Diet

XORTX Highlights Achievements of 2023 and Preparation for Registration Clinical Trial

Retrieved on: 
Tuesday, March 19, 2024
Consultant, Nephrology, Provisional application, XRX, Partnership, Chemistry, Kidney disease, Tablet, Orphan, Bryant University, University, EMA, Polycystic kidney disease, Trial of the century, Oxipurinol, MBA, GMP, Diet, PKD, Treatment, Society, Therapy, Patent, Rensselaer Polytechnic Institute, FDA, Marketing, Diagnosis, American Society of Nephrology, Uric acid, Pharmaceutical industry

Dr. Allen Davidoff, CEO of XORTX, stated, “2023 marked a year of substantial clinical, technological and regulatory progress, establishing the foundation for the Company’s 2024 goals.

Key Points: 
  • Dr. Allen Davidoff, CEO of XORTX, stated, “2023 marked a year of substantial clinical, technological and regulatory progress, establishing the foundation for the Company’s 2024 goals.
  • Each of these milestones permit the next step in the Company’s clinical development plan, being a “registration” clinical trial – XRX-OXY-201 in pursuit of accelerated approval and support of the Company’s lead program XRx-008 program for ADPKD.
  • Chemistry and Manufacturing, Clinical and Pre-Clinical Highlights – Produced drug substance for oxypurinol production and produced GMP drug substance; confirmed XORLO™ formulation, produced enhanced bioavailability and produced clinical supply of tablets for clinical trials.
  • August 29, 2023 – XORTX submitted an Orphan Drug Designation application to the EMA for the treatment of ADPKD.

FDA’s Approval of Breakthrough NASH Treatment Opens Door for a Long-Neglected Patient Population

Retrieved on: 
Thursday, March 14, 2024
Organization, Obesity, Cirrhosis, Exercise, Cardiology, Partnership, F2, Risk, Patient, Fatty liver disease, Hope, Diet, NASH, Language, Liver disease, Liver cancer, Hypertension, FDA, Drug development, JD, Food, GLI

Developed by Madrigal Pharmaceuticals, Rezdiffra™ (resmetirom) was approved for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis, in conjunction with diet and exercise.

Key Points: 
  • Developed by Madrigal Pharmaceuticals, Rezdiffra™ (resmetirom) was approved for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis, in conjunction with diet and exercise.
  • This breakthrough follows years of NASH patient-led, multi-stakeholder advocacy and partnership with researchers in both drug and diagnostic development.
  • “Today’s announcement represents the culmination of the work of the united NASH community.
  • It is particularly satisfying that we can mark Women’s History Month with a breakthrough from a female-founded company.

Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Moderate to Advanced Liver Fibrosis

Retrieved on: 
Thursday, March 14, 2024
Diagnosis, Fatty liver disease, Cirrhosis, Exercise, Entrepreneurship, Liver disease, Physician, F2, Patient, Research, Diet, Fibrosis, Drug development, NASH, Therapy, NAFLD, FDA, THR, Food, Pharmaceutical industry

Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.
  • Bill Sibold, Chief Executive Officer of Madrigal, stated, “NASH with moderate to advanced liver fibrosis is a serious and progressive liver disease that, until now, has not had an FDA-approved therapy.
  • Fibrosis improvement and NASH resolution were consistent regardless of age, gender, type 2 diabetes status, or fibrosis stage.
  • Madrigal is committed to helping appropriate patients who may benefit from Rezdiffra access the medication through the Madrigal Patient Support program.

Revolutionary Study at Ibogaine By David Dardashti Sheds Light on How Zodiac Signs Impact Treatment

Retrieved on: 
Thursday, March 14, 2024
Electricity, Ibogaine, Physics, Genetics, Brain, Diet, Quantum electrodynamics, Astrology, Environment, Microscope

MIAMI, March 14, 2024 (GLOBE NEWSWIRE) -- Ibogaine By David Dardashti is proud to release the results of its lead researcher, Gavriel Dardashti's study analyzing the effects of astrological signs on ibogaine treatment.

Key Points: 
  • MIAMI, March 14, 2024 (GLOBE NEWSWIRE) -- Ibogaine By David Dardashti is proud to release the results of its lead researcher, Gavriel Dardashti's study analyzing the effects of astrological signs on ibogaine treatment.
  • Gavriel Dardashti has established a new theory using quantum physics and astrology.
  • After studying thousands of individual cases, Gavriel Dardashti, a leader in quantum physics, found that one's zodiac sign may influence life outcomes.
  • Although the findings of the study indicate that astrology can affect ibogaine treatments, Gavriel points out that it is only one factor of many.

NewAmsterdam Pharma Doses First Patient in Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib and Ezetimibe in Patients with HeFH and/or ASCVD

Retrieved on: 
Tuesday, March 12, 2024
Consensus, Moyamoya disease, Cardiovascular disease, Myocardial infarction, Dyslipidemia, CVD, Cardiology, Risk, Patient, Apolipoprotein B, Consensus decision-making, Stroke, NAMS, ASCVD, Plaque, Artery, Diet, Cleveland Clinic, Ezetimibe, Clinical trial, Safety, FDC, Apolipoprotein, Genetic disorder, Physician, Pharmaceutical industry

NAARDEN, The Netherlands and MIAMI, March 12, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the dosing of the first patient and initiation of TANDEM, a pivotal Phase 3 clinical trial to evaluate obicetrapib and ezetimibe FDC in adult patients with Heterozygous Familial Hypercholesterolemia (“HeFH”) and/or Atherosclerotic Cardiovascular Disease (“ASCVD”) or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies.

Key Points: 
  • The ACC Expert Consensus set LDL-C goals of below the 70mg/dl for patients with ASCVD and below the 55mg/dl goal for ASCVD patients with very high risk.
  • The primary objective of the placebo-controlled, double-blind, four-arm, randomized TANDEM trial is to evaluate the effect of 10mg obicetrapib and 10mg ezetimibe FDC on LDL-C levels, compared to both ezetimibe 10mg and obicetrapib 10mg monotherapy and to placebo.
  • NewAmsterdam anticipates enrolling approximately 400 patients on maximally tolerated lipid-modifying therapies with HeFH, ASCVD or ASCVD risk equivalents and who have a baseline LDL-C of at least 70 mg/Dl.
  • Patients who have multiple risk factors for ASCVD are at high risk of experiencing a cardiovascular event in the near future.

Chasing Our Tails: Get Joy Unveils Startling Findings in Dog Wellness and Nutrition Survey

Retrieved on: 
Thursday, April 4, 2024
Pets, Consumer, Socialization, Overweight, Health, DVM, Obesity, Longevity, Prevalence, Exercise, Nutrition, Probiotic, Diabetes, Education, Knowledge, Perception, Sleep, Holism, Research, Cancer, Food, Overalls, Dog, Diet, Joy, Wellness, Research report, Pet, Multimedia, Family, Parent, Pet industry

Get Joy , a pioneer in holistic dog wellness, is unveiling a new research report titled "Chasing our Tails: When it Comes to Maximizing our Dog’s Health and Wellness, Are We Just Running in Circles?"

Key Points: 
  • Get Joy , a pioneer in holistic dog wellness, is unveiling a new research report titled "Chasing our Tails: When it Comes to Maximizing our Dog’s Health and Wellness, Are We Just Running in Circles?"
  • Tom Arrix, founder and CEO of Get Joy, identifies with this paradox, stating “My life took a profound turn when our family dog Cooper battled lymphoma.
  • In light of these findings, Get Joy urges dog owners to reassess their approach to nutrition and prioritize fresh, whole foods that promote gut health.
  • Get Joy is committed to further research and advancing canine wellness through education and advocacy, empowering dog owners with the knowledge and resources they need.

Corti Set to Disrupt the Health Wearable Market with the First Real-time, Continuous Monitor for Cortisol and Melatonin Hormones, the Key Stress and Sleep Hormones

Retrieved on: 
Thursday, April 4, 2024
Wearables, Mobile Technology, Technology, Mental Health, Fitness & Nutrition, Health Technology, Other Health, Health, General Health, Consumer Electronics, Moses Austin, Benchmarking, Hormone, Exercise, Professor, Inflammation, Biomarker, Research, Sleep, Melatonin, University, Doctor of Philosophy, Life, Eye, Diet, Management, Publication, Skin, Cortisol, Ageing, Medical device

The wearable features its proprietary passive-sweat sensor technology that non-invasively rests on your skin, day and night, continuously measuring biomarker levels.

Key Points: 
  • The wearable features its proprietary passive-sweat sensor technology that non-invasively rests on your skin, day and night, continuously measuring biomarker levels.
  • Now, it provides users with unmatched real-time insights into their wellness, establishing a new benchmark for the continuous monitoring of these critical biomarkers.
  • Corti redefines health monitoring by offering continuous, real-time visibility into the body's key stress and sleep hormones, Cortisol and Melatonin, marking a first in the wearable market.
  • Moreover, we are actively working with partnering businesses to discover new applications, enhancing its integration into various health and wellness ecosystems.

Nourish Raises $35M Series A to Expand Access to Registered Dietitians

Retrieved on: 
Wednesday, March 27, 2024
Other Health, Software, Telemedicine, Virtual Medicine, Oncology, Apps, Applications, Technology, Artificial Intelligence, Fitness & Nutrition, Health Insurance, Cardiology, Health, Diabetes, Blood pressure, Partner, BoxGroup, Growth, Y Combinator, Disease, TCV, Patient, Conditional sentence, Weight loss, Food, Thrive Capital, Index Ventures, Cancer, NPS, Insurance, Eating disorder, Adolescence, Diet, RDS, Access, Prediabetes, Medicine

Nourish , a telenutrition platform that connects people to registered dietitians covered by insurance, announced today that it has raised $35 million in Series A funding.

Key Points: 
  • Nourish , a telenutrition platform that connects people to registered dietitians covered by insurance, announced today that it has raised $35 million in Series A funding.
  • With $44M in total funding since its founding in 2021, Nourish plans to accelerate development of its digital platform for patients and providers, expand its network of registered dietitians (RDs), and deepen its strategic partnerships with insurance companies.
  • “Our goal is to create a win-win-win for patients, providers, and payers,” said Sam Perkins, co-founder, President and COO of Nourish.
  • “Nourish aims to help tens of millions of Americans by providing access to a dietitian and the incredible nutritional education, accountability, and care that they provide.

Amber Specialty Pharmacy Selected to Dispense Rezdiffra™ to Treat Noncirrhotic Non-Alcoholic Steatohepatitis

Retrieved on: 
Monday, March 25, 2024
Retail, Health, Other Health, Supermarket, Specialty, Pharmaceutical, F2, NASH, Diet, FDA, Cirrhosis, Exercise, Pharmacy

"Adding Rezdiffra to our patient care portfolio allows Amber Specialty Pharmacy to remain at the forefront of providing specialized medications that not only change lives, but also embody our commitment to innovation and excellence in health care,” said Jessica Ringena, president of Amber Specialty Pharmacy.

Key Points: 
  • "Adding Rezdiffra to our patient care portfolio allows Amber Specialty Pharmacy to remain at the forefront of providing specialized medications that not only change lives, but also embody our commitment to innovation and excellence in health care,” said Jessica Ringena, president of Amber Specialty Pharmacy.
  • “With Rezdiffra, we are focused on delivering transformative care in a way that positively impacts the lives of those battling chronic liver conditions."
  • For more than 25 years, Amber Specialty Pharmacy has delivered specialized care to individuals across the U.S. who live with chronic and complex health conditions.
  • Amber Specialty Pharmacy offers a range of comprehensive services that include medication management, therapy-specific counseling and 24/7 clinical support.

U.S. FDA Approves Broad New Labels for Esperion’s NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

Retrieved on: 
Friday, March 22, 2024
FDA, Health, Other Health, Pharmaceutical, Cardiology, Biotechnology, Photograph, Glucose, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, European Medicines Agency, Ezetimibe, Therapy, Anemia, Pain, Sinusitis, Esperion Therapeutics, Bempedoic acid, Abdominal pain, Risk, Gout, Webcast, Committee, Spasm, Splenic infarction, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, U.S. FDA, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Rupture, Molina Healthcare, Hypersensitivity, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Multimedia, Uric acid, Dietary supplement

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • View the full release here: https://www.businesswire.com/news/home/20240322544788/en/
    U.S. FDA approves broad new labels for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.