Industry news round-up: updates from May 2024
Discover the latest industry developments in real-world data (RWD) and real-world evidence (RWE) as reported in The Evidence Base from May 2024 in our regular monthly column.
NashBio and CuriMeta partner to enhance real-world health data for life sciences
NashBio and CuriMeta have announced a collaboration aimed at expanding and diversifying advanced real-world health datasets. Both companies, leaders in the field of RWD, will combine their expertise to create multi-modal, multi-omic datasets for life sciences research and development (R&D).
Verantos has launched the Inflammatory Bowel Disease Pragmatic Registry, using advanced AI to generate high-validity RWE for ulcerative colitis and Crohn’s disease.
Caris Life Sciences, a leading AI-powered precision medicine company, and COTA, Inc., an oncology data and analytics provider, have joined forces to combine their multi-modal data offerings. The collaboration aims to drive advancements in biopharmaceutical drug development and improve patient care in oncology.
CMS releases draft guidance for second cycle of Medicare Drug Price Negotiation Program
CMS releases draft guidance for the second cycle of Medicare Drug Price Negotiation Program, aiming to lower drug costs and improve access for Medicare beneficiaries through price negotiations.
EMA releases draft reflection paper on RWD in NIS for regulatory purposes, addressing methodological aspects and inviting stakeholder input until August 31, 2024.
The FDA and NIH introduce a draft glossary for consistent clinical and RWE research terminology and seek public feedback on the terms suggested.
IVI launches new project addressing patient-centered economic impacts in health care
IVI’s Phase II Project addresses patient-centered economic impacts (PCEI) in health care, engaging stakeholders to broaden understanding and improve patient-centered care.
FDA initiates Project 5 in 5 to progress use of pragmatic clinical trials in oncology
The US FDA’s Oncology Center of Excellence has launched a crowdsourcing initiative to identify five clinically relevant questions regarding FDA-approved oncology therapies to be addressed through pragmatic clinical trials over the next five years.
The newly announced collaboration between Lynx.MD and the New York Gastroenterology Associates aims to foster increased gastrointestinal-related research and development.
Exactis Innovation and PeriPharm partner to enhance real-world evidence studies
Exactis Innovation and PeriPharm have announced a strategic collaboration aimed at establishing a comprehensive resource hub for RWE studies.
Inflation Reduction Act’s Medicare Drug Price Negotiation Program: a threat to patient access?
A new Health Affairs Forefront article titled, ‘The IRA: Reducing Inflation Or Threatening Patient Access?’ by Richard Hughes IV (Epstein Becker & Green, P.C.) and Richard Kane (PhRMA), delves into the implications of the Inflation Reduction Act‘s (IRA) Medicare Drug Price Negotiation (MDPN) program, raising significant concerns about its impact on patient access to essential medications.
COTA extends FDA collaboration to enhance cancer research using real-world data
COTA and the FDA will advance cancer research using RWD, focusing on regulatory decision-making and improving treatment evaluation and availability.
European Commission adopts Joint Clinical Assessment rules to accelerate access to medicines
The European Commission has adopted Joint Clinical Assessment (JCA) rules to streamline evaluations of new medicines, aiming for faster, equitable access to innovative therapies across EU Member States by January 2025.
IDERHA’s report examines global RWD and RWE policies, highlighting advancements and challenges, aiming to foster coherence and transparency in evidence-based health care.
The ICH M14 draft guideline on pharmacoepidemiological studies using RWD has reached Step 2, opening for public consultation to establish standardized practices for medicine safety assessment.
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