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Novo plans to seek U.S. Food and Drug Administration approval of the high-dose pill later this year, but timing of a market launch is "to be determined," according to Mico Guevarra, medical director at Novo Nordisk. Novo Nordisk already markets an oral semaglutide, under the brand name Rybelsus, for treatment of type 2 diabetes, but its highest dose is 14mg. Oral semaglutide, according to the FDA label, needs to be taken in the morning on an empty stomach, 30 minutes before eating, drinking, or using any other oral medication - you are allowed only 4 ounces of plain water. If you eat too soon, the pill is less effective, but if you wait longer than 30 minutes its absorption may be enhanced. read moreNovo Nordisk said most patients in its obesity trial reported gastrointestinal side effects from oral semaglutide, including mostly mild-to-moderate nausea, constipation, diarrhea and vomiting.
Persons: semaglutide, Mico, Guevarra, Eli Lilly, LLY.N, Deena Beasley, Diane Craft Organizations: DIEGO, Nordisk, Food, Drug, Novo Nordisk, American Diabetes Association, FDA, Thomson Locations: Danish
A Pill Form of Ozempic Is on the Horizon
  + stars: | 2023-06-25 | by ( Dani Blum | ) www.nytimes.com   time to read: +2 min
Novo Nordisk, the company that manufactures Wegovy and Ozempic, funded both trials. “If you could say, ‘Well, actually, it doesn’t,’ that’s big.”The higher the dose of oral semaglutide, the more side effects seem to come with it. In the trial of people who were overweight or obese, 80 percent of those who took oral semaglutide reported gastrointestinal issues like vomiting, nausea, constipation or diarrhea. Pfizer has also tested its own pill in that drug class. Oral semaglutide is not new: There’s already a tablet form of the compound on the market, sold under the name Rybelsus.
Persons: , , Robert Gabbay, , Eli Lilly, Andrew Kraftson Organizations: Novo Nordisk, American Diabetes Association, New England, of Medicine, Pfizer, Drug Administration, Michigan Medicine Locations: Wegovy
Currently approved medicines for weight loss like Novo Nordisk’s Wegovy are given as once-weekly injections. Novo Nordisk’s Ozempic, which contains the same key ingredient as Wegovy, called semaglutide, and Lilly’s Mounjaro are both approved for Type 2 diabetes but used off-label for weight loss. Weight loss at 36 weeks ranged from 9.4% to 14.7%, compared with 2.3% on placebo, the results showed. Lilly’s is just one of a crop of experimental weight loss drugs seeking to join blockbusters like Wegovy on the market. Novo Nordisk reported results last month showing that a pill version of semaglutide yielded 15% weight loss over 68 weeks, similar to Wegovy’s results.
Persons: Eli Lilly’s, what’s, Lilly, Lilly’s, , Nadia Ahmad, orforglipron, “ you’re, Dr, Sean Wharton, White, Ahmad, it’s, Sanjay Gupta, semaglutide Organizations: CNN, New England, of Medicine, American Diabetes Association, Nordisk’s, Nordisk’s Ozempic, Wharton Medical Clinic, CNN Health, Novo Nordisk, Pfizer Locations: San Diego
Videos related to the subject “food noise explained” have been viewed 1.8 billion times on TikTok. When food noise fadesWendy Gantt, 56, said she first heard the term food noise on TikTok, where she had also learned about Mounjaro. Ozempic is more of a way to silence the food noise than anything else, she said. “It’s not like a magic drug that’s giving people an easy way out.”What causes food noise? There is no clinical definition for food noise, but the experts and patients interviewed for this article generally agreed it was shorthand for constant rumination about food.
Persons: Wendy Gantt, , , Kelsey Ryan, hasn’t, It’s, Ryan, “ It’s, Robert Gabbay, Janice Jin Hwang Organizations: American Diabetes Association, University of North Carolina School of Medicine Locations: Ozempic, Canandaigua, N.Y
Eli Lilly also is expected to present data on another weight-loss drug called orforglipron, which patients take orally instead of through an injection. Retatrutide, Mounjaro and weight-loss drug Wegovy, produced by rival Novo Nordisk (NVO), are all injectable. But if the data were to fall short of expectations, the analysts don't foresee much downside to J & J shares. However, with JNJ-2113, Morgan Stanley noted that J & J management has touted its efficacy profile "without the baggage of a JAK label." J & J has consistently denied those accusations.
Persons: Eli Lilly, Johnson, Morgan Stanley —, Eli Lilly Eli Lilly, Morgan Stanley, Eli Lilly's Mounjaro, Mounjaro, Lilly's, retatrutide, hasn't, haven't, Jim Cramer's, Jim Cramer, Jim, AJ Mast Organizations: American Diabetes Association, Novo Nordisk, U.S . Food, Drug Administration, Pfizer, Novo Nordisk's, Johnson, American Academy of Dermatology, topline, J's, LTL Management, CNBC, Bloomberg, Getty, & ' $ Locations: U.S, Novo, Indianapolis , Indiana
Every weekday the CNBC Investing Club with Jim Cramer holds a "Morning Meeting" livestream at 10:20 a.m. Watch Eli Lilly Eli Lilly (LLY) is set to present data on its earlier-stage diabetes-and-obesity drugs in the coming weeks, offering another potential upside catalyst for a stock that's already climbed nearly 40% over the past three months. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB.
Persons: Jim Cramer, Caterpillar Watch Eli Lilly, Jim, Eli Lilly Eli Lilly, it's, Eli Lilly, Jim Cramer's Organizations: CNBC, Caterpillar Watch, Nasdaq, Meta, Microsoft, Nvidia, Caterpillar Construction, Caterpillar, Diabetes
Both sides blame each other for high drug prices. Senator Bernie Sanders, who chairs the Senate Health, Education, Labor, and Pensions (HELP) Committee, is a fierce critic of both industries and will likely grill the executives. Optum Rx CEO Heather Cianfrocco will say manufacturers alone set the drug prices and abuse patent protections to stifle competition, her written testimony shows. Lilly, Novo Nordisk, and Sanofi all said in March they were cutting list prices by more than 70% for some insulin products. Uninsured people often have to pay full list prices, an average of $900 a month, forcing many to ration or skip doses.
In addition to Lantus, Sanofi said it will cut by 70% the list price for its fast-acting insulin, Apidra. The branded list price of Lantus is $438.07 for the pre-filled pens and $292.07 for a 10 ml vial. Rival Novo Nordisk on Tuesday said it would cut U.S. list prices for several insulin products by up to 75% next year. That followed Lilly's March 2 decision to cut list prices by 70% for Humalog and Humulin, its most commonly prescribed insulin products. Most Americans with insurance do not regularly pay list price for insulin, but they may have an insurance co-pay based on the drug's list price or pay full price up to a certain amount of money spent.
Sanofi already offers a $35 monthly cap on insulin for uninsured diabetes patients. The company is the last major insulin manufacturer to try to head off government efforts to cap monthly costs by announcing its own steep price cuts for the lifesaving hormone. Eli Lilly and Novo Nordisk made similar sweeping cuts earlier this month after years of political pressure and public outrage over the high costs of diabetes care. President Joe Biden's Inflation Reduction Act capped monthly insulin costs for Medicare beneficiaries at $35, but it did not provide protection to diabetes patients who are covered by private insurance. Approximately 8.4 million diabetes patients rely on insulin, the American Diabetes Association said.
Although insulin list prices are high in the U.S., drugmakers typically pay substantial rebates to private insurers and government programs, resulting in lower prices for most Americans with insurance. U.S.-listed Novo Nordisk shares rose as much as 1.7% to $142.95, while Denmark-listed shares closed marginally higher on Tuesday. Eli Lilly shares were down slightly. "I think it is a relatively natural consequence of what we have seen their competitor Eli Lilly do. Eli Lilly, Sanofi and Novo Nordisk make up 90% of the U.S. market for insulin.
Novo Nordisk joins Lilly in plans to slash U.S. insulin prices
  + stars: | 2023-03-14 | by ( ) www.reuters.com   time to read: +1 min
March 14 (Reuters) - Novo Nordisk (NOVOb.CO) said on Tuesday it would cut U.S. list prices for several insulin drugs by up to 75% next year, joining rival Eli Lilly as drugmakers come under pressure for high prices of the life-sustaining treatment. The moves follow President Joe Biden's Inflation Reduction Act last year that capped insulin prices for Medicare recipients at $35 per month, but that does not extend to patients without insurance. Novo will reduce the list price of its NovoLog insulin by 75%, and for Novolin and Levemir by 65%. The company also said it would reduce the list price of unbranded insulin products to match lowered price of respective branded insulin products. Eli Lilly and Co (LLY.N) said earlier this month that it would cut the list prices for its most commonly prescribed insulin products by 70% from the fourth quarter of this year.
President Joe Biden's federal budget proposal would cap insulin prices at $35 per month for people with private insurance plans. Biden called on Congress in his State of the Union speech to finish the job and cap insulin at $35 a month for everybody. Drugmaker Eli Lilly got ahead of a potential federal mandate, announcing earlier this month that it would cap insulin at $35 per month for people with private insurance at certain retail pharmacies. About 40% of people with diabetes have private insurance while 5% are not insured, according to the American Diabetes Association. Some Republicans in Congress oppose to the move to cap insulin prices.
Eli Lilly, along with Sanofi (SASY.PA) and Novo Nordisk (NOVOb.CO) make up 90% of the U.S. market for insulin. Biden, a Democrat, on Tuesday called on Congress and other manufacturers to lower the price of insulin as Lilly had done. The list price for Lispro, a cheaper version of its Humalog insulin, is currently $82.41 for 100 units/mL vials. List prices for drugs often differ from what patients actually pay, including after insurance and other assistance programs. Ricks said the company's insulin price cuts had been planned for some time and were accounted for in Eli Lilly's December financial forecast, which projected 2023 revenue of at least $30.3 billion.
The Inflation Reduction Act capped insulin prices for Medicare beneficiaries at $35 per month but did not protect people with private insurance or who don't have coverage from higher prices. In President Joe Biden's State of the Union speech, he called on Congress to cap insulin prices at $35 a month for everyone. Lilly said it will cap out-of-pocket costs at $35 per month effectively immediately at certain retail pharmacies for people with private insurance. One in five people with diabetes who have private insurance pay more than $35 per month for insulin, according to the Kaiser Family Foundation. Democrats in Congress had pushed to cap insulin at $35 per month last summer for people with private insurance, but Senate Republicans killed the measure.
Lilly to cut U.S. insulin prices by 70% from fourth quarter
  + stars: | 2023-03-01 | by ( ) www.reuters.com   time to read: +2 min
March 1 (Reuters) - Eli Lilly and Co (LLY.N) will cut list prices by 70% for its most commonly prescribed forms of insulin, Humalog and Humulin, beginning from the fourth quarter of this year, the drugmaker said on Wednesday. Around 8.4 million of the 37 million people in the United States with diabetes use insulin, according to the American Diabetes Association. Eli Lilly, along with Sanofi (SASY.PA) and Novo Nordisk (NOVOb.CO) make up 90% of the U.S. market for insulin. Drugmakers had previously priced insulin at more than $275 a vial, representing a 1,200% increase in price over the past 20 years, according to the advocacy group Insulin Initiative. Reporting by Bhanvi Satija in Bengaluru; Additional reporting by Susan Heavey, Editing by Arun KoyyurOur Standards: The Thomson Reuters Trust Principles.
Around 8.4 million of the 37 million people in the United States with diabetes use insulin, according to the American Diabetes Association (ADA). They tried, and failed, to extend the benefit to everyone with health insurance when they were voting on the IRA. Without Congressional approval, the Biden administration cannot impose the cap on private insurance plans and is unlikely able to create a subsidy for the uninsured, experts said. Some Medicaid plans for low-income individuals and private insurance plans also cap the monthly cost of insulin at $35. It is unclear if his proposal would include those without health insurance, who often have to pay the full price for the life-sustaining drug.
For the past two years, she's managed the condition using a drug called Ozempic, which helps people with diabetes keep blood sugar levels in check. "It's been very frustrating," Largent-Phillips, of Florida, said of the shortage, adding that her blood sugar levels have been fluctuating as she's had to change medications. If the body doesn't use it well, that sugar stays in the blood, resulting in high blood sugar levels. His wife, Gerilynn, who is a nurse, said his blood sugar levels have gone back up since being off Ozempic. Largent-Phillips, of Florida — who has been documenting her experience on TikTok — said that for now, she has to be vigilant about monitoring her blood sugar levels.
The lawsuit, filed in California Superior Court in Los Angeles, targets Eli Lilly and Co , Novo Nordisk A/S (NOVOb.CO) and Sanofi SA (SASY.PA), which together make more than 90% of the insulin drugs sold globally. Insulin drugs are used to control blood sugar in patients with diabetes. Eli Lilly and Sanofi both previously announced that they would cap the cost of a 30-day supply of insulin at $35 for uninsured patients. California said that the companies' dominance in the market has allowed them to hike insulin prices at patients' expense, violating the state's Unfair Competition Law. Prices of top-selling insulin drugs have soared in recent years.
How much does insulin cost? People with Type 1 diabetes need, on average, one to three vials of insulin per month, according to the American Diabetes Association. Patients with Type 2 diabetes don't always need to take insulin, but those who do can sometimes require more than people with Type 1 diabetes. Even people with what's considered good health insurance coverage can face steep costs in certain situations. In addition to insulin and insurance premiums, Gibson also must spend $550 every three months for glucose monitors and $1,100 for insulin pumps.
The Mark Cuban Cost Plus Drug Company negotiates directly with drugmakers. So far, that's been the strategy for the Mark Cuban Cost Plus Drug Company. In October, Cost Plus Drug Company announced a partnership with Capital Blue Cross. Cuban said he wanted Cost Plus Drug Company to be as transparent as possible on pricing. Cost Plus Drug Company is considering a test program for insulin that would offer a 90-day supply of insulin, or a total of 12 vials, for $170.
The Food and Drug Administration on Thursday approved the first drug to delay the onset of Type 1 diabetes. It’s been approved for people ages 8 and older who have early signs of Type 1 diabetes. Nearly 2 million people in the United States have Type 1 diabetes, according to the American Diabetes Association. People with Type 1 diabetes usually need multiple injections of insulin every day for the rest of their lives, often a great financial burden. The most common side effects of the medication include decreased levels of certain white blood cells, rash and headache, according to the FDA.
CNN —A biologic therapy that delays the onset of type 1 diabetes received approval from the US Food and Drug Administration on Thursday. The most common side effects reported in the trial participants were low white blood cells and lymph cells, rash and headache. Without insulin, blood sugar can build up in the bloodstream and break down the body’s own fat and muscle. With Tzield, doctors would screen individual family members of people with type 1 diabetes to see whether they have those specific antibodies. As of 2019, about 1.9 million people have type 1 diabetes in the United States, according to the American Diabetes Association, including 244,000 children and adolescents.
California plans to partner with Civica Rx, a nonprofit generic drug company, in the state's effort to produce its own low-cost insulin, according to two people familiar with the matter. Gavin Newsom announced in July that he had approved a budget that would allocate $100 million to allow the state to begin making its own insulin. It'll be the first state to produce insulin for its residents, which experts see as a road map for other states to make the lifesaving medication more affordable. California expects to announce the partnership in mid-December, although it hasn't been finalized and the state could select a different company, the sources said. A Civica Rx spokesperson didn't confirm the plan but said the company welcomes "the opportunity to partner with California."
The cost of insulin remains a barrier for many Americans with diabetes who depend on the drug, research published Monday suggests. It was the first time that the CDC had included questions about insulin use, though concerns about sky-high insulin prices have been reported for years. Meanwhile, those with public health coverage, such as Medicaid and Medicare, had the lowest rates of rationing. According to the American Diabetes Association, people with type 1 diabetes need, on average, two to three vials per month. He said the "most ambitious" proposal he would like to see in the U.S. is universal health coverage with no copays for consumers.
Patient advocates were disappointed with Sunday’s vote — Republican senators blocked the $35 insulin cap for private insurers — and expressed hope that federal and state measures could be included in legislation down the road. Clayton McCook of Edmond, Oklahoma, is among those who support capping the cost of insulin for people with private health insurance. A federal insulin cap for private insurance would have made “a huge difference to our family,” he said. “This year, with an evenly divided Senate, the insulin cap for people with private insurance didn’t secure enough votes,” Neuman said. McCook also advocated for changes besides a cap on insulin costs, saying Congress pass legislation that would lower the list price.
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