More than a year after it was rejected by the FDA, Satsuma Pharma's intranasal migraine therapy Atzumi (formerly STS101) has been given the go-ahead by the agency.
The drug – a new dry powder intranasal formulation of the well-established migraine therapy dihydroergotamine mesylate (DHE) – was submitted for approval in the US in 2023 as an easy-to-use, portable treatment option for acute migraine attacks, but was turned down in January 2024 due to issues with manufacturing data in Satsuma's marketing application.
In a statement, Satsuma, which is a subsidiary of Japan's Shin Nippon Biomedical Laboratories (SNBL), said that Atzumi is also the first product to be approved based on its SMART intranasal drug delivery technology, which combines a novel nasal delivery device with a proprietary powder formulation to deliver a dose of DHE that sticks to the nasal lining and enhances drug absorption.
Compared to liquid-based DHE nasal products – which include Impel Pharma's Trudhesa and Bausch Health's Migranal – Satsuma's product offers greater stability, less variable dosing, and a reduced tendency to drip out of the nose or down the back of the throat, according to the company.
Trudhesa was launched onto the market in 2021, and Impel makes similar claims for its product over Migranal, which has been on the US market for decades, although, sales failed to gather much momentum and Impel filed for bankruptcy protection in 2023.
A plan to liquidate the company was agreed last year, with the sale of its assets to "stalking horse" company JN Bidco LLC for $17.5 million, and Trudhesa remains available.
Satsuma now has an opportunity to stake a claim to the intranasal migraine segment and see if it can do better commercially with Atzumi – at one point, analysts were discussing potential peak sales of $400 million a year – although, since then, the acute migraine market has become increasingly crowded with the launch of non-DHE options.
Those include Pfizer's nasally-administered CGRP inhibitor Zavzpret (zavegepant) – added as part of its $11.6 billion takeover of Biohaven in 2022 – plus a series of oral CGRP inhibitors used for acute migraine, including Pfizer's Nurtec ODT (rimegepant) and AbbVie's Ubrelvy (ubrogepant).
"DHE plays a unique clinical role in the acute treatment of migraine, providing patients long-lasting effects and the unique ability to provide benefit, even when taken late in a migraine attack," said Dr Stewart Tepper, vice president of the New England Institute for Neurology and Headache in Stamford, Connecticut.
"The convenience of Atzumi, the only DHE nasal powder, will offer patients ease of use combined with the important known DHE clinical advantages," he added.
A new policy from the NIH in the US will cut billions of dollars of funding for research organisations and hospitals outside the US, in another signal of America's retreat from the world stage.
The NIH – which is the world's biggest funder of biomedical research – issued a new policy document yesterday that indicates it will halt all "foreign subawards" by October. Subawards are funding that a US researcher can direct to collaborators on a project from another country, and typically amount to around $500 million each year.
In a statement, NIH Director Jay Bhattacharya said the move had been taken because "this structure has grown increasingly difficult to track," leading to "a breakdown in trust and potentially the security of the US biomedical research enterprise."
The move has been criticised for overlooking the reality that scientific research relies heavily on close collaboration between researchers, and for taking a sledgehammer to thousands of ongoing research projects and clinical trials that could safeguard public health and patient lives.
Bhattacharya said the NIH is planning to implement a new grant structure to "support productive collaborations" between US and overseas institutions and, while there are no details yet, it is clear that subawards as they currently work are going to be eliminated. Furthermore, research projects that cannot continue without subawards will be terminated.
The consequences for clinical trials sponsored by the NIH, but with investigation sites overseas, are not clear at the moment.
Given the fixation of the Trump administration on cost-cutting and other moves like the abolition of USAID and exit from the WHO, the research community fears the result will be much less funding going overseas and further undermine the US' standing in biomedical research.
Earlier this week, senior Republican Sen Susan Collins criticised the Trump administration for policies that "threaten to undermine the foundation for our nation's global leadership" through sweeping funding cuts, the laying off of essential scientists, and muddled policies.
Former NIH Director and renowned geneticist Francis Collins, who stepped down from running a lab within the NIH in March, told the journal Nature that the abolition of subawards "will have tragic consequences" and mean that "more children and adults in low-income countries will now lose their lives because of research that didn't get done about diseases like malaria and tuberculosis."
The NIH's move was presaged by a General Accounting Office (GAO) report, published in March, which analysed more than 3,600 grants and suggested that a third had issues with the management and monitoring of subawards. However, that document recommends changes to the system to enhance oversight and stops well short of a total ban.
One senior NIH employee – who asked not to be identified – told Nature that, if the aim is to end overseas funding of research, "but they don't have the law to do that, this is a way they can do it."
Walmart isshowing increased support for American-made products through its "Grow With US" initiative, a new program aimed at providing U.S. small business owners with the training, mentorship and resources they need to succeed.
"Walmart is making it easier for U.S.-based entrepreneurs to navigate the complexities of retail and bring their products to a national stage," the world's largest retailer said in an announcement.
Grow With US consists of a four-step program that offers American small business owners access to financial assistance, e-learning modules with several different learning paths, opportunities to showcase their products and the ability to connect with an experienced mentor. The initiative is part of the company's "expanding commitment to small business development," according to the announcement.
Grow With Us aligns with similar Walmart programs around the world, including Vriddhi in India and Crece con Walmart in Mexico.
In fiscal year 2024, more than two-thirds of Walmart’s total product spend was on items grown, made or assembled in America. Small businesses, which account for more than 60% of Walmart's U.S. suppliers, play a "powerful role in bringing unique products to market," according to the company.
"Simply put, we want small businesses to work with Walmart, but we know getting started can feel complex," the company stated in the announcement.
Walmart has also announced that applications for its annual Open Call event – which gives U.S. businesses the opportunity to pitch their American-made or American-grown products to Sam's Club and Walmart merchants – will open June 24. The event itself takes place in October.
The announcement comes after Milo's Tea Company, a U.S. beverage company backed by Walmart, opened their newest $200 million manufacturing facility in Spartanburg, South Carolina on April 22. (Walmart)
The announcement of these new initiatives comes after Milo's Tea Company, a U.S. beverage company backed by Walmart, opened their newest $200 million manufacturing facility in Spartanburg, South Carolina on April 22.
"Small businesses are the backbone of our communities and there are countless stories of how businesses, like Milo’s, are finding long-term growth and success with Walmart," the company wrote in a statement.
Shell Plc is working with advisers to evaluate a potential acquisition of BP Plc, though it’s waiting for further stock and oil price declines before deciding whether to pursue a bid, according to people familiar with the matter.
The oil major has been more seriously discussing the feasibility and merits of a BP takeover with its advisers in recent weeks, the people said, asking not be identified because the information is private.
A teenager charged with firebombing a Tesla dealership in Kansas City in March has been granted release from custody by a US Magistrate judge who ruled that he wouldn’t be able to continue his “gender-affirming care” in prison.
Yes, really.
The guy is facing 20 years on a domestic terrorism charge but has been set free because he can’t trans himself from behind bars.
BREAKING: Judge releases suspected Tesla firebomber citing ADHD and no access to "gender-affirming care" pic.twitter.com/oKB9nzNgOL
McIntire is also on the autism spectrum and was diagnosed with both ADHD and depression, all of which require medications and treatments that excuse him from remaining in prison, his lawyers successfully argued.
“By moving back home with his parents, he will have access to the care providers who are familiar with him and his specific needs,” the court documents read:
Wow. Just wow.
Somehow millions of other people with ADHD managed not to engage in terroristic violence.
Somehow my ADHD only made it difficult to listen in school and in meetings, I never found myself accidentally firebombing cars
So this Tesla firebomber needs to move back in with his parents in order to help him have access to gender affirming care because he has “gender dysphoria”. Wow. pic.twitter.com/Mf2G7Prvi8
If only there were some sort of designated places to safely hold mentally disturbed individuals.
If he’s being released due to mental illness, then he should be held in a secure psychiatric facility. This is exactly what institutions used to be for.
Democratic Pennsylvania Senator John Fetterman's former chief of staff was so alarmed by his mental health last year that he sounded an alarm with the Walter Reed doctor who treated him during his lengthy in-patient stay for severe depression in 2023. Former aides who are in contact with Fetterman's shrinking inner circle say his behavior continues to cause periodic concern about his danger to himself and those around him.
“I’m worried that if John stays on his current trajectoryhe won’t be with us for much longer,” wrote Adam Jentleson in his 2024 email to Dr. David Williamson, neuropsychiatry chief at Walter Reed. Jentleson sent the email in May, weeks after he resigned from Fetterman's staff. In quitting, he became the fifth top aide to jump ship since Fetterman beat Trump-endorsed TV doctor Mehmet Oz in 2022.
Jentleson's 1,600-word email, first reported by New York Magazine, referenced many warning signs that Fetterman's family and other close confidants had been told to watch out for:
“We often see the kind of warning signs we discussed. Conspiratorial thinking; megalomania (for example, he claims to be the most knowledgeable source on Israel and Gaza around but his sources are just what he reads in the news — he declines most briefings and never reads memos); high highs and low lows; long, rambling, repetitive and self centered monologues; lying in ways that are painfully, awkwardly obvious to everyone in the room.”
"We do not know if he is taking his meds, and his behavior frequently suggests he is not," wrote Jentleson, and a staffer told New York there have been days when aides would make sure nobody from outside the office came into contact with him -- days when he was in "some sort of state" where he could potentially say some "really fucked-up shit to constituents." In February, Fetterman was recorded being uncooperative with a pilot directing the overweight senator to either adhere to FAA rules requiring that one's fastened seatbelt is visible, or get off the plane:
Video from February—when John Fetterman got in an argument with a pilot about wearing his seatbelt so it was visible. “Sir if you want to go to Pittsburgh, it's simple: you have to follow our instructions or you're gonna be asked to get off the airplane.” “We're not asking much.” pic.twitter.com/FQwMEcXBsD
Sources describe tension between Fetterman and his wife. "In March, Fetterman suddenly took an early-morning trip to Hartford, Connecticut, without telling his team why — leaving them at a loss for what to tell Gisele when she demanded to know why he was missing one of their kids’ birthdays," according to New York. Fetterman disputed the account, explaining he was visiting a grad-school friend's grave and claiming that his family and aides knew about it.
In his email last year, Jentleson also said Fetterman was avoiding his doctors: "He long ago ordered us to stop putting regular drop-bys with Dr. Monahan on his schedule, despite the fact that he had agreed to those as part of the plan." In group-texts from March 2024, staffers noted that the blood tests that were to be included in those appointments were "pillars of the recovery plan." Fetterman consultant Eric Stern wrote, "Is there any universe in which [his wife] Gisele could convince him to get his levels checked? I’m honestly just worried for him and don’t know who else could get through to him.”
Jentleson worried about Fetterman growing increasingly isolated, telling Williamson that “John has pushed out everyone who was supposed to help keep him on his recovery plan." He said the senator was spending hours gazing at this phone and composing tweets. Fetterman was said to have previously acknowledged that a preoccupation with social media was a principal "accelerant" of his depression.
"He engages in risky behavior," wrote Jentleson. "He drives recklessly: he FaceTimes, texts and reads entire news articles while driving — and I don’t mean while stopped at a light or something, he reads and FaceTimes while driving at high speeds." The warning about Fetterman's driving would soon prove prophetic -- almost fatally so. The next month, driving with his wife Gisele, Fetterman rammed his 2021 Chevy Traverse into the back of a car driven by a 61-year-old woman.
John Fetterman was found to be at fault for causing a major car crash in Western Maryland that totaled his SUV as well as the car of the woman he rear-ended. This guy's a total mess pic.twitter.com/Vd7DhuY8m5
“It’s a miracle no one died,” a police officer said. Both vehicles were totaled and all three people were hospitalized, with Gisele suffering a bruised lung and spinal fractures. Police Fetterman was going "well over" the 70 mph limit on I-70. Fetterman admitted to falling asleep at the wheel. His staff had worried about that very possibility, as Fetterman's accident happened after he took a red-eye flight from California where he appeared on Bill Maher's show. He ignored his aides' pleas to ask someone to pick him up at the airport and drive him.
Fetterman called the New York Magazine article a "hit piece" by two conspiring friends, Jentleson and writer Ben Terris, who "sourced anonymous, disgruntled staffers with lies or distorted half-truths," adding that “my ACTUAL doctors and my family affirmed that I’m very well.” His wife Gisele similarly accused Jentleson of lying.
Fetterman had a near-fatal stroke on May 13, 2022-- four days before the Pennsylvania primary -- and was left with communications impairments that were painfully evident on those occasions where his campaign dared put him in front of cameras and microphones:
This is why Fetterman didn’t want to debate until after early voting was well under way
His depression hospitalization came just days after a lengthy and jarring New York Timesprofile that obliterated previous campaign assurances of Fetterman's fitness for Senate duty following his stroke. His treatment included medications, talk therapy and therapeutic walks at Walter Reed's rooftop healing garden. According to a discharge brief written by Williamson, Fetterman suffered “severe symptoms of depression with low energy and motivation, minimal speech, poor sleep, slowed thinking, slowed movement, feelings of guilt and worthlessness." He didn't have suicidal thoughts, according to the doctor.
After all, the Biden scandal showed that Democrats are all too happy to conceal major mental impairments up until the point they pose a risk to the leftist agenda.
When the Founding Fathers drafted the Aliens Act of 1798, they intended it to act as an antibody against foreign armies, criminal networks, and individuals who sought to do America harm. They understood something we have forgotten. Every nation has not just a right to act in self-defense, but a duty to do so. When a nation neglects that duty, it risks becoming a haven for vile criminal elements from across the globe, and a battleground in other nation’s conflicts. No nation is obligated to harbor foreign criminals from justice in their home nations, much less allow them to continue their crime spree right here in the United States.
Until PresidentDonald Trumpinvoked the Alien Enemies Act, that was what the United States was doing. Harboring criminals like Adrian Rafael Gamez Finol, Miguel Oyola Jimenez, and Edgar Javier Benitez Rubio, the three members of Tren de Aragua charged with kidnapping, torturing, and murdering Ronald Ojeda in Chile. Ojeda was a genuine political refugee, a lieutenant in the Venezuelan army, who protested the criminal tyranny of Nicolás Maduro’s dictatorship and dreamed of one day returning home.
That day would never come. Rather than facing justice for those crimes, Ojeda’s three murderers currently reside in the United States, making a mockery of an asylum process designed for men like Ronald Ojeda.
Thanks to President Trump’s invocation of the Alien Enemies Act, Ojeda’s family may finally receive justice in Chile, and these murderers will no longer threaten the American people in their midst.
Ojeda’s murderers and their fellow members of Tren de Aragua are exactly who the Founding Fathers had in mind when they passed the Alien Enemies Act in 1798. They are not merely murderers, but members of a hostile Foreign Terrorist Organization that has committed "a predatory incursion" into the territory of the United States and engaged in "crime against the public safety," while in league with a foreign government.
The evidence is clear. TdA operates in conjunction with Cártel de los Soles, the Maduro regime’s-sponsored narco-terrorism enterprise based in Venezuela and was closely aligned with Tareck El Aissami, the Venezuelan regime’s former Vice President. Whether TdA exclusively murders, smuggles drugs, and traffics illegal immigrants over our borders on the orders of Venezuelan leaders, or freelances for self-enrichment is beside the point. It has killed on behalf of a hostile foreign government, that government has fostered its growth, and that government has encouraged it to invade the United States to advance its interests.
Critics argue that the Aliens Act is unnecessary and unjust and that it is possible to deport criminals individually. That Adrian Rafael Gamez Finol, Miguel Oyola Jimenez, and Edgar Javier Benitez Rubio remain in the country reflect poorly on such arguments. Still, those making them also fail to understand how organized crime works. While liberal law professors may quibble over whether every member of Tren de Aragua is guilty of every act, that is like pointing out that the mafia included getaway drivers and accomplices who did not take part in breaking the legs of extortion victims but merely drove other mafia members around and handled the paperwork afterward.
TdA does not allow people to join for fun because they want neat tattoos or as a form of welfare. It allows entry only to those who can contribute to its criminal campaign against the United States. By deporting TdA members under the Alien Enemies Act, the United States government is not making judgments about the contributions of individual TdA members but rather deferring to the organization itself.
The Alien Enemies Act was passed precisely because our Founding Fathers understood that the president would need to be able to take decisive action in response to threats from hostile foreign actors. In the 1790s, French revolutionary politicians raised criminal gangs in their struggles for power in Paris, many of which then relocated to America, where they supplemented their efforts to murder one another, and criminality for self-enrichment.
The United States government recognized the impossibility of differentiating between subgroups, which represented ever-shifting factions in Paris, and decided the question was ultimately unimportant. Every one of these individuals was a de facto member of a private army, and members of foreign private armies had no business operating on American soil.
That is also why the exact nature of the connections between organizations such as Tren de Aragua and foreign governments is irrelevant. Some critics, thinking they are clever, will argue that one of Tren de Aragua’s key patrons, the Venezuelan regime’s former Vice President Tareck El Aissami, was arrested and charged with treason in 2023. The private army of a foreign warlord does not cease to be a foreign army just because that warlord loses a battle. The assassination of Mexican politicians by drug cartels is precisely how those cartels exercise control of Mexican politics, not evidence against their political ambitions.
The Alien Enemies Act was designed to ensure that the politics of foreign nations would not spread to our shores. Whether they are currently winning or losing, Tren de Aragua is waging a terrorist campaign of murder across our hemisphere in the service of the Venezuelan regime, and we have the duty to expel anyone involved from our nation consistent with all other applicable laws.
As Secretary of State, I will continue to use every power at my disposal to protect the American people and defend our nation from foreign invasion. The Founding Fathers recognized the threat posed by foreign terrorist armies invading this nation and wisely provided the president with the power to defend America through the Alien Enemies Act. As long as it exists, I will use it to the fullest.
In a statement, Satsuma, which is a subsidiary of Japan's Shin Nippon Biomedical Laboratories (SNBL), said that Atzumi is also the first product to be approved based on its SMART intranasal drug delivery technology, which combines a novel nasal delivery device with a proprietary powder formulation to deliver a dose of DHE that sticks to the nasal lining and enhances drug absorption.
