News from Friday, January 10, 2024
Articles
Trump Says World Is Free-Riding on U.S. Health Spending. He Has a Point.
(1/10, David Wainer and Jon Sindreu, The Wall Street Journal) comments “...In Europe, pharmaceutical companies face strict price regulations and cost-effectiveness assessments, whereas the U.S. approval process focuses solely on whether a drug is safe and effective, allowing drug companies to more freely set the price of their medicines. Many drugs launched at high prices in the U.S. are unavailable in Europe, where their cost is carefully tied to their perceived benefit. But it is hard to argue with the idea that, by paying more, Americans seed the rest of the world with innovation.” Subscription Required
Patrizia Cavazzoni, Key FDA Official, to Leave Agency
(1/10, Ned Pagliarulo, Biopharma Dive) reports “...Cavazzoni joined the FDA’s Center for Drug Evaluation and Research seven years ago and in 2021 was picked to serve at its head, replacing longtime leader Janet Woodcock...Cavazzoni joined the FDA’s Center for Drug Evaluation and Research seven years ago and in 2021 was picked to serve at its head, replacing longtime leader Janet Woodcock.” Full
Press Releases
New EU Rules for Health Technology Assessments Become Effective
(1/10, European Medicines Agency Press Release) “...The regulation is an important step forward in accelerating and widening access to new medicines. In the European Union (EU), a centrally authorised medicine is accessible to patients when it has first gone through regulatory assessment by EMA and is authorised for use in patients, and secondly been evaluated by health technology assessment (HTA) bodies to help Member States take decisions about the use, price and reimbursement level of a new health technology taking into account its impact on the sustainability of the healthcare systems.” Full
Journals
Comparative Effectiveness of Outpatient COVID-19 Therapies in Solid Organ Transplant Recipients
Zachary A Yetmar, et al.
January 10, 2025, Transplant Infectious Disease
Prioritizing Attributes of Approaches to Analyzing Patient-Centered Outcomes That Are Truncated Due to Death in Critical Care Clinical Trials: A Delphi Study
Melanie Bahti, et al.
January 10, 2025, Trials