drug, Rheumatology, Fatigue, Pharmaceutical industry

PHILADELPHIA, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company’s fourth Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, has been allowed to proceed by the U.S. Food and Drug Administration (FDA) for a Phase 1/2 study in patients with generalized myasthenia gravis (gMG). The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 across two parallel gMG cohorts based on autoantibody status – one cohort of six patients with acetylcholine receptor (AChR) antibody-positive gMG and a second cohort of six patients with AChR antibody-negative gMG. Consistent with the previously announced CABA-201 IND application clearances for lupus, myositis and systemic sclerosis, the starting dose for the Phase 1/2 trial evaluating CABA-201 in gMG will be 1 x 106 cells/kg.

Key Points: 
  • Consistent with the previously announced CABA-201 IND application clearances for lupus, myositis and systemic sclerosis, the starting dose for the Phase 1/2 trial evaluating CABA-201 in gMG will be 1 x 106 cells/kg.
  • The announcement of our fourth CABA-201 IND clearance is also our first IND clearance for the product candidate in a predominantly autoantibody mediated disease.
  • Generalized MG affects approximately 85% of the between 50,000 and 80,000 estimated MG patients in the United States.
  • Standard of care therapies include cholinesterase inhibitors, steroids, immunomodulators, and biologics, which often provide modest clinical effect and require chronic administration, increasing the risk of serious long-term side effects.

BioCryst R&D Day Highlights New Diversified Pipeline of First-in-Class/Best-in-Class Therapies with Five Programs Expected in Clinical Development in Next 24 Months

Retrieved on: 
Friday, November 3, 2023
GMG, BioCryst Pharmaceuticals, FDA, Research, Patient, Drug design, IgA nephropathy, Plasma, CAD, Lupus nephritis, KLK5, Genetic disorder, RESEARCH, C2, DME, Eculizumab, Infection, Injection, Skin, Diabetes, Autoantibody, Ryan Murphy, Edema, Netherton, R, Autoimmune hemolytic anemia, HAE, Kallikrein, Growth, Disease, Dehydration, Muscle weakness, Immune system, Hemolysis, Solubility, Netherton syndrome, Clinical trial, Paratriathlon, Eye, Ravulizumab, Cold agglutinin disease, PARK, IP, SPINK5, Fine chemical, Pharmaceutical industry, Vaccine

A live webcast of the event will be available online in the investors section of the company website at www.biocryst.com .

Key Points: 
  • A live webcast of the event will be available online in the investors section of the company website at www.biocryst.com .
  • The team is excited to share our approach, and our expanded pipeline of new programs, at our R&D Day,” said Jon Stonehouse, president and chief executive officer of BioCryst.
  • The disease is caused by the deficiency of a natural inhibitor (SPINK5) of KLK5, a serine protease responsible for regulating skin shedding.
  • Netherton syndrome can be life threatening, especially during infancy when patients are vulnerable to dehydration and recurrent infections.

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.

Baudax Bio Announces Corporate Update

Retrieved on: 
Wednesday, October 18, 2023
FDA, IND, Consultant, Neuromuscular blocking agents, MD, Autoantibody, Acquisition, Research, Drug development, Quality of life, Clinical trial, Haemophilia A, Factor VIII, Patient, Pharmaceutical industry, Haemophilia

MALVERN, Pa., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that following recent shareholder approval of corporate actions related to its June 29 2023 acquisition of TeraImmune, the Company is now poised to initiate clinical development of TI-168, the Company’s next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitors. The Company anticipates initiating its Phase 1/2a clinical study of TI-168 in Hemophilia A patients with FVIII inhibitors with a modest initial budget in Q1 of 2024.

Key Points: 
  • The Company anticipates initiating its Phase 1/2a clinical study of TI-168 in Hemophilia A patients with FVIII inhibitors with a modest initial budget in Q1 of 2024.
  • “We are very pleased with the broad support received in last week’s special shareholder meeting, during which shareholders approved all remaining issues related to our acquisition of TeraImmune,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio.
  • “We believe this combination, which brings together TeraImmune’s research expertise with Baudax’s drug development experience for the initiation of clinical development of TI-168, represents the best path forward to create shareholder value.
  • This product candidate previously had an IND filed seeking to treat human subjects that received regulatory clearance, and has also recently been granted Orphan Drug Designation by the FDA.

FDA Grants Orphan Drug Designation to GC Biopharma's Drug Candidate for Thrombotic Thrombocytopenic Purpura

Retrieved on: 
Friday, October 6, 2023
Congress, Antibody, Food, ISTH, Autoantibody, International Society, Brain, Thrombosis, Thrombotic thrombocytopenic purpura, Heart, Mortality, Half-life, FDA, Marketing, International Society on Thrombosis and Haemostasis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, TTP, Disorder, ADAMTS13, PDUFA, Patient, Pharmaceutical industry

YONGIN, South Korea, Oct. 5, 2023 /PRNewswire/ -- GC Biopharma Corp. announced today that GC1126A, its drug candidate for Thrombotic Thrombocytopenic Purpura (TTP), received an Orphan Drug Designation on September 27 from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • YONGIN, South Korea, Oct. 5, 2023 /PRNewswire/ -- GC Biopharma Corp. announced today that GC1126A, its drug candidate for Thrombotic Thrombocytopenic Purpura (TTP), received an Orphan Drug Designation on September 27 from the U.S. Food and Drug Administration (FDA).
  • When designated as an orphan drug, there are incentives such as tax credits for clinical development costs and exemptions from PDUFA user fees Initial Pediatric Study Plan.
  • Speaking on this achievement, GC Biopharma stated, "We are dedicated to collecting data to develop a Best-in-Class treatment for such rare disorders.
  • We remain committed to our mission of providing patients with new treatment options by continuously developing innovative drugs."

Sengenics Corporation Launches i-Ome Discovery™ to Advance Immune Biomarker Discovery and Development

Retrieved on: 
Monday, October 2, 2023
Software, Research, Professional Services, Pharmaceutical, Data Management, Technology, Artificial Intelligence, Health Technology, Data Analytics, Science, Biotechnology, Health, Cancer, Proteome, Biomarker, Discovery, Protein, Corporation, Patient, Immune system, Autoimmunity, Medicine, Epitope, Autoantibody, Disease, Pharmaceutical industry, Vaccine

Sengenics Corporation LLC, a leader in immune response profiling to support scientific discovery and diagnostic development, today announced the launch of i-Ome Discovery, a comprehensive protein microarray platform for the analysis of autoantibodies associated with disease diagnosis and therapeutic intervention.

Key Points: 
  • Sengenics Corporation LLC, a leader in immune response profiling to support scientific discovery and diagnostic development, today announced the launch of i-Ome Discovery, a comprehensive protein microarray platform for the analysis of autoantibodies associated with disease diagnosis and therapeutic intervention.
  • i-Ome Discovery leverages Sengenics’ patented KREX® technology, which presents full-length autoantigen proteins that are properly folded and fully functional, allowing for highly sensitive, specific, and reproducible autoantibody detection.
  • I-Ome Discovery provides over 1,800 autoantigens that were selected for their biological relevance to several diseases including cancer, autoimmune, and neurodegenerative disorders.
  • “Sengenics is excited to release this immunoproteomic discovery platform to the research community which is seeking new biomarker signatures for patient stratification, therapeutic response prediction, and diagnostic development,” said Jerry Williamson, President and Chief Executive Officer of Sengenics.

Cabaletta Bio Receives FDA Clearance of IND Application for Treatment of Systemic Sclerosis with CABA-201

Retrieved on: 
Monday, October 2, 2023
Rheumatology, Food, Survival, Woman, Infertility, Skin manifestations of sarcoidosis, Lupus, Scleroderma, Myositis, CAR, Investigational New Drug, Patient, Risk, Autoimmune disease, Diagnosis, Mortality, American College, FDA, Pulmonary hypertension, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Systemic scleroderma, Skin, Autoantibody, Pharmaceutical industry

PHILADELPHIA, Oct. 02, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company’s third Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, has been allowed to proceed by the U.S. Food and Drug Administration (FDA) for a Phase 1/2 study in patients with systemic sclerosis (SSc). The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 across two parallel SSc cohorts – one cohort of six patients with severe skin manifestations and a separate cohort of six patients with severe organ involvement associated with systemic sclerosis. Consistent with the previously announced CABA-201 IND clearances for lupus and myositis, the starting dose for the trial, 1 x 106 cells/kg, was informed by the high degree of similarity between CABA-201 and the CD19-CAR T construct administered to a patient with severe, diffuse SSc in the recent Annals of Rheumatic Diseases publication.

Key Points: 
  • The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 across two parallel SSc cohorts – one cohort of six patients with severe skin manifestations and a separate cohort of six patients with severe organ involvement associated with systemic sclerosis.
  • SSc affects approximately 88,000 patients in the U.S., and typically affects middle-aged individuals, particularly women.
  • Standard treatment options, which have modest effects, include generalized immunosuppressive agents or drugs targeted to specific symptomatic manifestations.
  • Due to the lack of adequate treatments, the risk of mortality in systemic sclerosis remains high, with an average survival of approximately 12 years following diagnosis.

Zai Lab Obtains Breakthrough Therapy Designation for Efgartigimod Alfa Injection (Subcutaneous Injection) in Patients with Chronic Inflammatory Demyelinating Polyneuropathy in China

Retrieved on: 
Monday, September 18, 2023
SC, Safety, Policy, Breakthrough therapy, Quality of life, Medicine, ECI, Autoimmunity, HKEX, Chronic inflammatory demyelinating polyneuropathy, Patient, Risk, National Medical Products Administration, Breakthrough, Immunoglobulin G, CDE, International development, Biology, Center for Drug Evaluation and Research, NMPA, Infection, Autoantibody, Pharmaceutical industry, Rare-earth element, CIDP, Neuroscience

SHANGHAI, China and CAMBRIDGE, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Key Points: 
  • SHANGHAI, China and CAMBRIDGE, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
  • The Breakthrough Therapy Designation for efgartigimod SC was supported by data from both global and Chinese patients enrolled in the ADHERE study.
  • “We have seen how efgartigimod SC can meaningfully improve and stabilize disease symptoms in these patients.
  • Existing treatment options are quite limited, and problematic given the general reliance on long-term steroid or chronic immunoglobulin therapy.