Gastroesophageal reflux disease

Gastrointestinal Therapeutics and Diagnostics Technologies and Global Markets Report 2024-2028: Growing Trend toward Screening and Preventive Care and Adoption and Approval of Biological Drugs - ResearchAndMarkets.com

Retrieved on: 
Friday, April 5, 2024
Biotechnology, Pharmaceutical, Health, Medical Devices, Sanofi, Growth, Prevalence, AbbVie, Environment, Laxative, Incidence, Antacid, ESG, Gastroesophageal reflux disease, Malignancy, Constipation, Diarrhea, GI, GERD, Irritable bowel syndrome, Prescription, Inflammatory Bowel Diseases, Gastrointestinal disease, OTC, Therapy, Pancreatitis, IBS, Endoscopy, USD, PPI

The "Gastrointestinal Therapeutics and Diagnostics: Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Gastrointestinal Therapeutics and Diagnostics: Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering.
  • The Global Gastrointestinal Therapeutics and Diagnostics Market was valued at USD 86 Billion in 2023, and is expected to reach USD 122.5 Billion by 2028, rising at a CAGR of 7.30%.
  • This research study analyzes the GI diagnostics and therapeutics market, offers revenue forecasts, assesses future trends and provides strategic recommendations for the success of market participants.
  • This report estimates market data for 2022 (the base year) and forecasts for 2023 through 2028.

Implantica submits U.S. FDA Premarket Approval (PMA) application for RefluxStop® (first module)

Retrieved on: 
Wednesday, March 27, 2024
Cancer, PPI, CE, PMID, Patient, Internet, PMA, Literature, File, Gastroesophageal reflux disease, FDA, Certification, Pharmaceutical industry

The U.S. FDA has agreed to a modular submission process for the RefluxStop PMA application.

Key Points: 
  • The U.S. FDA has agreed to a modular submission process for the RefluxStop PMA application.
  • This process provides for ongoing review and feedback from the FDA as the modules are submitted.
  • The second and third (final) modules are anticipated to be submitted to the FDA in three-month intervals later this year.
  • Dr. Peter Forsell, CEO of Implantica, says, "This FDA filing is a key fundamental milestone for RefluxStop®3 and puts us in motion for the U.S. launch preparation ahead of the pending FDA approval.

Implantica completes Human Factors Validation Study for RefluxStop™ as part of the US FDA Premarket Approval Process

Retrieved on: 
Tuesday, March 26, 2024
Cancer, PPI, PMID, Gastroesophageal reflux disease, Patient, Internet, Foregut, GERD, Northwestern University, Surgeon, Certification, PMA, Literature, Human factors and ergonomics, FDA, Pharmaceutical industry

), a medtech company at the forefront of bringing advanced technology into the body, announces completion of the Human Factors Validation Study with 16 US surgeons as part of the US FDA Premarket Approval (PMA) process for RefluxStop™.

Key Points: 
  • ), a medtech company at the forefront of bringing advanced technology into the body, announces completion of the Human Factors Validation Study with 16 US surgeons as part of the US FDA Premarket Approval (PMA) process for RefluxStop™.
  • In March, 16 foregut surgeons in the United States (U.S.) participated in a Human Factors Validation Study of the RefluxStop™ procedure at Northwestern University's Simulation Lab in Chicago.
  • In the next step of the study, an independent third party is evaluating the data collected during testing in Chicago.
  • Dr. Peter Forsell, CEO of Implantica, says, "We're very grateful to the independent US surgeons and healthcare professionals who participated in the Human Factors Validation study, a key milestone for the FDA approval process.

FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight

Retrieved on: 
Friday, March 8, 2024
Gastroesophageal reflux disease, Research, Heartburn, Blood, Diet, Cholesterol, Dietary supplement, Obesity, Dizziness, Pancreatitis, Vomiting, Health care, History, Thyroid cancer, Fatigue, Hypoglycemia, Acute kidney injury, Depression, Patient, Kidney disease, Abdominal distension, Burping, Cosmetics, Cardiovascular disease, Suicide, Weight, Stroke, Nausea, Diabetic retinopathy, Pancreas, Insulin, Blood pressure, Multimedia, Overweight, Diarrhea, Novo Nordisk, Vaccine, Safety, Heated tobacco product, Indigestion, Heart, Human services, Priority review, Division, Headache, Inflammation, FDA, Food, Weight loss, Thought, Heart rate, Gallstone, Risk, Animal, Allergy, Constipation, Death, Flatulence, Public

"This patient population has a higher risk of cardiovascular death, heart attack and stroke.

Key Points: 
  • "This patient population has a higher risk of cardiovascular death, heart attack and stroke.
  • Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health."
  • Obesity or overweight affect approximately 70% of American adults.
  • Obesity and overweight are serious health issues that increase the risk for premature death and a variety of health problems, including heart attack and stroke.

Reversing Chronic Crohn's and Colitis Summit: The Path to Holistic Gut Healing

Retrieved on: 
Friday, February 16, 2024
CNC, Root cause analysis, Knowledge, Health, Gastroesophageal reflux disease, Heavy Metal Poisoning, Interview, Toxicity, Hope, Certification, Patient

CARLSBAD, Calif., Feb. 16, 2024 /PRNewswire/ -- DrTalks, a pioneering platform dedicated to advancing health, wellness, and medicine knowledge, is proud to announce the Reversing Chronic Crohn's and Colitis Summit. This groundbreaking virtual event serves as a platform for people grappling with chronic gut issues to gain insights into alternative treatments, root cause analysis, and holistic healing strategies that go beyond conventional medicine.

Key Points: 
  • The Reversing Chronic Crohn's and Colitis Summit is a premier virtual event that provides hope, knowledge, and support for people struggling with chronic gut conditions.
  • CARLSBAD, Calif., Feb. 16, 2024 /PRNewswire/ -- DrTalks , a pioneering platform dedicated to advancing health, wellness, and medicine knowledge, is proud to announce the Reversing Chronic Crohn's and Colitis Summit .
  • It will be hosted by a gut health expert who has overcome her own struggles with chronic gut conditions: Sinclair Kennally, CNHP, CNC .
  • She is set to interview dozens of experts in chronic gut conditions to discuss how to treat their root causes through holistic approaches.

Phathom Pharmaceuticals Announces VOQUEZNA® (vonoprazan) Tablets for Erosive GERD and Associated Heartburn Added to Express Scripts National Formularies for Commercial Patients

Retrieved on: 
Tuesday, February 13, 2024
Urinary tract infection, Gastroesophageal reflux disease, Research, Heartburn, Toxicity, Magnesium, Polyp, Liver, CYP, CGA, Achlorhydria, Esophagitis, Patient, PBM, Vitamin B12, Vonoprazan, Kidney, Spine, Lactation, Absorption, Hypokalemia, SCAR, Calcium, Express Scripts, TIN, Endoscopy, Tablet, Express, Magnesium deficiency, Hypocalcemia, Diarrhea, Hypersensitivity, Physician, Gastritis, Malabsorption, GERD, PPI, Hypertension, SJS, Enzyme inhibitor, EGFR, Stevens–Johnson syndrome, Indigestion, Nelfinavir, Clostridioides, Abdominal pain, Hip, Pharmacy, Enzyme, Glomus tumor, FDA, CDAD, Atazanavir, Risk, BMJ Open, Wrist, Drug, Impairment, Pharmaceutical industry

Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.

Key Points: 
  • Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.
  • doi:10.1136/ bmjgast-2022-000941
    VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated:
    for the healing of all grades of Erosive Esophagitis (Erosive Gastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn associated with Erosive GERD in adults.
  • for the maintenance of healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD in adults.
  • Renal Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with severe renal impairment (eGFR

Renexxion Ireland’s European Partner, Dr. Falk Pharma GmbH, has Elected PPI-non-responsive Symptomatic GERD as the Second Naronapride Indication to Develop and Commercialize in their Licensed Territories

Retrieved on: 
Wednesday, February 7, 2024
Partnership, Collaboration, Regurgitation, GI, IND, Patient, Gastroparesis, FDA, Food, D2, PPI, Gastroesophageal reflux disease, FACC, Disease, Heartburn, GERD, Pharmaceutical industry

Falk Pharma”), has elected to advance the development of naronapride for patients with proton-pump inhibitor non-responsive symptomatic gastroesophageal reflux disease (PPI-nrsGERD) as the second indication in their licensed territories.

Key Points: 
  • Falk Pharma”), has elected to advance the development of naronapride for patients with proton-pump inhibitor non-responsive symptomatic gastroesophageal reflux disease (PPI-nrsGERD) as the second indication in their licensed territories.
  • In October 2021, Renexxion and Dr. Falk Pharma announced an exclusive Licensing and Collaboration Agreement to advance naronapride initially for gastroparesis in Greater Europe (including UK), Russia, Central Asian Republics, and certain Australasian countries.
  • Today, Renexxion is pleased to confirm that Dr. Falk Pharma will also advance naronapride for PPI-non-responsive symptomatic GERD in these regions.
  • This is a welcomed addition to our pipeline which includes naronapride for gastroparesis.”
    “We are very pleased that our European partner, Dr. Falk Pharma, chose PPI-nrsGERD as its next indication for development for naronapride in their territories.

Implantica's RefluxStop™ featured in seven presentations accepted at the largest US GI conference, SAGES

Retrieved on: 
Thursday, February 1, 2024
Abstract, Surgeon, Certification, Conversion, Regional hospital, Society, Patient, Gastroesophageal reflux disease, Disease, Dysphagia, Paradigm, Nursing

SAGES brings together 2,500 of the world's leading experts on Gastrointestinal and Endoscopic surgery from 100 countries.

Key Points: 
  • SAGES brings together 2,500 of the world's leading experts on Gastrointestinal and Endoscopic surgery from 100 countries.
  • It's an honour that seven abstracts containing RefluxStop™ clinical outcomes data were accepted to the SAGES Scientific Program as part of four podium presentations, two e-posters, and one video presentation.
  • It speaks volumes about the rapidly growing interest from top surgeons in RefluxStop™'s unique way of treating GERD.
  • We're grateful these independent surgeons are committed to evaluating and reporting the impact that RefluxStop™ and surgical GERD treatment can have on patients."

Renexxion Ireland Ltd. Announces FDA Clearance of Investigational New Drug (IND) Application for Naronapride to Treat PPI-Non-Responsive Symptomatic GERD

Retrieved on: 
Wednesday, January 24, 2024
Patient, Gastroparesis, American Journal, PPI, Gastroesophageal reflux disease, FACC, IND, Safety, FDA, Investigational New Drug, Pharmacokinetics, GI, Pharmaceutical industry

ROSCREA, Ireland, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Renexxion Ireland Limited (“Renexxion”), a private biopharmaceutical company committed to delivering innovative drugs to patients with high unmet need in gastrointestinal (“GI”) disorders, announces U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application of naronapride for the treatment of patients with proton-pump inhibitor (PPI) non-responsive symptomatic gastroesophageal reflux disease (GERD) (PPI-nrsGERD).

Key Points: 
  • ROSCREA, Ireland, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Renexxion Ireland Limited (“Renexxion”), a private biopharmaceutical company committed to delivering innovative drugs to patients with high unmet need in gastrointestinal (“GI”) disorders, announces U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application of naronapride for the treatment of patients with proton-pump inhibitor (PPI) non-responsive symptomatic gastroesophageal reflux disease (GERD) (PPI-nrsGERD).
  • GERD is a multifaceted chronic condition that is estimated to affect approximately 70 million patients in the U.S., of which up to 30-40% continue to manifest symptoms despite first-line treatment with PPIs.
  • “With receipt of a May Proceed Letter and IND clearance, we look forward to advancing naronapride into the clinic for a second gastrointestinal indication of PPI-nrsGERD.
  • “Our European partner is currently enrolling gastroparesis patients in an ongoing multi-center Phase 2b study of naronapride in Europe.

Renexxion Ireland has Completed a Successful Pre-IND Consultation with the United States FDA for Development of Naronapride for Patients with PPI-non-responsive Symptomatic GERD

Retrieved on: 
Wednesday, December 20, 2023
Gastroenterology, Associate, Food, U.S. FDA, IND, GERD, Drug discovery, FACC, PPI, MD, Pharmacokinetics, Duke University, Gastroparesis, Gastroesophageal reflux disease, Patient, Safety, Pharmaceutical industry

PPI-nrsGERD affects over 20 million patients in the U.S., and current treatments are focused solely on the mechanism of acid suppression without addressing gastrointestinal (GI) motility.

Key Points: 
  • PPI-nrsGERD affects over 20 million patients in the U.S., and current treatments are focused solely on the mechanism of acid suppression without addressing gastrointestinal (GI) motility.
  • “Naronapride is a potential best-in-class pan-GI prokinetic which is currently in a multi-center Phase 2b study in patients with gastroparesis.
  • It has completed four Phase 2 studies in related GI indications including as monotherapy in newly diagnosed GERD.
  • “We look forward to collaborating with the Agency to demonstrate naronapride is both safe and effective for PPI-nrsGERD.”