News from Wednesday, April 16, 2025
Articles
Trump Pledges His Support for a Change to the IRA Long Sought by Drugmakers
(4/15, Zachary Brennan, Endpoints News) reports “President Donald Trump on Tuesday signed an executive order offering support for a change to the IRA’s ‘pill penalty’...Alex Schriver, SVP of public affairs at PhRMA, told Endpoints News that the industry lobbying group is ‘encouraged that there is growing support for fixing the IRA’s pill penalty that has already led to a 70% reduction in investment in small molecule medicines that are more convenient and affordable for patients.’” Subscription Required
Trump Throws Pharma 'Bread Crumb' Concession with Call to End IRA Pill Penalty
(4/16, Fraiser Kansteiner, Fierce Pharma) reports “...Aside from its focus on the small molecule-biologic divide under IRA, Trump’s executive order seeks to ‘improve the transparency of the Medicare Drug Price Negotiation Program,’ which the industry has rallied around as another common criticism of the Inflation Reduction Act. While the move ‘sounds positive,’ it ‘may not mean much’ in the end, the William Blair team caveated.” Full
Streamlining JCA Response with GenAI
(4/16, Gaugarin Oliver, PharmaPhorum) comments “...Using GenAI for extraction from global value dossiers (GVDs) can facilitate the identification of key clinical data elements needed for JCA submissions – for example, safety and efficacy data. To enhance clinical trial information in JCA submissions, GenAI can analyse real-world data (RWD) from sources such as electronic health records (EHRs), patient registries, and wearables, enriching a therapy’s effectiveness and safety dataset. Some pharma companies monitor social media as well for RWD, to further enrich their datasets.” Full
Press Releases
HealthVerity Partners with Recursion to Enhance Clinical Trial Analytics with Real-World Data
(4/16, HealthVerity Press Release) “...Through this agreement, Recursion will integrate HealthVerity de-identified data for over 340M covered lives within the US into its advanced data science and machine learning platforms, the Recursion OS, allowing for deeper insights into patient populations, enhanced trial design and feasibility assessments, as well as clinical operations workflows. By leveraging these high-quality, linked data assets, Recursion seeks to industrialize clinical development, reduce costs, and accelerate the development of novel therapeutics.” Full
Canada’s Drug Agency Announces New 5-Year Strategic Plan
(4/16, Canada’s Drug Agency Press Release) “This is our first strategic plan as Canada’s Drug Agency and we used the opportunity to define who we are, what we do, and how we can provide ever-improving value for decision-makers, patients, and health systems across the country. With this plan, we aspire to contribute to a healthier future for people in Canada through evidence. Getting there will take time, but we are ready to lead, convene, and collaborate with this plan to move toward this vision, for the benefit of health systems, patients, and all people in Canada.” Full
Journals
Evidence-Based Personalised Medicine in Critical Care: A Framework for Quantifying and Applying Individualised Treatment Effects in Patients Who Are Critically Ill
Elizabeth S Munroe MD, et al.
April 15, 2025, The Lancet Respiratory Medicine
The Lancet Respiratory Medicine
Methods Resources for Authors New to Conducting Systematic Reviews with Network Meta-Analysis: A Scoping Review
Lize-Mari Swanepoel, et al.
June 2025, Journal of Clinical Epidemiology