Bile acid

FDA Approves New Treatment Option for Patients with ALS

Retrieved on: 
Thursday, September 29, 2022
Adult, Temperature, Muscle, Upper respiratory tract infection, FDA, Food, Center, Diarrhea, Research, Center for Drug Evaluation and Research, Movement, Degenerative disease, Bile acid, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Paralysis, Walking, Attack, Disorder, Priority review, Amyotrophic lateral sclerosis, ALS, Water, Abdominal pain, Nausea, Disease, Death, Pharmaceutical industry

"The FDA remains committed to facilitating the development of additional ALS treatments."

Key Points: 
  • "The FDA remains committed to facilitating the development of additional ALS treatments."
  • ALS is a rare disease that attacks and kills the nerve cells that control voluntary muscles.
  • ALS causes the nerves to lose the ability to activate specific muscles, which causes the muscles to become weak and leads to paralysis.
  • The efficacy of Relyvrio for the treatment of ALS was demonstrated in a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study.

Eisai Launchs Bile Acid Transporter Inhibitor Goofice in Thailand

Retrieved on: 
Monday, July 19, 2021
Hepatology, Medical specialties, Anatomy, Branches of biology, Eisai, Bile acid, Elobixibat, Bile

TOKYO, July 19, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced that its Thailand subsidiary Eisai (Thailand) Marketing Co., Ltd. has launched the bile acid transporter inhibitor Goofice (generic name: elobixibat hydrate) in Thailand.

Key Points: 
  • TOKYO, July 19, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced that its Thailand subsidiary Eisai (Thailand) Marketing Co., Ltd. has launched the bile acid transporter inhibitor Goofice (generic name: elobixibat hydrate) in Thailand.
  • Goofice inhibits the bile acid transporter that regulates reabsorption of bile acids thereby increasing the flow of bile acids to the colon.
  • In Asia (Thailand, Indonesia, Philippines, Malaysia, and Singapore), Eisai is responsible for the commercialization and marketing of this product under a contract with EA Pharma.
  • Eisai will continue to make a further contribution to improve QOL for patients with chronic constipation in Thailand and other Asian countries, through maximization of the product value of Goofice.

Sigyn Therapeutics Reports Preliminary Results of Hepatic Encephalopathy Toxin Study

Retrieved on: 
Tuesday, July 13, 2021
Anatomy, Organs anatomy), Medical specialties, Hepatology, Acute liver failure, Liver, Hepatic encephalopathy, Bilirubin, Bile acid, Chronic liver disease

The goal of the hepatic toxin study was to collect supporting data that would expand the potential use of Sigyn Therapy to include chronic liver disease and acute liver failure indications, including HE.

Key Points: 
  • The goal of the hepatic toxin study was to collect supporting data that would expand the potential use of Sigyn Therapy to include chronic liver disease and acute liver failure indications, including HE.
  • In the hepatic toxin study, clinically relevant levels ofammonia, bilirubin and bile acids were spiked into 1000ml of human blood plasma and then circulated at through an adult version of Sigyn Therapy at normal treatment blood-flow rates.The study was conducted in triplicate over four-hour time periods.
  • The Company is also conducting studies to evaluate the potential use of Sigyn Therapy to treat acute forms of liver failure, including hepatic encephalopathy.
  • This press release contains forward-looking statements of Sigyn Therapeutics, Inc. (Sigyn) that involve substantial risks and uncertainties.

Albireo to Present at the William Blair Biotech Focus Conference 2021

Retrieved on: 
Thursday, July 8, 2021
Medical specialties, Hepatology, Food and Drug Administration, Branches of biology, Health care, Prescription Drug User Fee Act, Bile acid, Priority review, Bile

BOSTON, July 08, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced thatRon Cooper, President and Chief Executive Officer, will present at the William Blair Biotech Focus Conference on Thursday, July 15, at11:00 a.m. EDT.

Key Points: 
  • BOSTON, July 08, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced thatRon Cooper, President and Chief Executive Officer, will present at the William Blair Biotech Focus Conference on Thursday, July 15, at11:00 a.m. EDT.
  • To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the scheduled start time.
  • For PFIC, the FDA recently granted Priority Review and set a PDUFA goal date of July 20, 2021.
  • The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year.

New Report Explains Microbiome Impact on Glucose Control

Retrieved on: 
Monday, June 28, 2021
Health, Branches of biology, Clinical medicine, Pendulum, Bile acid, Diabetes, Ursodeoxycholic acid, Glucose, Butyric acid

Pendulum Glucose Control, is featured in the thought-leadership videos debuting at ADA's 81st Scientific Sessions.

Key Points: 
  • Pendulum Glucose Control, is featured in the thought-leadership videos debuting at ADA's 81st Scientific Sessions.
  • Its findings show Pendulum Glucose Control increases circulating butyrate and ursodeoxycholic acid (UDCA), a secondary bile acid in people with T2D, and supports the mechanism for improvement in glucose control.
  • "This data builds upon the research Pendulum Therapeutics presented at ADA's 79th Scientific Sessions two years ago.Our initial presentation showcased the efficacy of Pendulum's proprietary microbiome synbiotic formulation (Pendulum Glucose Control) and its ability to improve glucose control in patients with Type 2 Diabetes.
  • Pendulum Glucose Control, Pendulum Therapeutics' ground-breaking, flagship product,is featured inthe American Diabetes Association'sselection of thought-leadership videos that will debut at ADA's 81st Scientific Sessions.

Albireo to Present at Piper Sandler’s Virtual EASL Takeaway Day

Retrieved on: 
Thursday, June 24, 2021
Hepatology, Medical specialties, Life sciences, Branches of biology, Digestive system, Bile acid, AstraZeneca, Bile

BOSTON, June 24, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced thatRon Cooper, President and Chief Executive Officer, will present as part of a fireside chat at Piper Sandlers Virtual EASL Takeaway Day on Monday, June 28, at10:00 a.m. EDT.

Key Points: 
  • BOSTON, June 24, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced thatRon Cooper, President and Chief Executive Officer, will present as part of a fireside chat at Piper Sandlers Virtual EASL Takeaway Day on Monday, June 28, at10:00 a.m. EDT.
  • Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases.
  • Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden.
  • The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year.

Albireo to Showcase New Data at the EASL International Liver Congress™ 2021

Retrieved on: 
Thursday, June 10, 2021
Medical specialties, Hepatology, Anatomy, European Association for the Study of the Liver, Cholestasis, Liver disease, Liver, Biliary atresia, Primary biliary cholangitis, Bile acid, Bile duct

Data presentations on Phase 1 product candidate, A3907, in development for adult cholestatic liver disease

Key Points: 
  • Data presentations on Phase 1 product candidate, A3907, in development for adult cholestatic liver disease
    BOSTON, June 10, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced the presentation of data at the European Association for the Study of the Liver (EASL) International Liver Congress 2021, being held virtually June 23 26.
  • Data to be presented includes two oral presentations and seven posters across studies in rare pediatric cholestatic liver disease and in adult liver disease.
  • Bylvay is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and ALGS.
  • The FDA has granted Priority Review and set a PDUFA goal date of July 20, 2021.

Mirum Pharmaceuticals Showcases Maralixibat Transplant-Free Survival Data for Progressive Familial Intrahepatic Cholestasis and Long-Term Safety Analyses for Alagille Syndrome during WCPGHAN Annual Meeting

Retrieved on: 
Thursday, June 3, 2021
Biotechnology, Health, Science, Pharmaceutical, Research, Medical specialties, Hepatology, Digestive diseases, Clinical medicine, Progressive familial intrahepatic cholestasis, Alagille syndrome, Cholestasis, PFIC, Biliary atresia, Liver, Bile acid, Bile duct, Mirum Pharmaceuticals, Inc., Maralixibat, MIRUM PHARMACEUTICALS, INC., MARALIXIBAT

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) presented analyses from its clinical studies evaluating maralixibat in patients with Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis type 2 (PFIC2), two rare liver diseases affecting children.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) presented analyses from its clinical studies evaluating maralixibat in patients with Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis type 2 (PFIC2), two rare liver diseases affecting children.
  • These data demonstrated that patients with long-term maralixibat treatment who achieved serum bile acid (sBA) response had five-year transplant-free survival.
  • Mirums lead product candidate, maralixibat, is an investigational oral drug in development for Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), and biliary atresia.
  • More than 1,600 individuals have received maralixibat, including more than 120 children who have received maralixibat as an investigational treatment for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC).

Galmed Pharmaceuticals Provides Business Updates and Reports First Quarter 2021 Financial Results

Retrieved on: 
Thursday, May 13, 2021
Medical specialties, Anatomy, Hepatology, Branches of biology, Histopathology, Pathology, Steatosis, Alcohol and health, Liver, Bile acid, Fatty liver disease, CIDEB

b'Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism.

Key Points: 
  • b'Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism.
  • Aramchol\'s ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis.
  • The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells.
  • It is the fastest growing cause of liver cancer and liver transplant in the U.S. due to the rise in obesity.

Vivet Therapeutics Announces Multiple Projects Update, Including New VTX-803 Preclinical data To Be Presented At 2021 American Society Of Gene And Cell Therapy Annual Meeting

Retrieved on: 
Monday, May 10, 2021
Hepatology, Medical specialties, Anatomy, Bile acid, Cholestasis, Bile, Liver, Progressive familial intrahepatic cholestasis, Canals of Hering

In people with PFIC, liver cells are less able to secrete bile or essential components into the bile.

Key Points: 
  • In people with PFIC, liver cells are less able to secrete bile or essential components into the bile.
  • The disease is estimated to affect one in every 50,000 to 100,000 births in the United States and Europe.
  • Six types of PFIC have been genetically identified, all of which are similarly characterized by impaired bile flow and progressive liver disease.
  • In PFIC3, cholestasis results from the toxicity of bile in which detergent bile salts are not inactivated by phospholipids, leading to bile canaliculi and biliary epithelium injuries.\n'