FDA Says Sarepta Can Treat Ambulatory Patients With Gene Therapy
In a statement Monday, the regulator said that it had concluded that the death of an 8-year-old in Brazil was not related to the therapy.
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Fox News
42 minutes ago
- Fox News
Health officials warn of dangerous substance available in stores across the nation
Health officials are taking action against a substance that some are calling "gas station heroin." The FDA is recommending that 7-hydroxymitragynine (also known as 7-OH) — a byproduct of the plant kratom — be classified as a Schedule I drug. HHS Secretary RFK Jr. and FDA Commissioner Dr. Marty Makary emphasized the importance of getting ahead of yet another wave of addiction before it can sweep across the country. Makary compared the distribution of 7-OH to the early days of opioid prescriptions, before doctors understood the addictive nature of painkillers. "Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again," Makary said in an FDA statement. "7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic." During a news conference on Tuesday, Makary suggested that the public health community is often late to act against dangerous substances due to a "disconnect between the ivory towers and the streets." He then pondered aloud if experts had been to vape stores, as it "affects what we see in the operating room." According to the FDA, 7-OH is beginning to be recognized for its potential to be abused because of its ability to bind to opioid receptors. Additionally, the substance is widely available and may be appealing to children and teens as it is sold in fruit-flavored gummies and even ice cream cones. The FDA is also warning that 7-OH products "may not be clearly or accurately labeled as to their 7-OH content and are sometimes disguised or marketed as kratom." "I am in favor of this move because of the relationship of the 7-OH to the opioid receptors. This is essentially an opioid. It is semisynthetic and derived from the kratom plant whose leaves make a stimulant. There are no approved 7-OH drugs or diet supplements," FOX News Senior Medical Analyst Dr. Marc Siegel told Fox News Digital. "Bravo to the FDA for this move — it should be listed as a controlled substance." Kennedy spoke about his own battle with heroin addiction. The HHS secretary described his "iron willpower" and how he gave up candy and desserts for years, making him feel as though he could do anything, until he got his hands on heroin. "I felt that I could do anything with my willpower, but this compulsion was absolutely impervious to my will, and part of the problem was just the availability. It was too easy to get this drug for me," Kennedy said. He also noted that President Donald Trump's family has also grappled with addiction. Though the president has been sober his entire life, his brother, Fred Trump Jr., struggled with alcoholism for much of his life and died at the age of 43. "I had a brother, Fred, great guy," Trump said about his brother in 2017. "But he had a problem. He had a problem with alcohol. And he would tell me, 'Don't drink. Don't drink.'" Trump said at the time that he listened to his brother because he "respected him," adding that "to this day, I've never had a drink." Sen. Markwayne Mullin, R-Okla., who attended the news conference, supported the recommendation based on his family's experience with addiction, though he did not detail exactly to whom he was referring. "It's an addiction that is ruining lives," Mullin said at a Tuesday news conference. He went on to thank Kennedy on behalf of his own family and "every single family that has dealt with this" for acting against the powerful drug. The CDC reported in May that drug overdose deaths in the country dropped in 2024. The U.S. saw "80,391 drug overdose deaths in the United States during 2024 — a decrease of 26.9% from the 110,037 deaths estimated in 2023." Additionally, the CDC found that "overdose deaths involving opioids decreased from an estimated 83,140 in 2023 to 54,743 in 2024." Kratom, the plant from which 7-OH is derived, is a tropical tree native to Southeast Asia. The FDA notes that kratom is often used to self-treat a variety of conditions, such as pain, anxiety and depression. The agency notes that it has not approved any prescription or over-the-counter drug products containing kratom or its two main chemical components: mitragynine and 7-OH.
Yahoo
an hour ago
- Yahoo
Novo Lifer Takes Job of Reviving Europe's Weight-Loss Superstar
(Bloomberg) — Maziar Mike Doustdar spent more than three decades quietly climbing the ranks of Novo Nordisk A/S, from office clerk through logistics and marketing roles to head of international operations. Now the relatively unknown insider is moving into the spotlight with a daunting task: revive a once high-flying drugmaker from a steep descent that's wiped out two-thirds of its value in the past year. Budapest's Most Historic Site Gets a Controversial Rebuild San Francisco in Talks With Vanderbilt for Downtown Campus The World's Data Center Capital Has Residents Surrounded An Abandoned Art-Deco Landmark in Buffalo Awaits Revival Trump Administration Sues NYC Over Sanctuary City Policy Doustdar has pledged to work quickly, and there were hints on Tuesday that part of his response may involve cutbacks and job reductions. He said he would look at 'realigning the cost base,' though he didn't offer any details. Doustdar's appointment as Novo's new chief executive officer was announced alongside a stark reminder of the challenges ahead, particularly in the US, the biggest market for obesity treatments. The Danish firm, based just north of Copenhagen, cut its earnings outlook as its blockbuster weight-loss drug Wegovy continues to cede ground to archrival Eli Lilly & Co., whose competing treatment has gained momentum in the US market and beyond. The 54-year-old inherits a global powerhouse facing a critical point after being beset with supply shortfalls, drug pipeline failures and sharp competition that's shaken investor confidence in its prospects. Questions have already emerged on whether Doustdar — who has helmed Novo's non-US operations in recent years — is the right leader, given the company's headwinds are particularly linked to the US. He pushed back against any doubts on a call on Tuesday, defending his track record. The US is 'more than half of our business and we don't just sit there running our own area, but we support the CEO,' he said. 'So I've sat in this executive management team for more than 10 years and I know enough of the US business.' The past year has marked a sharp reversal of fortune for Novo, which became a household name for jump-starting the booming obesity drug market with its GLP-1 medicines. But it's failed to keep up with runaway demand and misjudged the speed and scale of competition, including a shadow market of copycat compounds. Mixed trial data and heightened political scrutiny over pricing have further shaken investor confidence. The stock's slump from its June 2024 peak has erased more than $400 billion from Novo, dethroning it as Europe's most valuable company. That ultimately cost its former CEO, Lars Fruergaard Jorgensen, his job in May. After the cut to the outlook, the shares fell almost 30% at one point on Tuesday. They closed down 23%, the biggest one-day drop on record. 'I don't like it,' Doustdar said of the share-price moves. He added that 'setbacks don't define companies. Our response does.' Novo is also hugely important to Denmark. The company has doubled its headcount over the past decade to more than 77,000 people, and just under a half of them work in its home country. In many ways, the drugmaker's influence in Denmark is outsized: for a time last year, its market value topped the size of the economy, its tax bill helps fund the government's increased defense spending and booming drug exports have forced the central bank to keep interest rates low. On Tuesday, Novo Chair Helge Lund described Doustdar as a 'natural challenger,' saying he 'has a bias for speed, for pace and for action.' The new CEO is an Austrian national, who was born in Iran and raised in the US. He joined Novo in 1992 in Vienna. He ran with the idea of speed when speaking to investors on Tuesday. 'We will sharpen our focus and move faster,' Doustdar said. 'We will operate more efficiently. We will advance our pipeline and keep pushing the boundaries of innovation, and we will invest to accelerate growth and deliver shareholder value. That is my promise to you.' —With assistance from Lisa Pham and Christian Wienberg. Burning Man Is Burning Through Cash It's Not Just Tokyo and Kyoto: Tourists Descend on Rural Japan Cage-Free Eggs Are Booming in the US, Despite Cost and Trump's Efforts Everyone Loves to Hate Wind Power. Scotland Found a Way to Make It Pay Off Elon Musk's Empire Is Creaking Under the Strain of Elon Musk ©2025 Bloomberg L.P.
The Hill
an hour ago
- The Hill
FDA recommends concentrated Kratom be scheduled as illicit substance
The Trump administration is recommending that a compound called 7-OH be scheduled as an illicit drug, Food and Drug Administration Commissioner Marty Makary announced Tuesday. The compound is a concentrated by-product of the Kratom plant whose ground leaves are sold as a dietary supplement to boost energy or provide pain relief. FDA officials said the substance has a 'high risk of addiction' and abuse in concentrated form because of its ability to bind to opioid receptors in the brain. Makary said the agency is urging the Drug Enforcement Agency to classify 7-OH as a Schedule 1 substance, placing it on list of drugs that include heroin, lysergic acid diethylamide (LSD) and ecstasy. 'We have a history in public health of being asleep at the wheel,' Makary said. 'Public health is supposed to prevent disasters, not just clean them up after they've killed thousands and thousands of people.' The American Kratom Association (AKA), a trade group representing the industry, applauded the recommendation to classify 7-OH as a Schedule 1 substance. 'This bold step is a critical milestone in protecting public health and consumer safety from dangerous synthetic products that masquerade as natural kratom,' the AKA said in a statement. A spokesperson for the group said that the FDA's decision shines a light on a 'massive and growing' problem in the kratom marketplace. Earlier this month, the FDA sent warning letters to seven companies regarding allegations that they are illegally marketing 7-OH products as dietary supplements or as a product that can relieve pain or manage anxiety. Department of Health and Human Services officials said during a Tuesday press conference that they have seen a 'disturbing' rise in reports of poisonings and emergency room visits linked to products containing 7-OH which can be found in tablets, gummies, mixed drinks or shots. But officials did not point to data on the scale of the rise in adverse health events. These products are often sold online or in convenience stores, gas stations and vape shops, officials said, with no 'quality control, no dosage control and no warnings.' 'This is a recipe for a public health disaster,' said Jim O'Neil, deputy secretary at the Department of Health and Human Services. 'Young people, veterans and people who suffer from chronic pain or addiction are being misled into thinking that these are safe alternatives. They're not.' Kratom has gained popularity as an alternative pain reliever amid the country's opioid epidemic with some studies suggesting that up to 15 million Americans have use it to treat chronic pain or opioid withdrawal symptoms. In small doses, Kratom can act as a stimulant but can also cause an 'opioid-like' drowsiness and euphoria, experts say. Concentrated Kratom or highly potent Kratom products can cause harmful side effects like nausea, vomiting and even seizures. Tuesday's announcement is the Trump administration's effort to prevent another 'wave of the opioid epidemic' from blindsiding the country, Makaray said. 'There's a lot we don't know. This may be the calm before the storm,' he said. 'It may be the tip of the iceberg, but let's be aggressive and proactive.' The DEA previously announced it would schedule kratom compounds as controlled substances in 2016 but opted not to after receiving intense pushback. Makary stressed that the Trump administration is targeting synthetic, concentrated kratom when asked by a reporter if officials were prepared to deal with similar pushback again.
