Inside Gibson Oncology: From a Compound Library to a Phase II Brain Cancer Trial
A conversation with Gibson Oncology President and CEO Randall B. Riggs Glioblastoma is the most common and most aggressive primary brain tumor in adults. Roughly 13,000 Americans are diagnosed each year, median survival runs 15 to 18 months, and fewer than one in ten patients are alive at five years. For those whose disease returns, there is no established standard of care. Part of the reason is access. The
The Psychedelic Drug Race Is Moving Beyond the Molecule
Session length, staffing, support requirements and repeat dosing may determine which treatments reach patients at scale. Psychedelic drugs are moving closer to FDA approval. Now comes the harder test: building treatment models that healthcare systems can actually deliver. That challenge was the focus of a recent FDA public hearing on the potential therapeutic use of psychedelic drugs in supervised settings. The agency sought input on provider training, patient monitoring, insurance
Takeda Sets the Benchmark for a New Class of Sleep-Wake Medicines
Takeda secured the first U.S. approval. Alkermes and Lilly are testing how far orexin receptor agonists can extend beyond narcolepsy type 1. Takeda’s Orzeyful recently became the first orexin receptor agonist approved in the United States for narcolepsy type 1, introducing a treatment that directly targets the biological pathway disrupted by the disease. Narcolepsy type 1 is caused by the loss of neurons that produce orexin, a signaling
Two Pills Take on Markets Built by Injections
Two pills use different molecular strategies to compete in markets established by injected therapies. In less than four months, the FDA approved two pills built around different approaches to oral drug design. Eli Lilly’s Foundayo activates the GLP-1 receptor with a nonpeptide small molecule. Merck’s Lipfendra delivers a macrocyclic peptide orally to block PCSK9. Both drugs enter classes whose clinical value was established largely by injected therapies.