Hepatotoxicity

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

Retrieved on: 
Tuesday, April 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

Retrieved on: 
Tuesday, April 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

Retrieved on: 
Tuesday, April 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

Retrieved on: 
Thursday, April 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®

Retrieved on: 
Tuesday, March 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: 
Tuesday, March 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.

Antengene Publishes Preclinical Paper on PD-L1/4-1BB Bispecific Antibody ATG-101 in Renowned Oncology Journal Cancer Research

Retrieved on: 
Wednesday, March 20, 2024
Research, Liver disease, Discovery Science, Growth, Hematology, Patient, Cancer research, AACR, Publication, MSS, Therapy, Translational medicine, PD-L1, ICIS, Hepatotoxicity, Vaccine

Cancer Research, a journal of the American Association for Cancer Research (AACR), publishes impactful original studies, reviews, and opinion pieces of high significance to the broad cancer research community.

Key Points: 
  • Cancer Research, a journal of the American Association for Cancer Research (AACR), publishes impactful original studies, reviews, and opinion pieces of high significance to the broad cancer research community.
  • In the Cancer Research paper, we present studies used to characterize the differentiated preclinical features and mechanism of action of ATG-101, a tetravalent PD-L1/4-1BB bispecific antibody.
  • "The dedication and relentless efforts of our research team have led to the publication of the preclinical work in the prestigious journal Cancer Research and the development of a new clinical program," said Dr. Jay Mei, Antengene's Founder, Chairman and CEO."
  • [1] ATG-101 is a tetravalent PD-L1×4-1BB bispecific antibody that stimulates anti-tumor immunity through PD-L1 blockade and PD-L1-directed 4-1BB activation.

Quolet announces completion of Phase 1 healthy volunteer study evaluating the safety and bioavailability of Cannabidiol in a novel formulation intended for treatment of various neurological and psychiatric diseases

Retrieved on: 
Thursday, February 22, 2024
Start-Up, Biotechnology, Alternative Medicine, Professional Services, Health, Cannabis, Pharmaceutical, Neurology, Mental Health, Natural Resources, Clinical Trials, Therapy, Anxiety, Capsule, Multimedia, KCL, Absorption, Blood, Schizophrenia, GRAS, AUC, Lung, Cmax, Risk, Hepatotoxicity, University, Innovation, SME, University of Oxford, THC, Disorder, Lymphatic system, DMF, Adipose tissue, Brain, Pharmaceutical industry

Quolet , a private clinical stage biopharmaceutical company, is announcing the completion of a Phase 1 healthy volunteer study evaluating pure Cannabidiol (CBD) ( clinicaltrials.gov NCT05032807 ).

Key Points: 
  • Quolet , a private clinical stage biopharmaceutical company, is announcing the completion of a Phase 1 healthy volunteer study evaluating pure Cannabidiol (CBD) ( clinicaltrials.gov NCT05032807 ).
  • Researchers at King’s College London partnered with the SEEK group to test whether its bioavailability could be improved by administering CBD in a novel patented lipid formulation.
  • This lipid formulation allows high doses of CBD (200mg) to be administered in capsules including only GRAS and/or pharmaceutical approved ingredients.
  • In one visit they were given the lipid-CBD, and in the other visit they were given standard CBD-only formulation.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab), in Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

Retrieved on: 
Thursday, March 7, 2024
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Orbis, BMY, PFS, Progression-free survival, Confidence interval, Research, Recurrence, MD, Pneumonitis, Immunotherapy, Hematology, Kidney, Food, Cancer, Bladder cancer, HSCT, Hepatotoxicity, Checkmate, Risk, Bristol Myers Squibb, Hepatitis, Dexamethasone, Cisplatin, History, Death, Patient, Colitis, Multiple myeloma, Nephritis, Disease, Mortality, Priority review, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1
    In the trial, with a median follow-up of approximately 33 months, treatment with Opdivo in combination with cisplatin and gemcitabine reduced the risk of death by 22%, demonstrating a median OS of 21.7 months versus 18.9 months with cisplatin-gemcitabine alone (Hazard Ratio [HR] 0.78; 95% Confidence Interval [CI]: 0.63, 0.96; p=0.0171).1,4 Patients receiving Opdivo in combination with cisplatin and gemcitabine had their risk of disease progression or death reduced by 28%, with a median PFS of 7.9 months compared to 7.6 months with cisplatin-gemcitabine alone (HR 0.72; 95% CI: 0.59, 0.88; p=0.0012).1
    Additionally, in exploratory analyses, treatment with Opdivo in combination with cisplatin and gemcitabine resulted in an objective response rate (ORR) of 57.6% (n=175) (95% CI: 51.8, 63.2) versus 43.1% (n=131) (95% CI: 37.5, 48.9) with cisplatin-gemcitabine alone.1,4 The complete response (CR) rate and partial response (PR) rate seen in patients treated with Opdivo in combination with cisplatin and gemcitabine was 22% (n=66) and 36% (n=109), respectively, versus 12% (n=36) and 31% (n=95) with cisplatin-gemcitabine alone.1
    “This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients a chance to live longer,”5 said Guru P. Sonpavde, MD, Medical Director of Genitourinary Oncology and the Phase I Clinical Research Unit and Christopher K. Glanz Chair for Bladder Cancer Research at the AdventHealth Cancer Institute, Orlando, Florida.
  • “Based on outcomes and the safety profile seen in the CheckMate -901 clinical trial, the approval of Opdivo in combination with cisplatin and gemcitabine has the potential to change how metastatic or unresectable UC is treated for certain patients and offers them new hope.”1
    Opdivo is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.
  • Please see Important Safety Information below.1
    “Bringing Opdivo to the first-line setting in UC with chemotherapy is the latest realization of our history of research and progress in immunotherapy, which has helped transform the treatment landscape for many cancers, including bladder cancer,”1,6 said Wendy Short Bartie, senior vice president and general manager, U.S. Hematology and Oncology at Bristol Myers Squibb.
  • “This milestone adds a meaningful expansion to our portfolio of Opdivo-based treatments in genitourinary cancers, where we now have offerings in UC spanning three indications across stages of disease and treatment needs.”1
    The FDA previously approved Opdivo for the adjuvant treatment of adult patients with UC who are at high risk of recurrence after undergoing radical resection of UC; it also previously approved Opdivo for the treatment of adult patients with locally advanced or metastatic UC who have had disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.1
    Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) leading to today’s approval was granted Priority Review status by the FDA, and was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.7 The review was also conducted under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in several other countries where the application remains under review.

Takeda Intends to Rapidly Initiate the First Global Phase 3 Trials of TAK-861, an Oral Orexin Agonist, in Narcolepsy Type 1 in First Half of Fiscal Year 2024

Retrieved on: 
Thursday, February 8, 2024
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, MRCP, Hepatotoxicity, NT2, Neurological disorder, Narcolepsy, WCR, Fiscal, Wakefulness, Caregiver, Head, Patient, ESS, DSM-IV codes, Medicine, Neuron, OX2R, Disease, Epworth Sleepiness Scale, MWT, Pharmaceutical industry

It is currently classified into two different types: narcolepsy type 1 (NT1) caused by significant loss of orexin neurons with resulting lack of orexin, and narcolepsy type 2 (NT2) where orexin levels are generally normal.

Key Points: 
  • It is currently classified into two different types: narcolepsy type 1 (NT1) caused by significant loss of orexin neurons with resulting lack of orexin, and narcolepsy type 2 (NT2) where orexin levels are generally normal.
  • Stimulating the orexin receptor 2 in NT1 patients targets the underlying pathophysiology of the disease to restore orexin signaling.
  • Based on these results, and in consultation with global health authorities, Takeda plans to initiate global Phase 3 trials of TAK-861 in NT1 rapidly in the first half of its fiscal year 2024.
  • Results from the Phase 2b trials have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023).