Drugs (Pharmaceuticals)

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    F.D.A. Looks to A.I. to Enhance Efficiency

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    With a Trump-driven reduction of nearly 2,000 employees, agency officials view artificial intelligence as a way to speed drugs to the market.The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.“The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.“I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Four States Ask F.D.A. to Lift Special Restrictions on Abortion Pill

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      The states consider it a move to force the F.D.A. to review and acknowledge extensive research showing the pill’s safety.In a strategy aimed at countering efforts to further restrict the abortion pill mifepristone, attorneys general of four states that support abortion rights on Thursday asked the Food and Drug Administration to do the opposite and lift the most stringent remaining restrictions on the pill.The petition filed by Massachusetts, New York, California and New Jersey might seem surprising given the opposition to abortion expressed by Trump administration officials. But the attorneys general consider it a move that would require the F.D.A. to acknowledge extensive scientific research that has consistently found mifepristone safe and effective, said an official with the Massachusetts attorney general’s office who worked on the filing and asked not to be named in order to share background information. It would also prevent the F.D.A. from changing mifepristone regulations while the petition is pending.The petition notes that at a May senate hearing, Robert F. Kennedy Jr., the health and human services secretary, responded to questions by Senator Josh Hawley, Republican of Missouri, who opposes abortion, by saying he had ordered the F.D.A. to do a “complete review” of mifepristone.“We want to make sure that when F.D.A. is making these decisions that they have all the data in front of them, all of the really powerful data that show that mifepristone is safe” the Massachusetts official said.The F.D.A. is required to respond within 180 days by granting or denying the request, or saying it needs more time. In its responses, the agency must document its position, which could be useful in lawsuits, including one that the four states could file if their petition is denied.Mifepristone, which blocks a hormone necessary for pregnancy development, was approved for abortion in America in 2000. The F.D.A. imposed an additional regulatory framework called Risk Evaluation and Mitigation Strategy, or REMS, on mifepristone. That framework has been used for only about 300 drugs, currently covering only about 60 medications.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Breast Cancer Patients Get Early Warning of Faltering Drugs With Blood Test

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      A clinical trial found that women could switch drugs without waiting for scans showing cancer progression, which improved their quality of life.Breast cancer patients whose tumors have spread to other parts of their bodies live from scan to scan. Is their treatment working? Or will they learn their cancer is growing again?But a new study sponsored by the drug company AstraZeneca showed that there is an alternative: Instead of waiting for a scan to show that a cancer is growing, it’s possible to find early signs that the cancer is resisting the drugs that were controlling it.To do that, researchers used a blood test to find mutations in cancer cells that let the tumors defy standard treatments. Early detection allowed patients to be switched to a different drug that overcomes the mutated cancer. The result was to keep the cancers in check longer, and allow patients to have more than an extra year without deteriorating quality of life.The study was reported Sunday at the annual meeting of the American Society of Clinical Oncology and published in The New England Journal of Medicine.Breast cancer specialists who were not associated with the study applauded the results, saying blood tests could transform the way they monitor patients.“This is a paradigm change,” said Dr. Mary Disis, professor of medicine and oncology at the University of Washington and the Fred Hutchinson Cancer Center.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Novo Nordisk to Replace C.E.O. After Losing Edge in Weight-Loss Drugs

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      The Danish drugmaker, which makes Ozempic and Wegovy, has seen its stock tumble as competition in the weight-loss drug market has grown fiercer.Novo Nordisk will replace its chief executive, Lars Fruergaard Jorgensen, the company announced Friday, citing a sharp decline in its stock price that stemmed from increased competition for its popular weight-loss drug.The Danish drugmaker said it was searching for a new chief executive to soon replace Mr. Jorgensen, who has led Novo Nordisk for eight years.The move reflects a remarkable fall in fortune for the maker of one of the most well-known drugs in the world, which is sold as Ozempic for diabetes and Wegovy for obesity. The company’s stock has fallen by 50 percent in the past year.

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      Novo Nordisk’s share price
      Source: FactSetBy The New York TimesSales of that drug created boom times for Novo Nordisk. In 2023, the company’s extraordinary success prompted the Danish central bank to keep interest rates lower than it otherwise would. For more than a year, Novo Nordisk’s market value surpassed Denmark’s entire gross domestic product.But investors have soured on the company as it has faced increasingly fierce competition. Lower-cost copycat versions of the weight-loss drugs made through a process known as compounding have cut into Novo Nordisk’s sales. Even more damaging has been competition from Eli Lilly, the maker of the drug sold as Mounjaro and Zepbound.Novo Nordisk had a head start, winning approval to market its drug for obesity more than two years before Eli Lilly. But Novo Nordisk has been rapidly losing market share to its competitor: American patients have filled more prescriptions this year for Zepbound than for Wegovy, and the gap has been widening, according to the industry data provider IQVIA.Eli Lilly is also developing new weight-loss drugs, including a daily pill, that are expected to set up years of blockbuster sales for the company. Novo Nordisk has a hazier path forward. More

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      Trump Plan Would Tie Some Drug Prices to What Peer Nations Pay

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      The president announced an executive order aimed at lowering U.S. drug costs, revisiting an idea that was blocked in court during his first term.President Trump will sign an executive order on Monday aimed at lowering some drug prices in the United States by aligning them with what other wealthy countries pay, he said on Truth Social on Sunday evening.The proposal he described, which alone cannot shift federal policy, is what he calls a “most favored nation” pricing model. Mr. Trump did not provide details about which type of insurance the plan would apply to or how many drugs it would target, but he indicated that the United States should pay the lowest price among its peer countries.“Our Country will finally be treated fairly, and our citizens Healthcare Costs will be reduced by numbers never even thought of before,” he wrote in his social media post.Any such plan will most likely be subject to challenges in court, and it is not clear whether it will pass legal muster, especially without action by Congress.In his first term, Mr. Trump tried unsuccessfully to enact a version of this idea for Medicare, the health insurance program that covers 68 million Americans who are over 65 or have disabilities. That plan would have applied only to 50 drugs, administered at clinics and hospitals, that are paid for by Medicare. A federal court blocked it, ruling that the administration had skipped steps in the policymaking process.The pharmaceutical industry bitterly opposes the idea, which would almost certainly cut into its profits, and has been lobbying against it as discussions of the policy have regained steam in Washington in recent weeks. Companies have warned that such a policy would lead them to spend less on research, depriving patients of new medicines.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Why Patients Are Being Forced to Switch to a 2nd-Choice Obesity Drug

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      CVS Caremark decided to stop offering Zepbound in favor of Wegovy for weight loss. It’s the latest example of limits imposed by insurance that disrupt treatments for patients.Tens of thousands of Americans will soon be forced by their health insurance to switch from one popular obesity drug to another that produces less weight loss.It is the latest example of the consequences of secret deals between drugmakers and middlemen, known as pharmacy benefit managers, that are hired by employers to oversee prescription coverage for Americans. Employers pay lower drug prices but their workers are blocked from getting competing treatments, a type of insurance denial that has grown much more common in the past decade.One of the largest benefit managers, CVS Health’s Caremark, made the decision to exclude Zepbound in spite of research that found that it resulted in more weight loss than Wegovy, which will continue to be covered.Those research findings, first announced in December, were confirmed in an article published on Sunday in The New England Journal of Medicine. The study involved a large clinical trial comparing the drugs that was funded by Eli Lilly, the maker of Zepbound. Earlier research not financed by Eli Lilly reached similar conclusions.Ellen Davis, 63, of Huntington, Mass., is one of the patients affected by Caremark’s decision. “It feels like the rug is getting pulled out from under my feet,” she said.After taking Zepbound for a year, she has lost 85 pounds and her health has improved, she said. She retired after working for 34 years at Verizon, which hired Caremark for her drug coverage.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

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      Patients Cut Off From Cheaper Obesity Drugs as FDA Halts Sales of Copycats

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      Hundreds of thousands of Americans stand to soon lose their access to cheaper weight-loss drugs, with a federal crackdown on copycat versions threatening to disrupt treatment and raise costs.The Food and Drug Administration has ordered producers and sellers of the less expensive products to wind down operations in the coming weeks now that it has declared there are no longer shortages of the blockbuster drugs Wegovy and Zepbound.Produced through a process of mixing drug ingredients known as compounding, the copycat medications had spawned a booming multi-billion-dollar industry. Patients turned to compounding because their health insurance would not pay for the brand-name drugs and they could buy the compounded versions for less than $200 a month in some cases.Eli Lilly and Novo Nordisk now offer the brand-name drugs for $500 a month in most cases to patients who pay with their own money instead of going through insurance. Until recently, patients sometimes had to pay over $1,300 a month.The F.D.A. ordered compounding for versions of Eli Lilly’s Zepbound to end last month. Small compounders have until April 22 to stop making and selling versions of Novo Nordisk’s Wegovy; large compounders have until May 22.It is not clear how the F.D.A. will enforce these deadlines. The Health and Human Services Department, which oversees the F.D.A., declined to answer questions for this article.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More

    • 88 Shares159 Views

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      Stocks Edge Higher Amid Trump Tariff Uncertainty

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      The Trump administration’s chaotic tariff rollout continues to spur volatility in the markets.Stocks inched higher in early trading on Tuesday, as the Trump administration’s chaotic tariff rollout continues to spur volatility in the markets.The S&P 500 opened up 0.5 percent, and the technology-heavy Nasdaq also gained slightly. President Trump’s whipsawing tariff policies are still driving sentiment on Wall Street, especially in sectors facing the threat of more levies or potential reprieves.Here’s what else to know:Bank stocks rose on Tuesday, as major U.S. lenders reported their latest earnings. Bank of America surpassed Wall Street’s profit and revenue expectations, and its shares rose about 5 percent Tuesday morning. Citigroup’s profits also beat estimates, sending its stock more than 2 percent higher.Tariff threats are taking center stage in the pharmaceutical and technology sectors, after the Trump administration on Monday took steps that appeared likely to result in new tariffs on pharma products and semiconductors. Shares in drugmaker Eli Lilly were up slightly on Tuesday morning, while Novartis stock was trading roughly flat. Shares in chip giant Nvidia were nearly 2 percent higher, after the company on Monday said it would invest in artificial intelligence infrastructure in the United States.Shares in Boeing, the aviation giant, fell about 1.5 percent on Tuesday following a report from Bloomberg News that China had instructed its airlines to halt deliveries of Boeing planes after the Trump administration imposed steep tariffs on Chinese goods.In the auto industry, shares in General Motors, Ford Motor and Stellantis — which jumped on Monday after Mr. Trump signaled that he might offer car companies some relief from tariffs — were mixed on Tuesday morning. Shares in General Motors and Ford both fell more than 1 percent, while Stellantis rose about a half percent. The sector, which is grappling with a 25 percent tariff on imported vehicles, is bracing for new levies on imported car parts.The U.S. dollar, long a haven in global financial markets, has been falling against other major currencies. But an index that tracks the currency against a basket of major trading partners stabilized early Tuesday, ending a five-day slide. More

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      Trump’s Tariff Threat for Drug imports Poses Big Political Risks

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      Levies on Americans’ daily prescriptions and other medicines could raise costs, spur rationing and lead to shortages of critical drugs.President Trump’s decision to move a step closer to imposing tariffs on imported medicines poses considerable political risk, because Americans could face higher prices and more shortages of critical drugs.The Trump administration filed a federal notice on Monday saying that it had begun an investigation into whether imports of medicines and pharmaceutical ingredients threaten America’s national security, an effort to lay the groundwork for possible tariffs on foreign-made drugs.Mr. Trump has repeatedly said he planned to impose such levies, to shift overseas production of medicines back to the United States. Experts said that tariffs were unlikely to achieve that goal: Moving manufacturing would be hugely expensive and would take years.It was not clear how long the investigation would last or when the planned tariffs might go into effect. Mr. Trump started the inquiry under a legal authority known as Section 232 that he has used for other industries like cars and lumber.Mr. Trump said in remarks to reporters on Monday that pharmaceutical tariffs would come in the “not too distant future.”“We don’t make our own drugs anymore,” Mr. Trump said. “The drug companies are in Ireland, and they’re in lots of other places, China.”We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe. More