Ursodeoxycholic acid

CymaBay Announces European Medicines Agency Accepts for Review the Marketing Authorization Application for Seladelpar for the Treatment of Primary Biliary Cholangitis

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월요일, 3월 4, 2024
Liver, Child, Marketing, EMA, Ursodeoxycholic acid, MAA, Chemistry, Cirrhosis, Inflammation, FDA, Quality of life, Food, Chief, Conditional sentence, PBC, Risk, European, Health care, Therapy, Fatigue, CHMP, European Medicines Agency, Primary biliary cholangitis, Patient, Itch

Seladelpar is an investigational, potent, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist or delpar, in development for PBC treatment.

Key Points: 
  • Seladelpar is an investigational, potent, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist or delpar, in development for PBC treatment.
  • The study’s primary endpoint measure reflects registrational studies of the current second line PBC treatment authorized by the EMA.
  • In this study seladelpar demonstrated statistically significant improvements in biochemical markers of disease progression and PBC-related pruritus (itch) pre-specified endpoints.
  • “Validation of the European Marketing Authorization Application for seladelpar and the start of the agency’s formal review is an important step forward in seladelpar’s journey to potential approval in Europe.

Intercept Announces FDA Acceptance of Supplemental New Drug Application for Ocaliva® (obeticholic acid) for the Treatment of PBC

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목요일, 2월 29, 2024
Therapy, Senior, Ursodeoxycholic acid, Pamlab, New Drug Application, FDA, Food, Shanda, PDUFA, Regulatory affairs, Database, PBC, Communication, Hepatology, Cirrhosis, Intercept, Primary biliary cholangitis, Patient, UDCA, Obeticholic acid, Intercept Pharmaceuticals, Advisory Committee, Pharmaceutical industry

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024.

Key Points: 
  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024.
  • In this communication, the agency informed Intercept that they are planning to hold an Advisory Committee meeting to discuss the application.
  • The precedent-setting sNDA for Ocaliva is intended to satisfy the post-marketing requirements to confirm a clinical benefit in patients with PBC.
  • Intercept and Alfasigma remain committed to supporting people living with PBC and look forward to advancing discussions with the agency.

CymaBay Reports Fourth Quarter and Year Ended December 31, 2023 Financial Results and Provides Corporate Update

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수요일, 2월 28, 2024
Alkaline phosphatase, Acquisition, Liver, Child, Therapy, EMA, Ursodeoxycholic acid, New Drug Application, Gilead Sciences, Education, IDEAL, FDA, Science, Quality of life, Food, Marketing, U.S. FDA, Breakthrough, ALP, Hospital, PBC, Phase 3, Cirrhosis, Hepatology, Seladelpar, Safety, ULN, European Medicines Agency, Numerical, Patient, MHRA, UDCA, Itch, NDA, NRS, Pharmaceutical industry

NEWARK, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the year and fourth quarter ended December 31, 2023.

Key Points: 
  • NEWARK, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the year and fourth quarter ended December 31, 2023.
  • “2023 was a seminal year for CymaBay with critical achievements in the development of our investigational therapeutic, seladelpar.
  • Net loss for the year ended December 31, 2023 and 2022 was $105.4 million and $106.0 million, or ($0.99) and ($1.21) per share, respectively.
  • Net loss for the three months ended December 31, 2023 was higher than the three months ended December 31, 2022 primarily due to higher operating expenses.

Budesonide in Primary Biliary Cholangitis Research Report 2024: Comprehensive Market Insights to 2032 with Focus on 7 Major Markets - ResearchAndMarkets.com

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화요일, 3월 5, 2024
Biotechnology, Pharmaceutical, Health, Outline, Ursodeoxycholic acid, Chronic liver disease, Budesonide, Strategic planning, Drug development, SWOT, Primary, PBC, Primary biliary cholangitis, Patient, UDCA, Research, Pharmaceutical industry

The healthcare industry witnesses a significant milestone as the Budesonide Market Size, Forecast, and Drug Insight - 2032 report is introduced to the research inventory.

Key Points: 
  • The healthcare industry witnesses a significant milestone as the Budesonide Market Size, Forecast, and Drug Insight - 2032 report is introduced to the research inventory.
  • This latest analytical document delineates the progressive outlook of budesonide in treating primary biliary cholangitis (PBC), providing a detailed market forecast and insights into drug development and innovation within the pharmaceutical arena through to 2032.
  • Primary biliary cholangitis, a chronic liver disease, presents a therapeutic challenge, compelling industry stakeholders to eagerly explore new treatment avenues.
  • With a thorough research methodology encompassing secondary and primary data, industry expertise, and comprehensive market analysis, the report equips stakeholders with pivotal insights.

CymaBay Announces FDA Acceptance of NDA and Priority Review for Seladelpar for the Treatment of Primary Biliary Cholangitis

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월요일, 2월 12, 2024
Alkaline phosphatase, Liver, Child, Ursodeoxycholic acid, New Drug Application, BTD, Cirrhosis, Inflammation, FDA, Quality of life, Food, Breakthrough, Chief, Conditional sentence, PDUFA, ALP, PBC, Seladelpar, Therapy, Fatigue, Patient, Itch, Mortality, NDA, Pharmaceutical industry

NEWARK, Calif., Feb. 12, 2024 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for seladelpar, an investigational treatment for the management of primary biliary cholangitis (PBC) including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to ursodeoxycholic acid. The FDA has granted priority review and set a Prescription Drug User Fee Act (PDUFA) target action date of August 14, 2024 and notified the company that it is not currently planning to hold an advisory committee meeting to discuss the application.

Key Points: 
  • PBC is a rare, chronic condition that can lead to inflammation and eventually liver cirrhosis.
  • People living with PBC can also experience symptoms that significantly impact their quality of life such as pruritus (itch) and fatigue.
  • Seladelpar is an investigational, potent, selective, orally active PPARδ agonist, or delpar, in development for PBC treatment.
  • "We are encouraged by the agency's decision to grant priority review for seladelpar, and its recognition of the significant need for new treatment options for people living with PBC.

Pliant Therapeutics Announces Positive Safety and Exploratory Efficacy Data from the INTEGRIS-PSC Phase 2a Trial of Bexotegrast 320 mg in Patients with Primary Sclerosing Cholangitis and Suspected Liver Fibrosis

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일요일, 2월 4, 2024
ALP, AGAF, IBD, Ascending cholangitis, Liver failure, Pharmacokinetics, SAN, Washington State University, Inflammation, Fibrosis, Cirrhosis, Itch, PSC, Ursodeoxycholic acid, MRI, Telephone, Magnetic resonance imaging, Inflammatory bowel disease, Patient, Safety, FDA, EMA, FACP, Disease, IPF, SAE, FRCP, ELF, Week, Therapy, Conference call, Alkaline phosphatase, Interest, UDCA, FACG, University, Webcast, Liver, Primary sclerosing cholangitis, Plasma, Liver disease, Conference, Medical imaging

SOUTH SAN FRANCISCO, Calif., Feb. 04, 2024 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced 12-week interim data from the 320 mg dose group of INTEGRIS-PSC, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis. The 320 mg group met its primary and secondary endpoints demonstrating that bexotegrast was well tolerated over a 12-week treatment period and its plasma concentrations increased with dose. There was no dose relationship for adverse events. Pruritus and cholangitis occurred less frequently on bexotegrast than on placebo.

Key Points: 
  • The trial’s exploratory efficacy endpoints assessed changes in the liver fibrosis markers, Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels, as well as liver biochemistry and magnetic resonance imaging (MRI) of the liver.
  • In addition, MRI imaging continued to show evidence of improved hepatocyte function and bile flow with bexotegrast at the 320 mg dose relative to placebo.
  • INTEGRIS-PSC is a multinational, randomized, dose-ranging, double-blind, placebo-controlled Phase 2a trial evaluating bexotegrast at once-daily oral doses of 40 mg, 80 mg, 160 mg, 320 mg or placebo for 12 weeks in 121 patients with PSC.
  • The 320 mg group enrolled 27 patients in the active arm and added 9 new patients to the pooled placebo arm.

Human medicines European public assessment report (EPAR): Ocaliva, obeticholic acid, Date of authorisation: 12/12/2016, Revision: 19, Status: Authorised

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화요일, 1월 2, 2024
Patient, Liver, Medical Subject Headings, Extrapyramidal system, Marketing, Cirrhosis, UDCA, Agency, Bile, INN, Risk, Fatigue, ATC, Primary biliary cholangitis, Itch, International, Bilirubin, Ursodeoxycholic acid, Language, Ascending cholangitis, European Medicines Agency, ALP, Tablet, Scar, Liver failure, Liver cancer, Select, Liver disease, Time, Safety, Fats, Anatomy, Medicine, IIA, Primary, Medical imaging

Human medicines European public assessment report (EPAR): Ocaliva, obeticholic acid, Date of authorisation: 12/12/2016, Revision: 19, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Ocaliva, obeticholic acid, Date of authorisation: 12/12/2016, Revision: 19, Status: Authorised

Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC

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목요일, 12월 7, 2023
Liver, UDCA, Chapter Two, Woman, FDA, MAA, Fatigue, Nausea, Primary biliary cholangitis, Inflammation, ADR, Patent, Liver disease, Diagnosis, AMF, CHMP, Ascending cholangitis, UCD, Business, ACLF, PDUFA, Itch, Risk, New Drug Application, OA, Common, EASL, MASH, Liver failure, Safety, Ammonia, Elafibranor, Therapy, Epidemiology, History, Patient, Cholangiocarcinoma, Food, Health care, EMA, Ursodeoxycholic acid, MHRA, Cirrhosis, Medicine, NTZ, EVP, Cholestasis, NASH, Research, Diarrhea, Bile, NDA, PBC, Abdominal pain, Clinical trial, European Medicines Agency, IPN, PPAR, P10, CCA, Fibrosis, Pharmaceutical industry

An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade.

Key Points: 
  • An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade.
  • The trial enrolled 161 patients who were randomized 2:1 to receive either elafibranor 80mg once daily or placebo.
  • ELATIVE also investigated the effect of treatment with elafibranor on pruritus (severe itch), a significant symptom burden amongst people living with PBC.
  • Findings from the secondary endpoint using the PBC Worst Itch NRS score, showed a reduction in pruritis for elafibranor, which was not statistically significant.

Intercept Announces New Phase 2 Data Showing Significant Impact of OCA-Bezafibrate Combination on Normalization of Multiple Key Biomarkers of PBC-Induced Liver Damage at AASLD The Liver Meeting® 2023

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월요일, 11월 13, 2023
UDCA, Primary biliary cholangitis, Hypertension, ALP, Research and development, OCA, Obeticholic acid, Hepatology, ALT, Intercept Pharmaceuticals, Aes, Ursodeoxycholic acid, PBC, AASLD, Intercept, PPAR, FXR, Serum, Data analysis, Alanine transaminase, FDA, Liver, Alkaline phosphatase, Bezafibrate, GGT, Therapy, University, Development, Biomarker, Itch, Magnetic resonance, Safety, Pharmaceutical industry, Fused quartz, Medicine, Boston, Patient

These data will be presented on Monday, November 13, 2023, at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® in Boston (poster #5019-C).

Key Points: 
  • These data will be presented on Monday, November 13, 2023, at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® in Boston (poster #5019-C).
  • One severe TEAE (pruritus, OCA5/B100 IR) occurred in Study 214; no TEAEs led to study discontinuation in Study 214.
  • The Company expects to have the necessary data from the OCA-bezafibrate combination program to submit a request in 2023 for an End-of-Phase 2 meeting with the FDA.
  • These data include analyses from both Phase 2 studies, in addition to Phase 1 and preclinical data.

WILLOW BIOSCIENCES REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

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화요일, 11월 14, 2023
UDCA, Research, Commercial, Bank statement, WLLW, Willow Garage, Steroid, API, Partnership, Ursodeoxycholic acid, R, TSX, Patent, Pharmaceutical industry, Fine chemical, Renewable energy, Video game, Willow, Q4

On July 20, 2023, Willow announced our savory food program with Kalsec Inc. progressed past the feasibility stage and into the R&D and scale-up work stage.

Key Points: 
  • On July 20, 2023, Willow announced our savory food program with Kalsec Inc. progressed past the feasibility stage and into the R&D and scale-up work stage.
  • On October 24, 2023, Aurora Cannabis Inc. and Willow announced a confidential settlement resolving the ongoing patent ligation in Canada.
  • Willow ended the quarter with approximately $4.0 million in cash as of September 30, 2023, plus receivables of over $0.6 million.
  • On September 12, 2023, Willow announced an insider led convertible debenture financing, which was closed on October 10, 2023 for gross proceeds of $0.8 million.