Hepatotoxicity

Takeda’s TAK-861 Phase 2b Late-Breaking Data Presentations at SLEEP 2024 Demonstrate Clinically Meaningful Impact of Oral Orexin Agonist in Narcolepsy Type 1 Compared to Placebo

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Lunedì, Giugno 3, 2024
General Health, Neurology, Health, Pharmaceutical, Clinical Trials, Cerebrospinal fluid, ESS, Breakthrough therapy, Patient, Neuron, Narcolepsy, Sleep paralysis, Data, Patient satisfaction, Safety, Hypnagogia, Sleep Research Society, Sleep, Hepatotoxicity, Somnolence, Epworth Sleepiness Scale, WCR, Head, EDS, DSM-IV codes, Quality of life, American Academy, Food, MWT, LTE, OX2R, Brain, FDA, Insomnia, Cataplexy, MRCP, Pharmaceutical industry

People with NT1 suffer from excessive daytime sleepiness (EDS), cataplexy (sudden loss of muscle tone), disrupted nighttime sleep, hypnagogic and hypnopompic hallucinations and sleep paralysis.

Key Points: 
  • People with NT1 suffer from excessive daytime sleepiness (EDS), cataplexy (sudden loss of muscle tone), disrupted nighttime sleep, hypnagogic and hypnopompic hallucinations and sleep paralysis.
  • TAK-861 is designed to address the orexin deficiency in NT1 by selectively stimulating the orexin receptor 2.
  • The trial also included additional exploratory endpoints that showed meaningful improvements in narcolepsy symptoms and functioning according to most participants.
  • No cases of hepatotoxicity or visual disturbances were reported in the Phase 2b trial or in the ongoing LTE study.

I-Mab Announces Encouraging Phase 1 Clinical Data of PD-L1x4-1BB Bispecific Antibody Ragistomig at ASCO 2024

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Giovedì, Maggio 23, 2024
ABL, Patient, Doctor of Philosophy, HealthOne, Immunotherapy, Ovarian cancer, CDT, PFS, Safety, KOSDAQ, PRS, Neoplasm, Efficacy, Abstract, Cancer, Interim, ASCO, Monoclonal antibody, Society, CBR, Observation, Hepatotoxicity, Pharmaceutical industry

Ragistomig was designed as a bispecific antibody to provide anti-PD-L1 activity and 4-1BB-driven T-cell activation in one molecule.

Key Points: 
  • Ragistomig was designed as a bispecific antibody to provide anti-PD-L1 activity and 4-1BB-driven T-cell activation in one molecule.
  • “We are pleased to present the Phase 1 data to date for ragistomig at ASCO 2024.
  • These data support further development of ragistomig as both a monotherapy and in combination with other compounds.
  • Observation of responses is also encouraging, including a 25% ORR and a 75% clinical benefit rate (CBR), at the optimal dose of 5 mg/kg.

South Rampart Pharma Publishes SRP-001's Unique Pain Relief Mechanism and Phase 1 Trial Results in Scientific Reports

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Giovedì, Maggio 16, 2024
RCT, Pharmacology, Half-life, Nonsteroidal anti-inflammatory drug, Patient, Pharmacokinetics, TRPV4, Ochsner Health System, Toxicity, Randomized controlled trial, Abuse, Liver, Prevalence, Scientific Reports, PAG, Safety, CNR1, PKS, AM404, Neuropathic pain, FAAH, Kidney, Gene, GLP, Brain, Mortality, Paracetamol, NAPQI, TRPV1, Pain, Hepatotoxicity, Science, CNR2, Pharmaceutical industry

NEW ORLEANS, May 16, 2024 (GLOBE NEWSWIRE) -- South Rampart Pharma, Inc., today announced the publication of a paper in Scientific Reports describing the manner in which SRP-001 works in the brain to alleviate pain and the results of a Phase 1 randomized controlled trial (RCT)1.

Key Points: 
  • NEW ORLEANS, May 16, 2024 (GLOBE NEWSWIRE) -- South Rampart Pharma, Inc., today announced the publication of a paper in Scientific Reports describing the manner in which SRP-001 works in the brain to alleviate pain and the results of a Phase 1 randomized controlled trial (RCT)1.
  • The study, by Bazan et al., is titled, " Transcriptomic signature, bioactivity and safety of a non-hepatotoxic analgesic generating AM404 in the midbrain PAG region ."
  • The publication reveals SRP-001's unique mechanism of action, producing higher amounts of N-arachidonoylphenolamine (AM404) than acetaminophen, a metabolite crucial for inducing pain relief in the midbrain’s periaqueductal grey (PAG) region.
  • Armed with known mechanisms for pain relief in the brain and compelling Phase 1 randomized trial data, we look forward to advancing SRP-001 into Phase 2 randomized and controlled studies for acute and neuropathic pain in the second half of 2024.”

MTTI Reports on 225Ac-EBTATE and 177Lu-EBTATE Radiopharmaceuticals at 2024 Society of Nuclear Medicine and Molecular Imaging Annual Meeting

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Martedì, Maggio 21, 2024
Oncology, Health, Clinical Trials, Radiology, Pharmaceutical, Biotechnology, SCLC, Half-life, Patient, Nephrotoxicity, Survival, SOC, University, SNMMI, Becquerel, Chemistry, Safety, Neoplasm, Radioactive decay, Toxicity, Cancer, Incidence, Hepatotoxicity, Evans blue, Mnet, Human, Serum albumin, Pharmaceutical industry

It selectively targets and binds to somatostatin receptor 2 on neuroendocrine and other tumors, which are then killed by the radionuclide payload.

Key Points: 
  • It selectively targets and binds to somatostatin receptor 2 on neuroendocrine and other tumors, which are then killed by the radionuclide payload.
  • We look forward to advancing our clinical trials with these radiotherapeutic drugs in small-cell lung and other cancers.”
    Molecular Targeting Technologies, Inc. (MTTI).
  • MTTI is committed to building value by translating innovative radiopharmaceuticals to improve human health.
  • of the University of Saskatchewan, and Molecular Targeting Technologies, Inc.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20240521449624/en/

Gennao Bio Debuts Preclinical Data for First-in-Class Antibody-Drug Conjugate from Gene Monoclonal Antibody Platform (GMAB ADC)

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Martedì, Aprile 9, 2024
Science, Radiology, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Human, Plasma, Survival, Yale University, Colorectal cancer, Neoplasm, DNA, Hepatotoxicity, Biology, AACR, ENT2, Cytoplasm, Yale school, Therapy, Poster, ADC, Vaccine

Gennao Bio , a privately held genetic medicines company developing first-in-class, targeted nucleic acid therapeutics, today announced new preclinical results on the application of its non-viral, cell penetrating gene monoclonal antibody (GMAB) platform technology as an antibody-drug conjugate (ADC) for the treatment of solid tumors.

Key Points: 
  • Gennao Bio , a privately held genetic medicines company developing first-in-class, targeted nucleic acid therapeutics, today announced new preclinical results on the application of its non-viral, cell penetrating gene monoclonal antibody (GMAB) platform technology as an antibody-drug conjugate (ADC) for the treatment of solid tumors.
  • The data were presented in a poster at the American Association for Cancer Research (AACR) Annual Meeting 2024.
  • In preclinical studies, our GMAB technology demonstrated selective delivery of payloads into tumors by targeting ENT2, a nucleoside transporter that is highly overexpressed in many tumors.
  • “These preclinical results reinforce the versatility of the GMAB platform and its ability to deliver therapeutic payloads beyond genetic medicine to targeted tissue,” Chris Duke, chief executive officer of Gennao.

PureTech Launches Seaport Therapeutics with $100 Million Oversubscribed Series A and Announces Management Transitions

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Martedì, Aprile 9, 2024
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, Depression, Eli Lilly, Major depressive disorder, Patient, Bristol Myers Squibb, PureTech Health, PRTC, Therapy, Creativity, Disorder, General counsel, CNS, Life, DSM-IV codes, Pleasure, Pharmacokinetics, Interim, Third Rock Ventures, U.S. FDA, Schizophrenia, KarXT, Teva Pharmaceuticals, ARCH Venture Partners, Merck, Anxiety, Merck & Co., Research and development, FDA, Lymphatic system, Hepatotoxicity, Sirna Therapeutics, Generalized anxiety disorder, Growth, Neuropsychiatry, Partner, Multimedia, Eli Lilly and Company, Probability, Liver, Medicine, Pharmaceutical industry

Following the Series A financing, PureTech will hold equity ownership in Seaport of 61.5 percent on a diluted basis.

Key Points: 
  • Following the Series A financing, PureTech will hold equity ownership in Seaport of 61.5 percent on a diluted basis.
  • Under its license agreement with Karuna, PureTech retains the right to receive milestone payments upon the achievement of certain regulatory approvals.
  • Eric Elenko, Ph.D., a PureTech co-founder and current Chief Innovation Officer, has been promoted to the role of President of PureTech.
  • Daphne Zohar, the Chief Executive Officer of Seaport, is the founder and former CEO of PureTech Health where she also co-founded Karuna Therapeutics.

Seaport Therapeutics Launches with $100 Million Oversubscribed Series A Financing Round to Advance Novel Neuropsychiatric Medicines

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Martedì, Aprile 9, 2024
Mental Health, Health, Neurology, General Health, Pharmaceutical, Biotechnology, Generalized anxiety disorder, Depression, Eli Lilly, U.S. FDA, Schizophrenia, KarXT, Major depressive disorder, ARCH Venture Partners, Patient, CNS, Anxiety, Bristol Myers Squibb, PureTech Health, DSM-IV codes, Pleasure, Neuropsychiatry, Research and development, Therapy, Pharmacokinetics, Partner, Disorder, Third Rock Ventures, Probability, FDA, Lymphatic system, Hepatotoxicity, Liver, Medicine, Pharmaceutical industry

Seaport Therapeutics , a clinical-stage biopharmaceutical company that is charting a proven path in neuropsychiatry, today announced the closing of a $100 million oversubscribed Series A financing round.

Key Points: 
  • Seaport Therapeutics , a clinical-stage biopharmaceutical company that is charting a proven path in neuropsychiatry, today announced the closing of a $100 million oversubscribed Series A financing round.
  • The round was co-led by ARCH Venture Partners and Sofinnova Investments along with Third Rock Ventures and Seaport founder PureTech Health.
  • Seaport is advancing a clinical-stage pipeline of novel neuropsychiatric medicines powered by its proprietary Glyph™ Technology Platform, which leverages the lymphatic system to create new medicines building on clinically validated mechanisms.
  • I am eager to support Seaport as an investor and board member as the team continues to advance its clinical-stage pipeline of novel therapeutics.”

U.S. FDA Renews DILIsym® Software Licenses for 7th Year

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Giovedì, Aprile 4, 2024
Data Management, Biotechnology, Technology, FDA, Health, Pharmaceutical, Health Technology, Research, Software, Artificial Intelligence, Science, Simulations Plus, Pharmacology, QST, Initiative, Partnership, Risk, QSP, SLP, Safety, Toxicology, Liver, Hepatotoxicity, Pharmaceutical industry

Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, said, “It is now known what properties to avoid to minimize liver toxicity in a new drug candidate -- but these same properties are often necessary to have therapeutic efficacy. By predicting safe dosing regimens of such drugs, DILIsym is now enabling successful development of important therapies that might otherwise be abandoned.”

Key Points: 
  • DILIsym is the industry gold standard for quantitative systems toxicology (QST) software designed for the prediction and investigation of drug-induced liver injury (DILI).
  • The one-year renewal provides the FDA with continued access to the DILIsym platform for authorized employees across all FDA divisions.
  • It also allows the FDA to evaluate the potential DILI risk across multiple populations, which supports informed decision-making regarding drug approvals.
  • Companies interested in a free trial version of the DILIsym software can request it here .

Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS®

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Martedì, Marzo 26, 2024
Ulcer, Myocardial infarction, Liver disease, Endo International, Hyperkalemia, Horizon Therapeutics, Patient, Stroke, History, Aspirin, CABG, Pain, Famotidine, Itch, NSAID, Stomach, Central nervous system, Edema, ACE, Risk, CNS, Perforation, Peptic ulcer disease, Heart failure, Anaphylaxis, Amgen, Fatigue, Hypertension, Delirium, Kidney, Coma, Tablet, Eosinophilia, Nonsteroidal anti-inflammatory drug, Senior, Rash, Lethargy, OTC, Creatinine, Hepatotoxicity, Ibuprofen, Hypersensitivity, Esophagus, Jaundice, Rheumatoid arthritis, Water retention, Seizure, Incidence, Gastrointestinal bleeding, Inflammation, Extrapyramidal system, Ischemia, Diarrhea, GI, Nausea, Diuretic, Bleeding, NSAIDS, Physician, Osteoarthritis, Pharmaceutical industry

DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.

Key Points: 
  • DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.
  • Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.
  • Ibuprofen and famotidine tablets should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
  • If ibuprofen and famotidine is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS®

Retrieved on: 
Martedì, Marzo 26, 2024
Ulcer, Myocardial infarction, Liver disease, Endo International, Hyperkalemia, Horizon Therapeutics, Patient, Stroke, History, Aspirin, CABG, Pain, Famotidine, Itch, NSAID, Stomach, Central nervous system, Edema, ACE, Risk, CNS, Perforation, Peptic ulcer disease, Heart failure, Anaphylaxis, Amgen, Fatigue, Hypertension, Delirium, Kidney, Coma, Tablet, Eosinophilia, Nonsteroidal anti-inflammatory drug, Senior, Rash, Lethargy, OTC, Creatinine, Hepatotoxicity, Ibuprofen, Hypersensitivity, Esophagus, Jaundice, Rheumatoid arthritis, Water retention, Seizure, Incidence, Gastrointestinal bleeding, Inflammation, Extrapyramidal system, Ischemia, Diarrhea, GI, Nausea, Diuretic, Bleeding, NSAIDS, Physician, Osteoarthritis, Pharmaceutical industry

DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.

Key Points: 
  • DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.
  • Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.
  • Ibuprofen and famotidine tablets should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
  • If ibuprofen and famotidine is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.