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That fueled investor concerns about new competition in the rapidly growing weight loss drug industry, sending shares of the current obesity players, Novo Nordisk and Eli Lilly , lower on Friday. Eli Lilly shares dropped nearly 3%, while Novo Nordisk's U.S.-traded shares fell more than 1%. Still, investors were pleased with Eli Lilly on Tuesday after the company assured them it can overcome ongoing supply constraints for its popular drugs. Eli Lilly hiked its full-year guidance in part due to optimism around increased production of Zepbound, its diabetes injection Mounjaro and similar drugs for the rest of the year. That signals Novo Nordisk is struggling to meet demand for the treatment.
Persons: Amgen, Eli Lilly, Bob Bradway, Bradway, Jay Bradner, autoinjector, Novo Nordisk's Wegovy, Eli Lilly's Zepbound, William Blair, Matt Phipps, Michael Yee, Amgen's Bradway, Karsten Munk Knudsen Organizations: Novo Nordisk, Novo Nordisk's, Jefferies, MariTide, Nordisk Locations: Novo Nordisk's U.S, North Carolina, Indiana, Ireland, Germany, U.S
How Technology Has Outpaced the Law
  + stars: | 2024-05-02 | by ( German Lopez | More About German Lopez | ) www.nytimes.com   time to read: +1 min
It was reasonable to expect the number of abortions in the U.S. to decline. The dynamic encapsulates a broader trend: The combination of a relatively new technology (the web) and an old one (the mail) has made it easier for Americans to bypass laws that they don’t like. Gun owners assemble untraceable firearms, known as ghost guns, from parts ordered online or made with 3-D printers, another relatively new technology. Today’s newsletter will cover some of the ways that technology has outpaced the law. The number of ghost guns seized at crime scenes increased more than tenfold from 2016 to 2021.
Persons: Roe, Fentanyl’s Organizations: U.S . Gun Locations: Florida, U.S, China, India
Amgen on Thursday said it will stop developing its experimental weight loss pill and instead move forward with its injectable drug and other products in development for obesity. Amgen is developing an injectable obesity treatment called MariTide, which is an ongoing mid-stage trial in obese or overweight adults without diabetes. The drugmaker's oral drug, called AMG-786, is the second weight loss pill to be discontinued over the last year. Investors are laser-focused on Amgen's pipeline of experimental weight loss treatments. Amgen's injectable treatment also appears to help patients keep weight off after they stop taking it based on some clinical trial data.
Persons: Amgen, Eli Lilly, Jay Bradner, Novo Nordisk's Wegovy, Eli Lilly's Zepbound, Zepbound Organizations: Novo Nordisk, Pfizer, Novo Nordisk's Locations: Amgen, Thousand Oaks , California, MariTide, Novo
The Federal Trade Commission on Tuesday said it is challenging hundreds of alleged "junk" patents held by pharmaceutical companies for 20 brand-name drugs, including Novo Nordisk's blockbuster drugs Ozempic, Saxenda and Victoza. The FTC issued letters to 10 companies, warning them that certain drug patents were improperly listed. Many of the drug patents are for Type 2 diabetes, along with asthma and inhalers for chronic obstructive pulmonary disease, or COPD. Generic drugmakers can only launch cheaper versions of a branded drug if the patents have expired or are successfully challenged in court. The FTC first challenged dozens of branded drug patents last fall, leading three drugmakers to comply and delist their patents with the FDA.
Persons: Novo, Boehringer, Lina Khan, Biden, drugmakers, Joe Biden's Organizations: Federal Trade Commission, FTC, Novo Nordisk, AstraZeneca, Covis Pharma, GlaxoSmithKline, Novartis, Teva Pharmaceuticals, Amphastar Pharmaceuticals, Food and Drug Administration, FDA Locations: U.S
A federal judge in New Jersey on Monday rejected Johnson & Johnson 's and Bristol Myers Squibb 's legal challenges to the Biden administration's Medicare drug-price negotiations, ruling that the program is constitutional. J&J and Bristol Myers Squibb did not immediately respond to requests for comment on the ruling. J&J, Bristol Myers Squibb, Novo Nordisk and Novartis presented their oral arguments before Quraishi during the same hearing in March. That same month, a federal judge in Delaware rejected AstraZeneca's separate lawsuit challenging the negotiations. In Texas, a third federal judge tossed a separate lawsuit in February.
Persons: Johnson, Bristol Myers, Joe Biden's, Zahid Quraishi, Quraishi, Bristol Myers Squibb's, AstraZeneca's Organizations: Bristol, Bristol Myers Squibb, Biden, White, Supreme, Final, of New, Novo Nordisk, Novartis, Chamber of Commerce Locations: New Jersey, U.S, of New Jersey, Delaware, Texas, Ohio
The Department of Justice is investigating McKinsey for advising opioid producers on boosting sales. The firm previously paid nearly $1 billion to resolve lawsuits related to its opioid work. The investigation is also looking at potential obstruction of justice by McKinsey and its employees. News of the investigation underscores how McKinsey's opioid work — which the firm said it stopped in 2019 — continues to plague the consultancy. In a 2018 email, for example, a since-fired McKinsey executive wrote to another senior executive about the firm's legal risk.
Persons: , Endo, Martin Elling Organizations: Justice, McKinsey, Service, McKinsey & Company, US Department of Justice, Street, Purdue Pharma, DOJ, of, Purdue Locations: Virginia, Western, of Virginia, of Massachusetts, Seattle
The Supreme Court on Thursday is set to consider whether former President Donald Trump is immune from federal prosecution on criminal election interference charges. Along with Smith's case in Washington, D.C., Trump is charged in Georgia with attempting to reverse his loss to Biden in that state's 2020 contest. Trump will not be at the Supreme Court to hear the oral arguments because he is required to attend his New York criminal trial. ET before the nine justices, three of whom were nominated by Trump during his one term as president. The Supreme Court agreed to take up the case after two lower courts rejected Trump's claim that he is immune from the indictment being prosecuted by Smith.
Persons: Donald Trump, Jack Smith's, Joe Biden, Trump, Smith Organizations: Defense Department, HHS, White, Trump, Washington , D.C, Biden, Supreme Locations: Washington , U.S, Washington ,, Georgia, Manhattan, York
Walgreens on Thursday said it will start to work directly with drugmakers to bring cell and gene therapies to U.S. patients as part of a broader expansion of its specialty pharmacy services. The company said it is launching a new business unit dedicated to its specialty pharmacy segment, which will include specialty pharmacy subsidiary AllianceRx. Meanwhile, Shields Health Solutions, a subsidiary that supports health system-owned specialty pharmacies, will remain under Walgreens's U.S. health-care division. Specialty pharmacies provide medications that require extreme care in handling, storage and distribution. Among the company's new investments to "transform" its specialty pharmacy services, it will open a newly licensed facility in Pittsburgh dedicated to services for cell and gene therapies.
Persons: drugmakers Organizations: Walgreens, Walgreens Boots Alliance, Shields Health Solutions, Walgreens's Locations: Manhattan , New York City, U.S, Pittsburgh
In today's big story, we're looking at how millennials have seen their wealth explode over the past few years. Millennials, the oft-maligned generation , are a lot better off financially than you might realize. A new report found millennials saw their wealth double from the end of 2019 through 2023, writes BI's Juliana Kaplan. Whatever the case, millennials' wealth can keep growing. The Department of Justice is investigating the consultancy for its past work advising opioid companies about how to boost their sales , The Wall Street Journal reported on Wednesday.
Persons: , Iurii Garmash, Tyler Le, millennials, BI's Juliana Kaplan, Harry Potter fanfiction didn't, Millennials, Gen Xers, eyeing, Juliana Kaplan, Gen, Chelsea Jia Feng, Jamie Dimon, Devin Nunes, Mark Zuckerberg, they've, There's, Nathan Congleton, Blackstone, Donald Trump's, Dan DeFrancesco, Jordan Parker Erb, Hallam Bullock, George Glover Organizations: Service, Business, Studio, Getty, millennials, Slaven, The New York Times, Nvidia, Trump Media, House Republicans, Meta, Green, Getty Images Google, Apollo, KKR, Justice, Street, Wednesday, McKinsey, NFL, US Locations: That's, Chelsea, premarket, NBCU, New York, London
GLP-1 drugs were originally developed to treat type 2 diabetes. Drugmakers are discovering the injections may also aid weight loss, heart issues, and sleep apnea. AdvertisementAnother new indication for injectable GLP-1 drugs: better sleep. On Wednesday, drugmaker Eli Lilly announced positive results from a large, phase-3 clinical trial, testing Zepbound (the drug name for tirzepatide) as a treatment for sleep apnea. Related storyAlready, GLP-1 drugs have been indicated for the treatment of:ObesityHeart diseaseAdvertisementIn clinical trials, GLP-1 drugs have also shown some promise for treating other conditions, including:Non-alcoholic fatty liver diseaseAddictionDepressionParkinson's and Alzheimer'sCancerThese breakthroughs may be tied to the gut-brain connectionScientists think that the main reason GLP-1 drugs work well is because of their effect on our body's gut-brain connection.
Persons: , drugmaker Eli Lilly, Eli Lilly, KATERYNA, Daniel Drucker, GLP, Eric Topol Organizations: Service, Food and Drug Administration, American Diabetes Association, University of Toronto
Sanofi has reached an agreement in principle to settle 4,000 US lawsuits linking the discontinued heartburn drug Zantac to cancer, the company said on Wednesday. Sanofi still faces about 20,000 lawsuits over Zantac in Delaware state court. That judge concluded that the opinions of the plaintiffs’ expert witnesses that Zantac can cause cancer were not supported by sound science. “We are pushing forward aggressively against GSK and Boehringer Ingelheim and are preparing for multiple trials in California state court this year,” Moore said. Lawsuits began piling up from people who said they developed cancer after taking Zantac.
Persons: Sanofi, “ Sanofi, Boehringer, Boehringer Ingelheim, Jennifer Moore, Brent Wisner, ” Moore, Zantac, ranitidine Organizations: Court, Sanofi, GSK, Pfizer, Boehringer, US Food and Drug Administration Locations: Delaware, Zantac, Wilmington, Florida, California
A highly popular class of drugs for diabetes and obesity is showing early potential to help patients with Parkinson's disease, too. But more research is needed to determine whether newer iterations of GLP-1s from Novo Nordisk and Eli Lilly may also help Parkinson's patients. The trial followed 156 people with early Parkinson's disease for a year. But one group was given an additional daily injection of Sanofi's drug, while the other was given a placebo. But use of Sanofi's drug was associated with an increased risk of gastrointestinal side effects, which are common across all GLP-1s.
Persons: Eli Lilly, Sanofi, drugmaker Organizations: Sanofi, Novo Nordisk, The New England, French Ministry of Health, Prevention, CNBC Locations: Novo, France, The
A new GLP-1 drug, pemvidutide, helped patients lose fat while guarding muscle, like exercise does. That's impressive when you compare it to existing GLP-1 drugs like Ozempic and Wegovy (semaglutide), or Mounjaro and Zepbound (tirzepatide). This is why doctors recommend patients on weight loss drugs do some strength training in tandem with their medication. Pemvidutide, like tirzepatide is a two-part drug that combines a GLP-1 drug with another drug in a single shot. "There is a growing appreciation that the quality of weight loss is as important as the quantity of weight loss," Scott Harris, Altimmune's chief medical officer, said in a release.
Persons: Drugmakers Eli Lilly, , Drugmaker Altimmune, Altimmune, Scott Harris, Eli Lilly, FierceBiotech, Versanis Organizations: Novo Nordisk, Service Locations: Altimmune, GLP
Some health experts have said that obesity drugs could shrink critical muscle mass, which could raise the risk of injuries and decrease strength. Those results are similar to those often seen with diet and exercise programs for weight loss. "There is a growing appreciation that the quality of weight loss is as important as the quantity of weight loss." For example, Eli Lilly is testing whether combining its weight loss drug with a monoclonal antibody from Versanis Bio might help patients lose weight while preserving muscle mass. The pharmaceutical giant recently acquired Versanis, which is part of a slate of companies targeting the muscle-loss aspect of weight loss.
Persons: Altimmune, Eli Lilly, Scott Harris Organizations: Novo Nordisk, Novo Nordisk's Ozempic Locations: Altimmune's, Novo
The blockbuster diabetes drug Ozempic could be manufactured for less than $5 a month, even as Novo Nordisk charges close to $1,000 per month for the injection in the U.S. before insurance, a study released Wednesday suggests. The study also comes after years of political pressure on Novo Nordisk and other drugmakers to slash high costs of diabetes care, especially insulin. Ozempic can generally be produced for less than various forms of insulin, according to the study published in JAMA Network Open. Novo Nordisk's list price for a monthly package of Ozempic is $935.77 before insurance and other rebates. In a statement on Wednesday, Novo Nordisk declined to provide production costs for Ozempic and its weight loss drug counterpart Wegovy.
Organizations: Nordisk, Yale University, King's College Hospital, Novo Nordisk, JAMA, Ozempic, University of Liverpool Locations: U.S, London
Mario Tama | Getty ImagesAmgen is taking a new approach as it tries to stand out in a crowded field of drugmakers racing to develop the next blockbuster weight loss drug. It's too early to say how competitive Amgen will be in the budding weight loss drug space, which Novo Nordisk and Eli Lilly have so far dominated. Goldman Sachs also projects that between 10 million and 70 million Americans will be taking weight loss drugs by 2028. The sustained weight loss in Amgen's study appears to contrast with results seen in clinical trials on Zepbound and Wegovy. An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City, U.S., December 11, 2023.
Persons: Mario Tama, Eli Lilly, Goldman Sachs, Zepbound, Eli Lilly's, Amgen's MartiTide, Caroline Apovian, Apovian, Joe Buglewicz, MariTide, Holly Lofton, Eli Lilly’s, Brendan McDermid, Reuters Amgen's, William Blair, Matt Phipps, Phipps Organizations: Getty, Novo Nordisk, Pfizer, Viking Therapeutics, Therapeutics, Zealand Pharma, Boehringer, Center, Weight Management, Wellness, Brigham, Women's, Washington Post, NYU Langone Health, Reuters, William Blair & Company, CNBC Locations: Thousand Oaks , California, Oaks , California, Novo, New York City, U.S
Medicare can start covering certain weight loss drugs for the first time — as long as they are approved for an added health benefit, the Centers for Medicare and Medicaid Services said Thursday. Medicare prescription drug plans administered by private insurers, known as Part D, currently cannot cover those drugs for weight loss alone. A provision of a 2003 law established that Medicare Part D plans can't cover drugs used for weight loss, but the program does cover obesity screening, behavioral counseling and bariatric surgery. A CMS spokesperson told CNBC last week that Medicaid programs would be required to cover Wegovy specifically for its new cardiovascular use. Around 1 in 5 state Medicaid programs currently cover GLP-1 drugs for weight loss.
Persons: Ozempic, Eli Lilly Organizations: Novo Nordisk, Medicare, Centers, Services, Drug, Food and Drug Administration, CVS, Aetna, International Foundation of Employee, CNBC, FDA Locations: London, Britain, U.S
The blockbuster drug — one of a handful of weight loss treatments to skyrocket in popularity over the last year — is now approved in the U.S. for heart health, too. The spokesperson added that state Medicaid programs would be required to cover Wegovy for its new cardiovascular use. But Gremminger said the standard of care for the long-term use of weight loss drugs is "in flux." State employees will no longer have insurance coverage for GLP-1s when used for weight loss at the beginning of next month. Both drugmakers have launched programs to help patients, with or without commercial insurance coverage, afford their weight loss treatments.
Persons: Klesty, John Crable, Wegovy, Jaime Almandoz, Joe Buglewicz, Shawn Gremminger, Hartley, Gremminger, Dale Folwell, We've, Folwell, Phelan M, Eli Lilly, Ceci Connolly, Julie Stich Organizations: Reuters, Novo Nordisk, CNBC, Medicare, Services, FDA, CVS, Aetna, International Foundation of Employee, Drug Administration, University of Texas Southwestern Medical Center, Washington Post, Getty, National Alliance of Healthcare, Taft, Nordisk, Nordisk's Ozempic, GOP, Carolina, Republican Governors Association, AP, Alliance of Community Health, U.S . Health, IFEBP, BMI Locations: U.S, Novo, Dallas, North Carolina, Orlando , Florida
He's launched a new company, Foundation Health, to help them do that quickly and at a low cost. Foundation aims to make it easy for insurers to set up their own online pharmacies and pharma companies to sell drugs directly to consumers. "The main focus area for us is to help health plans disintermediate PBMs," Afridi said. Foundation Health wants to help customers ditch big PBMsFoundation's software enables a few different things. Finally, direct-to-consumer health companies can plug into Foundation's technology to power their services, instead of building their own pharmacies and hiring doctors.
Persons: Umar Afridi, disruptors, Afridi, He's, disintermediate, Garry Tan, Y, they've, pocketing, Eli Lilly's, Jack Altman Organizations: California, Cuban, Plus, Business, Foundation Health, Foundation, pharma, Alt, Liquid Ventures, Exceptional, Storm Ventures, PageOne Ventures, Federal Trade Commission Locations: drugmakers
Now, the company is betting on cancer drugs to help it regain its footing after a rocky year marked by the rapid decline of its Covid business. That $43 billion Seagen acquisition doubled Pfizer's oncology drug pipeline to 60 different experimental programs. Some analysts noted that it might take a few years for some of Pfizer's cancer drugs in mid-stage development to show pivotal clinical trial data and become less risky. Revenue from the blockbuster breast cancer drug Ibrance and prostate cancer treatment Xtandi, which Pfizer shares with Astellas Pharma, has declined over the past year. They are among the most expensive prescription drugs in the U.S. Before the Seagen deal, 94% of Pfizer's cancer products were small-molecule drugs.
Persons: Wall, Seagen, Chris Boshoff, Boshoff, David Ryder, Trung Huynh, Joe Biden's, Chris Schott, Suneet Varma, RemeGe, Merck, Padcev, Guggenheim, Pfizer's, Pfizer hasn't, Dr, Mikael Dolsten, Irfan Khan Organizations: Nurphoto, Getty, Pfizer, Astellas Pharma, Guggenheim, Bloomberg, UBS, Medicare, Drug Administration, FDA, ADC, JPMorgan, Drugs, CNBC, CVS Pharmacy, Los Angeles Times Locations: Covid, Bothell , Washington, U.S, biologics, China, Eagle Rock , California
The label expansion may improve insurance coverage for Wegovy, which costs more than $1,300 per month out of pocket before any discounts. Many insurers, including Medicare, don’t cover drugs for weight loss, leaving patients scrambling to afford them. “This patient population has a higher risk of cardiovascular death, heart attack and stroke,” he added. More studies need to be done to show whether there are heart benefits for people who haven’t had a cardiac event. Wegovy continues to be in shortage, along with other GLP-1 medicines, as drugmakers struggle to keep up with demand.
Persons: CNN — Wegovy’s, , Dr, Harlan Krumholz, hasn’t, Eli Lilly, Wegovy, John Sharretts, haven’t, it’s, Sanjay Gupta, Jody Dushay, Beth, Dushay, Novo, Doug Langa, Organizations: CNN, US Food and Drug Administration, Yale University, Yale New Haven Hospital, Novo Nordisk, Diabetes, , CNN Health, Beth Israel Deaconess Medical Center, Harvard Medical School, Novo Nordisk’s, North America Operations
Cigna on Thursday said it will limit how much health plans and employers spend on weight loss drugs each year in a bid to expand insurance coverage for those highly popular treatments. The effort by insurance giant Cigna could make weight loss treatments more accessible. They deferred CNBC to Cigna for details on the insurance spending cap. Those medicines treat weight loss and diabetes by mimicking one or more hormones produced in the gut to suppress appetite and regulate blood sugar. Cigna said providing "financial predictability" through a cost cap will allow health plans and employers to better plan to manage GLP-1 spending.
Persons: Cigna, Eli Lilly Organizations: CNBC, drugmakers Novo Nordisk, Novo Nordisk Locations: Oslo, Norway, mull
President Joe Biden on Wednesday said the federal Medicare program should negotiate prices for at least 50 prescription drugs each year, up from the current target of 20 medicines. Biden has made lowering U.S. drug prices a key pillar of his health-care agenda and reelection platform for 2024. After the initial round of talks, Medicare can negotiate prices for another 15 drugs that will go into effect in 2027 and an additional 15 beyond that to take effect in 2028. Biden wants to raise that number to 50 to account for "major drugs that seniors rely on," according to the fact sheet. That could increase the number of drugs that Medicare could select for negotiation and bring more medicines to the negotiation process sooner.
Persons: Joe Biden, Biden, Neera Tanden Organizations: National Institutes of Health, White, Medicare, Supreme Locations: Bethesda , Maryland
VKTX YTD mountain Viking shares year to date Then, Viking shares more than doubled in trading on Tuesday, putting the stock on pace to report a more than 300% year-to-date gain, after the company said its GLP-1/GIP receptor agonist VK2735 hit all its primary goals in a phase 2 clinical trial. The Tema Cardiovascular and Metabolic ETF (HRTS) , which is up 12% year to date, owns Novo, Lilly and Viking. Still early days Some analysts and investors admit it is still very early days for obesity treatment and many questions remain to be answered. "We continue to expect above consensus growth in the space, as we are bullish on adoption from payers and broader obesity uptake," Meacham wrote. For obesity only, Lilly has already gained a 38% share, despite only being in the market for 13 weeks, he said.
Persons: Eli Lilly, Geoff Meacham, Meacham, Lilly, Yuri Khodjamirian, Khodjamirian, Jeff Jonas, Becton Dickinson, Novo, BofA's Meacham, What's, Tema's, it's, Gabelli's Jonas, he's, William Blair, Andy Hsieh, Hsieh Organizations: Novo Nordisk, Bank of America, Centers for Disease Control, Zealand Pharma, Viking Therapeutics, Zealand, Food and Drug Administration, Novo, Metabolic, Therapeutics, Pharmaceuticals, Rock, AstraZeneca, Roche, Gabelli Funds, FDA, Viking, Merck, Pfizer Locations: U.S, Tema, Novo Nordisk's, GLP, Lilly
Washington, DC CNN —The US economy is set to reap considerable benefits from Americans taking popular medications used for weight loss, including Ozempic and Wegovy, Goldman Sachs analysts wrote in a recent research report. Originally developed to treat type 2 diabetes, they proved to be highly effective at helping people shed weight in clinical trials. (Ozempic has not been approved for weight loss by regulators, though Wegovy, a similar drug, has.) Goldman Sachs argues that since poor health unambiguously weighs on the economy, improving health outcomes due to GLP-1s could lower costs and boost productivity, shoring up economic output. For some Americans who are obese but don’t have diabetes, obtaining those drugs has become difficult, if not impossible.
Persons: Goldman Sachs, Eli Lilly, Jody Dushay, Beth, Doug Langa, they’ve Organizations: DC CNN, Government, Novo Nordisk, Beth Israel Deaconess Medical, CNN Locations: Washington, United States, North America, Novo
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