Drugs (Pharmaceuticals)

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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

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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

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      UK Cuts Tariffs on Dozens of Products as Global Trade Tensions Rise

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      British officials also announced more financing for exporters as the country sought to protect firms hurt by tariffs.The British government ramped up actions to help protect businesses and households from some of the economic tumult created by President Trump’s decision to raise tariffs and upend the norms of global trade.The government said on Sunday it would suspend tariffs on 89 products for about two years to help businesses and consumers save money. The products include those for construction, such as plywood and plastics, and everyday household items, such as pasta and fruit juices.Officials will also increase financing support for exporters by 20 billion pounds ($26 billion), through partial loan guarantees, and give small businesses access to loans of up to £2 million.As Mr. Trump raises tariffs on most imports, including those from Britain, to a 10 percent base line and even higher for certain goods like cars and steel, the British government has sought to calm anxieties at home. Officials have said they want to move quickly to support companies as they try to sustain fragile economic momentum.“This week, we witnessed the uncertainty of a changing world,” Rachel Reeves, the chancellor of the Exchequer, wrote in The Observer, a Sunday newspaper. In response, the government “must rise to meet the moment,” she wrote.The announcements on Sunday followed other interventions by the government in recent days to bolster protections for firms affected by tariffs. On April 6, the government eased rules on electric vehicle sales after Mr. Trump imposed a 25 percent tariff on cars imported into the United States. British officials also relaxed regulations to speed up timelines for clinical trials to support the life sciences sector with Mr. Trump also expected to impose levies on the pharmaceutical industry.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 the Right Still Embraces Ivermectin

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      Five years after the pandemic began, interest in the anti-parasitic drug is rising again as right-wing influencers promote it — and spread misinformation about it.Joe Grinsteiner is a gregarious online personality who touts the anti-parasitic drug ivermectin. In a recent Facebook video, he produced a tube of veterinary-grade ivermectin paste — the kind made for deworming horses.He gave the tube a squeeze. Then he licked a slug of the stuff, and gulped.“Yum,” Mr. Grinsteiner said in the Feb. 25 video, one of a number of ivermectin-related posts he has made that have drawn millions of views on Facebook this year. “Actually, that tastes like dead cancer.”Ivermectin, a drug proven to treat certain parasitic diseases, exploded in popularity during the pandemic amid false claims that it could treat or prevent Covid-19. Now — despite a persistent message from federal health officials that its medical benefits are limited — interest in ivermectin is rising again, particularly among American conservatives who are seeing it promoted by right-wing influencers.Mr. Grinsteiner, 54, is a Trump supporter and country music performer who lives in rural Michigan. He has claimed in his videos that ivermectin cured his skin cancer, as well as his wife’s cervical cancer. In a video last month, he said a woman told him her nonverbal autistic child had become verbal after using ivermectin. In a recent phone interview, Mr. Grinsteiner said that he takes a daily dose of ivermectin to maintain his general well-being.There is no evidence to support people taking ivermectin to treat cancer or autism. Yet Mr. Grinsteiner believes that the medical and political establishments just want to keep average people from discovering the healing powers of a relatively affordable drug. 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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      Drugs Have Uses We Can’t Imagine. He’s Using A.I. to Find Them.

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      A little over a year ago, Joseph Coates was told there was only one thing left to decide. Did he want to die at home, or in the hospital?Coates, then 37 and living in Renton, Wash., was barely conscious. For months, he had been battling a rare blood disorder called POEMS syndrome, which had left him with numb hands and feet, an enlarged heart and failing kidneys. Every few days, doctors needed to drain liters of fluid from his abdomen. He became too sick to receive a stem cell transplant — one of the only treatments that could have put him into remission.“I gave up,” he said. “I just thought the end was inevitable.”But Coates’s girlfriend, Tara Theobald, wasn’t ready to quit. So she sent an email begging for help to a doctor in Philadelphia named David Fajgenbaum, whom the couple met a year earlier at a rare disease summit.By the next morning, Dr. Fajgenbaum had replied, suggesting an unconventional combination of chemotherapy, immunotherapy and steroids previously untested as a treatment for Coates’s disorder.Within a week, Coates was responding to treatment. In four months, he was healthy enough for a stem cell transplant. Today, he’s in remission.The lifesaving drug regimen wasn’t thought up by the doctor, or any person. It had been spit out by an artificial intelligence model.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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      How Much Should Weight Loss Drugs Like Wegovy and Zepbound Cost?

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      A new study found that fair prices for medications like Wegovy and Zepbound would be hundreds less per month than they are now.It’s easy to make a medical case for blockbuster weight loss drugs like Wegovy and Zepbound, which have been shown to prevent heart attacks and strokes and save lives.But for the employers and government programs being asked to pay for the medications, the financial case for them is less clear. Are the drugs’ benefits worth their enormous cost?The answer right now is no, according to a new study published on Friday in the journal JAMA Health Forum, by researchers at the University of Chicago.To be considered cost effective by a common measure used by health economists, the price of Novo Nordisk’s Wegovy would need to be cut by over 80 percent, to $127 per month, the researchers concluded. And Eli Lilly’s Zepbound would be cost effective only if its price fell by nearly a third, to $361 per month. (Zepbound warranted a higher price, the researchers said, because it produced greater benefits in clinical trials.)“There’s no doubt that the drugs are demonstrating tremendous health benefits,” said David Kim, a health economist at the University of Chicago and the senior author of the study, which was funded by government grants. “The problem is the price is too high.”There’s widespread hope that the drugs will effectively pay for themselves in the long run, by making patients healthier and preventing expensive medical bills. It’s not clear yet whether that will turn out to be true.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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      F.D.A. Expands Access to Clozapine, a Key Treatment for Schizophrenia

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      Federal regulators will no longer require patients to provide blood tests before receiving the drug from pharmacies.The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant schizophrenia, among the most devastating of mental illnesses.The agency announced on Monday that it was eliminating a requirement that patients submit blood tests before their prescriptions can be filled.Clozapine, which was approved in 1989, is regarded by many physicians as the most effective available treatment for schizophrenia, and research shows that the drug significantly reduces suicidal behavior. Clozapine is also associated with a rare side effect called neutropenia, a drop in white blood cell counts that, in its most severe form, can be life-threatening.In 2015, federal regulators imposed a regimen known as risk evaluation and mitigation strategies, or REMS, that required patients to submit to weekly, biweekly and monthly blood tests that had to be uploaded onto a database and verified by pharmacists.Physicians have long complained that, as a result, clozapine is grossly underutilized.Dr. Frederick C. Nucifora, director of the Adult Schizophrenia Clinic at the Johns Hopkins School of Medicine, said he believed that around 30 percent of patients with schizophrenia would benefit from clozapine — far more than the 4 percent who currently take it.“I have had many patients who were doing terribly, who struggled to function outside the hospital, and cycled through many medications,” he said. “If they go on clozapine, they really tend to not be hospitalized again. I’ve had people go on to finish college and work. It’s quite remarkable.”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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      Dr Martin Makary Chosen to Head the FDA

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      President-elect Donald J. Trump announced on Friday that he would nominate Dr. Martin A. Makary, a Johns Hopkins University surgeon with a contrarian streak, to be commissioner of the Food and Drug Administration.In a post on social media, Mr. Trump said: “F.D.A. has lost the trust of Americans and lost sight of its primary goal as a regulator.” He said that Dr. Makary would work under Robert F. Kennedy Jr., the president-elect’s choice for the cabinet-level role as health secretary, to “properly evaluate harmful chemicals poisoning our nation’s food supply and drugs.”“I am confident that Dr. Makary, having dedicated his career to high-quality, lower-cost care will restore the F.D.A. to the gold standard of scientific research and cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Mr. Trump said in a statement.Mr. Trump announced two other top health picks on Friday evening as well. He chose Dr. Dave Weldon, a physician and former congressman from Florida, to lead the Centers for Disease Control and Prevention.For years, Dr. Weldon championed the notion that thimerosal, a preservative once used widely in vaccines, caused an explosion of autism cases around the world. In 2007, he backed a bill proposing to take vaccine safety research out of the hands of the C.D.C. Health officials reject the idea that research shows any link between thimerosal and autism.Mr. Trump also put forward Dr. Janette Nesheiwat, a physician and Fox News contributor, to be surgeon general. She worked caring for patients after Hurricane Katrina, an announcement from Mr. Trump said, and on the front lines of the Covid pandemic in New York City. She also markets vitamin B and vitamin C dietary supplements.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