Industry news round-up: updates from February 2024
Discover the latest industry developments in real-world data (RWD) and real-world evidence (RWE) research from February 2024 in our regular monthly column.
xCures advances healthcare data landscape with expanded AI-assisted medical data platform
xCures has announced the expansion of its AI-assisted medical data platform to support real-time, regulatory-grade data in various therapeutic areas.
CMS targets sickle cell disease for groundbreaking outcomes-based model to tackle equitable access to novel cell and gene therapies
The Biden-Harris Administration identified sickle cell disease as the initial target for the Cell and Gene Therapy Access Model. First proposed by CMS in February 2023, this initiative aims to improve health outcomes, expand access to cell and gene therapies, and reduce healthcare costs for vulnerable populations.
LANGaware’s collaboration with Premier, Inc.’s PINC AI™ Applied Sciences to harness real-world data for advanced diagnostics in neurodegenerative and behavioral health diseases
LANGaware is set to collaborate with Premier, Inc.’s PINC AI™ Applied Sciences (PAS), leveraging RWD for developing therapeutics addressing neurodegenerative and behavioral health disorders.
Verisense® Health partners with Datavant for enhanced real-world data integration in digital health research
Verisense® Health will integrate Datavant’s data connectivity platform to expand its Digital Health Panel with additional RWD sources, advancing objective digital health research.
Addressing value in rare disease treatment through multi-stakeholder collaboration: insights from the IVI and EveryLife Foundation report
The IVI and EveryLife Foundation for Rare Diseases have released a report titled, “Valuing Rare Disease Treatments in Healthcare: Real Experience, Real Impact,” exploring common patient-centered outcomes and highlighting key steps needed to address the challenges in valuing treatments for rare diseases.
First lawsuit against Medicare’s Drug Price Negotiation Program in the Inflation Reduction Act dismissed
Federal court in Texas dismisses the joint suit filed by PhRMA, the National Infusion Center Association, and the Global Colon Cancer Association, which declared the drug pricing provisions included in the Inflation Reduction Act as ‘unconstitutional.’
New report makes recommendations for advancing health equity and fostering patient engagement in the implementation of CMS’ Drug Price Negotiation Program
The recent collaboration between The Innovation and Value Initiative, Alliance for Aging Research, Leavitt Partners, LLC, and National Pharmaceutical Council has shed light on critical health equity issues and patient engagement within the Drug Price Negotiation Program context.
Collaboration between HMA and EMA introduces electronic catalogs of real-world data sources and studies
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have jointly introduced two publicly accessible electronic catalogs: one dedicated to RWD sources and the other focused on RWD studies.
European health stakeholder organizations voice concerns over European Health Data Space regulation
In a press release, European health stakeholders have expressed concerns over the forthcoming EHDS regulation negotiations, urging EU institutions to prioritize expertise and time allocation to ensure safe and beneficial digital health, while safeguarding privacy and trust.
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