Bilirubin

FDA Approves New Antibiotic for Three Different Uses

Retrieved on: 
Wednesday, April 3, 2024
Daptomycin, Research, Hypersensitivity, Hypokalemia, Fungal infection, Aztreonam, Dizziness, Pneumonia, Survival, Dysgeusia, Potassium, Seizure, Abdominal pain, Dietary supplement, CABP, Headache, Patient, Public, Insomnia, Bacterial pneumonia, Food and Drug Administration, Animal, Bilirubin, Diarrhea, History, Mortality, Vancomycin, Leukopenia, Clostridioides, Human services, Injection site reaction, Nausea, Rash, Priority review, Bronchopneumonia, Skin, Fever, Heated tobacco product, Ceftriaxone, Safety, SAB, Anemia, Division, Phlebitis, Cosmetics, Vaccine, Infection, Food, Vomiting, Blood, Multimedia, FDA, Periodic breathing, ABSSSI, Pharmaceutical industry

"The FDA will continue our important work in this area as part of our efforts to protect the public health."

Key Points: 
  • "The FDA will continue our important work in this area as part of our efforts to protect the public health."
  • Zevtera's efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial .
  • In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects).
  • A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.

Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Retrieved on: 
Tuesday, January 9, 2024
Fungal infection, Liver, Marketing, Chills, INN, Risk, Leukopenia, Hypotension, Fungus, Hypertension, Nausea, DNA, Inflammation, Liver disease, Anatomy, IIA, CHMP, Diarrhea, Fever, Infection, ATC, Hepatomegaly, European, Neutrophil, Neoplasm, HIV, Tachycardia, Anemia, Hypocalcemia, Hypokalemia, Patient, Medical Subject Headings, Caspofungin, European Commission, Echinocandin, Kidney failure, International, Bilirubin, Neutropenia, Blood, Language, Thrombocytopenia, Magnesium, Select, Medicine, Vomiting, Phlebitis, Amphotericin B, Allergy, Fluconazole, Headache, Rat, Haematopoiesis, Committee, Checklist, Alkaline phosphatase, Rash, Medical device

Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

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

Retrieved on: 
Tuesday, January 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

Structure Therapeutics Provides Comprehensive GSBR-1290 Program Update Including Clinically Meaningful Proof-of-Concept Data From Phase 2a Clinical Study

Retrieved on: 
Monday, December 18, 2023
Metabolism, Șaeș, Division, Aes, Weight loss, Bilirubin, Nausea, Glycated hemoglobin, Duke University, GPCR, Obesity, Fatty liver disease, Patient, Safety, Therapy, Vomiting, Dietary supplement

ET

Key Points: 
  • ET
    SAN FRANCISCO, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic and cardiopulmonary diseases, today provided a comprehensive development program update for its highly selective oral GLP-1 receptor agonist, GSBR-1290.
  • “The unmet medical need for both T2DM and chronic weight management continues to be very large, and the GLP-1 receptor is a target with considerable potential.
  • The T2DM cohort enrolled 54 participants, randomized to GSBR-1290 45 mg (n=10) or 90 mg (n=26), or placebo (n=18), dosed once daily.
  • The primary endpoint of the Phase 2a study is safety and tolerability of GSBR-1290.

Syntron Bioresearch Product Pipeline Analysis- Pipeline Products and Ongoing Clinical Trials Overview - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 28, 2023
Biotechnology, Health, Clinical Trials, Medical Devices, Urobilinogen, Allergy, Research, Anemia, Bilirubin, Blood, Cancer, Fertility, Glucose, Infection, Intelligence, Oil

The "Syntron Bioresearch Inc - Product Pipeline Analysis, 2023 Update" company profile has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Syntron Bioresearch Inc - Product Pipeline Analysis, 2023 Update" company profile has been added to ResearchAndMarkets.com's offering.
  • Syntron Bioresearch Inc (SYNTRON) is a medical device company that develops and manufactures in-vitro immunodiagnostic test systems.
  • The company provides products such as immunochromatographic assays, enzyme immunoassays, biochemical and chemical assays, microstrip readers, colorimetric assay systems, microwell strip readers, microplate readers and microplate washers.
  • This report is a source for data, analysis, and actionable intelligence on the company's portfolio of pipeline products.

Mirum Pharmaceuticals Announces Data from EMBARK Phase 2b Study for Biliary Atresia

Retrieved on: 
Monday, December 18, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Liver, Spiroplasma mirum, Patient, Biliary atresia, Medication, Bilirubin, Science, Medical imaging, Nursing

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), today announced top-line results of the Phase 2 EMBARK study evaluating LIVMARLI® (maralixibat) oral solution versus placebo given as an adjuvant therapy to Kasai surgery in patients with biliary atresia.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), today announced top-line results of the Phase 2 EMBARK study evaluating LIVMARLI® (maralixibat) oral solution versus placebo given as an adjuvant therapy to Kasai surgery in patients with biliary atresia.
  • The study did not meet its primary endpoint of mean change in bilirubin from baseline to Week 26, or the key secondary endpoints.
  • “We are disappointed in the outcome of the study in this post-surgery, high-need disease setting,” said Chris Peetz, president and chief executive officer at Mirum.
  • “We are grateful to the patients, families, and clinicians who participated in the study and advanced the science around this rare liver disease.”

Long-term Follow-up Data From bluebird’s Gene Therapy Program in Sickle Cell Disease Support Durable, Potentially Curative Benefits Through Stable Production of Anti-Sickling Adult Hemoglobin and Resolution of Vaso-Occlusive Events

Retrieved on: 
Saturday, December 9, 2023
Health, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Adolescence, Nasal congestion, Safety, Food, Hemolytic anemia, Sickle cell disease, ASH, Pain, Priapism, Acute myeloid leukemia, Patient, Disease, Acute chest syndrome, Hospital, Quality of life (healthcare), Fatigue, HB, Leukemia, Busulfan, Division, VOE, RAF Sullom Voe, Hemolysis, Myelodysplastic syndrome, Exposition, University, Diagnosis, Society, Quality of life, Biology, Blood transfusion, Bilirubin, Comorbidity, Pharmaceutical industry, Medical imaging, Anemia, Hematology

The majority of adverse events in treated patients were attributed to underlying sickle cell disease or conditioning with busulfan.

Key Points: 
  • The majority of adverse events in treated patients were attributed to underlying sickle cell disease or conditioning with busulfan.
  • Lovo-cel is the most deeply studied gene therapy in development for sickle cell disease, with the most patients treated and longest follow-up in the field.
  • As of February 13, 2023, 59 patients were treated across the entire clinical development program with follow-up beyond 8 years in the earliest treated patients.
  • In sickle cell disease, hemolysis happens too quickly due to the fragility of sickled red blood cells, resulting in hemolytic anemia.

Mirum Pharmaceuticals Presents New Data at The Liver Meeting®

Retrieved on: 
Monday, November 13, 2023
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Infectious Diseases, Clinical Trials, Sleep, Hepatology, MDR3, Self-harm, Safety, Hepatocellular carcinoma, Bilirubin, Cholestasis, AASLD, Liver, Disease, Risk, Cholestatic pruritus, Hematology, Quality of life (healthcare), MYO5B, PFIC, Patient, Publication, Pregnancy, Nature, TJP2, Ascending cholangitis, GI, Hippeastrum mirum, Liver support system, Volixibat, ICP, IBAT, Progressive familial intrahepatic cholestasis, FIC, Augmented fifth, Growth, Doctor of Philosophy, Quality of life, AND, Itch, Medication, MCID, HIV disease progression rates, SBA, Chloride, Pharmaceutical industry, Nursing, Medical imaging, Dietary supplement, Boston, BSEP

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced new data from its LIVMARLI and volixibat programs presented at The Liver Meeting®, the American Association for the Study of Liver Diseases (AASLD) annual meeting in Boston, Massachusetts.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced new data from its LIVMARLI and volixibat programs presented at The Liver Meeting®, the American Association for the Study of Liver Diseases (AASLD) annual meeting in Boston, Massachusetts.
  • “PFIC is a chronic, debilitating cholestatic liver disease characterized by elevated bile acids and pruritus so severe that patients can be listed for liver transplant even in the absence of disease progression.
  • These data suggest overall improved liver health with maralixibat treatment in patients with PFIC that can be maintained long-term.
  • No clinically meaningful changes in liver enzyme levels or hematology parameters were observed after volixibat treatment.

AMRA Medical at AASLD The Liver Meeting® Showcases MRI-Based Technology and Muscle Biomarkers linked to liver disease severity and progression

Retrieved on: 
Thursday, November 9, 2023
Research, Surgery, Medical Devices, Clinical Trials, Health Technology, Biotechnology, Radiology, Health, Science, MELD, DSM-IV codes, Biomarker, Cirrhosis, Liver, Prevalence, Non-alcoholic fatty liver disease, Frailty, Liver disease, Phenotype, Multimedia, CVD, Circulatory system, Bilirubin, Mass, Type 2 diabetes, Cardiovascular disease, Abstract, AASLD, NAFLD, Patient, Sarcopenia, Medical imaging, Dietary supplement, T2D

A total of nine abstracts will be presented, focusing on how AMRA’s MRI-based muscle assessment score (MAsS) biomarkers are linked to liver disease severity and progression.

Key Points: 
  • A total of nine abstracts will be presented, focusing on how AMRA’s MRI-based muscle assessment score (MAsS) biomarkers are linked to liver disease severity and progression.
  • View the full release here: https://www.businesswire.com/news/home/20231109684555/en/
    The abstracts present MAsS as a promising tool to identify physical frailty and sarcopenia and as prognostic biomarkers for liver disease.
  • The AASLD’s The Liver Meeting® takes place November 10-14th in Boston, USA, with a number of AMRA attendees.
  • Those joining us at The Liver Meeting® can learn about how the MAsS biomarkers, muscle fat infiltration and muscle volume z-score, have been utilized in studies from early to end-stage liver disease.

CymaBay Reports Third Quarter and Nine Months Ended September 30, 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 7, 2023
Itch, UDCA, Cirrhosis, Breakthrough therapy, Conditional sentence, Liver, Conference, HIV disease progression rates, PBC, Bilirubin, Caregiver, Risk, Partnership, Primary biliary cholangitis, Safety, Conference call, Therapy, Patient, Liver support system, Medical imaging, Pharmaceutical industry

ET

Key Points: 
  • ET
    NEWARK, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced corporate updates and financial results for the third quarter ended September 30, 2023.
  • Research and development expenses for the three months ended September 30, 2023, and 2022 were $20.0 million and $15.5 million, respectively.
  • Net loss for the three months ended September 30, 2023 was higher than the three months ended September 30, 2022 primarily due to higher operating expenses.
  • ET to discuss third quarter financial results and provide a business update.