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FDA moves to fast-track review of psilocybin and methylone for mental health

Kraig Pakulski 0 8 Article rating: No rating
A sign for the Food And Drug Administration is seen outside of the headquarters in White Oak

By Jacqueline Howard, CNN

(CNN) — Some psychedelic drugs, once considered fringe, are now getting a step closer to possibly being approved for use as mental health treatments in the United States.

The US Food and Drug Administration on Friday issued national priority vouchers to three companies studying these psychedelic-based medicines: psilocybin, the active ingredient in “magic mushrooms,” for treatment-resistant depression; psilocybin for major depressive disorder; and methylone, a drug similar to MDMA, for post-traumatic stress disorder – better known as PTSD.

These vouchers were granted under the FDA Commissioner’s National Priority Voucher pilot program, which launched last year as a way to fast-track the review process for certain drugs and biological products seeking approval, potentially cutting down the time it takes for them to reach patients.

The FDA also is now allowing an early phase clinical study of a drug based on the psychedelic ibogaine as a potential treatment for alcohol use disorder to move forward, making the trial the first instance in which the FDA has allowed a clinical study in the United States of the drug, which is derived from the African Tabernanthe iboga plant. While the study has been allowed to proceed, this move does not mean the drug has been approved or found to be safe or effective. The agency says it will continue to review data as it becomes available.

“We are accelerating the research, approval, and responsible access to promising mental health treatments – including psychedelic therapies like ibogaine – to confront our nation’s mental health crisis head-on, especially for our veterans,” Health and Human Services Secretary Robert F. Kennedy, Jr. said in a news release Friday. “The FDA will prioritize therapies with Breakthrough Therapy designation, where early evidence shows meaningful improvement over existing options for serious mental illness.”

The FDA also announced that it plans to release final guidance to provide recommendations to sponsors developing these products.

This latest action by the FDA follows an executive order that President Donald Trump signed Saturday, directing FDA Commissioner Dr. Marty Makary to prioritize psychedelic drugs that have been granted “breakthrough therapy” status – a designation reserved for therapies that show substantial promise over existing treatment options.

Trump’s executive order calls for accelerating both research on and access to psychedelic treatments, including a $50 million investment in state governments to study how psychedelics might benefit people struggling with mental health disorders.

“These medications have the potential to address the nation’s mental health crisis, including conditions like treatment-resistant depression, alcoholism and other serious mental health and substance abuse conditions,” Makary said in a news release Friday. “As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence. We owe it to our nation’

Big business shows up in final days of arguments at Supreme Court

Kraig Pakulski 0 7 Article rating: No rating

By John Fritze, CNN

(CNN) — Big businesses are lining up at the Supreme Court as the justices hear the final arguments of the term, pressing the conservative majority to shield industries from multimillion-dollar jury verdicts, limit the marketing of generic drugs and neuter the government’s ability to issue fines.

Verizon, Monsanto and Cisco Systems are among the companies that have teed up major appeals at the high court this month.

Though the cases deal with vastly different legal issues, taken together, they could have widespread implications for the economy, affecting an expansive range of products from pacemakers to pet food and the ability of consumers and government regulators to hold companies accountable.

Among the most significant is an appeal from Monsanto, the agricultural giant that is fending off lawsuits from thousands of people who say the pesticide Roundup caused their cancer. The company is appealing a verdict that sided with a Missouri man, known to his neighbors as “spray guy,” who got cancer after regularly using the product.

“A ruling for Monsanto would reach far beyond pesticides, stripping states of their authority to protect their own citizens and closing the courthouse doors on people injured by dangerous products across industries,” Matthew Wessler, an attorney at Gupta Wessler who has argued several cases before the high court, told CNN. “This is not what Congress intended, and it would fundamentally undermine the civil justice system’s role in protecting public safety.”

Monsanto was purchased in 2018 by the German company Bayer.

In coming days, Cisco Systems will argue that the justices should limit the scope of a law that is intended to hold companies accountable for human rights abuses overseas. Last week, Verizon and AT&T challenged multimillion-dollar penalties the Federal Communications Commission levied against them for what the agency said was mishandling of customer data.

And in what is likely to be the final case argued before the Supreme Court this term, the maker of a generic drug is battling with the patent holder of Vascepa, a medication used to reduce the risk of heart attacks. The dispute deals with whether Hikma Pharmaceuticals, a London-based company with US headquarters in New Jersey, encouraged infringement of that patent in how it described its generic version in press releases and website posts.

That case has “the potential to deter drug manufacturers from selling generic drugs, which lower costs for consumers,” said Adina Rosenbaum, an attorney at Public Citizen Litigation Group, which filed friend-of-the-court briefs in the pharma and Monsanto cases.

Business-friendly court?

Business interests have had a mixed record at the Supreme Court in the first few months of opinions this year.

In its most substantial ruling of the year, a 6-3 majority in February tossed out President Donald Trump’s sweeping emergency tariffs — a huge win for importers and other companies.

Last week, a unanimous court let Chevron fight an order that it pay $740 million to clean up environmental damage to Louisiana’s coastline caused in part by its work for the government during World War II.

But the justices have sided against companies in other recent rulings, including a pair of decisions handed down Wednesday. One of those allowed an Army specialist who was severely injured by a Read more

Donald Trump’s ire and Russian criticism are helping Giorgia Meloni at home

Kraig Pakulski 0 10 Article rating: No rating

By Barbie Latza Nadeau

(CNN) — Dual insults — one from the US president and another from a Russian commentator — flung at Italian prime minister Giorgia Meloni appear to be uniting at least some of her critics behind her.

Last week, US president Donald Trump – who has historically had a close relationship with Italy’s conservative leader – decried Meloni as “unacceptable” after she stood up to him over his criticism of Pope Leo XIV.

“She is the one who is unacceptable because she doesn’t care if Iran has a nuclear weapon and would blow up Italy in two minutes if it had the chance,” he told Italian newspaper Corriere Della Sera. “I’m shocked by her. I ⁠thought she had courage. I was wrong.”

The dispute spilled over beyond the US-Italy relationship this week, when Russian television personality Vladimir Solovyov called her a “certifiable idiot” and “disgrace to the human race” over her “betrayal” of Trump and support of Ukraine.

Italy summoned the Russian ambassador to formally complain and Meloni posted a cryptic response on X.

“By nature, a diligent regime propagandist cannot impart lessons in either coherence or freedom. But these caricatures certainly won’t change our ways,” she wrote. “We, unlike others, have no strings attached, no masters, and we take no orders. Our compass remains one: Italy’s interests. And we will continue to follow it with pride, much to the chagrin of propagandists everywhere.”

Rather than bruising the Italian leader, the barbs have appear to have won her support at home, even uniting those who vehemently oppose and criticize her.

“Her opposition has always said she was subservient to Trump. Now it has been harder for her opponents to attack her,” Giovanni Orsina, director of the department of Political Science at Luiss University in Rome, told CNN. “More or less the same goes with the attack by the Russian. It was really very harsh and somehow this has obliged the opposition and even the pPresident of the Republic to defend her.”

President Sergio Mattarella, a left-wing politician, has often disagreed with Meloni’s government’s policies, especially those dealing with reproductive rights and immigration.

The spats also appear to be helping her approval rating here in Italy, where she recently suffered a defeat in a national referendum over judicial reform. After losing more than 10 points in weekly polls following the referendum , her popularity has crawled back up to pre-referendum levels, according to SWG-La7 political polls.

“I think this is an advantage – bottom line,” Orsina told CNN. “Not unqualified advantage but certainly more positive than negative for her. For the Italian public opinion, that kind of attack on the pope was a bit too much – and Meloni was able to answer Trump on grounds that were inarguably in her favor, or at least in a way Italians perceived her to be right.”

That is no small feat. Meloni used to be criticized by her opposers for being Trump’s best friend in Europe. In January 2025, the so-called “Trump whisperer” flew to Mar a Lago before his inauguration, where he hailed her as a “fantastic woman,” thanks in part to her close relationship with Elon Musk.

And it’

The ancient mountain kingdom where fantasy comes to life

Kraig Pakulski 0 15 Article rating: No rating

By Maureen O’Hare, CNN

(CNN) — The dense forests, twisting rivers and granite peaks of Northern Ireland’s Mourne Mountains have lived many lives and assumed many names.

They’re Westeros in “Game of Thrones.” They’re “Krypton” in the Superman prequel.

They’re also Transylvania in “Dracula Untold”, Sherwood in the upcoming “Death of Robin Hood” and the Forgotten Realms in “Dungeons and Dragons: Honor Among Thieves.”

As part of the Mourne Gullion Strangford global geopark, this mountain region in Ireland’s northeast achieved UNESCO recognition in 2023, but relatively small numbers of international visitors come to explore.

However, the lyrically named Kingdom of Mourne — it was never a sovereign state — has been inspiring imaginations globally for more than 75 years.

This sea-lapped landscape of 220 square miles was the real-life inspiration for “The Chronicles of Narnia,” the enduring 1950s novels by Belfast-born writer C.S. Lewis soon to be revived once again. They’ll get their fourth film adaptation in “Barbie” director Greta Gerwig’s “Narnia: The Magician’s Nephew” later this year.

Small and compact

While Gerwig’s “Narnia” is being filmed in England, Northern Ireland has a booming local film industry. Production of Season 1 and 2 of the new “Game of Thrones” prequel, “A Knight of the Seven Kingdoms,” is estimated to have returned more than $80 million to the economy alone.

“We are a small and very compact country. In fact, we are effectively the size of Greater Los Angeles, but with about 10% of the population,” says Andrew Reid, chief content officer for Northern Ireland Screen.

Only 1.9 million people live in Northern Ireland, but at any one time there will be 1,200 people hard at work on live-action scripted projects.

Thanks to good road infrastructure, crews can head in any direction from a production base in Belfast and quickly access a diverse range of landscapes — as can the fans and tourists who come to the region in their wake.

“You can be on a beach in the morning,” and back in Belfast in the afternoon, says Reid, or “up a mountain one day,” and then on a river, lake or in a forest the next.

Soft hills and rolling farmland

The coastline north of Belfast, with its windswept vistas reminiscent of the Scottish Highlands, has some of Ireland’s most dramatic scenery, including the world-famous Giant’s Causeway.

An hour south of Belfast, the Mourne Gullion Strangford global geopark is a softer landscape, with rolling hills and shadowy dells in which it’s easy for the mind to conjure up magical beasties.

“I have seen landscapes, notably in the Mourne Mountains and southwards, which under a particular light made me feel that at any moment a giant might raise his head over the next ridge,” wrote C. S. Lewis in his essay “On Stories.”

He was more specific in a letter to his brother Warren, writing, “that part of Rostrevor which overlooks Carlingford Lough is my idea of Narnia.”

The Lewis boys spent childhood vacations in Rostrevor, a neat and gaily painted village, now dotted with literary murals, close to the Northern Irish border.

To its north rise the mountains, richly forested in towering sitka spruce, one of the world’s tallest trees, and at their feet lie the still waters of Lewis’s beloved lough, a glacial ford which opens into the Irish Sea.

Thrown by a giant

Lewis wasn’t the first to dream of giants here. From the village, you can saunter past the Fairy Glen (reputed haunt of the “wee folk”) and climb the mountainside to discover spectacular views and a peculiar 50-ton boulder perched unexpectedly almost 1,000 feet above sea level.

The scientific explanation is that Cloughmore (from the Irish for “big stone”) is a glacial erratic, thought to have originated in Scotland a

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