Hepatotoxicity

Seagen Announces FDA Accelerated Approval of TUKYSA® (tucatinib) in Combination with Trastuzumab for People with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer

Retrieved on: 
Thursday, January 19, 2023
Research, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, MSD, Cancer, Rash, Standard of care, Bowel obstruction, Fever, Priority review, Colorectal Cancer Alliance, Food, Duke University Hospital, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Merck, Hepatotoxicity, RAS, Urinary tract infection, Inc., ORR, Trastuzumab, News, Diarrhea, Breast, Colorectal cancer, ALT, Nausea, Patient, Medicine, Pneumonia, Physician, DOR, Confidence interval, FDA, Fatigue, HER2, Abdominal pain, Senior, Diagnosis, Liver, Pharmaceutical industry

TUKYSA is approved under the FDA’s Accelerated Approval Program based on tumor response rate and durability of response from the phase 2 MOUNTAINEER clinical trial.

Key Points: 
  • TUKYSA is approved under the FDA’s Accelerated Approval Program based on tumor response rate and durability of response from the phase 2 MOUNTAINEER clinical trial.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • This is the first FDA-approved treatment in HER2-positive metastatic colorectal cancer.
  • The FDA previously granted Breakthrough Therapy Designation and Priority Review for TUKYSA in this setting.

Optime Care, Specialty Pharmacy Patient Management Organization Announces Enhanced Partnership with Rigel Pharmaceuticals, Inc. for Rezlidhia™ Patients

Retrieved on: 
Tuesday, December 13, 2022
Biotechnology, FDA, Health, Family, Consumer, Other Health, Pharmaceutical, Oncology, Other Science, Research, Managed Care, Genetics, Science, Women, Recurrence, Liver, Hepatotoxicity, Cancer, Uric acid, Mucositis, Disease, Woman, AML, URAC, Hypertension, Potassium, Transaminase, Rash, Sodium, Azacitidine, Partnership, Degenerative disease, Knowledge, HUB, ACHC, Fatigue, Hypotension, Alkaline phosphatase, Clinical trial, Constipation, Fatality, Leukocytosis, Probability, Retinoic acid syndrome, Creatinine, AST, Diarrhea, Jaundice, Postcholecystectomy syndrome, Weight gain, Market access, Dexamethasone, Purging disorder, Edema, Case management (US healthcare system), Mutation, Acute kidney injury, Lymphocyte, Lipase, Disorder, IDH1, CYP3A, Patient, Myelocyte, Nausea, FDA, Hydroxycarbamide, ALT, Breathe Me, Arthralgia, Bilirubin, Accreditation Commission for Health Care, Acute myeloid leukemia, Pharmaceutical industry, Generic drug, Rigel, Fever

Scott Yohe, Vice President Market Access at Rigel Pharmaceuticals, says, We are excited to work with Optime Care in the complete management of our Rezlidhia patients.

Key Points: 
  • Scott Yohe, Vice President Market Access at Rigel Pharmaceuticals, says, We are excited to work with Optime Care in the complete management of our Rezlidhia patients.
  • If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution.
  • Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption of REZLIDHIA.
  • Our experience with small patient populations, coupled with our strategic partnership with AscellaHealth , enhances our services and ability to serve the specialty pharmacy market.

New Scientific Publication Describes Twelve Reasons Why Organ-Chips are Better than Animal Testing

Retrieved on: 
Friday, December 16, 2022
Hepatotoxicity, Drug development, Federal Food, Drug, and Cosmetic Act, MPA, Pharmaceutical innovations, Doctor of Philosophy, Patient, Disease, Entrepreneurship, Science, Animal, Toxicity, Biology, Liver, Medicine, MPH, CCS, Human, Death, Multimedia, Safety, Emulate, Health, FFDCA, Medical device, Pharmaceutical industry, MD

As such, a growing number of stakeholders worldwide are demanding human relevancy across scientific research, including preclinical studies and drug development.

Key Points: 
  • As such, a growing number of stakeholders worldwide are demanding human relevancy across scientific research, including preclinical studies and drug development.
  • Specifically, the Emulate human Liver-Chips correctly identified 87% of drugs that caused serious liver toxicity and deaths in patients despite passing through animal testing.
  • Advanced testing methods based on human biology will revolutionize the way we approach medicine and health and lead to individualized medicine."
  • We champion technologies that are better for humans and that replace animal testing.

Emulate Publishes Landmark Study Validating Organ-on-a-Chip Technology for Predictive Toxicology in Preclinical Development

Retrieved on: 
Tuesday, December 6, 2022
Research, Medical Devices, Health Technology, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, International Consortium on Landslides, Innovation, Wyss Institute for Biologically Inspired Engineering, MPA, Government, Quality, Doctor of Philosophy, Hepatotoxicity, Harvard University, IQ, Patient, Patient safety, Toxicology, Toxicity, Research, Biology, Liver, Disease, Drug development, Pharmaceutical Development and Technology, Map, Wyss Institute, Founders Fund, Health, Engineering, Medical imaging, Pharmaceutical industry, Emulate

This first-of-its-kind study demonstrates the Emulate human Liver-Chip can better predict drug safety than other methods for modeling liver toxicity, said Jim Corbett, Chief Executive Officer of Emulate.

Key Points: 
  • This first-of-its-kind study demonstrates the Emulate human Liver-Chip can better predict drug safety than other methods for modeling liver toxicity, said Jim Corbett, Chief Executive Officer of Emulate.
  • Researchers assessed the performance of 870 Emulate human Liver-Chips across a blinded set of 27 known hepatotoxic and non-toxic drugs.
  • Often, compounds showing promise in preclinical efforts face high attrition during human trials due to poor predictive validity of preclinical models, especially for biologics.
  • Full study: Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology, Nature Communications Medicine , December 6, 2022
    For more information on Emulate, please visit emulatebio.com .

Eucure Biopharma, a Subsidiary of Biocytogen, Announces Partnership with ISU ABXIS for the Development of Tri-specific Antibodies using YH003 Antibody Sequence

Retrieved on: 
Tuesday, November 1, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Pharmacodynamics, CEO, HKEX, ISU, Multinational corporation, Toxic epidermal necrolysis, Mouse, PDAC, Cancer, Research, CD40, Degenerative disease, Hepatotoxicity, Melanoma, Haemophilia B, Restitutio ad integrum, Safety, Immunoglobulin G, Technology, Disease, Patient, Neoplasm, Therapy, KOSDAQ, Pharmaceutical industry

CD40 is a key co-stimulator in adaptive immune responses, said Yeob Hwang, CEO of ISU ABXIS.

Key Points: 
  • CD40 is a key co-stimulator in adaptive immune responses, said Yeob Hwang, CEO of ISU ABXIS.
  • We are glad for the opportunity to utilize Biocytogen/Eucure Biopharmas anti-CD40 antibody (YH003), as it has outstanding efficacy and safety profiles, both preclinically and clinically.
  • As a wholly owned subsidiary of Biocytogen, Eucure Biopharma focuses on antibody drug therapy for oncology and other indications.
  • Relying on a strong clinical development team with extensive experience, Eucure Biopharma develops innovative drugs to meet clinical needs for patients worldwide.

Eucure Biopharma, a Subsidiary of Biocytogen, Announces Partnership with ISU ABXIS for the Development of Tri-specific Antibodies using YH003 Antibody Sequence

Retrieved on: 
Tuesday, November 1, 2022
Oncology, Health, Other Health, General Health, Pharmaceutical, Biotechnology, Pharmacodynamics, CEO, HKEX, ISU, Multinational corporation, Toxic epidermal necrolysis, Mouse, PDAC, Cancer, Research, CD40, Degenerative disease, Hepatotoxicity, Melanoma, Haemophilia B, Restitutio ad integrum, Safety, Immunoglobulin G, Technology, Disease, Patient, Neoplasm, Therapy, KOSDAQ, Pharmaceutical industry

CD40 is a key co-stimulator in adaptive immune responses, said Yeob Hwang, CEO of ISU ABXIS.

Key Points: 
  • CD40 is a key co-stimulator in adaptive immune responses, said Yeob Hwang, CEO of ISU ABXIS.
  • We are glad for the opportunity to utilize Biocytogen/Eucure Biopharmas anti-CD40 antibody (YH003), as it has outstanding efficacy and safety profiles, both preclinically and clinically.
  • As a wholly owned subsidiary of Biocytogen, Eucure Biopharma focuses on antibody drug therapy for oncology and other indications.
  • Relying on a strong clinical development team with extensive experience, Eucure Biopharma develops innovative drugs to meet clinical needs for patients worldwide.

F2G Announces Data from Phase 2b Study at ID Week 2022 Showing Positive Therapeutic Response in Patients with Invasive Fungal Infections Treated with Olorofim

Retrieved on: 
Friday, October 21, 2022
News, European Medicines Agency, Nausea, Aspergillosis, SOC, Infection, US Foods, QIDP, Mycosis, Diarrhea, Patient, Fungus, Hematology, Standard of care, Hepatotoxicity, Mortality, Coccidioidomycosis, BID, Food, Scedosporiosis, ACM, Vomiting, DHODH, Food and Drug Administration, MD, Doctor of Philosophy, Immunosuppression, Safety, CNS, GLOBE, Goodyear F2G Corsair, Central nervous system, Antifungal, FDA, Breakthrough therapy, UZ Leuven, Pharmaceutical industry, Scopulariopsis, Overalls, Coccidioides, Aspergillus, Scedosporium

Approximately 75% of patients in this analysis had moderate to high levels of immunosuppression, with about half suffering from fungal infections due to Aspergillus.

Key Points: 
  • Approximately 75% of patients in this analysis had moderate to high levels of immunosuppression, with about half suffering from fungal infections due to Aspergillus.
  • Data came from 100 patients with proven invasive fungal infection or probable pulmonary invasive aspergillosis (IA).
  • Mortality remains unacceptably high in patients with severe and life-threatening fungal infections being treated with currently available therapies.
  • Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis.

South Rampart Pharma Announces Presentation at Arrowhead's 16th Annual Pain Therapeutics Summit

Retrieved on: 
Friday, October 21, 2022
Molecule, LinkedIn, Paracetamol, Therapy, Government, DC, Joint Medical Service (Germany), Nonsteroidal anti-inflammatory drug, Arrowhead, NIH, Twitter, Entrepreneurship, Pain, Kidney, Small molecule, Liver, Financial endowment, Hepatotoxicity, Company, Analgesic, Industry, Pharmacokinetics, Gastrointestinal tract, CEO, Patent, Safety, Fever, Chronic pain, Liver failure, FACS, Pharmaceutical industry, MD

NEW ORLEANS, Oct. 21, 2022 /PRNewswire/ -- South Rampart Pharma ("South Rampart" or the "Company"), a clinical-stage life science company advancing innovative medications for the treatment of pain, today announced that Hernan Bazan, MD, FACS, CEO and Co-Founder of South Rampart Pharma and the Endowed John Ochsner Professor of Cardiovascular Innovation at the Ochsner Clinic, will present at Arrowhead's 16th Annual Pain Therapeutics Summit.

Key Points: 
  • NEW ORLEANS, Oct. 21, 2022 /PRNewswire/ -- South Rampart Pharma ("South Rampart" or the "Company"), a clinical-stage life science company advancing innovative medications for the treatment of pain, today announced that Hernan Bazan, MD, FACS, CEO and Co-Founder of South Rampart Pharma and the Endowed John Ochsner Professor of Cardiovascular Innovation at the Ochsner Clinic, will present at Arrowhead's 16th Annual Pain Therapeutics Summit.
  • Taking place in Washington, DC, on November 14-15, 2022, the Pain Therapeutics Summit is the US's premier conference covering pain research and emerging therapeutics.
  • South Rampart Pharma was recently issued a composition of matter US patent for its library of pain treatment candidates.
  • This enormous and urgent unmet medical need is the problem we've set out to solve at South Rampart Pharma.

Pfizer Presents Scientific Advancements in Infectious Disease Prevention and Treatments at IDWeek 2022

Retrieved on: 
Tuesday, October 18, 2022
Health, Infectious Diseases, COVID-19, Research, Science, Pharmaceutical, Biotechnology, Risk, Health care, Subtypes of HIV, Anaphylaxis, Cystic fibrosis, Jaundice, Patient, Hepatitis, Initiation, Fact sheet, HIV-1, Stevens–Johnson syndrome, HIV, Hepatotoxicity, Drug, Plasma, HIV-1 protease, Ritonavir, CYP3A, Dysgeusia, Pharmaceutical industry

Drugs listed in Table 1 are a guide and not considered a comprehensive list of all possible drugs that may interact with PAXLOVID.

Key Points: 
  • Drugs listed in Table 1 are a guide and not considered a comprehensive list of all possible drugs that may interact with PAXLOVID.
  • Cases of Toxic Epidermal Necrolysis and Stevens-Johnson syndrome have been reported with ritonavir, a component of PAXLOVID (refer to NORVIR prescribing information).
  • Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
  • Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

Metabolism-Dependent Cytotoxicity Assay (MDCA) for the Evaluation of the DILI Potential of Drug Candidates, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Tuesday, October 4, 2022
GSH, Evaluation, Toxicity, Food, Doctor of Philosophy, Hepatotoxicity, Drug development, Pharmacology, Industry, Immortalised cell line, Glutathione, Hepatocyte, MDC, HEK293, Enzyme, Mitochondrial outer membrane permeabilization, Disulfiram-like drug, Toxicology, MDCA, Pharmaceutical industry

TORONTO , Oct. 4, 2022  /PRNewswire-PRWeb/ -- The metabolic activation and detoxification pathways of drug candidates is an important aspect of drug development. This information can be applied towards structural design to minimize toxicological liability of drug candidates, selection of animal species for preclinical evaluation of human toxicity, identification of at-risk populations based on metabolic activation and detoxification capacity and identification of environmental factors that may exacerbate drug toxicity via their induction of metabolic activating pathways and inhibition of detoxification pathways. An in vitro cytotoxicity assay can help enable this process.

Key Points: 
  • Attendees will learn the basis of developing the metabolism-dependent cytotoxicity assay (MDCA) and the utility of the MDCA.
  • The featured speaker will discuss plans to develop the MDC Index for comparative analysis to known drug-induced liver injury (DILI) drugs.
  • TORONTO, Oct. 4, 2022 /PRNewswire-PRWeb/ -- The metabolic activation and detoxification pathways of drug candidates is an important aspect of drug development.
  • For more information, or to register for this event, visit Metabolism-Dependent Cytotoxicity Assay (MDCA) for the Evaluation of the DILI Potential of Drug Candidates .