• Indiana: Peter Marks, former director of FDA's Center for Biologics Evaluation and Research, has joined Eli Lilly. In March, Marks was forced to resign from FDA by HHS Secretary Robert F. Kennedy Jr. In his new role at Lilly Research Laboratories, Marks will oversee molecule discovery and infectious diseases. "Lilly continually evaluates breakthrough science which could benefit patients," said company spokesperson Stefanie Prodouz. "Peter's expertise strengthens our abilities across multiple areas, both in our existing portfolio and in our work in emerging areas." According to STAT, Marks' decision to join Eli Lilly drew criticism from people who see regulatory agencies and the pharmaceutical industry as a revolving door. (Lawrence, STAT+ [subscription required], 10/7)
• Maryland: According to new research from the Lown Institute, U.S. hospitals have performed over 200,000 unnecessary back surgeries since 2020, costing Medicare almost $2 billion. In the analysis, Lown defined unnecessary spinal fusion/laminectomy procedures as those performed on patients with low back pain not related to certain health conditions, like scoliosis. Unnecessary vertebroplasties were defined as those performed on patients with spinal fractures caused by osteoporosis. An average of 13% of spinal fusions/laminectomies, as well as 10% of vertebroplasties, met the criteria for overuse. California, Florida, Texas, and Pennsylvania had the highest volume of spinal fusion overuse while Texas, Florida, and Ohio had the highest volume of vertebroplasty overuse. "Like everyone in America, older people with back pain deserve safe, evidence-based care that doesn't waste taxpayer dollars," said Lown Institute president Vikas Saini. "Reducing unnecessary procedures, particularly invasive ones that carry grave risks, is a moral imperative. Physicians, policymakers and hospitals must act to protect their constituents and patients." (Bettelheim, Axios, 10/9; Twenter, Becker's Hospital Review, 10/8)
• Maryland: FDA expanded the label for Regeneron's immunotherapy cancer treatment Libtayo to treat patients with cutaneous squamous cell carcinoma (CSCC) who are at a high risk of recurrence after surgery and radiation. CSCC is a common type of skin cancer, with approximately 1.8 million people diagnosed each year in the United States. In 2018, Libtayo was the first drug approved for CSCC. At the time, it was approved for patients with metastatic CSCC and patients with locally advanced CSCC who were not candidates for surgery or curative radiation. According to Vishal Patel, a professor of dermatology at George Washington University, Libtayo's label expansion is "practice-changing" for the at-risk patient group. "Until now, we lacked options to help prevent a devastating recurrence and immunotherapy was only available for patients with advanced CSCC, who were no longer candidates for curative surgery or curative radiation," Patel said. Currently, Regeneron is testing Libtayo as a combination therapy with another drug fianlimab against first-line melanoma. (Dunleavy, Fierce Pharma, 10/9)

In a rapidly changing pharmaceutical landscape, three foundational forces are set to shape the industry's future: artificial intelligence and machine learning in drug development, the urgent need for health equity, and the role of patient-reported outcomes. Discover why these forces are critical for manufacturers to consider in their strategic planning for 2025 and beyond.