drug research Archives - Medical Design Sourcing

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In a sign of shifting attitudes, the FDA has released draft guidance to facilitate the development of psychedelic drugs. Historically, psychedelics have a long history of use in certain cultures, such as the indigenous tribes of the Amazon Basin and Native American communities, for millennia as sacraments.These substances were used not only recreationally but also experimentally. One example is MK-Ultra, a covert U.S. government research program that explored using LSD for mind control. The Manson Family, notorious for its cult-like crimes in the late 1960s, also contributed to psychedelics’ notoriety.

This complex history, along with social and political responses to the countercultural revolution of the 1960s, contributed to a backlash against these substances. Classic psychedelics such as LSD, psilocybin, mescaline, and DMT experienced a swift fall from mainstream favor after the 196…

Lilly’s (NYSE:LLY) shares were up more than 5.36% to $425.88 after the company announced upbeat results from the phase 3 TRAILBLAZER-ALZ 2 study, which revealed that the experimental Alzheimer’s drug donanemab significantly slowed cognitive decline in patients with early symptomatic Alzheimer’s disease at 18 months.

Almost half of patients, 47%, who received donanemab had no disease progression one year after treatment began, compared with 29% who did not receive the investigational antibody. Donanemab recipients had a clinical decline of 35% compared to placebo recipients based on the primary outcome measure. The drug group had 40% less decline in the ability to perform activities of daily living.

A potential blockbuster

Donanemab seems likely to win FDA approval given the positive data. In September 2022, UBS projected that donanemab would generate peak risk-adjusted sales of $4.8 billion. But earlier this year, FDA sent Lilly a complete response …

drug research

FDA publishes draft guidance for psychedelic drug development

Donanemab slows cognitive decline in early Alzheimer’s patients by 35%