DIRS.INFO The most relevant business & tech news

An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021. REUTERS/Mike Segar/File PhotoAug 8 (Reuters) - Eli Lilly (LLY.N) on Tuesday raised its annual forecasts after beating estimates for quarterly results, driven by strong demand for its new diabetes drug Mounjaro, ahead of a decision on its use as a weight-loss treatment. The company is leaning on Mounjaro, approved last May in the U.S. for diabetes, to soften the hit from insulin price cuts and competition for cancer therapy Alimta. A decision on Mounjaro to treat obesity, expected later this year, could help the drugmaker tap a multi-billion dollar market. Lilly now expects annual revenue in range of $33.4 billion to $33.9 billion, compared with its prior range of $31.2 billion to $31.7 billion.

Persons: Eli Lilly, Mike Segar, Mounjaro, Wells, Mohit Bansal, Lilly, Bhanvi Satija, Mariam Sunny, Sriraj Organizations: Company, REUTERS, Novo Nordisk, Thomson Locations: Branchburg , New Jersey, U.S, Bengaluru

☆ Obesity drugs take brakes off Big Pharma’s growth
▼ + stars: | 2023-08-08 | by ( Robert Cyran | ) www.reuters.com time to read: +4 min

That’s what Eli Lilly (LLY.N) did in the second quarter, thanks to demand for its diabetes and weight loss drug Mounjaro. While doctors are currently free to prescribe Mounjaro for obesity, insurers and governments typically won’t pay for what some still insist is a vanity treatment. Even so a regulatory green light, and clear evidence that these drugs have tangible health benefits, will help loosen purse strings. The brakes are off these firms’ growth, and investors are counting on them remaining so. Mounjaro, the company’s diabetes drug, brought in revenue of $980 million, compared to $16 million a year ago.

Persons: Eli Lilly, LLY.N, Lilly, That’s, David Ricks, Mounjaro, Peter Thal Larsen, Sharon Lam Organizations: Reuters, Novo Nordisk, U.S . Food, Drug Administration, Merck, Investors, Thomson Locations: Danish, U.S, Novo

☆ Focus: US psychiatrists prescribe Wegovy to battle medication-induced weight gain
▼ + stars: | 2023-08-03 | by ( Elissa Welle | ) www.reuters.com time to read: +6 min

[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. The global market for weight-loss drugs is forecast to reach as much as $100 billion within the decade. Beyond severe mental health disorders, other patients struggling with obesity tend to suffer from mental health issues like depression and anxiety at higher levels than the general population, studies show. However, psychiatrists specializing in eating disorders are wary that drugs like Wegovy could exacerbate their patients’ focus on weight loss because they are so effective. Dr. Michael Weintraub, an endocrinologist at NYU Langone Health, said ideally psychiatrists will work with endocrinologists because weight-loss drugs require careful monitoring not related to mental health issues.

Persons: Jim Vondruska, Wegovy, Novo, It's, doggedly, Joseph Goldberg, Eli Lilly, Natalia Salomao, Dost Ongur, Brigham, Roy Chengappa, New Yorker Alexander Roger, Roger, Michael Weintraub, McLean's Ongur, Elissa Welle, Michele Gershberg, Bill Berkrot Organizations: REUTERS, Icahn School of Medicine, U.S . Food, Drug Administration, Reuters, Mass, Brigham McLean Hospital, University of Pittsburgh Medical Center, New Yorker, Fordham University, Nordisk, NYU Langone Health, Thomson Locations: Chicago , Illinois, U.S, Mount Sinai, New York, Europe, Danish, Boston

☆ Insight: Promising new Alzheimer's drugs may benefit whites more than Blacks
▼ + stars: | 2023-07-31 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +11 min

The company told Reuters that 49% of Black volunteers did not meet the trial's amyloid threshold requirements compared to 22% for whites and 55% for Hispanics. "Is it because MCI (mild cognitive impairment) or early dementia type-symptoms in Blacks are caused by other reasons more so than Alzheimer's?" In 96 dementia trials from 2000-2017, diverse populations only made up around 11% of enrollment, according to a 2018 study. Among Black people who died of Alzheimer's, their dementia was more likely to result from multiple causes, such as vascular disease. "Is it that it's not Alzheimer's disease?

Persons: Barrington, Vickie Riley, Charlie, Harriet Shaffer, Barrington Riley, –, Eli Lilly, Lilly, Crystal Glover, Eisai, Ivan Cheung, Cheung, Shobha, Biogen, Mark Mintun, Alzheimer's, Dr Lisa Barnes, Barnes, Joshua Grill, we're, Reisa Sperling, Brigham, Julie Steenhuysen, Caroline Humer, Suzanne Goldenberg, Daniel Flynn Organizations: Emory University Brain Health, Americans, Reuters, Prospective Black, Rush, Disease Research, and Drug Administration, FDA, Black, MCI, National Institutes of Health, Rush Center, University of California, Women's Hospital, Thomson Locations: Atlanta , Georgia, U.S, Chicago, Tokyo, Irvine, United States

☆ Quest Diagnostics launches Alzheimer's blood test for consumers
▼ + stars: | 2023-07-31 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +2 min

CHICAGO, July 31 (Reuters) - Quest Diagnostics (DGX.N) on Monday launched the first direct-to-consumer blood test to detect abnormal levels of beta amyloid, a key Alzheimer's protein which can appear years before dementia symptoms arise. The $399 test, called AD-Detect, uses the same technology as a blood test the company launched for use by doctors in early 2022. Users must first pay for the test on Quest's website. Quest will then arrange for an appointment with a telemedicine doctor to order it on their behalf. Quest's lab-developed test, created and performed in a single laboratory, has not undergone any FDA review.

Persons: Michael Racke, Biogen, Eli Lilly, Racke, Julie Steenhuysen, Richard Chang Organizations: Quest Diagnostics, Monday, U.S . Food, Drug Administration, Thomson Locations: Eisai, Alzheimer's

☆ Insight: Wegovy weight-loss injection factory plagued by sterile-safety failures
▼ + stars: | 2023-07-27 | by ( Maggie Fick | ) www.reuters.com time to read: +10 min

Microbial contamination of drugs injected into the body, rather than swallowed, can be deadly, the people said - although the FDA inspectors didn't report any signs of this sort of contamination at the Brussels factory. In both visits, the FDA inspectors found Catalent staff had repeatedly failed to investigate why equipment was malfunctioning. BLINDSIDED BY BOOMING DEMANDWithin months of launching Wegovy, Novo Nordisk was overwhelmed by demand in America, and told shareholders that its initial supply would not keep pace. From December that year and throughout 2022, Novo repeatedly pushed out the timeline for when the supply constraints would end. In late December 2022, Novo announced all five dose strengths were available again in the United States.

Persons: Wegovy, Catalent, Eli Lilly, LLY.N, Susan Bain, Karsten Munk Knudsen, Ambre James, Brown, James, Knudsen didn't, Steven Lynn, Lynn, David Talmage, didn't, Novo, Maggie Fick, Vincent Flasseur, Michele Gershberg Organizations: U.S . Food, Drug Administration, Reuters, FDA, Novo Nordisk, University of Southern, Novo executives, Novo, U.S, Manufacturing, Parenteral Drug Association, Thomson Locations: U.S, Brussels, Danish, University of Southern California, Wegovy, Novo, America, United States

☆ Eli Lilly's obesity drug succeeds in two late-stage studies
▼ + stars: | 2023-07-27 | by ( ) www.reuters.com time to read: +1 min

July 27 (Reuters) - Eli Lilly (LLY.N) said on Thursday its experimental obesity drug met the main goals in two late-stage studies, with the drug helping patients reduce 26.6% weight on average in one of the studies following intensive lifestyle changes. The company said both the late-stage studies also achieved all secondary goals. Overall safety of the drug tirzepatide, sold under the name Mounjaro for diabetes, was similar to that observed in previous studies. The results follow strong data for the drug from two earlier trials. Reporting by Bhanvi Satija and Leroy Leo in Bengaluru; Editing by Saumyadeb Chakrabarty and Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.

Persons: Eli Lilly, LLY.N, tirzepatide, Lilly, Bhanvi Satija, Leroy Leo, Saumyadeb Chakrabarty, Shounak Organizations: Thomson Locations: Bengaluru

☆ Exclusive: UK probes Novo's Ozempic, weight-loss drug Saxenda over suicidal, self-harming thoughts
▼ + stars: | 2023-07-26 | by ( Maggie Fick | ) www.reuters.com time to read: +4 min

Saxenda is Novo's older GLP-1 drug and has lower effectiveness than its newer obesity treatment Wegovy, which contains semaglutide. Novo told Reuters it had received a request on Monday from the MHRA about the agency's review of potential suicidal and self-harming thoughts related to GLP-1 drugs. The MHRA said AstraZeneca's GLP-1 drug for type 2 diabetes, called exenatide and marketed as Bydureon, was also included in the review. The MHRA said that two other GLP-1 drugs, Sanofi's (SASY.PA) lixisenatide and Eli Lilly's (LLY.N) dulaglutide, were also included. It is also investigating GLP-1 drugs for possible risk of thyroid cancer.

Persons: Novo, AstraZeneca's GLP, lixisenatide, Eli Lilly's, Sanofi, Eli Lilly, liraglutide, Alison Cave, Novo's, MHRA, Ozempic, GLP, Maggie Fick, Josephine Mason, Mark Potter, Jane Merriman Organizations: Novo Nordisk, European Union, The Medicines, Healthcare, Agency, Reuters, AstraZeneca, European Medicines Agency, Thomson Locations: Britain, Europe, United States

☆ Lilly drug slows Alzheimer's by 60% for mildly impaired patients in trial
▼ + stars: | 2023-07-17 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

Lilly expects the U.S. Food and Drug Administration to decide by the end of this year whether to approve donanemab. The company had previously reported that 24% of the overall donanemab treatment group had brain swelling. The deaths of three trial patients were linked to the treatment, researchers reported. For high tau patients, donanemab was shown to slow disease progression by about 17%, while the benefit was 35% for those with low-to-intermediate tau levels. Both medications are also being studied in large trials to see if they have an impact on delaying onset of Alzheimer's disease symptoms.

Persons: Seth Gale, Brian Snyder, Eli Lilly, Anne White, Lilly, Susan Kohlhaas, Liana Apostolova, White, Liz Coulthard, donanemab, Deena Beasley, Ludwig Burger, Will Dunham, Bill Berkrot, Caroline Humer Organizations: Alzheimer Research, Brigham, Women’s, REUTERS, Alzheimer's Association International, U.S . Food, Drug Administration, Alzheimer’s Research, Indiana University School of Medicine, Doctors, University of Bristol, JAMA, FDA, Alzheimer's Association, Health Organization, New York Stock Exchange, Thomson Locations: Boston , Massachusetts, U.S, Amsterdam, Eisai

☆ Exclusive: MoonLake Immunotherapeutics explores sale-sources
▼ + stars: | 2023-07-14 | by ( David Carnevali | ) www.reuters.com time to read: +2 min

July 14 (Reuters) - MoonLake Immunotherapeutics (MLTX.O), a developer of an antibody-derived treatment for inflammatory skin conditions, is exploring a sale, according to people familiar with the matter. Immunology-focused companies have been coveted acquisition targets, as highlighted by recent deals such as Merck & Co's (MRK.N) $10.8 billion acquisition of Prometheus BioSciences Inc and Eli Lilly's (LLY.N) $2.4 billion purchase of Dice Therapeutics (DICE.O). MoonLake is testing Sonelokimab for the treatment of other inflammatory conditions, including psoriatic arthritis and psoriasis. If successful, MoonLake would encroach on a market dominated by bigger peers such as Novartis AG (NOVN.S) and AbbVie Inc (ABBV.N). In 2022, MoonLake went public through a merger with a special purpose acquisition company, which helped it raise more than $200 million in cash.

Persons: drugmakers, Eli Lilly's, MoonLake, hidradenitis suppurativa, hidradenitis, Merck KGaA, David Carnevali, Josie Kao Organizations: Nasdaq, Merck, Co's, Prometheus BioSciences, Dice Therapeutics, Novartis AG, AbbVie Inc, Citigroup, Thomson Locations: Zug, Switzerland, New York

July 14 (Reuters) - Eli Lilly and Co (LLY.N) said on Friday it will buy privately held Versanis for potentially up to $1.93 billion to strengthen its position in the fast-growing market for weight-loss treatments. Shares of Eli Lilly rose 3% after the deal that gives it access to an experimental obesity drug being tested along with rival Novo Nordisk's (NOVOb.CO) weight-loss treatment in a mid-stage study. Analysts expect the market for weight-loss drugs to reach up to $100 billion within a decade, with early movers such as Eli Lilly and Novo Nordisk grabbing a large chunk of the market. "One of the key concerns with weight loss medications is the loss of lean mass. The goal is to lose more fat vs. muscle, but with any weight loss program calorie restriction could impact both," said BMO Capital Markets analyst Evan Seigerman.

Persons: Eli Lilly, Novo, Evan Seigerman, Lilly, Sriparna Roy, Arun Koyyur Organizations: Novo Nordisk's, Novo Nordisk, Capital, Novartis, Thomson Locations: Swiss, Bengaluru

☆ Uninsured US patients pay up to $330 for Eli Lilly’s $25 insulin, Senator Warren says
▼ + stars: | 2023-07-13 | by ( Patrick Wingrove | ) www.reuters.com time to read: +3 min

Warren’s survey of chain and independent pharmacies across all 50 states, carried out between June 9 and 28, found a third of drug stores charged $164 or more to uninsured patients for Lilly’s Insulin Lispro. Lilly said at the time it would drop the price of its Lispro insulin injection, a generic version of its own branded Humalog, to $25 a vial. The senator’s office found chain stores charged uninsured customers an average of $123 per vial for the generic insulin, compared to $63 at independent pharmacies. “This is a deeply troubling finding, revealing that the pharmacies offering the most affordable Insulin Lispro were the least likely to have it in stock,” the report said. Around 8.4 million of the 37 million people in the United States with diabetes use insulin, according to the American Diabetes Association.

Persons: Eli Lilly, George Frey, Eli, Elizabeth Warren’s, Lilly, Joe Biden’s, drugmaker, Warren, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: Company, REUTERS, Novo Nordisk, Sanofi, U.S, National Community Pharmacists Association, Democrat, Walgreens Boots Alliance, Walmart, Rite, CVS Health, Aid, CVS, Walgreens, Rite Aid, American Diabetes Association, Thomson Locations: Provo , Utah, U.S, Indianapolis, United States, New York

☆ Weight loss without Wegovy’s side-effects on biotech firms' radar
▼ + stars: | 2023-07-07 | by ( Maggie Fick | ) www.reuters.com time to read: +8 min

It leads to 22.5% weight loss, according to a Lilly trial published last year. The effect achieves far more weight loss than predecessors. An even earlier stage biotech firm, Antag Therapeutics in Denmark, told Reuters that the ballooning obesity market has improved its fundraising prospects. It curbs appetite by restoring the natural release of GLP-1 and other hormones, without causing nausea, Phase I data showed. The effect of the drug on weight loss is being tested in the Phase II study.

Persons: Rebecca Vogt, Handout, Wegovy, Vogt, Jayson Dallas, Noushin Irani, Mounjaro, Eli Lilly's, Lilly, Andrew Levin, Rivus, Mark Fineman, Ashish Nimgaonkar, Nimgaonkar, Alexander Sparre, Ulrich, Tim Opler, Opler, Stifel, Maggie Fick, Josephine Mason, Daniel Flynn Organizations: REUTERS, Nordisk's, Food and Drug Administration, U.S, Reuters, Rivus Pharmaceuticals, Investors, Deutsche, FDA, Pfizer, Capital Management, Rivus, Therapeutics, Johns Hopkins University, pharma, Antag Therapeutics, Aphaia Pharma, Thomson Locations: Irving , New York, U.S, GLP, Buffalo , New York, United States, Dallas, Baltimore , Maryland, Denmark, Switzerland

☆ Focus: Biotech firms target weight-loss drugs without Wegovy's side-effects
▼ + stars: | 2023-07-07 | by ( Maggie Fick | ) www.reuters.com time to read: +8 min

[1/7] Rebecca Vogt, a former user of the weight-loss drug Wegovy, poses for a photo, in Irving, New York, U.S., June 20, 2023. It leads to 22.5% weight loss, according to a Lilly trial published last year. An even earlier stage biotech firm, Antag Therapeutics in Denmark, told Reuters that the ballooning obesity market has improved its fundraising prospects. It curbs appetite by restoring the natural release of GLP-1 and other hormones, without causing nausea, Phase I data showed. The effect of the drug on weight loss is being tested in the Phase II study.

Trial data showed that the treatment slows progression of the brain-wasting disease by 27% for patients in the earliest stages of Alzheimer's. The FDA placed its strongest "boxed" safety warning on Leqembi's label, flagging the risk of potentially dangerous brain swelling for Alzheimer's drugs in the same class. Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer's patients. Biogen and Eisai stock has risen since FDA granted accelerated approval to Alzheimer's drug Leqembi earlier this yearLeqembi's new label explains the need to monitor patients for potentially dangerous brain swelling and bleeding associated with amyloid-lowering antibodies. The first FDA-approved disease-modifying Alzheimer's drug, Aduhelm, was also developed by partners Eisai and Biogen, but Medicare coverage restrictions have severely limited its use.

Persons: Leqembi, drugmakers, Ivan Cheung, Chiquita Brooks, LaSure, Babak Tousi, Tousi, Biogen, Dr, Erik Musiek, Eli Lilly, Co's, Cheung, Joanne Pike, Eisai, Leqembi's, Deena Beasley, Julie Steenhuysen, Bill Berkrot, Matthew Lewis Organizations: U.S . Food, Drug Administration, FDA, Medicare, Medicaid Services, Cleveland Clinic, Washington University, Barnes, Jewish, Alzheimer’s Association, Alzheimer's Association, Thomson Locations: ANGELES, U.S, Los Angeles, Chicago

☆ Eli Lilly to buy Sigilon Therapeutics to expand diabetes treatments
▼ + stars: | 2023-06-29 | by ( ) www.reuters.com time to read: +1 min

A major provider of diabetes drugs and insulin, Lilly owned nearly 8.44% stake in Sigilon as of March 27. It would pay $14.92 per share, or $34.6 million in upfront cash, for the rest of the company. Sigilon shareholders will get an additional $111.64 per share if they achieve certain developmental and regulatory milestones, Lilly said. The deal, which is expected to close in the third quarter of 2023, would give Lilly access to Sigilon's proprietary cell therapy candidate being developed to treat type 1 diabetes. The two companies have been partners since 2018, when Lilly paid Sigilon $63 million for a licensing deal to develop cell therapes targeting type 1 diabetes and made an undisclosed equity investment.

Persons: Eli Lilly, Lilly, Sigilon, Mariam Sunny, Shilpi Majumdar Organizations: Sigilon Therapeutics, Thomson Locations: Sigilon, Bengaluru

☆ Eli Lilly gorges on obesity options
▼ + stars: | 2023-06-27 | by ( ) www.reuters.com time to read: +2 min

NEW YORK, June 27 (Reuters Breakingviews) - Eli Lilly (LLY.N) has filled its plate with potential obesity treatments, unveiling data from two more on Monday. With so many options under development at Lilly, Novo Nordisk (NOVOb.CO) and others, it raises reasonable questions about capital allocation. Obesity drugs have investors salivating, but is this just more pharmaceutical R&D overkill? Pfizer’s cholesterol-lowering Lipitor, for one, reached consumers after rivals, and a decade after Merck’s version. Lilly’s research budget, projected at 24% of revenue this year, exceeds that of many peers, including Pfizer’s (PFE.N) 19%.

Persons: Eli Lilly, Robert Cyran, Aston Martin, Jeffrey Goldfarb, Sharon Lam Organizations: YORK, Reuters, Novo Nordisk, Twitter, Vodafone, Thomson Locations: Lilly, China, Canada

☆ Obesity drug Wegovy's popularity has US employers rethinking insurance coverage
▼ + stars: | 2023-06-27 | by ( Patrick Wingrove | ) www.reuters.com time to read: +6 min

[1/2] A selection of injector pens for the Saxenda weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023. A new and more expensive version of the drug specifically for weight loss, called Wegovy, had been approved in 2021 by U.S. health regulators. Employers that cover weight-loss drugs have required medical practices to document patients’ need for Wegovy since it was approved. The federal Medicare healthcare program for Americans aged 65 and older cannot cover weight loss treatments by law. Only 16 states – the most populous being California, Pennsylvania and Michigan – cover Wegovy and other obesity drugs under their Medicaid plans for low-income patients.

Persons: Jim Vondruska, Shawnte, Aon, Mercer, Willis Towers Watson, Eli Lilly, Jeff Levin, Levin, Scherz, Michael Manolakis, William Yancy, Manolakis, Patrick Wingrove, Michele Gershberg, Suzanne Goldenberg Organizations: REUTERS, New, Warner Bros, Warner Bros Discovery Inc, Reuters, Marsh & McLennan, Employers, Barclays Research, Novo Nordisk, Duke University, Thomson Locations: Chicago , Illinois, U.S, New York, Marsh, Wegovy, California, Pennsylvania, Michigan

☆ Analysis: Weight loss drug candidates multiply, spurring hopes of better outcomes, lower costs
▼ + stars: | 2023-06-27 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

More than 40% of Americans are obese, according to the U.S. Centers for Disease Control and Prevention, and demand is strong for treatments to reduce body weight as well as maintain weight loss. The company said it would continue to develop its twice-daily weight loss drug candidate. Structure Therapeutics (GPCR.O) is developing oral obesity drugs that it says are simpler to manufacture than the current injectables. "We define weight loss quality as the percentage of weight loss attributed to fat loss," said Versanis Chief Scientific Officer Lloyd Klickstein. "With diets, bariatric surgery, incretin drugs or other weight loss drugs, two-thirds to three-quarters of the weight loss is fat, but one-quarter to one-third is lean."

Persons: Robert Gabbay, Eli Lilly, Lilly's, Wegovy, Mico Guevarra, Lilly, Jeff Emmick, Ray Stevens, Boehringer Ingelheim, Versanis, Lloyd Klickstein, Chaguturu, Deena Beasley, Michele Gershberg, Jamie Freed Organizations: DIEGO, Novo Nordisk's, American Diabetes Association, Novo, U.S . Centers for Disease Control, ADA, Pfizer, Therapeutics, Zealand Pharma, Novartis, CVS Health, Aetna, Thomson Locations: San Diego, GLP

☆ Lilly experimental 'triple G' obesity drug leads to 24.2% weight loss in trial
▼ + stars: | 2023-06-26 | by ( Deena Beasley | ) www.reuters.com time to read: +2 min

Companies Eli Lilly and Co FollowJune 26 (Reuters) - Eli Lilly (LLY.N) on Monday said a mid-stage trial of its next-generation obesity drug candidate "triple G" showed that it led to weight loss of up to 24.2% after 48 weeks, surpassing results seen with other weight loss drugs. Lilly's Mounjaro, which is awaiting U.S. regulatory approval for treatment of obesity, targets GLP-1 as well as a second obesity-related hormone called GIP. Retatrutide targets GLP-1, GIP and the body's receptors for a third hormone, glucagon. Given the three targets, Lilly has nicknamed the drug triple G.The company reported last year that a trial of Mounjaro in people who were obese or overweight found it led to weight loss of 22.5% after 72 weeks. Lilly is conducting longer-duration phase 3 trials of retatrutide to see if weight loss might be further improved.

Persons: Eli Lilly, Lilly's, Lilly, ” Dan Skovronsky, Deena Beasley, Deepa Babington, Cynthia Osterman Organizations: American Diabetes Association, New England, of Medicine, Thomson Locations: San Diego

Pfizer CEO Albert Bourla has said an obesity pill could eventually be a $10-billion-a-year product for Pfizer. Truist Securities analyst Robyn Karnauskas said Lilly is now ahead in the race for a once-a-day obesity pill. Pfizer said last month that danuglipron helped patients lose weight on par with Novo Nordisk's (NOVOb.CO) Ozempic in a mid-stage study that tested it in patients with Type 2 diabetes. None of the patients in the lotiglipron trials reported liver-related symptoms or side effects, there was no evidence of liver failure and none required treatment, Pfizer said. Liver enzyme elevations observed in lotiglipron trials have not been seen in patients enrolled in danuglipron trials, the company added.

Persons: Albert Bourla, Eli Lilly, LLY.N, Robyn Karnauskas, Lilly, Pfizer, danuglipron, Manas Mishra, Leroy Leo, Michael Erman, Pooja Desai, Jason Neely, Deepa Babington Organizations: Pfizer Inc, Pfizer, NYSE Arca Pharmaceutical, Truist Securities, Novo Nordisk's, Thomson Locations: United States, Bengaluru, New Jersey

☆ Novo Nordisk says obesity pill leads to 15% weight loss; availability "to be determined"
▼ + stars: | 2023-06-26 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

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

☆ 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

☆ Novo Nordisk says EMA raised safety signal on drugs, shares fall
▼ + stars: | 2023-06-22 | by ( Nikolaj Skydsgaard | ) www.reuters.com time to read: +3 min

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

☆ Wall Street ends lower, pausing rally as Powell testimony looms
▼ + stars: | 2023-06-20 | by ( Stephen Culp | ) www.reuters.com time to read: +4 min

All three major U.S. equity indexes ended the session in the red but off session lows, with oil super-majors Exxon Mobil Corp weighing on the S&P 500 and the Dow. Including Tuesday's loss, the benchmark S&P 500 has advanced 14.3% so far this year. Of the 11 major sectors of the S&P 500 all but consumer discretionary stocks (.SPLRCD) ended in negative territory. The S&P 500 posted 14 new 52-week highs and no new lows; the Nasdaq Composite recorded 68 new highs and 87 new lows. Volume on U.S. exchanges was 11.15 billion shares, compared with the 11.36 billion average for the full session over the last 20 trading days.

Persons: Jerome, Robert Pavlik, Pavlik, We've, Rivian, Morgan Stanley, Daniel Zhang, Eli Lilly, Stephen Culp, Shristi Achar, Shubham Batra, Johann M, Aurora Ellis Organizations: Fedex, Dow, Nasdaq, Federal, Exxon Mobil Corp, Dakota Wealth, U.S . House Financial, Dow Jones, Energy, Rivian Automotive Inc, Tesla Inc, PayPal Holdings, KKR & Co, Nike, Alibaba Group, Adobe Inc, Dice Therapeutics, Fedex Corp, NYSE, Thomson Locations: Fairfield , Connecticut, China, Europe, Bengaluru

Search resuls for: "LLY.N"

25 mentions found