Sarepta resumes shipping of gene therapy Elevidys to patients who can walk
However, the use of the gene therapy remains on hold for Duchenne Muscular Dystrophy patients who cannot walk, the FDA said, adding that it is continuing to work with the company while investigating the death of two patients.
The FDA's recommendation for ambulatory patients - those who can walk - followed a probe that showed the death of an eight-year-old boy in Brazil, was unrelated to the gene therapy, the agency said.
Roche, which has partnered with Sarepta for commercialization outside the U.S., had previously said the patient's death was not related to the therapy, according to the reporting physician's assessment.
Sarepta is also facing intense scrutiny following the death of two non-ambulatory teenage boys associated with Elevidys, as well as a 51-year-old man who had received its experimental gene therapy SRP-9004.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Independent
4 minutes ago
- The Independent
Trump's agriculture secretary doubles down on suggestion people should work on farms to avoid losing Medicaid
Americans at risk of losing their Medicaid government health coverage because of new work requirements signed into law by the Trump administration should find employment on U.S. farms, according to Secretary of Agriculture Brooke Rollins. 'We have way too many people that are taking government program that are able to work,' Rollins said in an interview on Fox Business on Tuesday. 'This is not children. These are not disabled [people]. These are not senior citizens. These are able-bodied Americans who are taking government handouts.' In July, the Trump administration created new work requirements for Medicaid, a state-federal program providing healthcare to over 77 million mostly low-income people, as part of its One Big, Beautiful Bill spending package. Under the new requirements, passed alongside sweeping tax cuts disproportionately benefitting the rich, able-bodied people on Medicaid are required to show they have completed 80 hours of work or community service per month to maintain their coverage, with limited exceptions for parents and caretakers with young children, pregnant people, and other groups. The Congressional Budget Office, reviewing a draft version of the bill that passed the House, estimated the requirements would cause nearly 5 million people to lose coverage by 2034. Rollins has suggested that Medicaid recipients should head to the fields in the past. In July, in the face of concern that the administration's mass deportations would decimate the country's immigrant-heavy farm labor force, Rollins argued that 'more automation' and a '100 percent American workforce' could make up the losses. 'There are 34 million able-bodied adults in our Medicaid program,' he said. 'There are plenty of workers in America.' The Congressional Budget Office found that there were about 34 million working-age, non-disabled Medicaid enrollees in 2024, though analysts suggest Rollins is overstating the degree to which participants in the health program are unemployed and skimming from the government. An analysis from health policy group KFF found that there are about 26 million Medicaid-covered adults between the ages of 19 and 64 who don't receive disability benefits, and that nearly two-thirds of this group were working either full or part-time. Among the remaining portion, 12 percent said they were not working because they were caregiving, while 10 percent listed illness or disability and seven percent said school attendance kept them from working. Another study, from University of Massachusetts Boston researchers, found that among able-bodied, unemployed Medicaid recipients, almost 80 percent are female, their average age is 41, and their median individual income is $0. "It's clear based on their prior work history and family size/income that they are exceptionally poor and have likely left the workforce to care for adult children or older adults," researcher Jane Tavares told PolitiFact. "Even if these individuals could work, they would have very few job opportunities and it would come at the cost of the people they are providing care for." Other analysts point to states like Arkansas that have tried to use work requirements to cut costs and drive employment. The state, which attempted such requirements seven years ago, saw 18,000 people kicked off Medicaid rolls in the span of four months, yet saw no positive employment impact. 'There is not an epidemic of non-working able-bodied adults living high on Medicaid, despite such claims from the Trump administration,' Matt Bruenig, founder of the People's Policy Project, a progressive think tank, argued in a May op-ed in The New York Times. 'Medicaid work requirements are a solution to a problem that doesn't exist.' Among working-age Medicaid beneficiaries, about half are working, a quarter have a work-limiting disability, and an additional one-fifth will find employment or come off the program within 15 months, Bruenig said in the piece, leaving only about 6 percent of working-age Medicaid enrollees who probably can find work but haven't done so.
The Independent
4 minutes ago
- The Independent
Tennessee man who was executed while defibrilator was still active was ‘hurting so bad'
An inmate executed by the state of Tennessee reportedly cried out in pain shortly after the lethal injection began, with witnesses claiming he was "hurting so bad" despite an implanted defibrillator remaining active. Byron Black's death has sparked controversy, as he was put to death amid uncertainty over whether the device would shock his heart as the lethal chemicals took effect. Prison officials confirmed Black died at 10:43 a.m., approximately 10 minutes after the execution commenced. Asked for any last words, he replied, "No sir." As the process began, Black was observed looking around the room, lifting his head off the gurney multiple times, sighing and breathing heavily. All seven media witnesses present agreed he appeared to be in discomfort. A spiritual advisor prayed and sang over Black throughout the execution, at one point touching his face. "Oh, it's hurting so bad," Black was heard to say, restrained to the gurney with an IV line in his arm. The advisor responded, "I'm so sorry. Just listen to my voice." The execution proceeded despite a protracted legal battle over whether officials should have deactivated his implantable cardioverter-defibrillator (ICD). Black, 69, was in a wheelchair and suffered from numerous severe health conditions, including dementia, brain damage, kidney failure, and congestive heart failure, according to his attorneys. A trial court judge had initially agreed with Black's legal team that the defibrillator should be deactivated to prevent unnecessary pain and prolonging the execution. However, Tennessee's Supreme Court overturned this decision, stating the lower court lacked authority. The state had argued that the lethal injection would not cause the defibrillator to shock him, or that he would not feel it if it did. Black's attorney, Kelley Henry, condemned the execution, stating: "Today, the state of Tennessee killed a gentle, kind, fragile, intellectually disabled man in a violation of the laws of our country simply because they could." Ms Henry expressed particular concern over Black's head movement and complaints of pain, noting that the massive dose of pentobarbital used in lethal injections is intended to induce rapid unconsciousness. "The fact that he was able to raise his head several times and express pain tells you that the pentobarbital was not acting the way the state's experts claim it acts," she added. Prison officials have not commented on the witnesses' observations or Black's complaints of pain. Ms Henry confirmed that Black's defence team would meticulously review autopsy results, EKG data, and information from the defibrillator to ascertain the precise events during the execution. Black was convicted for the 1988 shooting deaths of his girlfriend, Angela Clay, 29, and her two daughters, Latoya, 9, and Lakeisha, 6. Prosecutors alleged he acted in a jealous rage, having been on work-release at the time, serving a sentence for shooting Ms Clay's estranged husband. Linette Bell, Angela Clay's sister, stated after the execution: "His family is now going through the same thing we went through 37 years ago. I can't say I'm sorry because we never got an apology." Black's legal team had previously made unsuccessful attempts to secure a new hearing regarding his intellectual disability, which they contend he has exhibited since childhood. Individuals with intellectual disabilities are constitutionally barred from execution in the US. His attorneys argued that a delay in an earlier attempt to raise this claim would have spared him under a 2021 state law, which denies hearings to death row inmates who have already had a similar request ruled upon "on the merits." Nashville District Attorney Glenn Funk's attempt to secure a new hearing for Black was denied, despite an expert who had previously determined Black did not meet the criteria for "mental retardation" in 2004, now concluding he met the new law's criteria for an intellectual disability diagnosis. The non-profit Death Penalty Information Centre and Black's attorneys have stated they are unaware of any other cases involving similar claims regarding implanted defibrillators or pacemakers during executions. The legal case also served as a reminder that most medical professionals consider participation in executions a violation of healthcare ethics. This marks Tennessee's second execution since May, following a five-year hiatus due to Covid-19 and state corrections officials' missteps. So far this year, 28 individuals have been executed by court order in the US, surpassing the 25 carried out last year and in 2018, and representing the highest total since 2015.
Daily Mail
an hour ago
- Daily Mail
More states ban certain people from buying junk food... is YOURS one of them?
Soda and candy have now been made off-limits to certain Americans in six more states as officials continue to clamp down on what people can buy with food stamps. Low-income residents in West Virginia, Florida, Colorado, Louisiana, Oklahoma, and Texas will be barred from buying the goods under the Supplemental Nutrition Assistance Program (SNAP). These restrictions are further built on top of a movement started earlier this year. Secretary of Agriculture Brooke Rollins has previously banned the foods from SNAP recipients in Nebraska, Iowa, Indiana, Arkansas, Idaho, and Utah. The controversial move is aimed at improving the health of the millions of Americans in those states who rely on food stamps. While the plans would ban sugary and high-calorie sweets, they would also exclude purchases of diet sodas and fruit juice with less than 50 percent natural juice, as these are high in sugar and artificial sweeteners. Restricting junk food from the $100billion-a-year federal SNAP program has been a key goal for health secretary Robert F Kennedy Jr and his 'Make America Healthy Again' agenda. The first-of-its-kind ban will become effective for all the participating states starting January 1, 2026 and last for at least two years. Other Republican-led states are set to roll out similar measures. Serving nearly 42million Americans, SNAP helps low-income families purchase fruits, vegetables, meat, poultry, fish, dairy products, breads and cereals, snacks and plants that can produce foods. It is run by the US Department of Agriculture (USDA) and administered through individual states. In general, benefits are available to people with an income at or below about $33,500 a year for a three-person household. Over the past two decades, lawmakers in several states have proposed halting SNAP payments for soda, chips, ice cream and 'luxury meats' like steak, as well as bottled water and decorated birthday cakes. However, despite multiple proposals being submitted, no other presidential administration, including President Donald Trump's first, has approved them in the past. Secretary Rollins said: 'It is incredible to see so many states take action at this critical moment in our nation's history and do something to begin to address chronic health problems. 'President Trump has changed the status quo, and the entire cabinet is taking action to Make America Healthy Again. 'At USDA, we play a key role in supporting Americans who fall on hard times, and that commitment does not change. Rather, these state waivers promote healthier options for families in need.' According to the USDA website, food stamps users spend over $600million a year on sweetened beverages including soft drinks and energy drinks. A 2024 scientific review published in the journal Public Health by British researchers found that energy drinks can raise the risk of physical and mental health problems among children. For example, kids who consume the beverages, which can contain more caffeine than a cup of coffee, are more likely to be overweight and develop heart problems. They also face a higher chance of getting mental health problems, such as anxiety, depression and suicide attempts. The ban comes as RFK Jr has continued to push for restricting junk food from SNAP since his nomination as Department of Health and Human Services (HHS) Secretary. The leader of the Make America Healthy Again movement has repeatedly called soda 'poison' and claimed it can cause damage to human health. Kennedy has also previously suggested Americans who eat donuts, guzzle sodas or smoke should not be provided with free healthcare. 'If you're smoking three packs of cigarettes a day, should you expect society to pay when you get sick?' he told CBS. The nation's top health official noted it is the American people's choice to 'eat donuts all day' and he would not to take it away. However, he went on to say junk food lovers cannot expect 'society to care for them' since there is possibility for them to get 'very sick.' His claims have long put him at odds with President Trump as the latter is known to enjoy multiple sodas per day, albeit the sugar-free versions. Shortly after being sworn-in for the second time, President Trump also re-installed a bright red button on his desk in the Oval Office to notify an aide that the commander-in-chief wants a fresh Diet Coke. The 79-year-old reportedly drinks multiple cans of Diet Coke a day and is known to indulge in an occasional burger and fries for his meals. Trump yet to make a comment on the newly announced wave of bans. Prior to these waivers, SNAP recipients could buy anything except alcohol, tobacco, hot and prepared foods, and personal care products. Antihunger groups oppose SNAP food restrictions, saying that research shows that program participants are no more likely than other low-income Americans to buy sugary drinks or snack foods. And they say that limiting food choices undermines the autonomy of people who receive a benefit of about $187 per month — or about $6.20 per day. 'They just seem to be targeting a specific population without having data that says that they are the issue or that this is going to improve,' said Gina Plata-Nino, a deputy director at the Food Research and Action Center, a nonprofit advocacy group. Trade groups representing beverage and candy makers criticized the effort, saying that they narrowly target SNAP participants. Representatives for the soda industry accused state and federal officials of 'choosing to be the food police rather than take truly meaningful steps to lift people off SNAP with good-paying jobs.' Chris Gindlesperger, a spokesman for the National Confectioners Association, called the approach 'misguided.' 'SNAP participants and non-SNAP participants alike understand that chocolate and candy are treats – not meal replacements,' Gindlesperger said.
