Hepatotoxicity

Intercept Announces Closing of Transaction with Advanz Pharma to Transfer Rights to Commercialize Ocaliva® for PBC Outside the U.S.

Retrieved on: 
Friday, July 1, 2022
FDA, Constipation, Warfarin, NASH, Patient, LinkedIn, Liver, Colesevelam, Adult, Hepatotoxicity, Abdominal pain, Colestipol, Theophylline, Fatty liver disease, BSEP, INR, GLOBE, CYP1A2, OCA, Population, Prothrombin time, Failure, Alkaline phosphatase, Bilirubin, Primary biliary cholangitis, Rash, Hyperlipidemia, MHRA, Jaundice, Obeticholic acid, UDCA, FXR, Bile, Intercept Pharmaceuticals, EMA, Intercept, Therapy, Autoimmune hepatitis, Ciclosporin, Arthralgia, Dizziness, Fatigue, Absorption, Survival, Nasdaq, Sleep, Ascites, ALP, Cirrhosis, Ursodeoxycholic acid, FLS, Hepatic encephalopathy, Dermatitis, Twitter, Alcoholic liver disease, PBC, Itch, Pharmaceutical industry, Vaccine, Medical imaging, Dietary supplement, Generic drug, Advanz Pharma

As a result of this transaction, Intercepts international business has been divested and its international commercial and medical infrastructure have transitioned to Advanz Pharma.

Key Points: 
  • As a result of this transaction, Intercepts international business has been divested and its international commercial and medical infrastructure have transitioned to Advanz Pharma.
  • Upfront consideration for the transaction is $405 million, subject to working capital, closing costs, France reimbursement liability and other adjustments.
  • OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC).
  • OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension.

INVESTIGATION ALERT: The Schall Law Firm Encourages Investors in Sanofi with Losses of $100,000 to Contact the Firm

Retrieved on: 
Friday, July 1, 2022
Class Action Lawsuit, Professional Services, Legal, Ethics, FDA, MS, Multiple sclerosis, Company, Suite, Hepatotoxicity, Food, Certification, NASDAQ, News, Pharmaceutical industry, Sanofi

The Schall Law Firm , a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Sanofi (Sanofi or the Company) (NASDAQ: SNY ) for violations of the securities laws.

Key Points: 
  • The Schall Law Firm , a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Sanofi (Sanofi or the Company) (NASDAQ: SNY ) for violations of the securities laws.
  • The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.
  • We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge.
  • The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Sanofi - SNY

Retrieved on: 
Friday, July 1, 2022
FDA, MS, LLP, GLOBE, Multiple sclerosis, Pomerantz, Hepatotoxicity, Food, Sanofi, NASDAQ, News, Company, Private investigator, Pharmaceutical industry

NEW YORK, July 01, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Sanofi SA (Sanofi or the Company) (NASDAQ: SNY).

Key Points: 
  • NEW YORK, July 01, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Sanofi SA (Sanofi or the Company) (NASDAQ: SNY).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Sanofi and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

Nonalcoholic Fatty Liver Disease (NAFLD) Research from Target RWE's Real-World Study Presented at International Liver Congress 2022

Retrieved on: 
Friday, June 24, 2022
NASH, Patient, ALT, Adult, Probability, Research, Real world data, Hepatotoxicity, Poster, NAFLD, Liver disease, Division, VCU School of Medicine, Health, Oklahoma Office of the Chief Medical Examiner, Publication, Nutrition, RWE, Therapy, ILC, Cardiovascular disease, Real, Longitudinal, Journal of Clinical Pathology, Entrepreneurship, Hypertension, Non-alcoholic fatty liver disease, Fatty liver disease, Time, Interim, Medical device, Pharmaceutical industry, Medicine, Physiology, Gastroenterology

DURHAM, N.C., June 24, 2022 /PRNewswire/ -- New TARGET-NASH data shows longitudinal trajectories of alanine aminotransferase (ALT) remained comparatively stable among patients with nonalcoholic fatty liver disease (NAFLD) in the latest real-world study by Target RWE .

Key Points: 
  • DURHAM, N.C., June 24, 2022 /PRNewswire/ -- New TARGET-NASH data shows longitudinal trajectories of alanine aminotransferase (ALT) remained comparatively stable among patients with nonalcoholic fatty liver disease (NAFLD) in the latest real-world study by Target RWE .
  • The TARGET-NASH real world study analyzed 3,600+ adult patients with NAFLD in the U.S. with 3 or more ALT measures.
  • "Researchers have not been able to keep pace with the rapidly growing disease burden of NAFLD that is increasing concern from a public health standpoint.
  • Dr. Sanyal is also co-chair of the TARGET-NASH steering committee and is a co-author of the study.

DILIsym Software Publication Outlines Impact on the CGRP Field for Migraine

Retrieved on: 
Thursday, June 16, 2022
Technology, Consulting, Other Technology, Professional Services, Software, Other Health, Biotechnology, Pharmaceutical, Health, Data Management, Solution, Population, FDA, CGRP, LinkedIn, Safety, Technology, Economics, Simulations Plus, Migraine, Company, U.S. Securities and Exchange Commission, Pharmacokinetics, Risk, Biotechnology, Mission statement, Research, Private Securities Litigation Reform Act, Biophysical environment, Liver injury, Drug discovery, Oxford University Press, Volunteering, Toxicological Sciences, Nasdaq, Software, Patient, Hepatotoxicity, ESG, SLP, Toxicology, Pharmaceutical industry

The results help explain the differentiation in liver safety between small molecule calcitonin gene-related peptide (CGRP) receptor antagonists designed to treat migraine, a debilitating and important unmet medical need.

Key Points: 
  • The results help explain the differentiation in liver safety between small molecule calcitonin gene-related peptide (CGRP) receptor antagonists designed to treat migraine, a debilitating and important unmet medical need.
  • DILIsym predicted the safety of next-generation molecules, which have now proven their safety in the clinic.
  • Rimegepant, for example, was approved for the preventative treatment of migraine by the FDA in the Spring of 2021.
  • Jeffrey Woodhead , Principal Scientist from Simulations Plus, is the first author of the publication entitled Comparing the Liver Safety Profiles of 4 Next-Generation CGRP Receptor Antagonists to the Hepatotoxic CGRP Inhibitor Telcagepant Using Quantitative Systems Toxicology Modeling.

Pfizer Reports Additional Data on PAXLOVID™ Supporting Upcoming New Drug Application Submission to U.S. FDA

Retrieved on: 
Tuesday, June 14, 2022
COVID-19, Research, Infectious Diseases, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Drug, CYP3A, Health care, Hives, Itch, Ritonavir, Risk, Hepatotoxicity, Jaundice, Angioedema, Breathe Me, Plasma, TEN, Fact sheet, HIV, HIV-1, Dysgeusia, Anaphylaxis, Patient, Initiation, Subtypes of HIV, HIV-1 protease, Stevens–Johnson syndrome, Hepatitis, Pharmaceutical industry

Consider the potential for drug interactions prior to and during PAXLOVID therapy; review concomitant medications during PAXLOVID therapy and monitor for the adverse reactions associated with the concomitant medications.

Key Points: 
  • Consider the potential for drug interactions prior to and during PAXLOVID therapy; review concomitant medications during PAXLOVID therapy and monitor for the adverse reactions associated with the concomitant medications.
  • Cases of anaphylaxis, TEN, and Stevens-Johnson syndrome have also been reported with components of PAXLOVID (refer to NORVIR labeling).
  • If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care.
  • Therefore, caution should be exercised when administering PAXLOVID to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis.

Pfizer to Invest $120 Million to Produce COVID-19 Oral Treatment in the U.S.

Retrieved on: 
Monday, June 6, 2022
Other Manufacturing, Research, Infectious Diseases, FDA, Clinical Trials, Manufacturing, Biotechnology, Pharmaceutical, Health, Science, Drug, Itch, Angioedema, Fact sheet, Subtypes of HIV, Plasma, Health care, Ritonavir, Stevens–Johnson syndrome, Dysgeusia, TEN, Hepatitis, Anaphylaxis, Patient, Initiation, Hives, HIV-1 protease, HIV, CYP3A, Hepatotoxicity, Risk, Jaundice, Breathe Me, Pharmaceutical industry

Cases of anaphylaxis, TEN, and Stevens-Johnson syndrome have also been reported with components of PAXLOVID (refer to NORVIR labeling).

Key Points: 
  • Cases of anaphylaxis, TEN, and Stevens-Johnson syndrome have also been reported with components of PAXLOVID (refer to NORVIR labeling).
  • Therefore, caution should be exercised when administering PAXLOVID to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis.
  • The proportions of subjects who discontinued treatment due to an adverse event were 2% in the PAXLOVID group and 4% in the placebo group.
  • Pfizer assumes no obligation to update forward-looking statements contained in this statement as the result of new information or future events or developments.

Puma Biotechnology Presents Outcomes from the Metastatic Breast Cancer Cohort of the SUMMIT Trial at the ASCO 2022 Annual Meeting

Retrieved on: 
Monday, June 6, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Lynx, ALT, Electrolyte, Constipation, Adult, Histology, Indigestion, Enzyme inhibitor, Antidiarrhoeal, Capecitabine, Nausea, HER3, CYP3A4, Fatigue, Abdominal pain, Food, Gastric acid, Puma Biotechnology, Arthralgia, Back pain, Dizziness, Upper respiratory tract infection, MBC, HER2, Appetite, FDA, Puma, Patient, Trastuzumab, Fetus, Kidney, Risk, Tablet, AST, Fulvestrant, Vomiting, Royal commission, Spasm, Diarrhea, Birth, Degenerative disease, Urinary tract infection, Stomatitis, European Commission, Transaminase, Rash, Fourth grade, Abdominal distension, Hepatotoxicity, Nosebleed, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Antacid, Neoplasm, Breast cancer classification, Safety, Pharmaceutical industry, Medical imaging, Vaccine

Alan H. Auerbach, Chief Executive Officer, and President of Puma Biotechnology added, HER2 mutations can be readily and accurately identified and are clinically actionable for targeted therapy in metastatic breast cancers.

Key Points: 
  • Alan H. Auerbach, Chief Executive Officer, and President of Puma Biotechnology added, HER2 mutations can be readily and accurately identified and are clinically actionable for targeted therapy in metastatic breast cancers.
  • We are very pleased with the updated activity seen with the combination of neratinib plus trastuzumab plus fulvestrant therapy in this heavily pretreated metastatic breast cancer patient population with HER2-mutated disease.
  • Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care.
  • Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357.

Ric Scalzo Institute of Botanical Research and Kelai Pharmaceutical Announce Research Partnership

Retrieved on: 
Tuesday, May 31, 2022
Advanced Drug Delivery Reviews, Knowledge, Canadian College of Naturopathic Medicine, Medicine, Hepatotoxicity, ADD, Botany, Therapy, Nature, Biosafety, Ethanol, Institute, Research, Partnership, SCNM, Intellectual property, Toxicity, Naturopathy, Southwest College of Naturopathic Medicine, Mental health, Outline of health sciences, Brunei Research Department (International), Water, Arizona State University, Pharmaceutical industry

Kava Research Begins at Biosafety Level 2 and Analytical Plant Chemistry Labs

Key Points: 
  • Kelai Pharmaceutical specializes in the development of advanced drug delivery (ADD) technologies that utilize natural compounds to create safer, more effective, and innovative therapies for addiction, mental health disorders, and related conditions
    "We are particularly excited about starting the discovery partnership with the Ric Scalzo Institute for Botanical Research that builds on a rich traditional use of Kava.
  • We see this as the platform for accelerating our forward-looking research and discoveries around Kava," said Jacqueline Jacques, ND, Chief Executive Officer, Kelai Pharmaceutical.
  • When considering botanical material for research, the team analyzes the plant's background, supply chain, ethnobotanical history, and relevant clinical data.
  • For more information on the Ric Scalzo Institute for Botanical Research, visit scnm.edu/research.

CAARE Joins Inaugural 'World Day of Animal Free Research' on May 27; Notes U.S. Legislation to Remove FDA's Animal Testing Mandate

Retrieved on: 
Thursday, May 26, 2022
People, Food and Drug Administration Modernization Act of 1997, Animal Free Research UK, Medicine, NEW, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Ethics, Liver, Fatality, Emulate, National Center for Health Research, Patient, Biology, Vaccine, Liver injury, Hiloni, Hepatotoxicity, Interstate Commerce Committee, Legislation, FDA, Method, Alternatives, World Day for Laboratory Animals, Public policy, Latin American Center for Human Economy, Lord Dowding Fund for Humane Research, Center, United States House Energy Subcommittee on Health, Toxicity, Human, United States House Committee on Energy and Commerce, CAARE, Genomics, USC Michelson Center for Convergent Bioscience, National, Animal, Pharmaceutical industry, Dietary supplement, Online gambling, Medical device, Experiment, Research, Animal

NEW YORK, May 26, 2022  /PRNewswire-PRWeb/ -- Citizens for Alternatives to Animals in Research and Experimentation (CAARE) – a non-governmental nonprofit that is promoting federal legislation to phase out the use of animals in testing – has announced its participation in the inaugural World Day of Animal Free Research on May 27, 2022, introduced in the UK by the organization, Animal Free Research.

Key Points: 
  • On this inaugural day, Citizens for Alternatives to Animal Research and Experimentation is highlighting pending federal legislation with the potential to pass this year that will remove the animal testing mandate from the FDA.
  • An estimated 90 to 95 percent of drugs and vaccines found safe in animal tests fail during human clinical trials.
  • "World Day for Animal Free Research recognizes that it's time we put more resources into modernizing medicine by shifting away from animals.
  • Citizens for Alternatives to Animal Research and Experimentation (CAARE), is a 501(c)(3) non-profit organization, established to highlight and promote research without animals.