Lykos and its founder, Rick Doblin, have for years tried to persuade regulators and the pharmaceutical industry at large that psychedelic drugs should be used in the treatment of certain mental health conditions. “After 38 plus years of work, I’m profoundly saddened by the FDA decision around this critically needed therapy, but am heartened that…
[Friday, August 9, 2024] “…it is time for Commissioner [Robert] Califf to exercise direct oversight and order the Agency [FDA] to reassess its biased attacks on kratom and psychedelics,” Mac Haddow, senior fellow of public policy for American Kratom Association… August 12, 2024; The Food and Drug Administration (FDA) has withdrawn a request for White…
The FDA declined to approve the new treatment submitted by Lykos Therapeutics, an organization that develops innovations to “transform mental healthcare,” deciding that there still isn’t enough evidence of benefit to outweigh the risks. The decision will have far-reaching ripple effects. Some psychedelic advocates will have to put celebrations they’ve been planning for decades on pause;…
A 77-year-old retired Marine Corps general has emerged as an unlikely advocate for treating veterans suffering from post-traumatic stress disorder with the psychedelic drug ecstasy… Jack Bergman flew helicopters in Vietnam, earned three stars, and is now in his fourth term representing a northern Michigan district in the House. A Republican, he sees promise in…
“Due to the age of the plants, Watermasters estimate that roughly 1.5 million gallons of water was saved by stopping water use at this time,” JCSO (Jackson County Sheriff’s Office), explained. “While regulatory agencies investigate permitted cannabis operations, IMET is focusing on the black-market marijuana trade in the Rogue Valley,” the agency said. “IMET is…
Regulators in Oregon have licensed the country’s first-ever state-legal psilocybin edibles manufacturer, the Southeast Portland company announced… The Milwaukie-based company’s brand… said in a press release… includes “dark chocolates precisely dosed with dried, homogenized mushrooms, have a chocolate-forward flavor with nutty and earthy notes from the mushrooms.” Original Article (Marijuana Moment):Oregon regulators grant first license…
…another big ‘if’ is whether the company will even obtain FDA approval for its MDMA-assisted therapy at all… Specifically, Lykos’ patent application claims a composition comprising a salt or solvate of MDMA along with one or more excipients, where the average particle size in the composition is, at its broadest, between 50 and 400 microns,…
A resoundingly negative vote by an advisory committee to the Food and Drug Administration on Tuesday [6/5/24] – though not binding – has diminished the chances of the sponsor, Lykos Therapeutics, from winning full approval for MDMA to treat post-traumatic stress disorder, industry observers said. But biotech executives, investors and researchers said in interviews that…
Officials say it took a coordinated takedown by more than 400 federal, state, and local agencies in Salem [Oregon], California and Arizona … prosecutors said Eduardo Mendoza, who went by the nickname of Casper, was arrested in Salem on Wednesday [6/5/2024]. Across the U.S.-Mexico border region of Southern California known as the Imperial Valley… the…
A 60-year-old township woman has been accused of running a psilocybin mushroom manufacturing facility at her Elwood Street home while she was caring for three minors, using one of the children to help with the operation. …the state [New Jersey] Division of Child Protection and Permanency called Lacey police after receiving information that Whalen was…
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