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U.S. Health Secretary Robert F Kennedy Jr. could deliver a policy win for the Trump administration in just a few months after the Food and Drug Administration enlisted GSK to help it fast-track approval of a decades-old drug to treat an autism-related disorder. The FDA’s unusual move will allow it to bypass a lengthy label update for generic versions of the drug, leucovorin, or new clinical trials, a tactic academics, lawyers and doctors questioned. A GSK spokesperson told Reuters it plans to complete the new use application for the branded version of leucovorin as quickly as possible. Once the British drugmaker does that work, the FDA would normally take about four to six months but could process the request even faster, said Giuseppe Randazzo of the Association for Accessible Medicines, a generic medicines lobby group. The accelerated process will give doctors additional justification to prescribe the drug for cerebral folate deficiency, a metabolic disorder that can lead to a range of neurological symptoms including some associated with autism, delivering on Kennedy’s promise to President Donald Trump and the Make America Healthy Again movement with which he is aligned. Without robust evidence, the label change represents at most a hollow bureaucratic victory, said Ameet Sarpatwari, a pharmaceutical policy researcher at Harvard Medical School. However, the drug, which is used to mitigate toxic effects of certain cancer treatments and sells for $34.14 for a bottle of 30 high-dose pills on Cost Plus Drugs, would more likely be covered for the condition by insurance plans with the label change. An HHS spokesperson said the evidence clearly supports leucovorin’s ability to address the causes of cerebral folate deficiency and improve patient outcomes. DEMAND RISES AFTER TRUMP PROMOTES DRUG Demand for the drug has increased, first after a February CBS story about its use in a nonverbal five-year-old boy, and more recently after Trump promoted its use. “My nurses have been saying the phone is ringing off the hook,” said Dr. Larry Gray, an expert in developmental and behavioral pediatrics, who sees patients with autism at Lurie Children’s Hospital of Chicago. Because the treatment is not approved for autism, the institution’s policy has been to only offer it in clinical trials, which are rare. The drug is FDA-approved, however, so doctors can prescribe it off-label. Kennedy has declared the rising rates of autism in the U.S., now estimated at 1 in 31 children by age 8, to be an epidemic and had pledged to find some answers behind its cause as well as cures by September. At a White House event on September 22, Kennedy, Trump and other health officials backed leucovorin as an autism treatment. They also warned against the use of Tylenol by pregnant women, saying studies suggested a link to autism. Health experts and medical groups called that warning dangerous and without sound scientific basis. RELYING ON OBSCURE RULE The FDA was able to speed the process by using an obscure rule to reinstate GSK’s approval application and request a label update adding cerebral folate deficiency, based on the agency’s own analysis of 40 patient cases found in a review of literature from 2009 to 2024. GSK sold the drug as Wellcovorin until 1997. A generic version, which is also called folinic acid and is a form of folate or vitamin B9, is now made by U.K.-based Hikma. Once GSKs application is approved, U.S. law requires generic drugmakers to match the change. The more commonly used label update process for generic drugs, which requires consultation with generic drugmakers, typically takes up to a year and a half, according to Skadden lawyer Rachel Turow. It is typically used for cancer drugs after new uses are proven in clinical trials, she and several other lawyers said. Aaron Kesselheim, professor of medicine at Harvard Medical School, described the process being used as “very atypical,” and said that without the FDA sharing its data or trials, it is hard to know if the agency is following the normal standard of evidence. LIMITED AVAILABLE EVIDENCE Dr. Andy Shih, chief science officer at the advocacy organization Autism Speaks, said the evidence for leucovorin’s use was limited and potentially suggestive of benefit for a small subgroup of autistic children. Larger trials are needed, he said. The evidence is based on four studies, each of which involved 50 to 60 patients, with three of them done by the same author, said Dr. Karam Radwan, director of the Neurodevelopmental Disorders Program at the University of Chicago, who uses the drug in his practice. “You want to replicate that with a different lab, in a different setting, to make sure we have enough support” for the change, he said. Three mid-stage trials are underway studying a new, liquid version of leucovorin as an early language impairment treatment for children with autism, according to the government clinical trials site. The earliest data is expected around December. The trials are being led by one autism researcher in partnership with the National Institutes of Health, the Department of Defense, and Autism Speaks, and involve up to 80 children each. Larger, more conclusive trials would take years. The FDA’s approach does not require new trials. This change should be based on scientific evidence, and so far, studies supporting its use are not robust, Radwan said. Additional reporting by Robin Respaut Patrick Wingrove, Maggie Fick and Julie Steenhuysen, Reuters
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Wall Street is hanging near its records on Monday, as technology stocks keep rising.The S&P 500 rose 0.3%, coming off its latest all-time high. The Dow Jones Industrial Average added 17 points, or less than 0.1%, as of 9:35 a.m. Eastern time, and the Nasdaq composite was 0.4% higher.Advanced Micro Devices soared 32.6% to help lead the market after announcing a deal where OpenAI will use its chips to power artificial-intelligence infrastructure. As part of the deal, OpenAI could own up to 160 million shares of AMD if it hits certain milestones.A frenzy around AI has been one of the main reasons Wall Street has been hitting record after record, though that’s also raising worries that prices have potentially shot too high. Much of the furor around AI in the last couple weeks has come from OpenAI, which has quickly become a $500 billion company, announcing deals with businesses around the world to develop more AI infrastructure.Another chip company, Nvidia, announced a deal last month where it would invest $100 billion in OpenAI as part of a partnership, creating criticism that the AI investment pipeline was beginning to appear like a circle. Nvidia fell 1.5% following the AMD announcement.Outside of tech, Comerica jumped 16.5% after Fifth Third Bancorp agreed to buy its rival in an all-stock deal valued at $10.9 billion. The combination would create the country’s ninth-largest bank. Fifth Third added 1%.Elsewhere on Wall Street, trading remained relatively quiet as the stock market continues to largely ignore the U.S. government’s shutdown. Past closures of the federal government have had minimal effect on the stock market or on the economy, and the bet on Wall Street is that something similar will happen again.Politics are playing a more active role in stock markets abroad, though, as Japanese stocks soared and French stocks slumped following their latest political shake-ups.Japan’s Nikkei 225 jumped 4.8% after the country’s Liberal Democratic Party chose Sanae Takaichi as its leader and likely Japan’s first woman prime minister. She was an ally of the late Prime Minister Shinzo Abe, who pushed for lower interest rates and market-friendly policies.The yen’s value dropped against the U.S. dollar on expectations that Takaichi will boost spending, likely adding to inflationary pressures. That in turn helped push up stocks of Japanese exporters, whose products can become more attractive on the global market because of a cheaper yen.“Obviously, investors like what she has been saying and certainly today judging by the number of stocks that moved and which stocks moved, it seems like pretty much led by foreigners so far,” Neil Newman, head of strategy at Astris Advisory Japan, said about Takaichi.In Paris, the CAC 40 index slumped 1.2% following the resignation of France’s new prime minister.Sébastien Lecornu resigned a day after he named his government, drawing a backlash across the political spectrum for his choice of ministers. French politics have been in disarray since President Emmanuel Macron called snap elections last year that produced a deeply fragmented legislature.In the bond market, the yield on the 10-year Treasury rose to 4.16% from 4.13% late Friday.The shutdown of the U.S. government means fewer economic data releases this week, though markets will have some earnings reports to comb through, including from Delta Air Lines, PepsiCo and Levi Strauss.Despite the shutdown, the Federal Reserve will release minutes from its meeting last month when it cut its benchmark interest rate for the first time this year. AP Business Writers Matt Ott and Elaine Kurtenbach contributed. Stan Choe, AP Business Writer
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Fifth Third on Monday agreed to buy regional lender Comerica in an all-stock deal valued at $10.9 billion, creating the ninth-largest U.S. lender with a robust presence in the Midwest. Regional lenders are looking to diversify revenue streams, strengthen balance sheets and expand into faster-growing markets as they recover from an industry-wide crisis in 2023 that shook investor confidence and exposed the risks of bank runs and troubles in commercial real estate. Analysts have said consolidation is crucial for smaller lenders to compete with the nation’s largest banks, with several banks looking to take advantage of a potentially lighter regulatory environment under the Trump administration. Comerica shareholders will receive 1.8663 Fifth Third shares for each Comerica share, valuing the deal at $82.88 per share based on Fifth Third’s closing price on October 3. Shares in Comerica were last up 12% before the bell, while Fifth Third fell 3%. “Record bank stock prices have also allowed for a greater currency to do deals, and today’s announcement will likely encourage more boardroom discussions about possible tie-ups, both large and small,” said Stephen Biggar, analyst at Argus Research. The S&P 500 Banks Index has surged nearly 21% this year, outpacing the benchmark S&P 500’s roughly 14% rise. GROWTH AVENUE Mergers and acquisitions have become crucial for regional lenders looking for a competitive edge in a highly saturated U.S. banking market. The latest deal expands Fifth Third’s reach to 17 of the 20 fastest-growing U.S. markets, including parts of the Southeast, Texas and California, and by 2030, more than half of its branches are expected to be located in these regions, it said. “This combination marks a pivotal moment for Fifth Third as we accelerate our strategy to build density in high-growth markets and deepen our commercial capabilities,” Fifth Third CEO Tim Spence said. Many lenders are looking to build larger, more diversified franchises with steadier revenue from businesses such as wealth management, payments and treasury services, as interest income gets squeezed by shifting Federal Reserve policy. Comerica CEO Curt Farmer will assume the role of vice chair in the combined company, while Peter Sefzik, its chief banking officer, will lead Fifth Third’s wealth and asset management business. The companies expect to have two $1 billion recurring and high return fee businesses Commercial Payments and Wealth and Asset Management, following the deal. The deal is expected to close by the end of the first quarter of 2026, after which Fifth Third shareholders will own about 73% of the combined company. Manya Saini and Arasu Kannagi Basil, Reuters
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