European Network for Health Technology Assessment

Merck’s KEYTRUDA® (pembrolizumab) Plus Concurrent Chemoradiotherapy Significantly Improved Progression-Free Survival (PFS) Versus Concurrent Chemoradiotherapy Alone in Newly Diagnosed, High-Risk Locally Advanced Cervical Cancer

Retrieved on: 
Friday, October 20, 2023
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Results from the trial showed that KEYTRUDA in combination with concurrent chemoradiotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to concurrent chemoradiotherapy alone for these patients.

Key Points: 
  • Results from the trial showed that KEYTRUDA in combination with concurrent chemoradiotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to concurrent chemoradiotherapy alone for these patients.
  • ET during a late-breaking abstract proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2023 (abstract #LBA38).
  • After a median follow-up of 17.9 months (range, 0.9-31.0), the KEYTRUDA regimen reduced the risk of disease progression or death by 30% (HR=0.70 [95% CI, 0.55-0.89]; p=0.0020) versus concurrent chemoradiotherapy alone in these patients.
  • The 24-month PFS rate was 67.8% for patients who received the KEYTRUDA regimen compared to 57.3% for those who received concurrent chemoradiotherapy alone.

Cumulus Neuroscience Presents Key Data at the 2023 ENCALS Annual Meeting on Patients with Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Dementia (FTD)

Retrieved on: 
Wednesday, July 12, 2023
Cognition, Frontotemporal dementia, Trinity College, Science Foundation Ireland, Neurodegenerative disease, Spinal cord, European Network for Health Technology Assessment, Academic Unit Preparatoria Hermanos Flores Magón, Brain, Research, Language, CNS, Brain cell, Doctor of Philosophy, Fatigue, Trinity College Dublin, Frasier, Behavior, Patient, EEG, Deficit spending, ECAS, Health, FTD, Function (mathematics), Memory, Caregiver, White coat hypertension, Disease, Regulation, Nursing, Medical imaging, Neurology, Cumulus cloud, ALS

The study also demonstrated that digital remote measurements can be used to stratify healthy subjects and patients, providing positive evidence for task validity and technical feasibility.

Key Points: 
  • The study also demonstrated that digital remote measurements can be used to stratify healthy subjects and patients, providing positive evidence for task validity and technical feasibility.
  • We are deeply grateful to the patients, caregivers and collaborators who dedicated their time to this important first-in-class study."
  • Key behavioral and EEG endpoints were evaluated cross-sectionally based on data from the first five sessions for each assessment.
  • Cumulus supports precision in CNS clinical trials for its industry partners by enabling remote monitoring of patients across multiple domains of brain function.

Cumulus Neuroscience Presents Key Data at the 2023 ENCALS Annual Meeting on Patients with Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Dementia (FTD)

Retrieved on: 
Wednesday, July 12, 2023
Cognition, Frontotemporal dementia, Trinity College, Science Foundation Ireland, Neurodegenerative disease, Spinal cord, European Network for Health Technology Assessment, Academic Unit Preparatoria Hermanos Flores Magón, Brain, Research, Language, CNS, Brain cell, Doctor of Philosophy, Fatigue, Trinity College Dublin, Frasier, Behavior, Patient, EEG, Deficit spending, ECAS, Health, FTD, Function (mathematics), Memory, Caregiver, White coat hypertension, Disease, Regulation, Nursing, Medical imaging, Neurology, Cumulus cloud, ALS

The study also demonstrated that digital remote measurements can be used to stratify healthy subjects and patients, providing positive evidence for task validity and technical feasibility.

Key Points: 
  • The study also demonstrated that digital remote measurements can be used to stratify healthy subjects and patients, providing positive evidence for task validity and technical feasibility.
  • We are deeply grateful to the patients, caregivers and collaborators who dedicated their time to this important first-in-class study."
  • Key behavioral and EEG endpoints were evaluated cross-sectionally based on data from the first five sessions for each assessment.
  • Cumulus supports precision in CNS clinical trials for its industry partners by enabling remote monitoring of patients across multiple domains of brain function.

Digital Therapeutics Alliance and Healthware Group Launched First DTx Policy Report and Website Dedicated to Helping Advance Equitable Access and Adoption of Safe and Effective DTx and Digital Medical Devices

Retrieved on: 
Monday, June 12, 2023
Other Health, General Health, Professional Services, Pharmaceutical, Telemedicine, Virtual Medicine, Biometrics, Medical Devices, Health Technology, Data Analytics, Biotechnology, Consulting, Health, Single-frequency network, AID, Monetary Policy Report to the Congress, DTA, Therapy, Education, Marketing, Coalition, Policy, Innovation, HTA, Multimedia, Ministry of Health (Saudi Arabia), DMD, Digital health, Patient, European Network for Health Technology Assessment, Knowledge, Growth, Ecosystem, Digital, Healthware International, Health technology assessment, Caregiver, Video game, Medical device, Database, European

Their collective efforts aim to establish comprehensive best practice frameworks for the utilization of digital medical devices (DMD), including digital therapeutics (DTx).

Key Points: 
  • Their collective efforts aim to establish comprehensive best practice frameworks for the utilization of digital medical devices (DMD), including digital therapeutics (DTx).
  • To address this challenge, this initial DTx Policy Report is focused on providing clarity on existing and evolving policy frameworks in Europe.
  • Founded in 2017, the Digital Therapeutics Alliance is a 501(c)(6) non-profit trade association of industry leaders and stakeholders engaged in the evidence-driven advancement of digital therapeutics.
  • DTA is mission driven to advance digital therapeutics globally by:
    To learn more, please visit: www.dtxalliance.org or follow us on LinkedIn.

Neuvivo's NP001 - an Immune System Regulator - Has Effect on Biomarkers of Microbial Translocation in ALS Patients Responsive to Treatment

Retrieved on: 
Thursday, June 2, 2022
Biomarker, LBP, Prognosis, Macrophage, EGF, LPS, Conference, Vital capacity, Doctor of Philosophy, Plasma, Neurodegeneration, Placebo, Inflammation, Travel, Patient, ALS, Immune system, Neopterin, Epidermal growth factor, PALO, Bacteria, European Network for Health Technology Assessment, Wound healing, Hospital, MD

PALO ALTO, Calif. and EDINBURGH, Scotland, June 2, 2022 /PRNewswire/ -- Today, at the ENCALS Conference (European Network to Cure ALS) Neuvivo presented an abstract titled: "Plasma biomarkers of microbial translocation are modulated in ALS patients clinically responsive to NP001".

Key Points: 
  • PALO ALTO, Calif. and EDINBURGH, Scotland, June 2, 2022 /PRNewswire/ -- Today, at the ENCALS Conference (European Network to Cure ALS) Neuvivo presented an abstract titled: "Plasma biomarkers of microbial translocation are modulated in ALS patients clinically responsive to NP001".
  • This is a process known to occur in patients with ALS and other neurodegenerative diseases.
  • In phase 2 studies with NP001 in ALS patients, clinical signs of disease activity and respiratory vital capacity were positively affected compared to controls.
  • "NP001 treatment reduced inflammation and importantly, enhanced production of wound healing factors," said Michael McGrath, MD, PhD, Chief Scientific Officer, Neuvivo.

Novocure Announces Favorable Recommendation to Continue the Phase 3 Pivotal INNOVATE-3 Study of Tumor Treating Fields in Ovarian Cancer

Retrieved on: 
Wednesday, March 23, 2022
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An independent data monitoring committee (DMC) reviewed the safety data for all platinum-resistant ovarian cancer patients enrolled on the trial.

Key Points: 
  • An independent data monitoring committee (DMC) reviewed the safety data for all platinum-resistant ovarian cancer patients enrolled on the trial.
  • The INNOVATE-3 study is designed to evaluate the safety and effectiveness of TTFields together with paclitaxel in patients with platinum-resistant ovarian cancer.
  • In the U.S., ovarian cancer ranks fifth in cancer deaths among women, with approximately 24,000 women diagnosed each year.
  • Novocure has ongoing or completed clinical studies investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.