RWE

Joint HMA/EMA Big Data Steering Group workshop on RWE methods, Online, European Medicines Agency, Amsterdam, the Netherlands, 14 June 2024

Retrieved on: 
Thursday, April 18, 2024
RWE, Patient, Joint, Date, EMA, Industrial design

Joint HMA/EMA Big Data Steering Group workshop on RWE methods

Key Points: 
  • Joint HMA/EMA Big Data Steering Group workshop on RWE methods
    EventHumanData on medicines
    Date
    Location
    This one-day hybrid Big Data Steering Group (BDSG) workshop will bring together representatives of regulatory agencies, pharmaceutical companies, patients, healthcare professionals, academia, and health technology assessment bodies to address the following objectives:
    You can register for the workshop at the following link:
    Registration for the Joint HMA/EMA Big Data Steering Group Workshop on RWE methods

Alira Health Joins Forces with APMA to Advance Podiatric Registry

Retrieved on: 
Wednesday, March 27, 2024
Real-World Evidence, Partnership, RWE, Health, Patient, Research, Foot, Ankle, American Podiatric Medical Association, Surgeon, CAE, MPH, APMA, DPM, Physician, Pharmaceutical industry

Framingham, Mass., March 27, 2024 (GLOBE NEWSWIRE) -- Alira Health , a global advisory and clinical research firm, joined the American Podiatric Medical Association (APMA), the largest professional association representing podiatrists, physicians and surgeons who treat the foot and ankle, as a corporate member to help advance APMA’s Podiatric Registry.

Key Points: 
  • Framingham, Mass., March 27, 2024 (GLOBE NEWSWIRE) -- Alira Health , a global advisory and clinical research firm, joined the American Podiatric Medical Association (APMA), the largest professional association representing podiatrists, physicians and surgeons who treat the foot and ankle, as a corporate member to help advance APMA’s Podiatric Registry.
  • The APMA registry supports researchers’ understanding of diseases and ways to treat them.
  • "APMA is excited by the opportunity to drive powerful research to improve patient care in conjunction with Alira Health," said APMA Senior Medical Director Dyane E. Tower, DPM, MPH, MS, CAE.
  • “Our partnership with APMA marks an advancement in accelerating innovation and new solutions for patients,” said Gabriele Brambilla, CEO of Alira Health.

Annexon Reports Fourth Quarter and Year-End 2023 Financial Results and Key Anticipated Milestones

Retrieved on: 
Tuesday, March 26, 2024
Diagnosis, Research, Brain, Geographic atrophy, Disease, RWE, International, Paratriathlon, Patient, ARCHER, G&A, Pivotal, EMA, Meta-analysis, Eye, European Medicines Agency, Medicine, Visual acuity, Immunoglobulin therapy, GBS, Facial muscles, Clinical trial, POC, Safety, Pharmacokinetics, Investment, SAD, FDA, BLA, AFL, CAD, Food, Pharmaceutical industry

BRISBANE, Calif., March 26, 2024 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today highlighted portfolio progress and reported fourth quarter and full year 2023 financial results.

Key Points: 
  • Finally, we anticipate clinical proof-of-concept data from our novel oral inhibitor ANX1502 later in the year.
  • ANX005 in GBS: First-in-class monoclonal antibody designed to block C1q and the entire classical complement pathway in both the body and the brain.
  • ANX005 in GBS: Topline data from pivotal, randomized, placebo-controlled Phase 3 trial expected in the second quarter of 2024.
  • Cash and operating runway: Cash and cash equivalents and short-term investments were $259.7 million as of December 31, 2023.

Mitsubishi Tanabe Pharma America Receives U.S. Food and Drug Administration Orphan Drug Exclusivity for RADICAVA ORS® (edaravone)

Retrieved on: 
Monday, April 8, 2024
MTPA, Orphan drug, ALS, RWE, ODE, Patient, ALS Association, Edaravone, Safety, HCP, FDA, Health, Food, Pharmaceutical industry

JERSEY CITY, N.J., April 8, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that the U.S. Food and Drug Administration (FDA) has recognized seven years of Orphan Drug Exclusivity (ODE) for RADICAVA ORS® (edaravone) based on their assessment that the oral form of edaravone constitutes a major contribution to patient care for people living with amyotrophic lateral sclerosis (ALS). The FDA's Orphan Drug program is designed to support the development of drugs that treat rare diseases which affect less than 200,000 people in the U.S. Previously, the FDA granted RADICAVA ORS Priority Review and Fast Track designations.

Key Points: 
  • The FDA's Orphan Drug program is designed to support the development of drugs that treat rare diseases which affect less than 200,000 people in the U.S.
  • Previously, the FDA granted RADICAVA ORS Priority Review and Fast Track designations.
  • The FDA recognized ODE for RADICAVA ORS because it provides a clinically superior option for patients due to its oral suspension route of administration that can help reduce the burden patients face with intravenous (IV) administration of previously approved RADICAVA® (edaravone).
  • "We thank Mitsubishi Tanabe Pharma America for continuing their efforts to help provide treatments to people living with ALS."

Heart Rhythm Clinical and Research Solutions and the Real World Evidence Consortium Launch EVERCOOL AF Study on Attune Medical’s ensoETM®

Retrieved on: 
Thursday, April 4, 2024
Research, Medical Devices, Surgery, Medical Supplies, Hospitals, Cardiology, Other Health, Pharmaceutical, Health, Science, Real, RWE, Atrial fibrillation, Procedural, Multimedia

Heart Rhythm Clinical and Research Solutions (HRCRS) and the Real World Evidence (RWE) Consortium have enrolled the first patient in the REView of ProcEdural FactoRs and Outcomes after Atrial Fibrillation Ablation with Active Esophageal COOLing (EVERCOOL AF) study.

Key Points: 
  • Heart Rhythm Clinical and Research Solutions (HRCRS) and the Real World Evidence (RWE) Consortium have enrolled the first patient in the REView of ProcEdural FactoRs and Outcomes after Atrial Fibrillation Ablation with Active Esophageal COOLing (EVERCOOL AF) study.
  • The study is part of a multi-center observational study evaluating the impact of proactive esophageal cooling on patient outcome, throughput, and experience in high volume centers.
  • This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20240404481691/en/

FPT and De Heus Partner to Elevate Security Operations in High-Tech Agribusiness

Retrieved on: 
Monday, March 25, 2024
Data Management, Security, Technology, Agriculture, Telecommunications, Natural Resources, Software, Face, Partnership, RWE, Risk, Employment, Artificial intelligence, Acquisition, Infrastructure, SIEM, Big data, Food quality, Water, Renewable energy, Machine learning, Multimedia, Movement, FPT, Retail

Global IT corporation FPT and De Heus recently entered a strategic partnership to foster the agriculture giant's security operations.

Key Points: 
  • Global IT corporation FPT and De Heus recently entered a strategic partnership to foster the agriculture giant's security operations.
  • Leveraging FPT's prowess in technology and high-quality workforce, this movement will bolster De Heus’ capabilities in terms of system monitoring, security breach detection, and defense measures to effectively mitigate cyber risk and safeguard its information system and security data on a global scale.
  • The partnership marks a significant milestone for De Heus' digital transformation strategy amid rising cyberattack concerns in the manufacturing and agriculture industries.
  • Established its first office in 2008 in France, FPT has expanded its presence to 16 offices across 9 countries, serving over 70 leading businesses across Europe.

USA Patient Registry Software Market Outlook to 2028, Featuring IQVIA, Optum (UnitedHealth Group), Phytel, Dacima Software, FIGmd, Syapse and Pharos Innovations - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 19, 2024
Oncology, Research, Software, University, Infectious Diseases, Education, Hospitals, Health Technology, Genetics, Health Insurance, Data Management, Science, Technology, Clinical Trials, Biotechnology, FDA, Insurance, Health, Professional Services, IOT (Internet of Things), Data Analytics, White House, Federal Government, Practice Management, Managed Care, Other Health, Public Policy, Government, Pharmaceutical, Other Science, Pancreatic disease, Consolidated, Patient, Conditional sentence, Optum, Health information management, Food and Drug Administration, Geography, NPF, RWE, Internet of things, Openclinica, DNA, Policy, Electronic health record, NIH, City, Privacy, CMS, Food, Organization, Prevalence, Federation, Internet, Cancer, Drug development, IQVIA, Evidence-based medicine, RDCRN, Type, Data science, Caregiver, Public health surveillance, Government agency, Registry, EHR, CDC, National Institutes of Health, Bangladesh Technical Education Board, Medicare, Collection, Medical device

The patient registry market in the US involves the collection, management & analysis of data related to patients with specific medical conditions & diseases.

Key Points: 
  • The patient registry market in the US involves the collection, management & analysis of data related to patients with specific medical conditions & diseases.
  • Patient registry software could facilitate data sharing and analysis among these entities, leading to increased adoption
    The patient registry software market in the USA is a part of the broader healthcare information technology sector.
  • Key players in the USA patient registry software market includes IQVIA, Dacima Software, OpenClinica, FIGmd, Dendrite Clinical Systems and various universities conducting medical clinical studies.
  • As technology & data science continue to evolve, the patient registry software market is likely to incorporate more advanced analytics techniques.

Analysis Group Announces Senior-Level Promotions

Retrieved on: 
Thursday, April 4, 2024
HTA, Consumer, Climate change, Bankruptcy, Algorithm, ERISA, Environment, Agriculture, Data analysis, RWE, Materiality, Biostatistics, Research, History, Policy, Epidemiology, Survival analysis, Insurance, Analysis Group, Advertising, Clinical trial, IP, Ground substance, Intellectual property, Telecommunications, Privacy, Marketing, Economics, Consultant

BOSTON, April 4, 2024 /PRNewswire/ -- Analysis Group , one of the largest international economics consulting firms, announces 32 promotions to vice president across nine offices.

Key Points: 
  • BOSTON, April 4, 2024 /PRNewswire/ -- Analysis Group , one of the largest international economics consulting firms, announces 32 promotions to vice president across nine offices.
  • "We are delighted to announce the largest group of consultant promotions to vice president in the history of our organization," said Martha S. Samuelson, CEO and Chairman of Analysis Group.
  • In Boston, Jonathan E. Baker specializes in the application of economic analysis to antitrust and competition, energy and environment, commercial dispute, class certification, and damages litigation matters.
  • Erica VanSant specializes in economic analysis of complex litigation matters in the areas of health care, antitrust, and IP.

AI-based Clinical Trials Solution Provider Market Report 2024-2034, Featuring CONSILX, AiCure, Unlearn.AI, Trials.Ai, Intelligencia, Symphony AI, GNS Healthcare, Verily, BioSymetrics & BioAge Labs

Retrieved on: 
Saturday, March 30, 2024
Cloud, ChromeOS, Kyoto University, Attention, Google Cloud, Target, Cardiovascular disease, Software as a service, Forecasting, Prevalence, AstraZeneca, Drug discovery, Intelligence cycle, Incidence, RWE, Patient, 2.0, Biomarker, Research, Cancer, AI, Overalls, Fujitsu, Data collection, Medidata Solutions, Clinical trial, Parexel, Drug development, Artificial intelligence, USD, Medical device

Rising introduction of cutting-edge AI-based clinical trial platforms is predicted to boost the market growth during the forecast period.

Key Points: 
  • Rising introduction of cutting-edge AI-based clinical trial platforms is predicted to boost the market growth during the forecast period.
  • Its application in drug trials proves beneficial for enhancing the cost-effectiveness, clinical outcomes, and time efficiency of the drug development process, known for its resource-intensive nature.
  • This shift aims to optimize clinical outcomes while minimizing both the cost and time associated with drug trials.
  • Tara is specifically crafted to expedite the patient matching process with eligible clinical trials, resulting in enhanced recruitment at substantially reduced expenses.

Electronic Clinical Outcome Assessment Solution Analysis Report 2024: Global Market to Reach $3.9 Billion by 2029, Driven by Growing Outsourcing of Clinical Trial Processes to CROs

Retrieved on: 
Tuesday, March 19, 2024
Clinical trial, American Opportunity Tax Credit, Mental health, Growth, RWE, Patient, PRO, Acquisition, Registry, Data collection, Patient satisfaction, Investment, Drug development, BYOD, USD, Region, Wearable, Medical device

On the other hand, the sensitivity of patient health data requires robust security measures.

Key Points: 
  • On the other hand, the sensitivity of patient health data requires robust security measures.
  • Concerns about data breaches, unauthorized access, or cybersecurity threats may impede the adoption of eCOA solutions to a certain extent over the forecast period.
  • In 2022, Asia-Pacific was expected to register the highest growth for electronic clinical outcome assessment (eCOA) solutions systems in the forecast period.
  • Clinical trials segment is estimated to hold the largest share of electronic clinical outcome assessment (eCOA) solutions market, by application
    Based on application, the Electronic Clinical Outcome Assessment (eCOA) Solutions market is segmented into clinical trials, observational studies and real-world evidence (RWE) generation, patient management and registries, and other applications.