IQR

New Real-World Retrospective Analysis Presented at AUA 2024 Reports 86% Recurrence-Free Survival (RFS) at 24 Months with JELMYTO® Across All Studied Patient and Disease Characteristics in Cohort of Responders to Induction Therapy

Retrieved on: 
Sunday, May 5, 2024

Among the 30% of the complete responders who received maintenance therapy, RFS at 24 months was 100%, vs. 61% for those who did not receive maintenance therapy.

Key Points: 
  • Among the 30% of the complete responders who received maintenance therapy, RFS at 24 months was 100%, vs. 61% for those who did not receive maintenance therapy.
  • “Notably, there seems to be no discernible difference in disease recurrence based on tumor characteristics or timing of administration, including primary chemoablation or post-endoscopic ablation.
  • Data was collected from 15 centers on patients treated with JELMYTO for upper tract urothelial cancers (UTUC).
  • Recurrence-free survival was calculated in 53 patients with LGTa disease at baseline who had no evidence of disease following JELMYTO induction.

The International Myeloma Foundation and Black Swan Research Initiative® Announce the Release of New iStopMM Cohort Study: A Multivariable Prediction Model for Bone Marrow Sampling on Individuals with MGUS

Retrieved on: 
Thursday, April 11, 2024

IMF Chief Scientific Officer and co-author of the iStopMM cohort study Dr. Brian G.M.

Key Points: 
  • IMF Chief Scientific Officer and co-author of the iStopMM cohort study Dr. Brian G.M.
  • Groups 2 and 3 were evaluated at the study clinic for initial assessment and follow-up, including bone marrow sampling,” according to the study.
  • However, [this] model requires validation in other populations.”
    To know the full details of the iStopMM cohort study , view it online.
  • This research was funded by the International Myeloma Foundation and the European Research Council.

Glytec Announces Support for Landmark New CMS Measures to Improve Diabetes Reporting

Retrieved on: 
Thursday, April 18, 2024

BOSTON, April 18, 2024 /PRNewswire/ -- Glytec, whose industry leading SaaS platform empowers collaborative diabetes management and insulin dosing from the hospital to the home, announces a major step forward in its advocacy and partnership efforts to drive excellence in diabetes care and a commitment to enable hospitals and providers to measure and improve outcomes for patients.

Key Points: 
  • Recently, CMS proposed the addition of two new mandatory electronic clinical quality measures (eCQMs) related to Severe Hypoglycemia and Severe Hyperglycemia for the CY 2026 reporting period.
  • The proposed rule change issued on April 10, 2024, impacts hospitals through the Hospital Inpatient Quality Reporting (IQR) program.
  • We are proud to align with industry experts, partners, clients, and CMS in supporting measures to advance diabetes care, reduce health inequities, and move beyond antiquated, paper-based solutions."
  • The mandatory measures are related to glucose and diabetes management, which have been significant challenges for the healthcare industry.

American Journal of Respiratory and Critical Care Medicine Publishes Full, Positive Results of Apnimed’s MARIPOSA Study on AD109, an Investigational Oral Drug for Obstructive Sleep Apnea

Retrieved on: 
Tuesday, October 10, 2023

AD109 has the potential to be the first-in-class oral treatment for people with mild, moderate and severe OSA.

Key Points: 
  • AD109 has the potential to be the first-in-class oral treatment for people with mild, moderate and severe OSA.
  • The study met its primary endpoint, reduction in Apnea-Hypopnea Index (AHI4, 4% desaturation definition for hypopneas).
  • There were no serious adverse events (SAEs) and no new or unexpected adverse events in the MARIPOSA trial.
  • There were no serious adverse events (SAEs) and no new or unexpected adverse events in the MARIPOSA trial.

Xenon Pharmaceuticals Announces Publication of Results from XEN1101 Phase 2b “X-TOLE” Clinical Trial in Peer-Reviewed Journal Article in JAMA Neurology

Retrieved on: 
Monday, October 9, 2023

VANCOUVER, British Columbia, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced the medical journal JAMA Neurology has published peer-reviewed efficacy and safety results from the X-TOLE Phase 2b randomized clinical trial of XEN1101, a novel potassium channel opener, in adults with focal epilepsy.

Key Points: 
  • VANCOUVER, British Columbia, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today announced the medical journal JAMA Neurology has published peer-reviewed efficacy and safety results from the X-TOLE Phase 2b randomized clinical trial of XEN1101, a novel potassium channel opener, in adults with focal epilepsy.
  • Importantly, the efficacy and safety findings of this clinical trial supported the further clinical development in epilepsy of XEN1101, which is currently being evaluated in Phase 3 clinical trials in patients with focal onset seizures (FOS) and primary generalized tonic-clonic seizures.
  • Mr. Ian Mortimer, Xenon’s President and Chief Executive Officer, stated, “We are pleased to report that the peer-reviewed results from our Phase 2b X-TOLE study of XEN1101 in adults with focal epilepsy have been published in the prestigious JAMA Neurology journal.
  • The article entitled “Efficacy and Safety of XEN1101, a Novel Potassium Channel Opener, in Adults With Focal Epilepsy A Phase 2b Randomized Clinical Trial” was posted today on the JAMA Neurology website .

Attralus Announces Presentation of Clinical Data for 124I-Evuzamitide (AT-01), a Novel Amyloid-Specific PET Imaging Agent, at the 28th Annual Scientific Session of the American Society of Nuclear Cardiology

Retrieved on: 
Monday, October 2, 2023

Attralus-Sponsored Test-Retest repeatability study demonstrates excellent repeatability and supports the potential use of AT-01 imaging to monitor disease progression in patients with cardiac amyloidosis.

Key Points: 
  • Attralus-Sponsored Test-Retest repeatability study demonstrates excellent repeatability and supports the potential use of AT-01 imaging to monitor disease progression in patients with cardiac amyloidosis.
  • AT-01 uptake in cardiac amyloidosis shows moderate and statistically significant correlations with traditional measures of cardiac structure and function.
  • These data were included in oral and poster presentations at the 28th Annual Scientific Session of the American Society of Nuclear Cardiology (ASNC) taking place September 29-October 1, 2023, in Toronto, Canada.
  • These findings support the potential use of this novel imaging agent to monitor disease progression in patients with cardiac amyloidosis.

NeuroMetrix to Exhibit Quell® Fibromyalgia and Present New Clinical Data at the American Academy of Pain Medicine 2023 Annual Meeting

Retrieved on: 
Tuesday, March 21, 2023

WOBURN, Mass., March 21, 2023 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) will exhibit Quell Fibromyalgia at the American Academy of Pain Medicine 39th Annual Meeting on March 23 - 26 in Ft. Lauderdale, FL.

Key Points: 
  • WOBURN, Mass., March 21, 2023 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) will exhibit Quell Fibromyalgia at the American Academy of Pain Medicine 39th Annual Meeting on March 23 - 26 in Ft. Lauderdale, FL.
  • In addition, two scientific posters reporting new data on the use of Quell in patients with fibromyalgia will be presented.
  • Quell Fibromyalgia utilizes proprietary wearable neuromodulation technology and is the only FDA authorized medical device to help reduce the symptoms of fibromyalgia.
  • "We are also looking forward to presenting new clinical data that builds on the use of Quell in fibromyalgia.

Press Release: NEJM publishes once-weekly efanesoctocog alfa Phase 3 data demonstrating its potential to transform the treatment landscape for people with hemophilia A

Retrieved on: 
Wednesday, January 25, 2023

These data demonstrate that efanesoctocog alfa delivered normal to near-normal factor activity levels (>40%) for the majority of the week with once-weekly dosing.

Key Points: 
  • These data demonstrate that efanesoctocog alfa delivered normal to near-normal factor activity levels (>40%) for the majority of the week with once-weekly dosing.
  • “We are excited about the potential for efanesoctocog alfa to address unmet needs by allowing people living with hemophilia to enjoy an active lifestyle.
  • Treatment with efanesoctocog alfa prophylaxis resulted in significant and clinically meaningful improvements in physical health, pain, and joint health.
  • Efanesoctocog alfa provided mean factor activity >40 IU/dL for the majority of the week and at 15 IU/dL at Day 7.

Autolus Therapeutics to Present Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2022

Retrieved on: 
Monday, December 12, 2022

Importantly, we have not observed antigen negative relapse,” said Dr. Martin Pule, Chief Scientific Officer at Autolus.

Key Points: 
  • Importantly, we have not observed antigen negative relapse,” said Dr. Martin Pule, Chief Scientific Officer at Autolus.
  • “In the AUTO4 study, some patients have experienced durable metabolic CRs, including one patient up to the one-year mark.
  • A simultaneous audio webcast and replay will be accessible on the events section of Autolus website.
  • In collaboration with Autolus’ academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL.

Results of Four Studies Demonstrating Clinical, Economic Value of iRhythm’s Product Portfolio Presented at American Heart Association ’22

Retrieved on: 
Monday, November 7, 2022

The studies demonstrate health economic and clinical value of the Zio AT and XT product lines across a range of diseases and clinical settings.

Key Points: 
  • The studies demonstrate health economic and clinical value of the Zio AT and XT product lines across a range of diseases and clinical settings.
  • The presented studies have important clinical implications, said Dr. Mintu Turakhia, iRhythms chief medical officer and chief scientific officer.
  • The analysis found that systematic screening for AFib in an at-risk population with the iRhythm Zio XT patch provided high value from a health economic perspective.
  • Through a relentless focus on patient care, iRhythms vision is to deliver better data, better insights, and better health for all.