Polyp (medicine)

Fujifilm Receives 510(k) Clearance for SCALE EYE®, a Novel Endoscopic Imaging Technology for Measuring Colonic Lesions

Retrieved on: 
Monday, February 26, 2024

LEXINGTON, Mass., Feb. 26, 2024 (GLOBE NEWSWIRE) -- FUJIFILM Healthcare Americas Corporation, a leading provider of endoscopic imaging and endosurgical solutions, has been granted FDA 510(k) clearance for SCALE EYE, a new endoscopic imaging technology and part of its expanding ELUXEO Endoscopic Imaging System.

Key Points: 
  • LEXINGTON, Mass., Feb. 26, 2024 (GLOBE NEWSWIRE) -- FUJIFILM Healthcare Americas Corporation, a leading provider of endoscopic imaging and endosurgical solutions, has been granted FDA 510(k) clearance for SCALE EYE, a new endoscopic imaging technology and part of its expanding ELUXEO Endoscopic Imaging System.
  • Measurement time was 2.8 seconds using SCALE EYE, compared to 8 seconds when measuring with forceps.
  • Comparing size measurement of colorectal polyps using a novel virtual scale endoscope, endoscopic ruler or forceps: A preclinical randomized trial.
  • Introduction and preliminary evaluation of novel endoscope with pinpoint laser technology for adequate size estimation of colon lesions.

Upstream Bio Initiates a Phase 2 Clinical Trial of Verekitug (UPB-101) in Severe Asthma and Doses First Patients

Retrieved on: 
Thursday, March 7, 2024

Upstream Bio , a clinical-stage biotech company advancing new therapies to treat inflammation, today announced the dosing of the first patients in its Phase 2 VALIANT clinical trial of verekitug (UPB-101) in patients with severe asthma.

Key Points: 
  • Upstream Bio , a clinical-stage biotech company advancing new therapies to treat inflammation, today announced the dosing of the first patients in its Phase 2 VALIANT clinical trial of verekitug (UPB-101) in patients with severe asthma.
  • Verekitug is a recombinant fully human immunoglobulin G1 monoclonal antibody designed to block the thymic stromal lymphopoietin receptor (TLSPR) and thus inhibit TSLP-driven inflammation.
  • Verekitug is currently under investigation in a Phase 2 study for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
  • The study will evaluate verekitug’s efficacy in the treatment of severe asthma as reflected by the registrational primary endpoint of the annual asthma exacerbation rate (AAER).

MANDARA Phase III data published in New England Journal of Medicine show remission is an achievable goal in eosinophilic granulomatosis with polyangiitis (EGPA) with FASENRA

Retrieved on: 
Friday, February 23, 2024

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases.

Key Points: 
  • AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases.
  • Fasenra met the primary endpoint in the MANDARA Phase III trial in eosinophilic granulomatosis with polyangiitis (EGPA).
  • Burden of illness and costs associated with eosinophilic granulomatosis with polyangiitis: evidence from a managed care database in the United States.
  • A Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) (NATRON).

On Feb 6th, Penn Medicine Becker ENT & Allergy Opens a New Location to Increase Access to Quality Care in Woodbury, NJ

Retrieved on: 
Wednesday, February 28, 2024

WOODBURY, N.J., Feb. 28, 2024 /PRNewswire-PRWeb/ -- Expanding Patient Care: Penn Medicine Becker ENT & Allergy's New Woodbury Facility

Key Points: 
  • WOODBURY, N.J., Feb. 28, 2024 /PRNewswire-PRWeb/ -- Expanding Patient Care: Penn Medicine Becker ENT & Allergy's New Woodbury Facility
    The new Penn Medicine Becker ENT & Allergy location in Woodbury is part of their ongoing mission to deliver comprehensive care for ear, nose, throat, and allergy issues to more patients.
  • What the New Penn Medicine Becker ENT & Allergy Location Means for Woodbury, NJ
    The opening of the new Becker ENT location in Woodbury is a major boon for the local community.
  • Penn Medicine Becker ENT & Allergy offers a vast array of ENT and allergy services .
  • Contacting Penn Medicine Becker ENT & Allergy for Care in Woodbury, NJ
    To experience the quality and personalized care that Penn Medicine Becker ENT & Allergy offers, residents of Woodbury, NJ, and surrounding areas can schedule an appointment.

Public advisory - APO-Mometasone nasal spray: Two lots recalled due to possible risk of infection

Retrieved on: 
Monday, February 19, 2024

Apotex Inc. is recalling two lots of APO-Mometasone nasal spray due to possible bacterial contamination with Burkholderia cepacia complex (Bcc).

Key Points: 
  • Apotex Inc. is recalling two lots of APO-Mometasone nasal spray due to possible bacterial contamination with Burkholderia cepacia complex (Bcc).
  • APO-Mometasone nasal spray is a prescription drug used to treat seasonal and year-round nasal allergy symptoms (such as itchy, stuffy or runny nose and sneezing) in children 3-11 years old.
  • It is also used to treat sinusitis (sinus inflammation) in adults and children 12 years of age and older, and nasal polyps in adults.
  • The effects of Bcc vary widely, ranging from no symptoms at all to serious infections.

FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure

Retrieved on: 
Friday, February 16, 2024

Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.

Key Points: 
  • Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.
  • "While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs."
  • Current treatment requires strict avoidance of the food(s) the patient is allergic to, and prompt administration of epinephrine to treat anaphylaxis should accidental exposures occur.
  • Xolair is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure.

Japan First in the World to Approve Dupixent® (dupilumab) for Chronic Spontaneous Urticaria (CSU)

Retrieved on: 
Friday, February 16, 2024

TARRYTOWN, N.Y. and PARIS, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy. Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.

Key Points: 
  • Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.
  • CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch.
  • CSU is typically treated with histamine-1 (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria.
  • In addition to CSU, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis.

Press Release: Japan first in the world to approve Dupixent® for chronic spontaneous urticaria (CSU)

Retrieved on: 
Friday, February 16, 2024

Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.

Key Points: 
  • Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.
  • CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch.
  • CSU is typically treated with histamine (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria.
  • In addition to CSU, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis.

Internist Shirin Peters, M.D. of Bethany Medical Clinic, Shares Top Tips for the Challenges of Winter Allergies

Retrieved on: 
Thursday, February 15, 2024

has identified at-home recommendations to combat winter allergy symptoms, helping allergy sufferers manage triggers, ease concerns, and avoid future flare-ups.

Key Points: 
  • has identified at-home recommendations to combat winter allergy symptoms, helping allergy sufferers manage triggers, ease concerns, and avoid future flare-ups.
  • “Many associate seasonal allergies just with spring but winter presents a different challenge to allergy sufferers.
  • Moreover, simple lifestyle changes and at-home tips can help manage symptoms and bring some relief during these cooler months,” says Dr. Peters, with Bethany Medical Clinic.
  • Dr. Peters shares preventative measures to decrease your chances of winter and indoor allergies and lower your risk of developing sinusitis and nasal polyps.

Optinose Announces the Publication of ReOpen Phase 3 Clinical Trial Program Evaluating XHANCE in the Journal of Allergy and Clinical Immunology: In Practice

Retrieved on: 
Thursday, January 18, 2024

YARDLEY, Pa., Jan. 18, 2024 (GLOBE NEWSWIRE) --  Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced peer-reviewed publication of results from both ReOpen1 and ReOpen2 in the Journal of Allergy and Clinical Immunology: In Practice1.

Key Points: 
  • The ReOpen program evaluated XHANCE for treatment of adults with chronic sinusitis (chronic rhinosinusitis).
  • “Patients with chronic sinusitis often suffer for years and may use multiple over-the-counter treatments in a search for ways to alleviate their symptoms.
  • Chronic sinusitis is also common: data suggests it is one of the top diagnoses in adult outpatient physician visits.
  • The safety profile and tolerability of XHANCE for patients in the ReOpen trials was generally consistent with its currently labeled safety profile.