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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
In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailObesity weight loss market will remain a duopoly between Novo Nordisk and Eli Lilly: BofA’S MeachamGeoff Meacham, Bank of America Securities, joins 'Fast Money to discuss the state of the weight-loss drug market as Eli Lilly and Novo Nordisk compete for market share.
Persons: Eli Lilly, BofA’S Meacham Geoff Meacham Organizations: Novo Nordisk, Bank of America Securities
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
Morgan Stanley thinks little-known drug developer Evotec could benefit from artificial intelligence advancements in Europe and new collaborations with peer companies. EVO YTD mountain Evotec SE stock has surged 40% from the start of the year. Meanwhile, a security breach in April did little to caution Quigley away from the stock. The analyst highlighted the company's potential to better use AI to aid in drug development in the future, as well as partnerships with big pharma names. "A number of Pharma companies are investing in internal AI/ML efforts," he added.
Persons: Morgan Stanley, Morgan Stanley's, James Quigley, Quigley, Evotec, Eli Lilly, — CNBC's Michael Bloom Organizations: pharma, Merck & Co, Bristol Myers Squibb, Novo Nordisk Locations: Europe, Germany
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
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
Those are the qualities that outperforming portfolio manager Jordan Cvetanovski has looked for in stocks for the past nearly 20 years. Since its inception in 2022 to May 31, his Pella Global Generations Fund has delivered nearly 20%, outperforming its benchmark — the MSCI ACWI (the MSCI's flagship global stock index) — by 7%. As an investor, Cvetanovski, who is based in Sydney, Australia, said he invests only in his own 34-stock fund, the Pella Global Generations Fund. Investing 'won't be as simple as it was' Cvetanovski said his method of investing has stayed "exactly the same" through the years. Following sustainability criteria is one of Pella Global Generations Fund's objectives.
Persons: Jordan Cvetanovski, I've, , Carmignac, Cvetanovski, IQVIA, there's, Tesla, EVs Organizations: CNBC Pro, Pengana International, Pengana Capital Group, Fund, Generations Fund, Pella Funds, 3i, Adobe, McLennan, Novo Nordisk, UnitedHealth Locations: Pella, Sydney, Australia, China, U.S, Europe
A weekly injection of Wegovy leads to an average weight loss of around 15%, alongside changes to diet and exercise. That has effectively delayed the launch in most of Europe, following the recent launch of Wegovy in Denmark and Norway. Novo Nordisk has also had to overcome problems at a contract manufacturer. Novo Nordisk also said the number of people with obesity is forecast to rise to 1.5 billion by 2035. Research and development chief Martin Lange said that the company plans to investigate how to maintain the weight loss after stopping the drug.
Persons: Lars Fruergaard Jorgensen, Camilla Sylvest, Jorgensen, Wegovy, Martin Lange, Maggie Fick, Nikolaj Skydsgaard, Jennifer Rigby, Louise Heavens, Emma Rumney Organizations: pharma, Novo Nordisk, World Health Organisation, WHO, World Obesity Federation, Reuters, Research, Thomson Locations: COPENHAGEN, Europe, United States, U.S, Danish, Wegovy, Denmark, Norway, London, Copenhagen
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
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
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 company reported a larger-than-expected quarterly loss and cut its annual revenue forecast for the second time, but strength in its biologics unit drove quarterly sales past tempered Wall Street estimates. Catalent's "results cleared an admittedly low bar", Stephens analyst Jacob Johnson said. "After a number of shoes dropping and a lot of noise recently, today was a good first or second step." Catalent reported a third-quarter loss of 9 cents per share, compared with Wall Street estimates for a loss of 3 cents, according to IBES data from Refinitiv. The company will also amend its 2022 results filing with a $26 million deduction caused by a revenue recognition error at its Bloomington plant.
Persons: Stephens, Jacob Johnson, Alessandro Maselli, Maselli, Catalent, Bhanvi Satija, Sriparna Roy, Devika Organizations: Novo Nordisk's, Thomson Locations: Maryland, Brussels, Indiana, Bloomington, Bengaluru
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
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
Novo's inability to keep up with a burst in U.S. demand for Wegovy has effectively delayed the launch in Britain and elsewhere in Europe. A company spokesperson would not comment on any commitment to supply its drug for the British pilot. The British government said that only 35,000 people would have access to Wegovy under the specialist hospital services, but tens of thousands more could be eligible. Duane Mellor, a dietitian and senior lecturer at Aston University's medical school, told Reuters drugs like Wegovy were a tool, not the solution. Wegovy works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that triggers the feeling of fullness in the body after eating.
Persons: Jim Vondruska, Sunak, Eli Lilly's, Eli Lilly, Phil McEwan, Novo, Keen, Wegovy, Duane Mellor, Simon Cork, Ludwig Burger, Maggie Fick, Anusha, Helen Reid, Lincoln, Mark Potter Organizations: REUTERS, National Health, Novo, British, NHS, NICE, National Institute for Health, Care, Wegovy, Nordisk, ., Heor Ltd, Reuters, Aston, Anglia Ruskin University, Thomson Locations: Chicago , Illinois, U.S, Britain, England, Europe, United States, British, Cardiff, Denmark, Norway, Frankfurt, London, Bengaluru
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
Novo Nordisk in talks buy controlling stake in Biocorp
  + stars: | 2023-06-05 | by ( ) www.reuters.com   time to read: +1 min
June 5 (Reuters) - Danish drug developer Novo Nordisk said on Monday it had started talks to buy a controlling stake in French medical device designer Biocorp (ALCOR.PA). The price represents a premium of 19.5% over Biocorp's closing market price on June 2 and the transaction values Biocorp at about 154 million euros, the companies said. Certain minority shareholders, representing 19.0% of the share capital of Biocorp, will also transfer shares to Novo Nordisk and the transaction will be followed by a squeeze-out procedure. The block purchase should take place during the third quarter of 2023 and the filing of the subsequent offer should take place in September 2023, Novo said. ($1 = 0.9349 euros)Reporting by Michal Aleksandrowicz in Gdansk; Editing by Kim CoghillOur Standards: The Thomson Reuters Trust Principles.
Persons: Biocorp, Novo, Michal Aleksandrowicz, Kim Coghill Organizations: Novo Nordisk, Thomson Locations: Danish, Biocorp, Gdansk
But she knows — from experience — that probably won't be possible if she has to stop taking the drug once her manufacturer-issued coupons expire. But the injections don't work once people stop taking them. Li Ran/Xinhua via Getty ImagesMany health insurers and employers have long declined to pay for weight-loss drugs. He has resumed taking weight-loss medication but said he hoped to go down to a lower dose. Want to tell us about your experience with health insurance and weight-loss drugs?
Persons: Tara Rothenhoefer, Rothenhoefer, Eli Lilly's, Insider's Gabby Landsverk, , Wegovy, Rothenhoefer Novo, we're, Dr, Martin Lange, Novo, Eli Lilly, Li Ran, Sean Duffy, Omada, Duffy, hungrier, Nisha Patel, it's, " Lange, Bill, Gabby Landsverk, Shelby Livingston, Hilary Brueck Organizations: Rothenhoefer Novo Nordisk, Novo Nordisk, Getty, National Library of Medicine Locations: San Francisco, Novo, Xinhua, slivingston
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
Check out the companies making headlines in midday trading. DraftKings — Shares of the sports gambling platform soared 8% in midday trading. Earlier on Monday, UBS upgraded the stock to buy from neutral on strong growth in new states. Zions Bancorporation — The bank stock jumped 6.7% after Hovde Group initiated coverage of Zions at outperform, with a $40 price target, according to FactSet. Norfolk Southern — Norfolk Southern gained less than 1% during midday trading.
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.
We are selling 50 shares of Eli Lilly (LLY) at roughly $442 each. Following Monday's trade, Jim Cramer's Charitable Trust will own 150 shares of LLY, decreasing its weighting in the portfolio to about 2.5% from 3.33%. We're taking some Eli Lilly off the table Monday afternoon on the stock's breakout to another new all-time high. The FDA in early January granted accelerated approval to a drug similar to donanemab, which was developed by Japanese pharmaceutical firm Eisai and U.S.-based partner Biogen (BIIB). Like Pfizer's drug, Lilly is working on an oral type-2 diabetes and chronic weight management drug called orforglipron, which could be similar to the Mounjaro injectable.
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