Hepatotoxicity

Pfizer to Supply Global Fund Up to 6 Million PAXLOVID™ Treatment Courses for Low-and-Middle-Income Countries

Retrieved on: 
Thursday, September 22, 2022
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, COVID-19, Clinical Trials, Initiation, TEN, Hepatitis, Stevens–Johnson syndrome, Hepatotoxicity, CYP3A, Drug, Risk, Hives, Subtypes of HIV, Itch, Fact sheet, Dysgeusia, HIV, HIV-1, Ritonavir, Patient, Angioedema, Jaundice, HIV-1 protease, Cystic fibrosis, Health care, Plasma, Anaphylaxis, Breathe Me, Pharmaceutical industry

Hypersensitivity reactions have been reported with PAXLOVID including urticaria, angioedema, dyspnea, mild skin eruptions, and pruritus.

Key Points: 
  • Hypersensitivity reactions have been reported with PAXLOVID including urticaria, angioedema, dyspnea, mild skin eruptions, and pruritus.
  • 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.

EQS-News: Atriva Therapeutics announces Topline Results from the Proof of Concept (POC) / Phase 2a RESPIRE study (zapnometinib) in patients hospitalized with COVID-19

Retrieved on: 
Tuesday, September 20, 2022
Adult, Safety, World, POC, Global, Respiratory Medicine, Tablet, Trial of the century, Incidence, Projection, COVID-19, Odds ratio, ODD, Panther, FDA, Prevalence, Orthornavirae, Food, Severe acute respiratory syndrome coronavirus 2, CSS, Respiratory syncytial virus, Therapy, Patient, Program, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, RSV, Viral load, MEK, Standard of care, Orthohantavirus, Cell, Pulmonology, Omicron, Data, Degenerative disease, WHO, RNA, Patent, Death, Hepatotoxicity, Medical imaging, Pharmaceutical industry, Vaccine, Delta

Patients enrolled in RESPIRE were well balanced between groups, with 40% of patients requiring supplemental oxygen in the zapnometinib arm and 41% requiring supplemental oxygen in the placebo arm.

Key Points: 
  • Patients enrolled in RESPIRE were well balanced between groups, with 40% of patients requiring supplemental oxygen in the zapnometinib arm and 41% requiring supplemental oxygen in the placebo arm.
  • Safety data from RESPIRE indicate a favorable profile, with a balanced incidence of treatment-emergent adverse events (TEAEs) between study groups.
  • Dr. Stephan Stenglein, CMO Atriva Therapeutics, adds: We are pleased to see impressive data from our first clinical study (RESPIRE).
  • RESPIRE1 is a randomized, double-blind, placebo-controlled, international, multi-center POC (Proof of Concept) / Phase 2 clinical trial in adult patients with moderate-to-severe COVID-19.

EMD Serono to Highlight Data at ESMO 2022 with Potential for Transformative Impact on Cancer Patients

Retrieved on: 
Wednesday, September 7, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Fatigue, UC, Hepatotoxicity, Liver, Pfizer, Pleural effusion, Thyroiditis, Grade 3, Maintenance, Hypothyroidism, TEN, Breathe Me, PD-1, Grade 2, Photophobia, Pulmonary embolism, PD-L1, Nausea, Patient, Avelumab, Field line, Stevens–Johnson syndrome, Incidence, Eosinophilia, Pneumonitis, Headache, Insulin, FDA, Diabetes, Hyperthyroidism, Creatinine, Diarrhea, Hyperglycemia, Kidney, Erythroderma, Pneumonia, AST, Hepatitis, Colitis, Rash, Hypophysitis, MCC, Lists of diseases, Fourth grade, Endocrinology, Hypopituitarism, Dermatitis, Degenerative disease, Prednisone, Neoplasm, HIV disease progression rates, RCC, DRESS, Brain Quest Grades 3 & 4, SJS, Infection, ALT, Edema, Merck Group, Drug, Adrenal insufficiency, Diabetic ketoacidosis, Vaccine, Pharmaceutical industry, Cytomegalovirus, Angela Merkel

Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Key Points: 
  • Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
  • Immune-mediated pneumonitis occurred in 1.2% (21/1738) of patients, including fatal (0.1%), Grade 4 (0.1%), Grade 3 (0.3%) and Grade 2 (0.6%) adverse reactions.
  • Immune-mediated colitis occurred in 1.5% (26/1738) of patients, including Grade 3 (0.4%) and Grade 2 (0.7%) adverse reactions.
  • Immune-mediated adrenal insufficiency occurred in 0.5% (8/1738) of patients, including Grade 3 (0.1%) and Grade 2 (0.3%) adverse reactions.

World Pharma ADMET Testing Market Research Report 2022 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, September 6, 2022
Health, Pharmaceutical, ADME, Partnership, Molecular imaging, COVID-19, Neurotoxicity, NCL, II, Promega, Hepatotoxicity, Application, Research, NLC, Vaccine, Toxicity, Coronavirus, OMICS, Charles River Laboratories, Absorption, Medicine, Nephrotoxicity, CAGR, Therapy, Failure, III, ADMET, Toxicology, Drug discovery, Clinical trial, Acquisition, Drug development, Metabolism, Patient, Pharmaceutical industry, Fine chemical, Technology

The "Pharma ADMET Testing Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Testing Type, Technology, and Application" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Pharma ADMET Testing Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Testing Type, Technology, and Application" report has been added to ResearchAndMarkets.com's offering.
  • Thus, the increasing need for ADME testing in drug development boosts the pharma ADMET testing market.
  • Based on technology, the pharma ADMET testing market is segmented into cell culture, high throughput, molecular imaging, and OMICS technology.
  • The COVID-19 pandemic positively impacted the pharma ADMET testing market due to the increased number of researchers across APAC.

South Rampart Pharma Announces Late-Breaking Presentation at IASP 2022 World Congress on Pain

Retrieved on: 
Thursday, August 25, 2022
Quotient, Drug overdose, Chronic pain, NINDS, Fever, CEO, Small Business Innovation Research, Paracetamol, FACS, Safety, Pharmacokinetics, Nonsteroidal anti-inflammatory drug, National Institute, Hepatotoxicity, Liver, IASP, Therapeutic index, Death, Kidney, Acute liver failure, STTR, DA, World Congress of Mountain Jews, LinkedIn, ER, NIH, Analgesic, Texas Tech University Health Sciences Center, Pharmacology, National Institute of Neurological Disorders and Stroke, SBIR, Company, Twitter, Lists of diseases, Unitus Seed Fund, International Association, Congress, International Association for the Study of Pain, Development, Patient, Pharmaceutical industry, Poultry, MD, Pain, Stroke

NEW ORLEANS, Aug. 25, 2022 /PRNewswire/ -- South Rampart Pharma ("South Rampart" or the "Company"), a clinical-stage life science company advancing innovative medications for the treatment of pain and fever, today announced that the Company will present a late-breaking abstract at the International Association for the Study of Pain (IASP) 2022World Congress on Pain, which will take place on September 20-23, 2022, in Toronto, Canada.

Key Points: 
  • NEW ORLEANS, Aug. 25, 2022 /PRNewswire/ -- South Rampart Pharma ("South Rampart" or the "Company"), a clinical-stage life science company advancing innovative medications for the treatment of pain and fever, today announced that the Company will present a late-breaking abstract at the International Association for the Study of Pain (IASP) 2022World Congress on Pain, which will take place on September 20-23, 2022, in Toronto, Canada.
  • South Rampart's CEO and Co-founder, Hernan Bazan, MD, FACS, will deliver the presentation.
  • The World Congress on Pain is the largest global gathering of pain professionals.
  • South Rampart Pharma is a clinical-stage life science company dedicated to advancing the safe treatment of pain by developing new small molecule solutions that can overcome many risks associated with current pain medicines.

Zylö Receives $600,000 NIH Phase I Grant to Develop a Novel Therapeutic to Treat Onychomycosis (Nail Fungus)

Retrieved on: 
Friday, August 19, 2022
Department of Medicine – University of Pamplona, Risk, Onychomycosis, NIH, GLOBE, Drug resistance, Toxicity, Microbiology, Clemson University, Erectile dysfunction, National Institute, Infection, Pain, National Institute of Allergy and Infectious Diseases, Quality of life, Therapy, Twitter, Program, Acne, Atomic mass, Atopic dermatitis, Wound healing, Hepatotoxicity, SBIR, Albert Einstein College of Medicine, Medicine, Nitric oxide, Pharmaceutical industry, Management

GREENVILLE, SC, Aug. 19, 2022 (GLOBE NEWSWIRE) -- Zylö Therapeutics Inc., developer of the Z-pod® topical delivery platform, has been awarded a two-year $600,000 Small Business Innovation Research (SBIR) grant to generate a final formulation of Zylö’s proprietary nitric oxide-releasing topical drug candidate optimized for the treatment of onychomycosis. The grant is sponsored by the National Institute of Allergy and Infectious Diseases, a division of the NIH.

Key Points: 
  • The grant is sponsored by the National Institute of Allergy and Infectious Diseases, a division of the NIH.
  • Onychomycosis is an extremely common and difficult-to-treat fungal nail infection that causes nail disfigurement, pain, associated infections, and psychosocial effects that negatively impact quality of life.
  • Our novel nitric oxide-releasing product promises to increase nail penetration, thereby enhancing efficacy, but without the side effects typically experienced with systemic drugs.
  • Notably, the Z-pod technology can also be adapted to provide sustained topical delivery of nitric oxide for multiple therapeutic indications.

Attorneys Cheer PACT Act Passage

Retrieved on: 
Wednesday, August 3, 2022
Non-Hodgkin lymphoma, Hepatotoxicity, Address, Woman, Dementia, Infertility, PACT, Veteran, Blair Brandt, GiFT, Marines, Republican, Teacher, Man, Senate, Pharmaceutical industry

COLUMBIA, S.C., Aug. 2, 2022 /PRNewswire/ -- Americans of all stripes cheered today as the United States Senate finally passed the long-awaited Honoring Our Promise to Address Comprehensive Toxics (PACT) Act in a bipartisan 86 - 11 vote which not only expanded health care and disability benefits to millions of veterans exposed to toxic burn pits, but also clears the way for the potentially hundreds of thousands of Americans exposed to toxic water at Camp Lejeune from 1953-1987.

Key Points: 
  • "It's an important step, it's a moral vote and it's long overdue."
  • Today's vote sends the Camp Lejeune Justice Act , included in the PACT Act, to President Joe Biden's desk where, if signed, it will reopen the claim period for an additional two years so anyone impacted by the toxic water can seek medical and compensatory damages.
  • The PACT Act has drawn particular attention when Republican opposition blocked the bill from passage last week sparking a national backlash and outcry.
  • Click HERE for more information about the Camp Lejeune water contamination and its health impacts.

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

Retrieved on: 
Tuesday, August 2, 2022
LLP, Company, Multiple sclerosis, GLOBE, Food, NASDAQ, News, MS, FDA, Sanofi, Pomerantz, Hepatotoxicity, Pharmaceutical industry

NEW YORK, Aug. 02, 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, Aug. 02, 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.

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

Retrieved on: 
Tuesday, July 26, 2022
LLP, Company, Multiple sclerosis, GLOBE, Food, NASDAQ, News, MS, FDA, Sanofi, Pomerantz, Hepatotoxicity, Private investigator, Pharmaceutical industry

NEW YORK, July 26, 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 26, 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.

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

Retrieved on: 
Tuesday, July 5, 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.