Summary
January 5, 2026 | 11:30 AM – 2:30 PM ET
Presented by the Lyceum Society
To attend, click the “Register” button at the time of the presentation. It will take you directly to the Zoom call.
Welcome and Introductions: 11:30 AM to 11:45 AM
Main Presentation: 11:45 AM to 2:30 PM
New Drug Approvals in 2025: How did the FDA fare?
2025 has been a tumultuous year in Washington. Notwithstanding DOGE layoffs and the government shutdown, the Food and Drug Administration (FDA) has approved 41 drugs and biologicals this year. While some will likely be blockbusters with sales above a billion dollars a year by 2030, some of the rest might be considered bespoke biologicals—exquisitely-targeted drugs for smaller populations (e.g., hereditary angioedema, which affects about 1/50,000 people across all ethnicities). But, when there are fewer potential patients, the research and development cost has to be spread across patients receiving the therapy. When data is available, we’ll talk about cost and, with drug price controversy embedded in the ongoing health insurance crisis, who should or can or might pay, and how much.
Speaker
Clif Hotvedt‘s diverse scientific background reflects his experience in the pharmaceutical industry, as a medical writer in the regulatory and clinical affairs departments of Ives Laboratories and at leading public relations firms including Robert Marston & Associates, Manning Selvage & Lee, and Ketchum, where he served as vice president and global director of medical & scientific affairs. For 46 years, he has counseled companies on over 100 small molecule drugs, biologicals and devices for indications including cardiovascular disease, rheumatology, metabolic disease, dermatology, central nervous system disease, vaccines, infectious disease, and cancer.
A New Mexico State University graduate in secondary education and journalism, Clif continues to use his teaching background to develop and present courses on the FDA approval process, pharmacokinetics, pharmacodynamics, and biostatistics among other topics for coworkers and clients. Clif is a member of the Lyceum Society and has been a frequent presenter at our meetings. His previous topics have included: “The FDA Drug Approval Process”(November 2015); “How the new PCSK9 Cholesterol-Lowering Drugs work” (May 2016); “How to read a Drug Label” (April 2017); “Biosimilars: the New ‘Generics’?(June 2018); “The Human Microbiome” (May 2019); “Drug Pricing” (June 2020); “Artificial Intelligence (AI) and Health Care” (October 2020); “Drug Pricing Revisited” (November 2020); and “The Nobel Prize in Physiology or Medicine 2022” (December 2022).
Pricing
All: Free
About the Series
The Lyceum Society is a collegial venue promoting fellowship, education, and discussion among retired members of The New York Academy of Sciences. Learn more and explore other events hosted by the Lyceum Society.
Registration
This event is open for registration.