• Georgia: The University of Georgia (UGA) plans to launch an independent medical school, transitioning away from a 14-year partnership with the Medical College of Georgia at Augusta University. The development of the university's medical school will be supported by funding from NIH, as well as more than $240 million raised from alumni and industry partners, the university said. "The School of Medicine will significantly expand the pool of medical professionals in Georgia, attract more top-tier scientists and researchers to the state, and produce more physicians to serve underserved and rural Georgia communities," said Jere Morehead, president of UGA. The university did not say when the new school would open. (Deveraux, Modern Healthcare, 2/14)
• Maryland: FDA last week posted warning letters it sent to two websites — Synthetix Inc. DBA Helix Chemical Supply and US Chem Labs — that claim to sell the underlying chemicals in popular weight-loss drugs like Ozempic, Wegovy, and Zepbound. While the websites claim the chemicals they sell are "for research use" and "not for human consumption," FDA said it found dosing information and claims about the clinical benefits of the products on the sites. FDA said the sites have 15 working days to respond to the letters and detail any steps they've taken to address the violations. (Chen, STAT+ [subscription required], 2/15)
• Maryland: FDA last week approved a new cellular cancer therapy to treat patients with metastatic melanoma. The treatment, which is called Amtagvi and is developed by Iovance Biotherapeutics, is also called TIL (tumor-infiltrating lymphocytes) therapy. TIL therapy is a type of immunotherapy that harvests patients' own immune cells. Amtagvi is the first cell therapy to be approved to treat solid tumors. According to FDA, its decision to approve the treatment was based on the results of a phase 2 clinical trial. During the trial, 153 patients who had been on a median of three types of therapy before received Amtagvi, and 31% responded to the therapy. Among patients who responded to the therapy, 42% were still responding 18 months later. Currently, Iovance is conducting a larger phase 3 trial to confirm its results. While Amtagvi's is currently only approved to treat melanoma, experts say it could also potentially treat other solid tumors, which make up 90% of all cancers.  "It is our hope that future iterations of TIL therapy will be important for lung cancer, colon cancer, head and neck cancer, bladder cancer and many other cancer types," said Patrick Hwu, CEO of the Moffitt Cancer Center who has worked with Iovance on their clinical trials of TIL therapy. (Edwards et al., NBC News, 2/16; Chen, STAT+ [subscription required], 2/16)

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