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The company's chief rival, Denmark-based Novo Nordisk (NVO), also published promising data on drugs in its pipeline, including its own oral weight-loss treatment. Other pharmaceutical companies are racing to compete with Novo Nordisk and Eli Lilly, including Amgen (AMGN) and Pfizer (PFE). Barclays on Tuesday projected Eli Lilly's three leading obesity-and-diabetes drugs could generate nearly $49 billion in combined sales in 2030. Eli Lilly Eli Lilly has multiple drugs in development that fall under the GLP-1 umbrella in various stages of clinical development. Novo Nordisk Novo Nordisk currently dominates the market for GLP-1 drugs, with three products in the class on the U.S. market already: Ozempic, Wegovy and Rybelsus.
Persons: It's, Eli Lilly, Eli Lilly's, retatrutide, Lilly, there's, Lilly's, Geoff Meacham, Eli Lilly Eli Lilly, Jim Cramer, Evan David Seigerman, , — Morgan Stanley, Wegovy, Rybelsus, Jim Cramer's, Jim, Mike Segar Organizations: Club, Novo Nordisk, New England, of Medicine, American Diabetes Association, Pfizer, Reuters, Barclays, Bank of America, CNBC, JPMorgan, Drug Administration, Equity, BMO Capital, Novo Nordisk Novo Nordisk, GLP, FDA, Nordisk, Company Locations: San Diego, Denmark, GLP, It's, Novo, Novo Nordisk's, Branchburg , New Jersey
Drugmakers are jockeying to capitalize on the next major innovation coming to the blockbuster weight loss industry: effective, convenient and potentially affordable obesity pills. But for now, one experimental oral drug from Eli Lilly appears to have an edge over pills from Novo Nordisk and Pfizer — even though it may not win U.S. approval first. Pills are also typically cheaper than injections, though it's unclear if that will be the case with the obesity pills. None of the three drugmakers has provided estimates for how much the new obesity pills would cost. Eli Lilly is still in the middle of phase three clinical trials on its oral drug, orforglipron, meaning it's likely to hit the market later.
Persons: It's, there's, Eli Lilly, Pfizer — Organizations: Novo Nordisk, Pfizer, CNBC, Food and Drug Administration Locations: U.S, orforglipron
What's more, some showed no signs their weight loss was leveling off, suggesting they could continue to shed pounds. (Both use semaglutide, but Ozempic is marketed as a type 2 diabetes treatment, while Wegovy is primarily for weight loss.) Bank of America's Geoff Meacham said retatrutide "exceeded expectations" for weight loss. "This is important, as while the overall 22.4% weight loss was impressive, looking at men and women separately, weight loss was 21.9% and 28.5%, respectively, with the slope in females not yet plateauing. Schott also described the weight loss as "impressive" and said it will likely compare favorably with Novo's next-generation drug CagriSema, which is expected to show weight loss of more than 25% when it releases its next update.
Persons: Eli Lilly, What's, Lilly, Lilly's, Carter Gould, Gould, orforglipron, Bank of America's Geoff Meacham, retatrutide, Meacham, Chris Schott, Schott, Novo's, Evan David Seigerman, Seigerman, Morgan Stanley, Terence Flynn, — CNBC's Michael Bloom Organizations: American Diabetes Association, Wall, Novo Nordisk, Barclays, Bank of America's, JPMorgan, Lilly, BMO Capital, Indianapolis, ~$ Locations: Novo
Novo Nordisk 's high-dose experimental obesity pill helped overweight or obese adults lose around 15% of their body weight, according to new late-stage clinical trial results. Novo Nordisk told Reuters it plans to file for Food and Drug Administration approval of the drug later this year. But the highest dose of Rybelsus is 14 milligrams, while the company's experimental obesity pill has a far larger dose of 50 milligrams. Other companies are also developing oral weight loss treatments to appeal to those who don't want weekly injections. Pfizer is also developing its own weight loss pill, called danuglipron, which patients take twice a day.
Persons: Eli Lilly, Dr, Filip Knop, Knop, Eli Lilly's, Elon Musk Organizations: Novo Nordisk, Reuters, Food and Drug, Pfizer, University of Copenhagen, Novo, Companies, Novo Nordisk's Ozempic, National Institutes of Health Locations: Danish
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
Novo Nordisk shares slip on EMA drug safety signal
  + stars: | 2023-06-22 | by ( ) www.reuters.com   time to read: +2 min
reported that the European Medicines Agency (EMA) had raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs. "Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic," Lars Otto Andersen-Lange, media relations director at Novo Nordisk, told Reuters. report referred to a May 8 statement from EMA, which raised a thyroid cancer safety signal for several drugs in the GLP-1 class, including semaglutide. But a "causal association" between semaglutide and thyroid cancer had not been demonstrated in large-scale clinical trials and post-marketing surveillance, he said. EMA's safety signal had also included GLP-1 drugs from competitors Eli Lilly (LLY.N), Astrazeneca (AZN.L) and Sanofi (SASY.PA).
Persons: Lars Otto Andersen, Lange, Andersen, " Andersen, Eli Lilly, Soren Lontoft Hansen, Nikolaj Skydsgaard, Maggie Fick, Alexander Smith Organizations: Novo Nordisk, European Medicines Agency, EMA, Nordisk, Reuters, Astrazeneca, Sanofi, Thomson Locations: COPENHAGEN, Novo, Denmark's Novo, Copenhagen
The European Medicines Agency (EMA) raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs. "Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic," Lars Otto Andersen-Lange, media relations director at Novo Nordisk, told Reuters. reported the EMA safety signal. report referred to a May 8 statement from EMA, which raised a thyroid cancer safety signal for several drugs in the GLP-1 class, including semaglutide. EMA's safety signal also included GLP-1 drugs from competitors Eli Lilly (LLY.N), Astrazeneca (AZN.L) and Sanofi (SASY.PA).
Persons: Eli Lilly, Ozempic, Lars Otto Andersen, Lange, Andersen, " Andersen, Soren Lontoft Hansen, semaglutide, Nikolaj Skydsgaard, Maggie Fick, Alexander Smith Organizations: Sanofi, Novo Nordisk, European Medicines Agency, EMA, Nordisk, Reuters, Astrazeneca, FDA, Thomson Locations: Astrazeneca, COPENHAGEN, Denmark's Novo, Copenhagen
Ozempic and Wegovy are both forms of semaglutide, a drug originally developed for diabetes. OEL SAGET/AFP via Getty ImagesOzempic and Wegovy are the brand names used by the drug manufacturer, Novo Nordisk. Tirzepatide, marketed as Mounjaro, is a similar "game-changer" drug, and is yet to be approved for weight loss but can be used off-label for this purpose. Ozempic has become the byword for semaglutide and similar drugs that cause weight loss, regardless of which brand a person is taking or why. They work by suppressing appetite, but side effects such as muscle loss, nausea, and diarrhea have been reported, and it's common to regain the weight after stopping treatment.
Persons: SAGET Organizations: Getty, Novo Nordisk, Semaglutide, FDA Locations: AFP
June 20 (Reuters) - Wegovy maker Novo Nordisk (NOVOb.CO) on Tuesday said it had sued some medical spas and wellness clinics in the United States for selling products claiming to contain semaglutide, the key ingredient in its popular weight-loss and diabetes drugs. The Danish drugmaker said it had filed federal court lawsuits in states including New York, Florida, Tennessee and Texas, accusing the spas of selling unapproved variations of its drugs. Novo Nordisk asked the courts for orders blocking the sales of the unauthorized drugs and an unspecified amount of money damages. Four of the companies named in the lawsuits in Florida, Texas and Tennessee did not immediately respond to requests for comment. Reporting by Nikolaj Skydsgaard and Blake Brittain; Editing by Ed Osmond and Alexander SmithOur Standards: The Thomson Reuters Trust Principles.
Persons: Eli Lilly, Danish drugmaker, Nikolaj Skydsgaard, Blake Brittain, Ed Osmond, Alexander Smith Organizations: Novo Nordisk, U.S . Food, Drug Administration, FDA, Barclays, Nordisk, Thomson Locations: United States, U.S, Danish, New York , Florida , Tennessee, Texas, Florida , Texas, Tennessee
Americans are clamoring for new weight-loss drugs, but companies aren't rushing to pay for them. At most, half of US employers help pay for weight-loss drugs for their workers, according to several estimates. "The drug companies, providers, and patient groups are insisting that weight loss will improve health and therefore offset these massive costs. Known as GLP-1 agonists, the drugs — Wegovy and Ozempic from Novo Nordisk and Eli Lilly's Mounjaro — mimic a gut hormone known as glucagon-like peptide 1, helping to suppress people's appetites and slow their digestion. Brent Eberle, the chief pharmacy officer at Navitus, said very few of the employers that worked with his pharmacy-benefit manager paid for weight-loss drugs.
Persons: that's, They're, AJ Loiacono, Li Ran, James Gelfand, Eli Lilly's, Ozempic, drugmakers, Brent Eberle, Navitus, Eberle, it's, Pat Gleason, Gleason, Wegovy, Eli Lilly, Lilly, Florian Gaertner, Loiacono Organizations: Morning, Novo Nordisk, Getty, Workers, Drugmakers, Therapeutics, Blue, Mayo Clinic, and Drug Administration, Capital Locations: Novo, Xinhua
Novo Nordisk on Tuesday sued five medical spas and wellness clinics for allegedly selling cheaper, unauthorized versions of the company's weight loss drugs Ozempic and Wegovy. The suits accused the spas and clinics of marketing and selling "compounded" drug products that claim to contain semaglutide, the active ingredient in both Ozempic and Wegovy. Novo Nordisk asked the courts for orders blocking the sales of the unauthorized drugs and an unspecified amount of money damages. The spas and clinics named in the lawsuits include Pro Health Investments, Champion Health & Wellness Clinics and Flawless Image Medical Aesthetics. The FDA last month warned about the safety risks of unauthorized versions of Ozempic and Wegovy after reports emerged of adverse health reactions to compounded versions of the drugs.
Persons: Ozempic, Danish drugmaker, didn't Organizations: Novo Nordisk, CNBC, Food and Drug Administration, Pro Health Investments, Health, Wellness, Effinger, Ekzotika Corp, FDA Locations: Los Angeles , California, Danish, New York , Texas, Florida, Tennessee
Credit Suisse analyst Trung Huynh has combed through social media and is impressed by the awareness — and demand — for GLP-1 medications such as Eli Lilly 's Mounjaro. Among those observations are reports of other potential benefits that patients taking Mounjaro, or tirzepatide, are seeing. Others taking the drug reported benefits such as a reduction in addiction behaviors such as smoking, drinking, gambling and shopping, among other things. However, this may be a function of patients who are trying to use Mounjaro off-label for obesity, he said. Credit Suisse has an outperform rating on Lilly shares, with a $490 price target, which implies more than 9% upside from where Lilly shares closed Wednesday.
Persons: Trung Huynh, Eli Lilly, Huynh, Mounjaro, agonism, Lilly hasn't, semaglutide —, Lilly, , Michael Bloom Organizations: Credit Suisse, Food and Drug Administration, Novo Nordisk
The Truth About ‘Nature’s Ozempic’
  + stars: | 2023-06-07 | by ( Dani Blum | ) www.nytimes.com   time to read: +1 min
As the demand for Ozempic — the injectable diabetes medication that has become coveted for inducing weight loss — continues to intensify, people across TikTok are posting about alternatives. Some gush about other diabetes drugs, like Mounjaro; some tout so-called “generic” Ozempic from compounding pharmacies. And some are trumpeting what they claim is a cheaper option, readily available in pharmacies and online: “nature’s Ozempic,” better known as berberine. Experts say that while berberine has proven metabolic effects on the body, whether it can actually induce weight loss remains murky. “Generally, it’s a really good compound that has some good evidence behind it,” said Dr. Melinda Ring, an integrative medicine specialist at Northwestern Medicine.
Persons: , berberine, Melinda Ring Organizations: Ozempic, Northwestern Medicine Locations: Asia
The Ozempic craze has hit China, causing shortages and price hikes, reports say. Poeple using it to lose weight has caused shortages for Type 2 diabetes patients, doctors say. People in China are rushing to buy up Ozempic for weight loss, causing a boom in prices and leaving shortages for diabetes patients, according to reports. Semaglutide — marketed as Wegovy when used for weight loss in the US — has proven in some studies to be effective in causing weight loss. The platform has also deleted thousands of posts by people sharing their experiences with the drug, CNN reported.
Persons: semaglutide, , Semaglutide —, It's Organizations: Bloomberg, CNN, China, Huadong, Novo Nordisk Locations: China, Guangzhou, Canada, Mexico
Hong Kong CNN —Ozempic, originally a medication for treating diabetes, is in high demand worldwide with celebrities and social media users touting it as a miracle drug for weight loss. “This is a wonder drug,” according to a popular series of posts on Xiaohongshu, a Chinese social app similar to Instagram. Soaring pricesThe social media hype was so enormous that Xiaohongshu launched a crackdown in February and deleted more than 5,000 posts sharing weight loss experiences with Ozempic. Fill the shortageThe weight loss drug market in China is expected to boom in the coming years. Novo Nordisk has applied to China’s drug regulator to widen the scope of use for semaglutide, according to the National Medical Products Administration.
Persons: Hong Kong CNN — Ozempic, they’ve, ” Ozempic, Xiaohongshu, Ozempic, Kevin Frayer, hasn’t Organizations: Hong Kong CNN, Daily, First Affiliated, of Sun, University, Novo Nordisk, Tebon Securities, National Medical Products Administration, ., CNN, Huadong, Intellectual, Beijing Intellectual Property Locations: Hong Kong, China, Ozempic, Guangzhou, Shanghai, Hangzhou, Beijing
FDA warns about safety risks of tailored weight-loss drugs
  + stars: | 2023-06-01 | by ( ) www.reuters.com   time to read: +1 min
REUTERS/Lucas Jackson/File PhotoJune 1 (Reuters) - The U.S. Food and Drug Administration (FDA) warned about the safety risks of using compounded or custom-made versions of popular weight-loss drugs such as Wegovy and diabetes drug Ozempic. The FDA warned patients to refrain from using a compounded drug if an approved drug is available. Compounded drugs are created by combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. The agency said it does not review compounded versions of these drugs for safety, effectiveness, or quality, adding, it had received reports that compounders might be using salt forms of semaglutide, which are different active ingredients than those used in the approved drugs. The U.S. is expected to account for as much as 90% of weight-loss drug sales due to the number of potential patients and higher pricing than other countries, industry analysts and executives say.
Persons: Lucas Jackson, Novo, Mariam Sunny, Rashmi Organizations: REUTERS, U.S . Food, Drug Administration, Thomson Locations: New York, U.S, Bengaluru
There are three routes lawmakers and regulators could use to add coverage for weight-loss drugs. Older Americans hoping to get their hands on powerful weight-loss drugs such as Ozempic and Wegovy may find it impossible to access them. Should Medicare cover weight loss medication, it could also unlock access for people who have private coverage. "A decision by Medicare to cover weight-loss drugs would put pressure on employers and other private insurers to cover weight-loss drugs too," said Tricia Neuman, a senior vice president at KFF who co-authored a recent brief on the subject. There are three potential strategies that could be used to expand Medicare coverage to weight-loss drugs.
The results are another boost for Novo Nordisk whose weekly Wegovy injection has transformed the weight-loss market since its U.S. launch in June 2021, capturing the attention of patients, investors and even celebrities worldwide. The Danish drugmaker said in a statement that the headline results were statistically significant and showed superior weight loss when compared to a placebo. A global launch of the oral 50 milligram (mg) semaglutide drug is contingent on portfolio prioritisations and manufacturing capacity, the company added without giving further details. The results are comparable to the company's Wegovy injection, said Martin Holst Lange, head of development at Novo Nordisk. Novo Nordisk has had supply issues and struggled to keep up with soaring U.S. demand for Wegovy.
Omada Health, a leader in managing diabetes, is grappling with how it can play a role. Health companies are at a crossroads in deciding how to respond to the frenzy for prescription weight-loss drugs such as Ozempic and Wegovy. Now, as the rise of these powerful drugs upends the weight-loss industry, Omada is grappling with how it can play a role. Instead of prescribing the drugs, Omada is pitching itself as a gatekeeper, akin to the role health insurers usually play. One survey from 2022 found that only about a fifth of companies cover weight-loss drugs for their workers.
Ms. Davis, 55, did not have diabetes, but had gained 50 pounds during menopause and developed hypothyroidism, she said, and was eager to lose weight. After seeing someone claiming to be a doctor on TikTok saying he could help patients obtain a generic version of the medication, she reached out. After a few days and a brief video consultation with someone who introduced herself as a nurse practitioner, Ms. Davis had a prescription in hand. “It was really fast,” Ms. Davis said. In the scramble to find Ozempic, patients are seeking out telehealth platforms, medical spas and compounding pharmacies for what some tout as “generic” versions of the drug.
[1/2] A selection of injector pens for the Wegovy weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023. AMGENAmgen's (AMGN.O) experimental obesity drug, AMG133, showed a mean weight loss of 14.5% after 12 weeks of treatment at the highest monthly dose. The company plans to test higher doses of the drug over a longer treatment window in a mid-stage trial. ZEALAND PHARMADenmark's Zealand Pharma (ZELA.CO) and Boehringer Ingelheim's experimental obesity treatment achieved up to 14.9% weight loss in a mid-stage trial on Wednesday. OPKO HEALTH Opko Health (OPK.O) has completed a mid-stage trial of its obesity drug, pegapamodutide, which it expects will have fewer side effects.
Persons: Jim Vondruska, Wegovy, Eli Lilly, ELI LILLY Lilly, Mounjaro, LLY.N, danuglipron, AMGEN, ALTIMMUNE, Mariam Sunny, Pratik Jain, Sriparna Roy, Sriraj Kalluvila, Anil D'Silva Organizations: REUTERS, Novo Nordisk, Pfizer, NOVO NORDISK Novo Nordisk, Novo, PFIZER Pfizer Inc, danuglipron, THERAPEUTICS, Therapeutics, ZEALAND PHARMA Denmark's Zealand Pharma, Thomson Locations: Chicago , Illinois, U.S, Bengaluru
Trendy weight-loss drugs cost much more in the US than in other countries. The price of semaglutide, the drug sold as Wegovy, was three times higher in the US than in the UK. If you're searching for affordable weight-loss drugs, you may be better off looking outside of the US. New weight-loss drugs are unaffordableGetty ImagesWegovy and Ozempic are part of a class of weight-loss drugs known as GLP-1 agonists that have soared in popularity in recent months. Drug prices are highest in the USThe variation in prices for weight-loss drugs across the world is striking.
LONDON, May 8 (Reuters) - Diabetes drugs that also promote weight loss such as Novo Nordisk’s (NOVOb.CO) Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some of the most difficult-to-treat brain disorders, including Alzheimer’s disease. Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs. She said she has since been approached by pharmaceutical companies at an increasing pace, and is currently running an Alzheimer’s trial evaluating intranasal insulin in combination with another diabetes drug. Four companies with GLP-1 drugs, including two larger drugmakers, say they are watching for results of trials testing Novo's drug in Alzheimer's. Dementia affects more than 55 million people globally and the market for Alzheimer’s drugs is expected to grow to $9.4 billion by 2028 and for Parkinson’s to $6.6 billion, according to pharmaceutical data provider Citeline.
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