Malabsorption

Shineco Develops Revolutionary New Product with Varied Applications to Positively Impact the Health Care Industry

Retrieved on: 
Mittwoch, Mai 1, 2024
Conditional sentence, Brain, Drug, Enzyme, Patient, Bone marrow, Acetone, Organelle, Soybean, Inflammation, Methane, Protein, Cell, Laboratory, Mineral, Pregnancy, Blood, Yolk, Health, Apoptosis, Human body, Death, Research, Vitamin, Water, Carbon, Functional food, Phospholipid, Kaifeng, Dietary fiber, Disease, Convalescence, Agonal respiration, Human, Mitochondrion, SISI, Food, Medicine, PC, Golgi, Carbohydrate, Nutrient, Beauty, Signal transduction, Temperature, Ageing, Microsome, Lipid, Cell damage, Malabsorption, Growth, Fats, Phosphorus

Cells are the basic units of life, and the health and vitality of cells directly affect the health of the entire body.

Key Points: 
  • Cells are the basic units of life, and the health and vitality of cells directly affect the health of the entire body.
  • Cells need to continuously obtain nutrients from the external environment to support their normal growth, division and metabolic activities.
  • When cells receive sufficient and balanced nutrients, they can maintain optimal conditions, perform various life activities, and maintain cell health.
  • The layout of the three major fields will create natural active water phospholipids into a super new category in the health industry.

STATE OF CELIAC DISEASE IN CANADA - UNDERDIAGNOSED, UNAFFORDABLE AND UNSAFE FOOD: SURVEY

Retrieved on: 
Mittwoch, Februar 28, 2024
Anxiety, Hospital, RISK, Restaurant, Genetic disorder, Radar, Diarrhea, Friends, Weight loss, Coeliac disease, Diabetic neuropathy, Federation, Malabsorption, Food, Increment, Risk, Frustration, HEALTH, Depression, Family, Headache, Disease, Migraine, Diagnosis, Child, Bloating, Brain, Dietary supplement

Twenty years after the first comprehensive survey of Canadians living with celiac disease, new results show the condition remains largely underdiagnosed, the gluten-free diet is often unaffordable, and many risk being exposed to unsafe food.

Key Points: 
  • Twenty years after the first comprehensive survey of Canadians living with celiac disease, new results show the condition remains largely underdiagnosed, the gluten-free diet is often unaffordable, and many risk being exposed to unsafe food.
  • Celiac Canada surveyed 7,500 Canadians with celiac disease on topics like what symptoms they experience, how long they went before being diagnosed, and how they manage living with the disease (eating challenges in social settings, the availability and cost of gluten-free food, and the psycho-social challenges of managing celiac disease).
  • Have all provinces add blood tests for celiac disease to the standard requisition used by family doctors.
  • Help healthcare professionals better recognize the increasing neurological and mental health signs of celiac disease (neuropathy, migraines, depression, anxiety) and not just the traditional disease symptoms (like bloating, weight loss, diarrhea).

Phathom Pharmaceuticals Announces VOQUEZNA® (vonoprazan) Tablets for Erosive GERD and Associated Heartburn Added to Express Scripts National Formularies for Commercial Patients

Retrieved on: 
Dienstag, Februar 13, 2024
Urinary tract infection, Gastroesophageal reflux disease, Research, Heartburn, Toxicity, Magnesium, Polyp, Liver, CYP, CGA, Achlorhydria, Esophagitis, Patient, PBM, Vitamin B12, Vonoprazan, Kidney, Spine, Lactation, Absorption, Hypokalemia, SCAR, Calcium, Express Scripts, TIN, Endoscopy, Tablet, Express, Magnesium deficiency, Hypocalcemia, Diarrhea, Hypersensitivity, Physician, Gastritis, Malabsorption, GERD, PPI, Hypertension, SJS, Enzyme inhibitor, EGFR, Stevens–Johnson syndrome, Indigestion, Nelfinavir, Clostridioides, Abdominal pain, Hip, Pharmacy, Enzyme, Glomus tumor, FDA, CDAD, Atazanavir, Risk, BMJ Open, Wrist, Drug, Impairment, Pharmaceutical industry

Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.

Key Points: 
  • Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.
  • doi:10.1136/ bmjgast-2022-000941
    VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated:
    for the healing of all grades of Erosive Esophagitis (Erosive Gastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn associated with Erosive GERD in adults.
  • for the maintenance of healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD in adults.
  • Renal Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with severe renal impairment (eGFR

First Wave BioPharma Announces Entry into Term Sheet for Business Combination with ImmunogenX Establishing a Leading Late-Stage GI-Focused Biopharmaceutical Company

Retrieved on: 
Montag, Dezember 18, 2023
Documentation, Gastrointestinal disease, Food, Malabsorption, FDA, Prevalence, Disease, Mortality, Stanford University, Inflammation, Coeliac disease, First wave, NIH, Patient, Therapy, Pharmaceutical industry

BOCA RATON, Fla., Dec. 18, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that the company has signed a non-binding term sheet for a business combination with ImmunogenX, a clinical-stage biotherapeutics company developing Phase 3-ready latiglutenase, a potentially first-in-class, targeted, oral biotherapeutic for celiac disease. Pursuant to the term sheet, First Wave BioPharma will acquire ImmunogenX in an all-stock transaction with the combined company focused on advancing a GI pipeline comprised of multiple late-stage clinical assets, including latiglutenase and capeserod, which First Wave BioPharma recently in-licensed from Sanofi. Following consummation of the transaction, First Wave BioPharma will continue to trade on Nasdaq under the ticker symbol “FWBI”. The transaction, which has been approved by the Boards of Directors of both companies, is subject to the negotiation and execution of definitive documentation, approval of the stockholders of both First Wave BioPharma and ImmunogenX and other customary closing conditions and is expected to close in the first half of 2024.

Key Points: 
  • Pursuant to the term sheet, First Wave BioPharma will acquire ImmunogenX in an all-stock transaction with the combined company focused on advancing a GI pipeline comprised of multiple late-stage clinical assets, including latiglutenase and capeserod, which First Wave BioPharma recently in-licensed from Sanofi.
  • Following consummation of the transaction, First Wave BioPharma will continue to trade on Nasdaq under the ticker symbol “FWBI”.
  • Operational and financial leadership positions will be comprised of current First Wave BioPharma executives, while clinical, regulatory affairs, and scientific positions will be led by executives of ImmunogenX.
  • Celiac disease is characterized by damage to the lining of the small intestine, causing malabsorption, gastrointestinal dysfunction and debilitating symptoms.

Phathom Pharmaceuticals Announces FDA Acceptance for Filing of VOQUEZNA® (vonoprazan) Tablets New Drug Application for the Treatment of Heartburn Associated with Non-Erosive GERD

Retrieved on: 
Mittwoch, Dezember 6, 2023
Quality of life, CYP, Kidney, Risk, Heartburn, Enzyme inhibitor, FDA, TIN, Hypertension, Achlorhydria, Magnesium, Liver, PPI, SJS, Magnesium deficiency, Chest pain, Atazanavir, Endoscopy, Impairment, SCAR, Vitamin B12, Malabsorption, Absorption, PDUFA, CDAD, Calcium, New Drug Application, Gastritis, Enzyme, Food and Drug Administration, Clostridioides, Vonoprazan, Patient, Hip, Hypokalemia, Food, Polyp, GERD, Nelfinavir, Toxicity, EGFR, Wrist, Diarrhea, Hypocalcemia, NDA, Abdominal pain, Urinary tract infection, Hypersensitivity, Stevens–Johnson syndrome, Glomus tumor, Spine, Indigestion, Drug, CGA, Lactation, Pharmaceutical industry

The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024.

Key Points: 
  • The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024.
  • “Non-Erosive GERD represents a substantial segment of the U.S. GERD population, affecting millions of individuals and impacting their quality of life.
  • Symptoms impact overall quality of life and can include episodic heartburn, especially at night, regurgitation, problems swallowing, and chest pain.
  • for the maintenance of healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD in adults.

ATUM Partners with Anagram Therapeutics to Extend Collaboration to Develop Orally Delivered Enzyme Therapies for Malabsorption and Nutrient Metabolism Disorders

Retrieved on: 
Mittwoch, Oktober 4, 2023
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Anagram, Partnership, EPI, GPS, Therapy, Fats, Digestion, Malnutrition, Enzyme, Quality of life, Cystic fibrosis, Absorption, Biomarker, Life expectancy, Trial of the century, Plasma, Machine learning, Malabsorption, Enzyme replacement therapy, Safety, Pharmaceutical industry, ATUM

"We are excited by the initiation of the ANG003 clinical study, an enzyme replacement therapy engineered using our multidimensional optimization GPS platform," said Claes Gustafsson, Chief Commercial Officer at ATUM.

Key Points: 
  • "We are excited by the initiation of the ANG003 clinical study, an enzyme replacement therapy engineered using our multidimensional optimization GPS platform," said Claes Gustafsson, Chief Commercial Officer at ATUM.
  • It has been an honor to work closely with the Anagram team to harness this technology for the purpose of addressing malabsorption and nutrient metabolism disorders."
  • The study design includes up to four possible combinations of orally delivered lipase, protease, and amylase administered with a test meal.
  • “Initiating this clinical study and dosing the first patient is a significant milestone, as we continue to evolve orally delivered enzymes as therapeutics for malabsorption and nutrient metabolism disorders.”

First Wave BioPharma Announces Initial Topline Results from Phase 2 SPAN Clinical Trial Investigating Enhanced Adrulipase Formulation

Retrieved on: 
Donnerstag, Juli 13, 2023
Biologics license application, EPI, CFA, Exocrine pancreatic insufficiency, Clinical trial, BOCA, First wave, CNA, Arbutus Biopharma, Patient, Data, Cystic fibrosis, SPAN, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Safety, Malabsorption, Medical imaging, Pharmaceutical industry

Initial data from the study indicate the enhanced adrulipase formulation was safe and well tolerated and demonstrated an improvement over prior formulations of adrulipase.

Key Points: 
  • Initial data from the study indicate the enhanced adrulipase formulation was safe and well tolerated and demonstrated an improvement over prior formulations of adrulipase.
  • First Wave BioPharma is continuing to assess the data and expects to report additional findings on primary and secondary endpoints in approximately eight weeks.
  • The Phase 2 SPAN clinical trial was designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving thirteen (13) patients.
  • “Preliminary data from the Phase 2 SPAN clinical trial indicate our enhanced microgranule delivery formulation of adrulipase was safe and well tolerated,” said James Sapirstein, President and CEO of First Wave BioPharma.

First Wave BioPharma Chairman and CEO Issues Letter to Stockholders

Retrieved on: 
Mittwoch, Juli 5, 2023
Biologics license application, Patent, Intellectual property, Letter, EPI, Food, CFA, Exocrine pancreatic insufficiency, United States Patent and Trademark Office, Clinical trial, BOCA, Quality of life, First wave, Cystic fibrosis, Patent Cooperation Treaty, IP, CNA, PCT, Stomach, PERT, Public expenditure, World Organization of the Scout Movement, Capsule, Patient, Cystic Fibrosis Foundation, WIPO, Growth, SPAN, Health, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CF, BLA, Safety, Gastrointestinal disease, Malabsorption, Pharmaceutical industry, Holding company, Shareholder

BOCA RATON, Fla., July 05, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chairman, President and CEO of First Wave BioPharma, has issued a Letter to Stockholders providing an update on the Company’s clinical programs and recent events.

Key Points: 
  • BOCA RATON, Fla., July 05, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chairman, President and CEO of First Wave BioPharma, has issued a Letter to Stockholders providing an update on the Company’s clinical programs and recent events.
  • We are pleased to announce that the last patient in the study has completed their last visit.
  • On June 22, 2023, First Wave held its 2023 Annual Meeting of Stockholders (the “Annual Meeting”) during which stockholders had the opportunity to vote on five proposals.
  • As always, I extend my appreciation to our stockholders for your continued support.

First Wave BioPharma Announces Final Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation

Retrieved on: 
Mittwoch, Juni 28, 2023
EPI, Food, CFA, Exocrine pancreatic insufficiency, Clinical trial, BOCA, First wave, CNA, PERT, Patient, Cystic fibrosis, SPAN, CF, Safety, Malabsorption, Pharmaceutical industry

The Phase 2 multi-center clinical trial ( NCT05719311 ) is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving thirteen (13) patients.

Key Points: 
  • The Phase 2 multi-center clinical trial ( NCT05719311 ) is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving thirteen (13) patients.
  • The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA).
  • “Dosing the final patient is a key milestone in the Phase 2 SPAN clinical trial investigating our enhanced enteric microgranule delivery formulation of adrulipase for the treatment of EPI in CF patients,” said James Sapirstein, President and CEO of First Wave BioPharma.
  • Each patient will be started on a low dose of adrulipase.

First Wave BioPharma Strengthens Intellectual Property Estate

Retrieved on: 
Dienstag, Juni 27, 2023
Patent, EPI, CFA, Exocrine pancreatic insufficiency, United States Patent and Trademark Office, BOCA, First wave, Patent Cooperation Treaty, IP, PCT, CNA, World Organization of the Scout Movement, Publication, Patient, Cystic fibrosis, WIPO, SPAN, CFA Institute, Safety, Malabsorption, Pharmaceutical industry

The PCT includes 157 countries and covers virtually all worldwide industrialized markets.

Key Points: 
  • The PCT includes 157 countries and covers virtually all worldwide industrialized markets.
  • “The patent publications for our enhanced enteric microgranule delivery formulation of adrulipase and its use for the treatment of malabsorption highlight First Wave’s ability to introduce important drug innovations for the treatment of underserved disease indications,” said James Sapirstein, President and CEO of First Wave BioPharma.
  • The Phase 2b SPAN trial is designed to investigate the safety, tolerability, and efficacy of a new enteric microgranulation formulation of adrulipase.
  • Patients will be screened at baseline to ensure that they have a coefficient of fat absorption (CFA) of at least 80%.