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☆ Johnson & Johnson forecasts as much as 6% sales growth in 2024
▼ + stars: | 2023-12-05 | by ( ) www.reuters.com time to read: +2 min

Dec 5 (Reuters) - Johnson & Johnson (JNJ.N) on Tuesday forecast revenue growth of 5-6% for the next year, as it banks on strong demand for cancer treatments Darzalex and Carvykti and resilient sales of blockbuster drug Stelara. The company has narrowed its focus on its drugs and medical devices business since it hived off its consumer health unit earlier this year. Sales of blockbuster psoriasis treatment Stelara in Europe are expected to come under pressure as early as next year as a key patent on the drug expires. Sales of the drug largely come from its use as a treatment for inflammatory bowel diseases (IBD), Wolk said. J&J's 2024 revenue growth forecast excludes sales of its COVID vaccine.

Persons: Johnson, Joseph Wolk, Wolk, J, Bhanvi, Patrick Wingrove, Anil D'Silva Organizations: Johnson, Thomson Locations: Europe, United States, Bengaluru, New York

Dec 5 (Reuters) - Eli Lilly (LLY.N) on Tuesday said its recently approved obesity treatment Zepbound is now available in U.S. pharmacies and could cost $550 a month for customers whose health insurance does not cover the drug, or half the list price. Wall Street analysts expect sales of Zepbound to reach about $2 billion in 2024, and for sales of Novo Nordisk's (NOVOb.CO) rival obesity drug Wegovy to hit around $7.5 billion. An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021. When the U.S. Food and Drug Administration approved Zepbound in November, Lilly said it would launch after the U.S. Thanksgiving holiday. Lilly's obesity drug has the same active ingredient, tirzepatide, as its previously approved diabetes drug Mounjaro, which has been used off-label for weight loss since its 2022 launch.

Persons: Eli Lilly, Wegovy, danuglipron, Zepbound, Lilly, Mike Segar, Eli Lilly's, Patrick Wingrove, Manas Mishra, Khushi, Arun Koyyur, Alexander Smith, Bill Berkrot Organizations: Wall Street, Novo, Pfizer, Company, REUTERS, CVS, U.S . Food, Drug Administration, U.S, Thomson Locations: U.S, Branchburg , New Jersey, Indianapolis, New York, Bengaluru

☆ US obesity docs expect Lilly weight-loss drug to show similar heart benefit as Wegovy
▼ + stars: | 2023-12-01 | by ( Patrick Wingrove | ) www.reuters.com time to read: +5 min

REUTERS/Mike Segar Acquire Licensing RightsDec 1 (Reuters) - Some leading U.S. obesity specialists say they expect Eli Lilly’s (LLY.N) powerful weight-loss drug Zepbound will produce the same or similar heart benefits as Novo Nordisk’s (NOVOb.CO) popular Wegovy as they belong to the same class of medicines. In Novo's pivotal Wegovy trial involving 17,604 overweight and obese people without diabetes, the drug reduced incidence of heart attack, stroke or heart-related death by an impressive 20%. The product, which has the same active ingredient - tirzepatide - as its previously approved diabetes drug Mounjaro, is expected to start shipping it before the end of the year. They said they would readily prescribe Wegovy (semaglutide) if their patients' insurance did not cover Lilly’s drug, or if future trial results do not produce similar heart benefits. Lilly declined to comment on doctors' views that Zepbound might have the same or similar cardiovascular benefits as Wegovy.

Persons: Eli Lilly, Mike Segar, Eli Lilly’s, Lilly, Danish drugmaker, Edmond Wickham, Emily, Zepbound, Tirzepatide, ”, Rohit Kedia, Novo, Chad Weldy, semaglutide, tirzepatide, Farxiga, Boehringer Ingelheim, Lilly’s Jardiance, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: Company, REUTERS, Novo, Wegovy, Virginia Commonwealth University . The, Virginia Commonwealth University . The U.S . Food, Drug Administration, Wall Street, Barclays, Providence, Stanford University, Thomson Locations: Branchburg , New Jersey, Danish, Virginia Commonwealth University . The U.S, Zepbound, U.S

☆ Novo Nordisk finds compounded Wegovy up to 33% impure, sues Florida pharmacies
▼ + stars: | 2023-11-30 | by ( Patrick Wingrove | ) www.reuters.com time to read: +3 min

[1/2] Injection pens of Novo Nordisk's weight-loss drug Wegovy are shown in this photo illustration in Oslo, Norway, November 21, 2023. The Danish drugmaker said it found impurities in all the drugs tested from Wells Pharmacy and Brooksville Pharmaceuticals, both based in Florida. Novo said the compounded versions of Wegovy tested from Brooksville were also less potent than advertised, with one sample shown to be at least 19% weaker than indicated. The drugmaker has already filed 12 lawsuits against medical spas, weight-loss clinics and compounding pharmacies offering products that claim to contain semaglutide. The case against Wells was filed in the U.S. District Court, Middle District of Florida, Ocala division and the suit against Brooksville in U.S. District Court, Middle District of Florida, Tampa division.

Persons: Victoria Klesty, Danish drugmaker, Novo, Brooksville, ” Jason Brett, Eli Lilly, Mounjaro, Wells, Patrick Wingrove, Josephine Mason, Bill Berkrot, Jane Merriman Organizations: REUTERS, Novo Nordisk, Wells Pharmacy, Brooksville Pharmaceuticals, U.S . Food, Drug Administration, FDA, Novo's, Middle District of, Brooksville, Thomson Locations: Oslo, Norway, Victoria, Danish, Florida, Wells, U.S, Middle District, Middle District of Florida, Ocala, Tampa

☆ Suspected fake Ozempic causes hypoglycemia in 11 in Lebanon
▼ + stars: | 2023-11-28 | by ( Patrick Wingrove | ) www.reuters.com time to read: +4 min

Three of the people who took the suspected fake Ozempic did so to control their diabetes, while four took it for weight management, Karam said. People with diabetes need to closely manage their blood sugar, which can be done with a variety of medicines including Ozempic. Lebanon's Ministry of Public Health issued two recalls related to Ozempic in January 2023, according to its website. Karam said Ozempic is neither purchased nor provided by the Ministry of Public Health. Several people have been hospitalized in Austria for hypoglycemia after taking potentially fake versions of Ozempic.

Persons: Rita Karam, Eli Lilly's, Novo's, Karam, Ozempic, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: Lebanese Ministry of Public Health, Lebanon's Ministry of Public Health, Novo Nordisk, World Obesity, Obesity, International Diabetes Federation, Ministry of Public Health, Reuters, Thomson Locations: Lebanon, Germany, Egypt, Russia, United States, Novo, Britain, Belgium, Austria

A sign is pictured outside an Eli Lilly and Company pharmaceutical manufacturing plant at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021. Incretins are peptide-based drugs such as Mounjaro that mimic gut hormones to suppress appetite and stimulate insulin secretion. Lilly said it had announced investments of more than $11 billion in global manufacturing in the past three years. Major production sites that Lilly runs outside of its U.S. home market are in Ireland, France, Spain, Italy and China. The new Alzey site will employ up to 1,000 highly skilled workers such as engineers, technicians and scientists, said Lilly.

Persons: Eli Lilly, Mike Segar, Lilly, Karl Lauterbach, Lauterbach, generics, Patrick Wingrove, Matthias Williams, Jason Neely, David Evans Organizations: Company, REUTERS, Rights, Reuters, U.S ., Novo Nordisk, European Union, pharma, The U.S ., Thomson Locations: Branchburg , New Jersey, Germany, Alzey, U.S, United States, Danish, Berlin, Fegersheim, France, European, Indiana , North Carolina, Limerick, Ireland, Spain, Italy, China, The U.S

☆ Novo Nordisk says Wegovy heart benefits due to more than weight loss
▼ + stars: | 2023-11-11 | by ( Patrick Wingrove | ) www.reuters.com time to read: +4 min

A 0.25 mg injection pen of Novo Nordisk's weight-loss drug Wegovy is shown in this photo illustration in Oslo, Norway, September 1, 2023. REUTERS/Victoria Klesty/Illustration/File Photo Acquire Licensing RightsPHILADELPHIA, Nov 11 (Reuters) - Novo Nordisk (NOVOb.CO) on Saturday said the heart protective benefits of its wildly popular Wegovy obesity treatment are due to more than weight loss alone, according to new data presented at a major medical meeting on Saturday. Given that patients had not started losing weight when the cardiovascular benefits first appeared suggests the heart protection was not purely the result of weight loss, Novo said. Though the trial was not conducted to test weight loss, participants lost an average of nearly 10% of their total body weight. Novo said patients in the heart study were not required to track diet and exercise as they are in obesity trials.

Persons: Victoria Klesty, Wegovy, Novo, Martin Lange, Lange, Eli Lilly's, Patrick Wingrove, Bill Berkrot Organizations: REUTERS, Rights, Novo Nordisk, American Heart Association, New England, of Medicine, Novo Nordisk's, U.S . Food, Drug Administration, Thomson Locations: Oslo, Norway, Victoria, Philadelphia, U.S, EU

A vial labelled "Novavax V COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. Still, the Maryland-based biotech, which has been banking on cost cuts and commercial sales of its retooled COVID shot to help it stay afloat, reiterated its "going concern warning". The company expects the 2023-2024 U.S. market for COVID shots to be between 30 million and 50 million doses. The company's updated COVID shot, using a more traditional technology than the mRNA-based vaccines of rivals Pfizer (PFE.N) and Moderna (MRNA.O), was authorized in the U.S. in October. Novavax missed out on the COVID vaccine windfall that benefited rivals due to manufacturing issues that delayed its filing for approval when the pandemic was raging.

Persons: Dado Ruvic, Novavax, Jim Kelly, John Jacobs, Jacobs, Bhanvi, Patrick Wingrove, Sriraj Kalluvila, Bill Berkrot Organizations: REUTERS, U.S, Department of Health, Human Services, Pfizer, Moderna, Thomson Locations: Maryland, U.S, United States, Bengaluru, New York

The FDA approved tirzepatide for weight loss under the brand name Zepbound. It has been available as Mounjaro for type 2 diabetes since 2022 and had increasingly been used "off-label" for weight loss while the obesity approval was pending. Zepbound will be available in the U.S. by the end of the year at a list price of $1,059.87 a month, according to Lilly. That compares with a list of $1,349 per-package for Novo Nordisk's (NOVOb.CO) wildly popular weight-loss drug Wegovy. After Wednesday's FDA approval, Lilly can now promote the drug for weight loss.

Persons: Eli Lilly, Mike Segar, Eli Lilly's, ” John Sharretts, Lilly, Morningstar, Damien Conover, Conover, drugmaker, Robert Kushner, Mounjaro, Patrick Wingrove, Leroy Leo, Bhanvi, Shinjini Ganguli, Bill Berkrot Organizations: Company, REUTERS, U.S . Food, Drug Administration, U.S, FDA, FDA’s Center, Drug, Research, Novo Nordisk's, Reuters, Northwestern University Feinberg School of Medicine, Thomson Locations: Branchburg , New Jersey, U.S, Indianapolis, United States, New York, Bengaluru

Many of the patents at issue in the Food and Drug Administration's Orange Book listing of approved products were for devices such as asthma inhalers and epinephrine autoinjectors, the FTC said. "Wrongfully listed Orange Book patents by pharma companies can raise drug prices for Americans, harm fair competition, and delay better drugs," FTC Chair Lina Khan said on X, formerly known as Twitter. The Orange Book identifies drugs and products that the FDA has deemed safe and effective. The FTC says companies sometimes improperly list patents in the Orange Book that can delay market entry of lower priced generics. AbbVie was informed the FTC would dispute four patents in the Orange Book having to do with Restasis Multidose, eye drops used for chronic dry eye.

Persons: Andrew Kelly, Lina Khan, Boehringer Ingelheim, Mylan, AbbVie, Restasis, Diane Bartz, Patrick Wingrove, Bill Berkrot Organizations: Food and Drug Administration, FDA, REUTERS, AstraZeneca, GSK, U.S . Federal Trade Commission, Food, FTC, pharma, Thomson Locations: White Oak , Maryland, U.S, WASHINGTON, Israel, Viatris

☆ Unlike Pfizer, Moderna can meet 2023 COVID forecast, analysts say
▼ + stars: | 2023-11-01 | by ( Khushi Mandowara | ) www.reuters.com time to read: +3 min

Syringes with needles are seen in front of a displayed Moderna logo in this illustration taken, November 27, 2021. Around 20 million people need to be vaccinated with Moderna's updated COVID-19 vaccine for the company to reach $2 billion in 2023 sales from the private market, a figure four analysts told Reuters was achievable. The company has said it expects total U.S. COVID vaccine demand to be as much as 100 million doses in the fall season. Moderna forecast $6 billion to $8 billion for sales of its COVID-19 vaccine in 2023, $2 billion to $4 billion of which is expected to come from the commercial market. The COVID vaccine is Cambridge, Massachusetts-based Moderna's lone marketed product.

Persons: Dado Ruvic, Oppenheimer, Hartaj Singh, Michael Yee, Yee, Manas Mishra, Khushi, Patrick Wingrove, Bill Berkrot Organizations: REUTERS, Reuters, U.S, Moderna, Pfizer, Jefferies, GSK, Thomson Locations: Cambridge , Massachusetts, United States, Bengaluru, New

Homeland Security, as well as companies that help identify counterfeit products such as Israel’s BrandShield. Fake weight-loss drugs will be a key focus in the agency’s annual counterfeit medicines report, due next year, the official said. “We have counterfeit products and stolen products,” the official said. "We will look online and if we find something that infringes (obesity drug trademarks) we'll get it taken down,” said Yoav Keren, BrandShield CEO. When a consumer buys those fakes, “what you get are expired drugs, counterfeit drugs, or nothing,” he added.

Persons: George Frey, Eli Lilly, BrandShield, Novo’s Ozempic, ”, Jim Mancuso, Mancuso, Europol, Novo, Lilly, “, Ozempic, Yoav Keren, MHRA, Eli, Mounjaro, Patrick Wingrove, Aurora Ellis Organizations: Novo Nordisk, Pharmacy, REUTERS, Novo Nordisk’s, Pharmaceutical Security Institute, drugmakers Novo Nordisk, Europol, Interpol, U.S . Homeland Security, U.S . Food, Drug Administration, U.S . Department of Homeland, Coordination Center, PSI, Medicines, Healthcare, Agency, Health Organization, Ireland’s, Products Regulatory Authority, Reuters, Thomson Locations: Provo , Utah, U.S, America, Europe, Germany, Egypt, Russia, North America

☆ Eli Lilly sues online pharmacies to ban US imports of fake Mounjaro
▼ + stars: | 2023-10-19 | by ( Patrick Wingrove | Companies Need To Integrate Climate Reporting Across Functions To Comply With California S New Law | Henry Engler | ) www.reuters.com time to read: +2 min

Eli Lilly logo is shown on one of the company's offices in San Diego, California, U.S., September 17, 2020. Lilly is accusing the online pharmacies of infringing its trademark for Mounjaro, falsely associating themselves with Lilly and approved tirzepatide, and making false or misleading statements in their advertisements related to tirzepatide. “The unapproved drug products are dangerous research chemicals that are not approved for human consumption and have no connection to Eli Lilly or Mounjaro,” Lilly said in its lawsuit. Lilly is the only company with U.S. Food and Drug Administration approval to sell tirzepatide products. The suit comes exactly one month after Eli Lilly sued 10 U.S. medical spas, wellness centers and compounding pharmacies at federal courts in Arizona, Florida, Georgia, Minnesota, South Carolina and Utah for selling products claiming to contain tirzepatide.

Persons: Eli Lilly, Mike Blake, drugmaker, Britain’s Biolabshop, Audrey Beauty, Lilly, Mounjaro, ” Lilly, Patrick Wingrove, Bill Berkrot Organizations: REUTERS, U.S . International Trade Commission, Labs, Mew Mews Company, ITC, Federal Register, U.S . Food, Drug Administration, FDA, Thomson Locations: San Diego , California, U.S, Indianapolis, Poland, Arizona , Florida, Georgia, Minnesota, South Carolina, Utah, Nordisk’s

The logo of Johnson & Johnson is seen on a Brussels' office of the company in Diegem, Belgium September 21, 2023. J&J raised its annual profit forecast, helped by strong sales from its pharmaceutical business, and shares of the U.S. healthcare conglomerate were off about 1%. Excluding its consumer health unit, J&J now expects 2023 adjusted profit of $10.07 to $10.13 per share, up from its previous view of $10.00 to $10.10. Sales at J&J's medical device unit came in at $7.46 billion, shy of Wall Street estimates of $7.58 billion. J&J finalized the biggest shake-up in its 137-year history in August with the spinoff, but retained a 9.5% stake in its iconic consumer health business.

Persons: Johnson, Yves Herman, J, Vamil Divan, Joseph Wolk, Ozempic, Wolk, Bhanvi Satija, Sriparna Roy, Patrick Wingrove, Shounak Dasgupta, Bill Berkrot Organizations: Johnson, REUTERS, Guggenheim Partners, Vamil, Reuters Graphics, J, Thomson, &' $, & $, & $ Locations: Brussels, Diegem, Belgium, Bengaluru, New York

The logo of Johnson & Johnson is seen on a Brussels' office of the company in Diegem, Belgium September 21, 2023. Investors are focused on how J&J, now a standalone pharmaceutical and medical devices company, will reach its goal of $57 billion in drug sales by 2025. Johnson & Johnson recorded a $21-billion gain in the third quarter from the spin-off of its consumer health unit. Stelara, J&J's top-selling anti-inflammatory drug, brought in sales of $2.86 billion in the quarter, above LSEG estimates of $2.61 billion. Excluding its consumer health unit, J&J now expects 2023 adjusted profit of $10.07 to $10.13 per share, compared with its previous outlook of $10.00 to $10.10 per share.

Persons: Johnson, Yves Herman, MedTech, Cantor Fitzgerald, Louise Chen, Stelara, Joseph Wolk, Wolk, J, Bhanvi Satija, Sriparna Roy, Patrick Wingrove, Shounak Dasgupta Organizations: Johnson, REUTERS, Innovative Medicine, Reuters, Thomson, & $, & $ Locations: Brussels, Diegem, Belgium, Stelara, U.S, United States, Bengaluru, New York

☆ Over 7 million Americans have gotten updated COVID vaccines
▼ + stars: | 2023-10-12 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

Millions of doses of another updated COVID vaccine from Novavax (NVAX.O) have also been made available to Americans this week, according to the company. Last year's booster targeting the original virus and another variant was rolled out about 10 days earlier. By Sept. 28, 2022, almost 7.6 million Americans had received the updated shots. U.S. public health officials have been optimistic that Americans will get the new vaccines and have recommended that everyone ages 6 months and older receive one. About 17% of the U.S. population, or 56.5 million people, ultimately received last year's version of the vaccines.

Persons: Emily Elconin, Patrick Wingrove, Bill Berkrot Organizations: REUTERS, U.S . Department of Health, Human Services, Pfizer, Moderna, U.S . Centers, Disease Control, Thomson Locations: Waterford , Michigan, U.S, Moderna, Novavax

☆ Novo Nordisk stops Ozempic kidney trial after early signs of success
▼ + stars: | 2023-10-10 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

Pens for the diabetes drug Ozempic sit on a production line to be packaged at Danish drugmaker Novo Nordisk's site in Hillerod, Denmark, September 26, 2023. Novo said the trial would be halted almost a year early based on a recommendation from the independent data monitoring board overseeing the study. Independent monitors can recommend stopping a trial early if there is clear evidence that a drug was going to succeed or fail based on interim analyses. Semaglutide is also the active ingredient in Novo Nordisk's powerful weight-loss drug Wegovy. Novo's success has also created an economic boom for Denmark, according to Danish economists, analysts, and executives at the Novo Nordisk Foundation.

Persons: Tom Little, Novo, Danish drugmaker, Wegovy, Emily Field, Patrick Wingrove, Sriparna Roy, Bill Berkrot Organizations: REUTERS, Novo Nordisk, Barclays, Novo Nordisk Foundation, Thomson Locations: Hillerod, Denmark, Danish, New York, Bengaluru

☆ Weight-loss drugs fuel boom for firms that fill syringes
▼ + stars: | 2023-10-09 | by ( Maggie Fick | ) www.reuters.com time to read: +6 min

[1/5] Catalent's automated visual inspection systems that check every pre-filled syringe to ensure product integrity are seen, in Brussels, Belgium, 2023. Eli Lilly's (LLY.N) Mounjaro is expected to be approved for weight-loss in the United States this year. The U.S. Inflation Reduction Act is also boosting development of biologic drugs, some of which are injected. Injectables are increasingly used in elderly care settings, and some new Alzheimer's and generic arthritis drugs are administered by injection. One healthcare investor said CDMOs' ability to boost capacity will determine how fast the obesity drug market grows.

Persons: Wegovy, it's, Savant, Morgan Stanley, Eli Lilly's, Mounjaro, Chris Chen, Cornell Stamoran, Fujifilm Diosynth, Germany's Vetter, Lilly, Marc Casper, CDMOs, Luke Sergott, Catalent, Catalent's Stamoran, Maggie Fick, Patrick Wingrove, Josephine Mason, Catherine Evans Organizations: REUTERS Acquire, Pfizer, HK, Fujifilm, Fujifilm Corp, Novo, Reuters, Research, Insight Partners, Barclays, Thomson Locations: Brussels, Belgium, Handout, United States, WuXi, Europe, GLP, Anagni, Italy, Bloomington , Indiana, U.S, New York

Flags with the Novo Nordisk logo flutter outside their Danish company's offices in Copenhagen, Denmark, September 26, 2023. The office's Patent Trial and Appeal Board denied the requests by Mylan Pharmaceuticals, which is owned by Viatris (VTRS.O), to review the validity of the Wegovy and Ozempic patents. A spokesperson for Novo Nordisk said the company will "vigorously defend" its intellectual property. Novo has filed several U.S. patent lawsuits against companies including Pennsylvania-based Viatris that are seeking to market generic versions of the drugs. Viatris has separately asked a West Virginia federal court to invalidate the patents as part of the litigation.

Persons: Tom Little, Wegovy, Ozempic, Mylan, Viatris, Novo's Wegovy, Novo, Blake Brittain, Patrick Wingrove, Will Dunham, David Bario Organizations: Novo Nordisk, Danish, REUTERS, Rights, U.S . Patent, Mylan Pharmaceuticals, Viatris, West, Thomson Locations: Copenhagen, Denmark, Pennsylvania, West Virginia, Washington, New York

☆ Cough syrup deaths overseas prompt US crackdown on toxic testing
▼ + stars: | 2023-09-26 | by ( Patrick Wingrove | ) www.reuters.com time to read: +6 min

Defendants and lawyers attend a court hearing in the case of child deaths linked to contaminated cough syrups, in Tashkent, Uzbekistan August 16, 2023. Cough syrups made in India and Indonesia have been linked to deaths of more than 300 children globally. The medicines were found to contain high levels of DEG and EG, leading to acute kidney injury and death. IMPORT ALERTSThe FDA warning letters give manufacturers an opportunity to fix quality control problems or face penalties. In addition, 13 U.S. makers of consumer products like earwax removers, nasal spray, hand soap and shampoo, including Lex, were threatened with possible seizures and injunctions by the FDA.

Persons: Stringer, Paul Hastings, Peter Lindsay, syrups, Lex, Charlene Paz, Greg Landry, Patrick Wingrove, Rishika, Joyce Lee, Michele Gershberg, Bill Berkrot Organizations: REUTERS, U.S, FDA, Drug Administration, EG, Reuters, South, South Korea's LCC, LCC, Daxal Therapeutics, Herbals, South Korea’s KM Pharmaceutical, Sangleaf Pharma, Massachusetts College of Pharmacy & Health Sciences, Thomson Locations: Tashkent, Uzbekistan, U.S, India, South Korea, Switzerland, Canada, Egypt, Washington ,, Indonesia, United States, Florida, South Korea's, South, New York, Rishika Sadam, Hyderabad, Seoul

[1/2] A box of Mounjaro, a tirzepatide injection drug used for treating type 2 diabetes and made by Lilly is seen at Rock Canyon Pharmacy in Provo, Utah, U.S. March 29, 2023. In four separate lawsuits filed in Florida and Texas federal courts, Eli Lilly is seeking orders barring Better Life Pharmacy, ReviveRX, Rx Compound Store and Wells Pharmacy Network from selling tirzepatide, and requesting unspecified damages. Lilly is the only company with U.S. Food and Drug Administration approval to sell tirzepatide drugs. "Defendants use Lilly’s trademark to attract customers and generate revenues and profits, including by passing off as 'Mounjaro' their own unapproved compounded drugs purporting to contain tirzepatide, and doing so for a use for which Mounjaro is not approved, namely weight loss," Eli Lilly said in the lawsuits. However, the agency has said that depending on circumstances, compounded drugs can be made and distributed with fewer restrictions when the original drug appears on its drug shortages list, which Mounjaro currently does.

Persons: Lilly, George Frey, Eli Lilly, Ozempic, Mounjaro, Patrick Wingrove, Bill Berkrot Organizations: Pharmacy, REUTERS, Wells Pharmacy, U.S . Food, Drug Administration, Novo Nordisk, U.S, FDA, Thomson Locations: Provo , Utah, U.S, Florida, Texas, Indianapolis, Arizona , Florida, Georgia, Minnesota, South Carolina, Utah

☆ Moderna flu shot succeeds in late-stage study
▼ + stars: | 2023-09-13 | by ( Patrick Wingrove | ) www.reuters.com time to read: +4 min

The effectiveness of Moderna's flu vaccine was demonstrated across all age groups, including older people, and was found to be safe and tolerable, according to the company. Moderna also said it had found that its shot was equal or superior to Sanofi's high-dose flu vaccine in a separate early head-to-head study. Following the U.S. Food and Drug Administration's authorization on Monday, Moderna said it would start shipping COVID vaccine doses across the United States. "The vaccine's manufacturing runs from June to October and we are already producing it. All the purchase orders are being fulfilled," a Rovi spokesperson said, referring to the COVID vaccine.

Persons: Dado Ruvic, Moderna, Jefferies, Michael Yee, Stephen Hoge, Hoge, we've, We've, COVID, Spain's, Patrick Wingrove, Will Dunham, Mark Porter Organizations: REUTERS, Moderna, U.S . Centers for Disease Control, U.S . Food, Sanofi, Thomson Locations: United States, Moderna, Massachusetts, Britain, Canada, Japan, China, New York, Bengaluru

☆ Moderna to scale down manufacturing of COVID vaccine
▼ + stars: | 2023-09-13 | by ( Patrick Wingrove | ) www.reuters.com time to read: +3 min

The downsizing, Hoge added, will help Moderna adjust to the endemic phase of the disease, which had led to falling demand for COVID vaccines as payers scale back orders for the shots. Moderna predicted in August that U.S. demand for the vaccine would reach 50 to 100 million doses in the fall season. Following the U.S. Food and Drug Administration's authorization on Monday, Moderna said it would start shipping COVID vaccine doses across the United States. The effectiveness of Moderna's flu vaccine was demonstrated across all age groups, including older patients, and was found to be safe and tolerable, according to the company. Moderna also said it had found that its shot was equal or superior to Sanofi's high-dose flu vaccine in a separate early head-to-head study.

Persons: Stephen Hoge, Hoge, Moderna, we've, We've, COVID, Patrick Wingrove, Bhanvi, Will Dunham Organizations: Moderna, Sanofi, Wednesday, U.S . Centers for Disease Control, U.S . Food, Thomson Locations: Moderna, Massachusetts, United States, Britain, Canada, Japan, China, New York, Bengaluru

☆ Moderna, Pfizer say updated COVID shots generate strong response vs newer variant
▼ + stars: | 2023-09-06 | by ( Patrick Wingrove | ) www.reuters.com time to read: +3 min

Moderna said its shot generated an 8.7-fold increase in neutralizing antibodies against BA.2.86 compared with an untreated natural antibody response in clinical trials in humans. Pfizer said its updated vaccine with partner BioNTech (22UAy.DE) elicited a strong antibody response against BA.2.86 in a preclinical study in mice. Moderna, Pfizer/BioNTech and relative newcomer to the COVID vaccine market Novavax (NVAX.O) have created versions of their shots aimed at the XBB.1.5 subvariant, the dominant variant through most of 2023. Moderna shares were down 1.6% and Pfizer shares were off nearly 3% in afternoon trading. The Omicron offshoot carries more than 35 mutations in key portions of the virus compared with XBB.1.5, the target of the updated shots.

Persons: Moderna, Jacqueline Miller, BioNTech, Cowen, Tyler Van Buren, Dado Ruvic, Patrick Wingrove, Michael Erman, Bill Berkrot Organizations: Pfizer, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, ” Moderna, Moderna, REUTERS, CDC, Omicron, U.S . Food, Drug Administration, Britain's Medicines, Healthcare, Agency, Reuters, Thomson Locations: Switzerland, South Africa, Israel, Denmark, U.S, Britain, New York, New Jersey

☆ Moderna says updated COVID vaccine is effective against newer variant
▼ + stars: | 2023-09-06 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

[1/2] A vial and sryinge are seen in front of a displayed Moderna logo in this illustration taken January 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo Acquire Licensing RightsSept 6 (Reuters) - Moderna (MRNA.O) on Wednesday said clinical trial data showed its updated COVID-19 vaccine will likely be effective against the highly-mutated BA.2.86 subvariant of the coronavirus that has raised fears of a resurgence of infections. The Omicron offshoot carries more than 35 mutations in key portions of the virus compared with XBB.1.5, the dominant variant through most of 2023 and the target of the updated shots. Moderna said it had shared the new finding on its vaccine with regulators and submitted it for peer review publication. European regulators have since backed the Pfizer/BioNTech shot, with Britain's Medicines and Healthcare products Regulatory Agency approving the vaccine on Tuesday, but have yet to make any announcements on Moderna’s updated vaccine.

Persons: Dado Ruvic, Jacqueline Miller, Moderna, COVID, BioNTech, Patrick Wingrove, Bill Berkrot Organizations: REUTERS, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, ” Moderna, CDC, Omicron, U.S . Food, Drug Administration, Pfizer, Moderna, Britain's Medicines, Healthcare, Agency, Reuters, Thomson Locations: The Massachusetts, Switzerland, South Africa, Israel, Denmark, U.S, Britain, New York

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