logo
Sarepta says eight-year-old death deemed unrelated to Elevidys

Sarepta says eight-year-old death deemed unrelated to Elevidys

Sarepta (SRPT) said in a statement Friday night: 'Just before 6:00 p.m. ET today, the U.S. Food and Drug Administration issued a press release announcing an investigation into the death of an eight-year-old Duchenne muscular dystrophy patient who had received Elevidys gene therapy. The death of this patient was deemed unrelated to treatment with Elevidys…Sarepta reported this event to FDA on June 18, 2025, via the FDA's postmarketing electronic database, FAERS. At Sarepta, patient safety and well-being are always our top priority. We are committed to upholding the highest safety standards for all of our therapies, and do so in accordance with applicable law and commitment to full regulatory transparency. Elevidys is the only approved gene therapy for families and children devastated by Duchenne, a rare, progressive and ultimately fatal disease. We remain committed to working closely with the FDA to ensure that all decisions are grounded in science and the best interests of patients, considering the compelling need of these families to access disease-modifying therapy.'
Elevate Your Investing Strategy:
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Social media weighs in on High Noon, Celsius mix-up
Social media weighs in on High Noon, Celsius mix-up

Yahoo

time18 minutes ago

  • Yahoo

Social media weighs in on High Noon, Celsius mix-up

News that some popular canned cocktails were mislabeled as non-alcoholic energy drinks instantly drew online comparisons to a Willy Wonka-like golden ticket search. Meanwhile, others raised concerns about the mix-up's implications for people who are sober or abstaining from alcohol. High Noon issued a recall on July 29 for its Beach Variety 12-pack vodka seltzers after some cans were mislabeled as Celsius Astro Vibe Sparkling Blue Razz Edition drinks, according to the U.S. Food and Drug Administration's website. "Consumption of the liquid in these cans will result in unintentional alcohol ingestion," the recall said. High Noon recall: Vodka seltzers mislabeled as Celsius energy drinks What to know about High Noon recall caused by Celsius cans High Noon said some Celsius cans were mistakenly filled with the alcoholic beverage. The mix-up happened after a shared packaging supplier erroneously shipped empty Celsius cans to High Noon, the company said. According to the recall notice, the affected packs were sent to stores in Florida, Michigan, New York, Ohio, Oklahoma, South Carolina, Virginia and Wisconsin between July 21 and July 23: High Noon Beach Variety Packs (12-pack of 12 fluid ounce cans), lot codes include: L CCC 17JL25 14:00 to L CCC 17JL25 23:59 and L CCC 18JL25 00:00 to L CCC 18JL25 03:00 Celsius Astro Vibe Sparkling Blue Razz Edition (12 fluid ounce cans), lot codes include: L CCB 02JL25 2:55 to L CCB 02JL25 3:11 "We are working with the FDA, retailers, and distributors to proactively manage the recall to ensure the safety and well-being of our consumers," High Noon said in a statement to USA TODAY. No illnesses have been reported in connection to the recall so far, according to High Noon. Internet reacts to High Noon, Celsius mix-up Social media users were quick to react to the unusual blunder that caused the recall, with many saying they were hoping to find the affected cans for an unexpected booze break. "This is the one recall i want to be apart of," one person wrote on TikTok. Others on X, formerly Twitter, chimed in with the same sentiment. Some even compared such a discovery to "Charlie and the Chocolate Factory." The famous children's series is based on a contest to find a golden ticket in order to tour Willy Wonka's factory. Some people, on the other hand, raised concerns about the possible implications that mixing up an energy drink with an alcoholic one could have. Contributing: Fernando Cervantes Jr., USA TODAY Melina Khan is a national trending reporter for USA TODAY. She can be reached at This article originally appeared on USA TODAY: High Noon, Celsius recall elicits various social media reactions

Freeze Dried Fruit Recall With Possible 'Fatal Infections' Warning
Freeze Dried Fruit Recall With Possible 'Fatal Infections' Warning

Newsweek

time21 minutes ago

  • Newsweek

Freeze Dried Fruit Recall With Possible 'Fatal Infections' Warning

Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Doehler Dry Ingredient Solutions, LLC initiated a nationwide recall of its Member's Mark Freeze Dried Fruit Variety Pack after internal testing discovered contamination with Listeria monocytogenes, a potentially life-threatening bacterium. Why It Matters The affected products were distributed to Sam's Club locations in over 40 states from July 1 to July 25, 2025, according to a U.S. Food and Drug Administration (FDA) alert published on July 31. So far, no illnesses have been reported in connection with the recall. Listeria monocytogenes is known to cause listeriosis, a foodborne illness particularly dangerous for vulnerable populations like young children, the elderly, and pregnant women. Healthy people typically experience short-term ailments such as fever, headaches and diarrhea, but the infection can be fatal in people with compromised immune systems. The FDA and USDA have stressed that resourceful recall systems are critical for minimizing the impact of foodborne illnesses on public health and for maintaining consumer confidence in the food supply chain. A photo of a Member's Mark Freeze Dried Fruit Variety Pack 15-count box recalled due to Listeria contamination. A photo of a Member's Mark Freeze Dried Fruit Variety Pack 15-count box recalled due to Listeria contamination. FDA/Member's Mark What To Know The recall affects Member's Mark Freeze Dried Fruit Variety Pack, sold in 15-count boxes with the UPC code 1 93968 50900 2. Affected products carry lot numbers ranging from 25175 to 25206 and have use-by dates from June 24, 2027, to July 25, 2027. The products were packaged in foil pouches inside a corrugated box, with the lot number and expiration date located on the bottom. These were distributed in Sam's Club stores across the following states: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming. The contamination was identified during routine internal product testing by Doehler Dry Ingredient Solutions, LLC. Following confirmation, and in line with FDA protocols, the company initiated a voluntary recall and coordinated with federal officials to notify the public and retail partners. Consumers who purchased the recalled product should not eat it. They are instructed to dispose of the product immediately and may obtain a full refund at any Sam's Club location. Additional questions can be directed to Doehler Dry Ingredient Solutions, LLC's Customer Service at (770) 387-0451, Monday through Friday, from 8 a.m. to 5 p.m. ET. What People Are Saying Doehler Dry Ingredient Solutions, LLC, in a statement to the FDA on July 30: "Consumers who possess the recalled product should not consume it. They are advised to discard the product and can visit any Sam's Club location for a full refund." What Happens Next Doehler Dry Ingredient Solutions, LLC, is working with retailers and the FDA to remove affected products from the supply chain. Consumers are expected to continue receiving updates via the FDA and company channels if further risks are identified. Federal authorities remind the public to monitor food recall alerts and properly clean surfaces that have come into contact with the recalled product to prevent cross-contamination.

The Man Who Was Too MAHA for the Trump Administration
The Man Who Was Too MAHA for the Trump Administration

Atlantic

time21 minutes ago

  • Atlantic

The Man Who Was Too MAHA for the Trump Administration

Vinay Prasad, until Tuesday one of the country's top medical regulators, just got a bitter taste of what it means to have real power. In recent months, the academic hematologist-oncologist, medical contrarian, and polemic podcaster had become a central figure at the U.S. Food and Drug Administration. In May, he was chosen to lead its Center for Biologics Evaluation and Research—a position that gave him authority over vaccines and gene therapies. In June, Marty Makary, who is currently the FDA commissioner, bestowed upon him an even more important role: chief medical and scientific officer of the entire agency. This week, Prasad abruptly departed. We don't know the exact reason behind Prasad's departure. According to a Department of Health and Human Services spokesperson, he resigned to 'spend more time with his family.' (Neither Prasad nor HHS responded to my request for comment.) Politico reports that President Donald Trump ordered his removal this week over the objections of Makary and Health and Human Services Secretary Robert F. Kennedy Jr. Whatever the particulars, Prasad's sudden need for a better work-life balance suggests the administration is following a time-honored approach to medical regulation: Business comes first. Prasad's troubles began in the first weeks of his tenure at the FDA, when he overruled the agency's own scientific reviewers by limiting the use of COVID vaccines. In doing so, he managed to anger the country's pro- and anti-vaccine factions at the same time. While many public-health experts criticized the decision to limit access to the shots, Kennedy's allies in the 'Make America healthy again' movement felt betrayed by the fact that the government had allowed mRNA shots to remain available at all. Prasad also faced a blitz from the pharmaceutical industry and patient-advocacy groups after the FDA tried to suspend distribution of a gene therapy for Duchenne muscular dystrophy called Elevidys, over safety concerns. For those affected by this rare, incurable condition, the move was seen as an outrageous denial of their right to weigh the drug's risks and benefits for themselves, and an extinguishing of what had been at least a glimmer of hope. Two days later, the right-wing provocateur Laura Loomer publicly accused Prasad of 'sabotaging Trump's deregulatory agenda,' and an opinion writer for The Wall Street Journal declared him a 'one-man death panel.' I know Prasad a bit: I've twice been a guest on his podcast, and I've followed his prolific academic work and public commentary about evidence-based medicine since about 2016, when he was a young professor at Oregon Health & Science University working to identify low-value medical practices. We've had our disagreements over the years. But with respect to Elevidys and drugs like it, our views are in alignment. We share the worry, for example, that the FDA keeps lowering its approval standards for drugs that keep getting more expensive. 'The American economy can handle a great deal of wasteful health-care spending,' Prasad told me in an interview in 2021. 'But it can't tolerate an infinite number.' His skepticism of Elevidys, in particular, is both long-standing and well-founded. The therapy has not been conclusively shown to slow the progression of the muscle-wasting disease it targets, but it does often induce vomiting and damage patients' livers. Worryingly, it also appears to be related to a pair of deaths. Prasad's predecessor in his role at CBER, Peter Marks, approved the drug, which costs $3.2 million per course of treatment, in spite of his own staff's uncertainty about its benefit. (Marks was forced out by Kennedy this spring, after the two clashed over access to vaccine-safety data.) Read: The sanewashing of RFK, Jr. That Prasad should take a tough line on drug regulation was perfectly in keeping with his history. He rose to prominence on that basis: To his many fans, he was a dogged and courageous industry watchdog; to his many critics, a self-righteous pharma scold. That mainstream Republicans should balk at this approach, and strive to undo it, was equally predictable. Politicians, particularly those on the right, have for years supported patients' ability to obtain still-unproven therapies. During Trump's first term, the president signed into law the 'Right to Try Act,' which expanded access to experimental drugs. That law was championed by Republican Senator Ron Johnson, who, according to reporting from STAT, may have been instrumental in Prasad's ouster. One might have guessed that things were different now in Washington—that Kennedy's eccentric philosophy had ushered in a novel form of conservative leadership, in which business interests didn't always lead the way. Thus far, however, the MAHA movement has done little to adjust the status quo. Instead, it has mostly wallowed in its own contradictions. We've been told that cooking with seed oils is toxic but that treating measles with cod-liver oil is great; and that both deworming pills and microbe-laden raw milk are good for you. MAHA leaders have declared the FDA a ' sock puppet of industry ' from which Prasad himself would provide a ' welcome reprieve,' while also championing the public's right to choose its food and drugs (even as they interfere with the distribution of some vaccines). So which is it? Should people have easy access to almost any health-care intervention, or should the government protect vulnerable patients from drugs for which there isn't rigorous evidence of benefit? For years, Prasad has been clear on where he stands in that regard. 'It is not a case of patients who crave risk facing off with regulators who abhor it,' he wrote in a medical journal in 2019. Rather, the current system, in which 'reliable data are inconsistently generated,' has failed patients who wish to make informed decisions about their care. Whenever this tension has been tested in the Trump administration, MAHA leaders have almost always seemed inclined to move the other way. A recent op-ed by the FDA's Makary and Mehmet Oz, the head of the Centers for Medicare & Medicaid Services, summed up the current regulatory approach as follows: Agency bureaucrats should cooperate with industry leaders instead of antagonizing them, and the government should favor 'market solutions' over 'prescriptive regulation.' Indeed, even as the news of Prasad's firing was coming out, Makary was promoting his 'national listening tour' of private interests. 'Looking forward to hearing from more pharma and biotech CEOs!' he wrote on X. Prasad himself appeared to recognize which way the wind was blowing. From the moment he took office, he was tempering his point of view. Before he became a political appointee, Prasad was dogmatic in his dismissal of evidence that did not emerge from large, randomized clinical trials. ('As readers know, my philosophy is RCT or STFU,' he wrote in his newsletter in 2023.) But Prasad seemed to back away from this idea even in his opening remarks to his new colleagues and staffers. 'Randomized controlled trials are not always necessary, and when they are done, they are not always informative,' he reportedly said on May 7, his second day on the job. Such appeasement efforts proved insufficient to protect him from rival forces in the Republican Party, if not also in the MAHA movement itself. For the moment, Prasad has been replaced at CBER by the wealthy biomedical entrepreneur George Tidmarsh. Surely that will come as a relief to a constituency that seems to hold immense sway with this administration: America's drug companies and medical-device makers.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store