Short bowel syndrome

Protara Therapeutics Announces Alignment with FDA on Registrational Path Forward for IV Choline Chloride in Patients Dependent on Parenteral Nutrition

Retrieved on: 
Friday, April 5, 2024
Choline, Plasma, Liver, Nutritional science, Route of administration, Liver disease, Steatosis, Short bowel syndrome, Metabolism, Patient, Choline chloride, Cancer, ESPEN, Parenteral nutrition, Adolescence, Liver injury, Hepatology, Tubing (recreation), Fibrosis, Guideline, Society, Therapy, Copenhagen University Hospital, Safety, Pharmacokinetics, PN, FDA, ASPEN, Rigshospitalet, Food, Feeding tube, Extractive metallurgy

IV Choline Chloride has the potential to become the first FDA-approved IV formulation of choline for the 40,000 PN patients in the U.S.

Key Points: 
  • IV Choline Chloride has the potential to become the first FDA-approved IV formulation of choline for the 40,000 PN patients in the U.S.
  • The Company plans to advance the development of IV Choline Chloride as a source of choline for adult and adolescent patients on long-term PN.
  • The FDA has granted IV Choline Chloride Orphan Drug Designation for the prevention of choline deficiency in PN patients.
  • “We look forward to advancing the clinical development of IV Choline Chloride, which we believe has the potential to become the first FDA approved IV choline therapy for patients dependent on PN.

Virginia Milk Bank Seeks Donors for Hospitalized Babies

Retrieved on: 
Wednesday, March 20, 2024
Breast milk, Jaundice, Retinopathy, Nutrient, Lactation, Disease, Memory, Short bowel syndrome, CHKD, Risk, Necrotizing enterocolitis, Hospital, Milk, American Academy, Infant, Death, NICU, Life, Protein, Kidney disease, Intraparenchymal hemorrhage, Woman, Holiday, Antibody, Oxygen, Premature, Paratriathlon, Charli, ROP, Pediatrics (journal), Pediatrics, Dairy

Knowing that her breast milk was the best nutrition for Charli, Moultrie tried pumping to get her milk supply started.

Key Points: 
  • Knowing that her breast milk was the best nutrition for Charli, Moultrie tried pumping to get her milk supply started.
  • After two weeks of consistently pumping with scant results, Moultrie was grateful to learn that Charli could receive safe, pasteurized human milk through the hospital's donor milk bank.
  • The milk bank also has a legacy program for women who have lost a baby but want to donate their milk to help other infants.
  • “But there are times around the holidays and during the summer when we only have enough milk for hospitalized babies.”
    This means the milk bank is not always able to provide milk to babies who have been discharged from the hospital with a doctor’s prescription for pasteurized donor human milk.

Entera Bio Announces Robust Pharmacokinetic Data for First-in-Class Oral GLP-2 Peptide Tablet Treatment for Patients with Short Bowel Syndrome

Retrieved on: 
Wednesday, March 20, 2024
Zealand Pharma, Plasma, Rat, LC-MS/MS, Short bowel syndrome, Half-life, Inflammation, Patient, Tablet, Teduglutide, POC, OPKO Health, Injection, Entera, Pharmaceutical industry

The program is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.

Key Points: 
  • The program is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.
  • Currently, the only approved GLP-2 agonist, which is marketed under the name Gattex® (teduglutide), requires daily sub-cutaneous injections.
  • Entera and OPKO completed a proof of concept (PoC) single dose pharmacokinetic study in rodents as the first validation for oral administration of the GLP-2 treatment.
  • This data is consistent with previously reported PK data relating to OPKO’s GLP-2 peptide’s long acting profile, which had initially been developed as a weekly subcutaneous injection.

Entera Bio Announces Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Friday, March 8, 2024
OXM, Woman, Injection, Research, Bone fracture, Clinical research associate, Type D, FDA, BMD, PTH, Food, Hypoparathyroidism, Obesity, Coeliac disease, Weight loss, Oxyntomodulin, Cmax, Elective surgery, Sport, Short bowel syndrome, OPKO Health, DSM-IV codes, Ecosystem, SABRE, Patient, D&O, Intellectual property, Fracture, Athlete, Sports medicine, Tablet, Osteoporosis, Insurance

JERUSALEM, March 08, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides, today reported financial results and key business updates for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • JERUSALEM, March 08, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides, today reported financial results and key business updates for the fourth quarter and year ended December 31, 2023.
  • Following our December 2023 financing, we expect to have sufficient cash to fund operations through the first half of 2025,” said Miranda Toledano, CEO of Entera.
  • Financial Results for the year Ended December 31, 2023
    As of December 31, 2023, Entera had cash and cash equivalents of $11.0 million.
  • Operating expenses for year ended December 31, 2023 were $8.9 million, as compared to $13.0 million for the year ended December 31, 2022.

Ironwood Pharmaceuticals Announces Positive Topline Results from Global Phase III Trial of Once-Weekly Apraglutide in Adults with Short Bowel Syndrome with Intestinal Failure (SBS-IF)

Retrieved on: 
Thursday, February 29, 2024
Pharmaceutical, Health, Clinical Trials, FACS, SBS, FRCS, Principal, PS, Short bowel syndrome, Safety, Pelvic floor dysfunction, Patient, Transplant, Medication, Ironwood Pharmaceuticals, MBBS, NDA, Pharmaceutical industry

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced positive topline results from its pivotal Phase III STARS trial, which evaluated the efficacy and safety of once-weekly subcutaneous apraglutide in reducing parenteral support (PS) dependency in adult patients with short bowel syndrome with intestinal failure (SBS-IF).

Key Points: 
  • Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced positive topline results from its pivotal Phase III STARS trial, which evaluated the efficacy and safety of once-weekly subcutaneous apraglutide in reducing parenteral support (PS) dependency in adult patients with short bowel syndrome with intestinal failure (SBS-IF).
  • Based on these results, Ironwood plans to submit a new drug application (NDA) and other regulatory filings for apraglutide for use in adult patients with SBS who are dependent on PS.
  • The global, multicenter, double-blind, randomized, placebo-controlled trial evaluated the efficacy and safety of weekly subcutaneous injections of apraglutide in adult patients with SBS-IF.
  • Topline safety results were generally consistent with the safety profile demonstrated in apraglutide studies to date.

Ironwood Pharmaceuticals to Present Four Abstracts at the ASPEN 2024 Nutrition Science & Practice Conference

Retrieved on: 
Friday, February 23, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Managed Care, Health, Fitness & Nutrition, Ironwood Pharmaceuticals, SBS, Ileostomy, Nutrition, Safety, University, PS, Quality of life, Infection, Drug development, Jejunostomy, Hope, Short bowel syndrome, Risk, Conference, Faculty, Society, Nutrient, Pharmacokinetics, Route of administration, Abstract, ASPEN, Feeding tube, Medication, STARS, Pharmaceutical industry

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, announced today that the company will present findings from four studies evaluating apraglutide in adults with short bowel syndrome with intestinal failure (SBS-IF), a condition in which they are dependent on parenteral support, during the American Society for Parenteral and Enteral Nutrition (ASPEN) 2024 Nutrition Science & Practice Conference.

Key Points: 
  • Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, announced today that the company will present findings from four studies evaluating apraglutide in adults with short bowel syndrome with intestinal failure (SBS-IF), a condition in which they are dependent on parenteral support, during the American Society for Parenteral and Enteral Nutrition (ASPEN) 2024 Nutrition Science & Practice Conference.
  • ASPEN is being held from March 2-5, 2024, in Tampa, Florida.
  • SBS is a serious and chronic condition where there is diminished absorptive capacity for fluids and/or nutrients, typically resulting from extensive intestinal resection.
  • “These findings continue to deepen our understanding of GLP-2 and the potential of apraglutide to help adult patients with SBS who are dependent on PS, including those with colon-in-continuity.

NorthSea Therapeutics Initiates Phase 2A Trial of Orziloben (NST-6179) in Intestinal Failure-Associated Liver Disease (IFALD)

Retrieved on: 
Wednesday, February 21, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Liver, Collagen, Myofibroblast, PD, Liver disease, Cirrhosis, Learning, Short bowel syndrome, Conference, Hepatology, Liver failure, Safety, Steatosis, Rigshospitalet, PN, Therapy, Pharmacokinetics, Cholestasis, Fatty liver disease, Patient, ASPEN, Fibrosis, Disease, NASH, Pharmaceutical industry

The trial is a randomized, double-blind, Phase 2a, placebo-controlled study, which will be conducted at multiple sites across North America.

Key Points: 
  • The trial is a randomized, double-blind, Phase 2a, placebo-controlled study, which will be conducted at multiple sites across North America.
  • It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Orziloben in adult subjects with IFALD.
  • Commenting on the milestone, Rob de Ree, NST’s CEO, said: "Dosing the first patient in our Phase 2a trial for Orziloben in IFALD is a significant achievement for NorthSea Therapeutics, and is a testament to our commitment to advance innovative treatments for liver diseases.
  • In one pre-clinical model of PN-induced liver injury, Orziloben treatment completely prevented severe cholestasis and the development of fibrosis.

Ironwood Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Results; Achieves 2023 Financial Guidance

Retrieved on: 
Thursday, February 15, 2024
Managed Care, Biotechnology, Pharmaceutical, Health, Acquisition, Liver, Autoimmune disease, Income tax, Hepatology, FDA, Food, Endometriosis, PBC, Interest expense, Constipation, Annual general meeting, Short bowel syndrome, Safety, Society, GAAP, The Lancet, UEG, Pharmacokinetics, Food and Drug Administration, Primary biliary cholangitis, Interest, Patient, Disease, STARS, Phase, Interstitial cystitis, Trial of the century, Ageing, United European Gastroenterology, CIC, Research, SBS, Depreciation, Video game

Total revenues in the fourth quarter of 2023 were $117.6 million, compared to $107.2 million in the fourth quarter of 2022.

Key Points: 
  • Total revenues in the fourth quarter of 2023 were $117.6 million, compared to $107.2 million in the fourth quarter of 2022.
  • Operating expenses in the fourth quarter of 2023 were $80.0 million, compared to $38.8 million in the fourth quarter of 2022.
  • Adjusted EBITDA was $39.9 million in the fourth quarter of 2023, compared to $68.7 million in the fourth quarter of 2022.
  • Ironwood generated $35.8 million in cash from operations in the fourth quarter of 2023, compared to $79.2 million in cash from operations in the fourth quarter of 2022.

Ironwood Pharmaceuticals Maintains FY 2023 Financial Guidance and Announces FY 2024 Financial Guidance

Retrieved on: 
Monday, January 8, 2024
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Growth, Conference, Medication, SBS, GI, STARS, Short bowel syndrome, Ironwood Pharmaceuticals, Pharmaceutical industry

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced financial guidance for full year 2024.

Key Points: 
  • Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced financial guidance for full year 2024.
  • “We are on track to deliver on our 2023 LINZESS U.S. net sales guidance, driven by continued strong prescription demand and remain encouraged about the future growth potential of the brand.
  • In addition, we expect to deliver greater than $150 million in adjusted EBITDA in 2024.
  • We believe the advancement of our pipeline programs, combined with continued strong LINZESS demand growth, uniquely position our company for success in our mission to be the leader in GI.”
    Ironwood is maintaining its previous FY 2023 financial guidance and is providing FY 2024 financial guidance.

Zealand Pharma submits New Drug Application to the US FDA for glepaglutide in short bowel syndrome

Retrieved on: 
Friday, December 22, 2023
FDA, Patient, Food, Short bowel syndrome, Risk, NDA, MD, SBS, Pharmaceutical industry

Copenhagen, Denmark, December 22, 2023 – Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) (CVR-no.

Key Points: 
  • Copenhagen, Denmark, December 22, 2023 – Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) (CVR-no.
  • 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult patients with short bowel syndrome (SBS) dependent on parenteral support.
  • “Short bowel syndrome with intestinal failure is a complex, chronic and severe condition in which individuals are dependent on receiving fluids and nutrition parenterally.
  • While life-sustaining, parenteral support poses significant restrictions on daily life and carries a risk of serious and life-threatening complications.