RWE

Anavex Life Sciences Reports Fiscal 2024 First Quarter Financial Results and Provides Business Update

Retrieved on: 
Wednesday, February 7, 2024
Clinical trial, Marketing authorisation, FDA, Expanded access, Genome, Frontotemporal dementia, Safety, Food, OLE, Real, CNS, Medicine, Publication, Committee, RTT, Rett syndrome, Patent, Marketing, CHMP, European, Human, DSM-IV codes, Research, Patient, Drug development, Pharmacokinetics, Pharmacology, Central nervous system, Webcast, Conference call, Doctor of Philosophy, Treatment, EDGAR, MECP2, Union, Therapy, EMA, RWE, Alzheimer's disease, European Medicines Agency, Neurodevelopmental disorder, Bank statement, Conference, Pharmaceutical industry

NEW YORK, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome, schizophrenia and other central nervous system (CNS) diseases, today reported financial results for its fiscal quarter ended December 31, 2023.

Key Points: 
  • The Marketing Authorisation would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer’s disease.
  • We intend to further assess the results and discuss with the regulatory authorities next steps.
  • General and administrative expenses for the quarter of $2.6 million compared to $3.3 million for the comparable first quarter of fiscal 2023.
  • Research and development expenses for the fourth quarter of $8.7 million compared to $12.1 million for the comparable first quarter of fiscal 2023.

Helius Medical Technologies, Inc. Announces Alignment with FDA on Registrational Program for Treatment of Stroke Patients

Retrieved on: 
Tuesday, February 6, 2024
Medical school, HSDT, Gait, Patient, Pons, FDA, Falling, RWE, Food, Helios, FGA, Risk, Stroke, Medical device

NEWTOWN, Pa., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, announced today that it has concluded its interaction with the U.S. Food and Drug Administration (“FDA”) on optimizing the development plan for its stroke program which aims to evaluate the effects of cranial-nerve non-invasive neuromodulation (“CN-NINM”) delivered using PoNS Therapy® on gait and dynamic balance in chronic stroke survivors. Helius’ registrational program includes two controlled studies. The clinical program will leverage a randomized, controlled, double blinded investigator-initiated trial (“IIT”), led by Dr. Steven Kautz at the Medical University of South Carolina (“MUSC”) and a Company-sponsored study to enroll approximately 100 subjects. Dr. Kautz’s IIT began enrollment of 60 participants in September 2023 with the collaboration of Dr. Mark Bowden at Brooks Rehabilitation as a second site.

Key Points: 
  • “Vetting the registrational program and design of our clinical studies with the FDA is an important milestone for Helius and meeting the agency’s expectations will give us the most efficient path to delivering PoNS Therapy to stroke patients,” said Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer.
  • Across all stroke patients in the database, 69.2% of patients experienced at least a 5-point FGA improvement, which is larger than the 4.2-point minimal detectable change usually seen in stroke patients.
  • “One of our chief objectives is to optimize access to PoNS Therapy for stroke patients suffering from gait and balance deficit in North America.
  • PoNS received breakthrough designations in both multiple sclerosis and stroke in the United States, potentially benefiting, with a new indication, an estimated 90% of stroke patients who are covered by Medicare.

Chilmark Research Forms Elite Advisory Board

Retrieved on: 
Monday, February 5, 2024
Maker, VBC, HIT, Research, Partner (business rank), Emergency, RWE, MBA, Health care, CMIO, AWS, Management

AUSTIN, Texas, Feb. 5, 2024 /PRNewswire/ -- Leading healthcare IT industry analyst firm Chilmark Research today announced the formation of the company's first-ever Advisory Board. This new committee was established to represent a variety of roles and experiences within the healthcare industry, ensuring diversity in both expertise and personal experiences with the U.S. healthcare ecosystem.

Key Points: 
  • Therefore, it is essential that we explore new approaches to adding value to the market as it matures," notes John Moore III, Managing Partner, Chilmark Research.
  • "Chilmark has always relied on a loose and unofficial cohort of advisors within our network, and this new board formalizes some of these relationships for longer-term involvement in shaping our work.
  • As we look to the future of Chilmark and our research in the health IT vertical, these venerated professionals will be key to identifying the most critical technologies and trends that merit our research efforts to help propel the industry ever-forward."
  • To learn more about the topics that Chilmark will be following in 2024 and beyond, feel free to reach out .

Jennifer Rider Appointed ConcertAI Head of Real-World Evidence Services

Retrieved on: 
Tuesday, January 30, 2024
Real-World Evidence, Abstract, Interview, Oncology, Research, AI, Clinical Cancer Research, Public, Flexner Report, FDA, Publication, Public health, Aetion, RCT, RWE, Harvard University, Epidemiology, MPH, Doctor of Science, Harvard Medical School, Drug development, Health, Doctor of Philosophy, University, University of Wisconsin–Madison, RWD

CAMBRIDGE, Mass., Jan. 30, 2024 /PRNewswire/ -- ConcertAI, the leader in oncology Real-World Data (RWD) and AI SaaS Solutions and for healthcare and life sciences, today announced Jennifer Rider, ScD, MPH, as the leader of the company's Real-World Evidence Services, focusing on regulatory applications of RWD as part of registration trials, breakthrough designation solutions post-approval studies, and regulatory registries. 

Key Points: 
  • Dr. Rider has over 20 years of experience in cancer epidemiology and real-world evidence research.
  • She first joined ConcertAI in 2020, moving from there to lead Aetion's Oncology Center of Excellence.
  • "Real-world evidence has taken on a more formal role in regulatory decision-making with the FDA's formalization of their guidance late last year ," said Jeff Elton, PhD, CEO of ConcertAI.
  • To hear more from Jennifer directly, listen to her interview on the latest episode of The ConcertAI Podcast here .

25.75% CAGR Growth in the Virtual Power Plant Market from 2023 to 2028 due to the increase in the integration of renewable energy sources - Technavio

Retrieved on: 
Tuesday, January 30, 2024
RWE, Artificial intelligence, Wind, AMI, VPP, ENGIE, Primary energy, PG&E, Sunrun, Generator, Tesla, Inc., Communication, Growth, Generac, Carbon, SCE, ABB, RWE AG, USD, Duke Energy, Machine learning, Smart, Plant, Schneider Electric, Internet of things, Renewable energy

An increase in the integration of renewable energy sources is the key factor driving growth.

Key Points: 
  • An increase in the integration of renewable energy sources is the key factor driving growth.
  • Virtual power plants (VPPs) play a crucial role in addressing the intermittent nature of renewable energy sources like solar and wind power.
  • The global market is expected to grow rapidly during the forecast period due to the increase in the integration of renewable energy sources.
  • The turbine oil market size is forecast to increase by USD 630.89 million, at a CAGR of 8% between 2023 and 2028.

HEALWELL AI Provides Corporate Update Highlighting its Growth and Value Creation Strategy and Recent Commercial Successes

Retrieved on: 
Tuesday, January 23, 2024
Real-World Evidence, Diabetes, RWE, Artificial intelligence, Dermatology, Patient, Vascular disease, Research, Hospital, Ophthalmology, EMR, Health, Knowledge, Intelligence, Migraine, AI, Heart failure, Algorithm, Growth, Digital, Artificial intelligence in healthcare, Software, Investment, Lung, TSX, Acquisition, AIDX, WELL, Physician, OTCQX, Prevalence, CDS, HEALTH, Data science, EHR, Pharmaceutical industry

HEALWELL subsidiary Pentavere has launched an innovative Real-World Evidence (RWE) product for Dermatologists to better support unmet patient needs.

Key Points: 
  • HEALWELL subsidiary Pentavere has launched an innovative Real-World Evidence (RWE) product for Dermatologists to better support unmet patient needs.
  • This product is called DERMAID and has already established its market presence with an immediate commercial win from a top 5 pharmaceutical company.
  • TORONTO, Jan. 23, 2024 (GLOBE NEWSWIRE) -- HEALWELL AI Inc. (“HEALWELL” or the “Company”) (TSX: AIDX, OTCQX: HWAIF), a healthcare technology company focused on AI and data science for preventative care, is pleased to provide a corporate update highlighting updates on the Company’s recent commercial successes and acquisition strategy.
  • Another key growth strategy for HEALWELL is to grow its operating businesses that work closely with the life sciences and pharmaceutical industries.

Phase 4 Study Evaluating Use of ADSTILADRIN® (nadofaragene firadenovec-vncg) in Real-World Setting

Retrieved on: 
Wednesday, January 24, 2024
Research, FDA, Clinical Trials, Biotechnology, Managed Care, Health, Pharmaceutical, Science, Oncology, Ageing, RWE, Mortality, Carcinoma in situ, Patient, PST, Progression-free survival, Ferring Pharmaceuticals, ASCO, CIS, EQ-5D, BCG, University, Society, Urinary bladder, Recurrence, Food, Carcinoma, Safety, Work, Disease, Bladder cancer, Doctor of Health Science, Progress, Real, Clinical trial, NMIBC, Physician, Pharmaceutical industry

ABLE-41 (NCT06026332) is an ongoing Phase 4 observational study evaluating the effectiveness, overall experiences, patterns of use, and safety of ADSTILADRIN® (nadofaragene firadenovec-vncg) in a U.S. real-world setting.

Key Points: 
  • ABLE-41 (NCT06026332) is an ongoing Phase 4 observational study evaluating the effectiveness, overall experiences, patterns of use, and safety of ADSTILADRIN® (nadofaragene firadenovec-vncg) in a U.S. real-world setting.
  • “I am thrilled to be part of this ongoing research and among the first uro-oncologists to be treating patients with ADSTILADRIN in a clinical setting.
  • Final results from this prospective, multi-institutional study are expected at the end of 2026.
  • Trials in Progress Poster Session B: Urothelial Carcinoma
    Abstract #TPS705, Friday, Jan. 26 at 5:45 - 6:45 p.m. PST

Pragma Bio and DayTwo Join Forces to Illuminate the Path to IBD Disease Management

Retrieved on: 
Wednesday, January 17, 2024
Technology, Research, Health Technology, Software, Biotechnology, Health, Pharmaceutical, Science, Artificial Intelligence, RWE, DSM-IV codes, Patient, Drug design, Phenotype, Synthetic biology, Collection, Metagenomics, Partnership, IBD, Drug discovery, Quality of life, Metabolism, Safety, Disease, Toxicity, Therapy, Biomarker, Real, Data, Inflammatory bowel disease

Pragma Bio believes that those phenotypically correlated biosynthetic pathways are the hidden path to predict and make novel clinical biomarkers and small molecules to change the landscape of IBD disease management.

Key Points: 
  • Pragma Bio believes that those phenotypically correlated biosynthetic pathways are the hidden path to predict and make novel clinical biomarkers and small molecules to change the landscape of IBD disease management.
  • Pragma Bio and DayTwo aim to identify biosynthetic pathways associated with IBD.
  • This approach overcomes many existing hurdles of drug design and optimizes for both safety and significantly improved management of disease.
  • By harnessing cutting-edge technology and comprehensive datasets, Pragma Bio and DayTwo will make groundbreaking contributions to the field of IBD research and therapeutics,” said Aamir Rehman, CEO of DayTwo.

Specialty Networks Unveils the PPS Analytics Platform for Rheumatology to Enhance Patient Care and Practice Efficiency

Retrieved on: 
Wednesday, January 24, 2024
RWE, Patient, MPC, Eurosport 1, Urology, Rheumatology, Intelligence, Algorithm, Analytics, Practice management, PPS, Human, Gastroenterology, Physician, Nursing

CLEVELAND, Jan. 24, 2024 /PRNewswire/ -- Specialty Networks, a provider of urology, gastroenterology, and rheumatology care performance and population management solutions for community-based specialty practices, has launched their technology and services platform, PPS Analytics, to United Rheumatology members. United Rheumatology was acquired by Specialty Networks in 2022.

Key Points: 
  • CLEVELAND, Jan. 24, 2024 /PRNewswire/ -- Specialty Networks , a provider of urology, gastroenterology, and rheumatology care performance and population management solutions for community-based specialty practices, has launched their technology and services platform, PPS Analytics, to United Rheumatology members.
  • United Rheumatology was acquired by Specialty Networks in 2022.
  • PPS Analytics is an AI-enabled technology platform designed to help identify, navigate, and engage patients to improve adherence to clinical care pathways and protocols for diagnostics and therapeutic interventions.
  • We are quite excited to launch PPS Analytics to our United Rheumatology member practices."

Russell Westbrook Enterprises Invests in Arizona Athletic Grounds

Retrieved on: 
Tuesday, January 23, 2024
RWE, Eye, LOS, Russell Westbrook, NBA, Partnership, Football, Sport, Basketball, Baseball, AAG

LOS ANGELES and MESA, Ariz., Jan. 23, 2024 /PRNewswire/ -- Russell Westbrook Enterprises ("RWE") has joined the ownership group in Arizona Athletic Grounds ("AAG"). RWE will focus on Basketball programming for AAG as well as community engagement through Westbrook's Why Not? Foundation.

Key Points: 
  • Foundation Efforts
    LOS ANGELES and MESA, Ariz., Jan. 23, 2024 /PRNewswire/ -- Russell Westbrook Enterprises ("RWE") has joined the ownership group in Arizona Athletic Grounds ("AAG").
  • Nine-time NBA All-Star and entrepreneur, Russell Westbrook has always had an eye for forward thinking businesses and a passion for giving back to the community.
  • Our goal at RWE is to help Arizona Athletic Grounds become a hub for national basketball tournaments," said Donnell Beverly, President of RWE.
  • Arizona Athletic Grounds is the premier youth sports and entertainment facility in the Western United States.