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Reliance on foreign manufacturers is the top reason the U.S. struggles to head off shortages, says Sen. Gary Peters, a Michigan Democrat who chairs the Homeland security committee.
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In November, the Centers for Disease Control and Prevention released new guidelines for prescribing opioids for pain, allowing physicians more flexibility. But doctors, patients, and advocates wonder if the updated standards will be too little, too late to help chronic pain patients in a country still focused on fighting the ongoing opioid crisis.
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The Danish drugmaker's move follows a similar announcement by rival Eli Lilly earlier this month. More than 8 million Americans use insulin, according to the American Diabetes Association.
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Researchers say some Mexican pharmacies that cater to U.S. tourists and medical travelers are selling medications that look safe but are laced with deadly fentanyl and methamphetamines.
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The removal announcement from Covis Pharma comes roughly four years after Makena failed to show a benefit in helping mothers carry pregnancies to term.
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The company is tapping into a red-hot market for drugs that address obesity with the purchase of telehealth operator Sequence, which can prescribe medications such as Ozempic, Wegovy and Trulicity.
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The FDA has long blocked the importation of cheap medicine, agreeing with pharmaceutical manufacturers that it opens the door to opioids. The agency’s own data shows that rarely happens.
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Drug pricing experts predict the move will help other initiatives to bring lower-cost insulin to market and maintain pressure on Eli Lilly to keep its prices down.
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The FDA has new tools to hold drug companies accountable for promises they make about medications. But the agency has yet to show its hand in using this new power.
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Lilly said it will cut the list prices for its most commonly prescribed insulin, Humalog, and for another insulin, Humulin, by 70% or more in the fourth quarter, which starts in October.