Industry news round-up: updates from October 2024
Explore the latest advancements in real-world data (RWD), real-world evidence (RWE) and health technology assessment (HTA) as featured on The Evidence Base during October 2024.
New MHRA Data Strategy underscores role of real-world evidence for timely regulatory decision-making
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched its 2024–2027 Data Strategy, aiming to use data, digital technology, and RWE to enhance patient safety, public health, and innovation in healthcare regulation.
Draft EU HTA regulation implementing act sets out rules for joint scientific consultations
The fourth implementing act has been released, with the European Commission seeking feedback on the proposed rules joint scientific consultations.
New research study utilizing RWD uncovers genetic associations in ME/CFS and long COVID
PrecisionLife and Metrodora Institute's MetX study uses RWD to identify the genetic associations in ME/CFS and long COVID, aiming to advance personalized treatment options for these conditions.
CMS guidelines finalize process for second cycle of the Medicare Drug Price Negotiation Program
The draft guidance outlines how the US Centers for Medicare & Medicaid Services intends to implement the Medicare Drug Price Negotiation Program for the second round of drugs subject to price controls in 2027.
Lifebit and Flatiron Health expand into Japan to advance cancer research with secure RWD access
Lifebit and Flatiron Health aim to advance cancer research in Japan through secure RWD access, improving care with high-quality datasets and global insights.
PCORI has awarded funding to 25 US health systems, supporting evidence-based research to advance antibiotic prescribing and weight loss treatments.
Veradigm expands real-world data capabilities with NLP-driven EHR insights
Veradigm will integrate NLP into its EHR dataset, enhancing RWD analysis and research by transforming unstructured data into structured, regulatory-grade insights.
Norstella launches new fully integrated data asset to support drug development
NorstellaLinQ is the biopharma industry's first fully integrated data asset, combining 74 billion data points, including RWD, to enhance drug development and decision-making.
Tempus and BioNTech to enhance oncology development with AI and real-world data
Tempus and BioNTech are partnering to leverage AI and RWD, aiming to advance oncology research and accelerate the development of new cancer therapies.
Potential unintended consequences of the Inflation Reduction Act on oncology drug development
A new study reveals that the IRA's Drug Price Negotiation Program may reduce incentives for oncology drug manufacturers to pursue subsequent indications, limiting patient treatment options.
European Medicines Agencies Network Strategy 2028: key highlights and public reactions
The EMA and HMA have launched a public consultation for the European Medicines Agencies Network Strategy 2028, which emphasizes six strategic focus areas including accessibility, data, AI, and antimicrobial resistance.
New report from the Center for Innovation & Value Research highlights economic burdens in healthcare
The Center’s report highlights how patient journey mapping uncovers hidden healthcare costs, improving research and decision-making on economic burdens faced by patients and caregivers.
European Commission progresses EU HTA Regulation with second adopted implementing act
The European Commission has adopted the second implementing act under the EU HTA Regulation, establishing rules for information exchange related to JCAs and joint scientific consultations in the context of HTAs.
Evidation and 1upHealth collaborate to expand real-world data utilization in health research
Evidation and 1upHealth will work together to enhance RWD sharing in health research, enabling individuals to consent to share health records seamlessly.
Ontada and Microsoft collaboration enhances oncology RWD with AI
Ontada and Microsoft collaborate to accelerate unstructured oncology data processing using Azure AI, improving RWD for drug development, patient care, and research insights.
CRDSA releases report on data platforms supporting real-world data in regulatory submissions
The Clinical Research Data Sharing Alliance's paper highlights the role of data platforms in regulatory submissions, supporting prior clinical trial data and RWD use for improved trial efficiency.
Third EU HTA Regulation implementing act sets out rules on conflicts of interest
The new regulation mandates conflict-of-interest declarations in HTAs, ensuring transparency, impartiality, and rigorous standards for unbiased healthcare evaluations.
HDR UK selects new data partners for pilot RWE Network initiative
Seven data partners will join HDR UK's pilot RWE Network, which aims to establish a UK-wide research framework using interoperable health data across NHS settings.
Tempus and Korean-based JW Pharmaceutical team up to foster RWD-driven drug development
Tempus will collaborate with JW Pharmaceutical to enhance oncology research using RWD and biological modeling, advancing data-driven drug development in Korea.
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