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Around the nation: FDA will fast-track review of psychedelics for depression, PTSD


FDA has granted fast-track review to three companies studying psychedelic treatments for depression and post-traumatic stress disorder (PTSD), in today's bite-sized hospital and health industry news from California, Georgia, and Maryland.

  • California: OpenAI recently launched a new advanced AI model called GPT-Rosalind for life sciences research. The model is designed to help researchers analyze literature, generate hypotheses, plan experiments, and connect insights across complex datasets. It specifically focuses on early-stage discovery since improvements in this area could significantly impact downstream drug development timelines. In the United States, the drug development process typically averages between 10 and 15 years. Currently, GPT-Rosalind is available as a research preview through ChatGPT, Codex, and the API for select users. OpenAI is also working with several biopharma and research organizations, including Amgen, Moderna, and Thermo Fisher Scientific, to apply the new model across the discovery process. "Our unique collaboration with OpenAI enables us to apply its most advanced capabilities and tools in new and innovative ways, with the potential to accelerate how we deliver medicines to patients," said Sean Bruich, SVP of AI and data at Amgen. (Bean, Becker's Health IT, 4/17; Maddox, Fierce Biotech, 4/17)
  • District of Columbia: FDA has granted fast-track review to three companies studying psychedelic treatments for depression and PTSD. Two companies are testing psilocybin for certain types of depression, and one company is testing methylone, a drug similar to MDMA, for PTSD. According to The Hill, the priority review vouchers were awarded after President Donald Trump issued an executive order that directed federal agencies to loosen restrictions and accelerate research into psychedelic drugs. "As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence," FDA Commissioner Marty Makaray said in a statement. "We owe it to our nation's veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency." FDA is also allowing an early phase clinical trial of a derivative of ibogaine, a psychoactive derived from the African Tabernanthe iboga shrub, to move forward. In the trial, DemeRx NB will study the effects of noribogaine hydrochloride on alcohol use disorder. (Weixel, The Hill, 4/24)
  • Georgia: According to CDC, tick bites are causing their highest rates of ED visits in almost a decade. Tick bites can spread bacteria, viruses, and parasites that cause diseases. During the second week of April, tick bites were associated with 71 out of every 100,000 ED visits. The Northeast region of the United States has seen the largest increase in tick-related ED visits, followed by the Midwest. To reduce the risk of potential tick bites, CDC recommends avoiding wooded and brushy areas with high grass and leaf litter. The agency also recommends people check animals that go outside every day when the weather is warm. (Taub, The Hill, 4/21)

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