Drugs

Nucleus RadioPharma Names Former FDA Head as CEO

Contract development and manufacturing organization Nucleus RadioPharma has appointed former FDA commissioner Stephen Hahn (Trump Administration 2019-2021) as its chief executive officer. Hahn joins Nucleus after serving as CEO-partner of Flagship Pioneering and CEO of Harbinger Health since 2021. Before joining FDA, he was the chief medical executive at MD Anderson Cancer Center in Houston.

“Radiopharmaceuticals represent one of the most promising frontiers in oncology, offering treatments that are less toxic, less invasive and far more precise in targeting cancer cells,” the company says. However, it says, the products remain extremely limited due to logistical issues. “Three interdependent issues drive these supply chain challenges: a fragile and insufficient supply of key isotopes, limited GMP-compliant infrastructure capable of handling a range of medical isotopes and an underdeveloped operational capacity to manage radioactive drugs,” it explains.

Hahn says radiopharmaceuticals are the “next frontier” in precision oncology care, but “without the infrastructure to deliver these treatments, their impact is fundamentally limited. At Nucleus RadioPharma, we have an extraordinary team that is committed to breaking those barriers. Together, we will scale the systems and infrastructure needed to make these lifesaving therapies available to all who need them.”

Founded in 2022 through a collaboration between Eclipse and Mayo Clinic, Nucleus has raised $72 million in funding to date, including participation from AstraZeneca, according to the company. It says they are building a network of advanced facilities, starting in Mesa, AZ, and Spring House, PA that will integrate research, development and commercial-scale production under one roof.

“In his first year as CEO, Hahn will focus on completing the company’s GMP readiness at its Rochester, Minnesota, facility, expanding R&D capabilities, launching Nucleus’ data platform and forging strategic partnerships,” the company says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome