News from Friday, December 6, 2024
Articles
Accelerated Approval: FDA Revises Guidance to Reflect Revised Withdrawal Procedures
(12/5, Ferdous Al-Faruque, Regulatory Focus) reports “The [FDA] on Thursday issued draft guidance that would replace the accelerated approval portion of its broader guidance covering its various expedited pathways to reflect changes to the accelerated approval program brought on by recent legislation.” Full
USPTO Withdraws Proposed Patent Rule Criticized by Pharma Industry
(12/5, Nicole DeFeudis, Endpoints News) reports “...The proposal received more than 300 public comments, including harsh criticism from the pharmaceutical industry. Multiple drugmakers, including AbbVie and Amgen, argued that the rule would have a chilling effect on innovation. Federal agencies argued that it would prevent patent thickets and encourage competition.” Full
EU HTA Regulation: Lack Of Scientific Consultation Capacity ‘Concerning’
(12/6, Eliza Slawther, Pink Sheet) reports “...Between five and seven joint scientific consultation (JSC) slots have been scheduled for 2025 under the new EU Health Technology Assessment (HTA) Regulation, a number that EUCOPE and other industry representatives have said is insufficient.” Subscription Required
Press Releases
UH Urology Institute Awarded $9.2 Million by the Patient Centered Outcomes Research Institute
(12/5, University Hospitals Press Release) “University Hospitals has been approved for $9.2 million in research funding by the Patient-Centered Outcomes Research Institute. The study is led by David Sheyn, MD, division director of urogynecology and pelvic reconstructive surgery at University Hospitals Urology Institute, and aims to study bulking versus sling for treating urinary incontinence at the time of vaginal prolapse repair.” Full
Food as Medicine: Treating Gestational Diabetes Through Tailored Meals
(12/5, Northwestern News Release) “...Northwestern Medicine, Brown University and California Polytechnic State University are part of a new nationwide study to examine whether medically tailored meals can help address the rise in gestational diabetes mellitus (GDM). The five-year study, funded by a $10 million award from the Patient-Centered Outcomes Research Institute (PCORI), will be one of the first to pair medically tailored meals with existing home-visiting programs to target GDM. The approach has been shown to improve health outcomes and reduce food insecurity, but little research has examined its use to treat GDM specifically.” Full
PCORI Awards $1 Million to UB Researcher to Use AI in Analyzing Social Determinants of Health
(12/6, University of Buffalo Press Release) “A University at Buffalo researcher has received a funding award of over $1 million from the Patient Centered Outcomes Research Institute to leverage artificial intelligence to integrate multiple data sources and develop statistical and computational methods for extracting knowledge from these data.” Full
Canada’s Drug Agency Receives Letter From Health Minister Regarding Pharmacare
(12/5, Canada’s Drug Agency Press Release) “Canada’s Drug Agency has received a letter from The Honourable Mark Holland that outlines our time-limited work related to An Act respecting pharmacare, which received royal assent on October 10, 2024. We have begun to undertake the work outlined in the legislation and the letter, building on our mandate to provide health system leaders with independent evidence and advice to inform policy decisions about drugs, health technologies, and health systems.” Full
Journals
Ponatinib Vs. Asciminib in Post-Second-Generation Tyrosine Kinase Inhibitor Therapy for Chronic-Phase Chronic Myeloid Leukemia: A Matching-Adjusted Indirect Comparison
Valentin Garcia-Gutierrez, et al.
November 20, 2024, Frontiers in Oncology
Double Sampling for Informatively Missing Data in Electronic Health Record-Based Comparative Effectiveness Research
Alexander W. Levis, et al.
December 5, 2024, Statistics in Medicine