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Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023. Eli Lilly said Friday that the Food and Drug Administration has pushed back its approval decision deadline for the drugmaker's experimental Alzheimer's treatment donanemab in a surprise move. The agency plans to call a last-minute meeting of its outside advisors to further review the treatment's safety and efficacy in a late-stage trial, Eli Lilly said. It's another setback for Eli Lilly, which is racing to compete with Biogen and Eisai. In 2021, the FDA approved an earlier, ill-fated Alzheimer's drug called Aduhelm from Biogen and Eisai, despite a negative recommendation from the agency's advisory panel.
Persons: Eli Lilly, Eli Lilly's, Leqembi, Anne White Organizations: and Drug Administration, FDA Locations: Indianapolis , Indiana, Biogen
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
Novo Nordisk 's blockbuster drug Ozempic cut the risk of kidney disease progression and related health complications in diabetic patients, according to initial late-stage trial results released Tuesday. Ozempic specifically lowered the risk of kidney disease progression, major cardiac events and death by 24% in diabetic patients with chronic kidney disease compared to a placebo. Chronic kidney disease would be a big additional treatment opportunity for Ozempic: Roughly 40% of people with diabetes also have the condition. The trial, called FLOW, first started in 2019 and followed roughly 3,500 patients with diabetes and moderate to severe chronic kidney disease. Last year, a late-stage trial on Wegovy showed that it cut the risk of heart attacks and strokes by 20%.
Persons: Ozempic, , Eli Lilly Organizations: Novo Nordisk, U.S Locations: Riedisheim, France, Europe, Danish, Novo
CNN —Zimbabwe’s President Emmerson Mnangagwa and first lady Auxillia have come under a slate of new US sanctions imposed that also targeted senior government officials accused of corruption and human rights abuses. Incumbent President Mnangagwa, 81, who was the speaker of the Zimbabwean parliament in 2003, was among 76 high-ranking officials hit by the US sanctions at the time. And as long as members of Corporate Zimbabwe are under sanctions, we are under sanctions,” he added. His wife, Auxillia Mnangagwa, was also sanctioned for her alleged complicity in corruption. Mnangagwa, nicknamed “The Crocodile,” succeeded authoritarian leader Mugabe in 2017 after helping to orchestrate the coup that ousted him.
Persons: CNN —, Emmerson Mnangagwa, Auxillia, Constantino Chiwenga, Oppah Muchinguri, Washington “, Robert Mugabe, Mnangagwa, Wally Adeyemo, Joe Biden, Nick Mnangagwa, Mnangagwa’s, , Farai Marapira, ” Marapira, ” Mnangagwa, “ Mnangagwa, Auxillia Mnangagwa, , Mugabe Organizations: CNN, Defense, Washington, Treasury, US Treasury Department, Corporate Locations: Zimbabwe, Corporate Zimbabwe
In this article VKTX Follow your favorite stocks CREATE FREE ACCOUNTCr | Istock | Getty ImagesBiotech company Viking Therapeutics has emerged as a strong potential entrant — or takeover target — in the budding weight loss drug market. Their treatments sparked the weight loss drug industry gold rush over the past year despite their hefty price tags and barriers to insurance coverage. It's too early to say whether Viking's drug could have an edge over existing or developing weight loss treatments. The pharmaceutical giant could also launch a slate of other weight loss treatments over the next few years that may have advantages over Zepbound, whether they offer more weight loss or convenience. That could give Viking the commercial and manufacturing capabilities needed to compete in the weight loss drug market.
Persons: Eli Lilly, Eli Lilly's Zepbound, Viking, Goldman Sachs, Eli Lilly’s, Brendan Mcdermid, GLP, Brian Lian, William Blair, Andy Hsieh, Hsieh, Eli Lilly's, Jefferies, Akash Tewari, doesn't, Mike Segar, Lian, William Blair's Hsieh, Oppenheimer, Jay Olson Organizations: Getty Images Biotech, Viking Therapeutics, Novo Nordisk, Reuters, Viking, Novo, U.S . Food, Drug Administration, Company, Deutsche Bank, CNBC Locations: New York City, Branchburg , New Jersey
A federal judge on Friday rejected AstraZeneca 's legal challenge to Medicare's new power to negotiate the prices of certain costly prescription drugs with manufacturers. The decision is another win for the Biden administration in a bitter legal fight with the pharmaceutical industry over the constitutionality of those price talks. The opportunity to sell drugs to more than 49 million Medicare and Medicaid beneficiaries is a "powerful incentive" for manufacturers to participate in the price talks with the government, Connolly wrote. The ruling comes a month after a federal judge in Texas tossed a separate lawsuit challenging the price talks. On March 7, Bristol Myers Squibb, Novo Nordisk, Novartis and Johnson & Johnson will present their oral arguments to a federal judge in New Jersey in the same hearing.
Persons: AstraZeneca, Biden, AstraZeneca's, Colm Connolly, Connolly, Johnson Organizations: U.S . Department of Health, Human Services, Washington , D.C, Manufacturers, Supreme, District, AstraZeneca, Chamber of Commerce, Bristol Myers Squibb, Novo Nordisk, Novartis, Johnson, CNBC PRO Locations: Washington ,, Delaware, Texas, Ohio, New Jersey
CVS and Walgreens will start selling the abortion pill mifepristone this month at certain pharmacy locations in states where it is legal to do so, spokespeople for the companies told CNBC on Friday. Mifepristone is the first pill used in the two-drug medication abortion regimen. Before the FDA's regulatory change, only a few mail-order pharmacies or specially certified doctors or clinics could distribute mifepristone. The regulatory change will potentially expand abortion access as the Biden administration wrestles with how best to protect abortion rights. Medication abortion is the most common method of terminating a pregnancy in the U.S., according to data from the Centers for Disease Control and Prevention.
Persons: Mifepristone, Biden, Wade Organizations: Alamo Women's, CVS, Walgreens, CNBC, Food and Drug Administration, New York Times, FDA, Drug Administration, Centers for Disease Control Locations: Carbondale , Illinois, Massachusetts, Rhode, New York , Pennsylvania , Massachusetts, California, Illinois, U.S
Pfizer 's vaccine against respiratory syncytial virus maintained protection for older adults across two full seasons of the disease in an ongoing late-stage clinical trial, the company announced Thursday. The shot's efficacy declined slightly compared with the levels of protection after one RSV season, but the new data suggests that the jab generally offers durable protection for adults ages 60 and above, who are more vulnerable to severe illness from RSV. The jab showed 66.7% efficacy against that condition after one RSV season. Pfizer noted that the vaccine showed consistent efficacy against RSV A and RSV B, which are the two major subtypes of the virus, after the second RSV season. Analysts don't expect the committee to make a final recommendation until June – a decision that may have huge implications for Moderna , which is hoping to launch its own RSV jab this year.
Persons: Organizations: Pfizer, GlaxoSmithKline, Centers for Disease Control, Moderna Locations: Northern, Southern
Novavax generated fourth-quarter sales of $291.3 million, down from the $357.4 million in the year-earlier period. Novavax expects full-year 2024 revenue to come in between $800 million and $1 billion. Novavax anticipates first-quarter revenue to come in at $100 million, which reflects the tail end of the current Covid vaccination season. The cuts will help Novavax focus on further developing its combination vaccine targeting Covid and the flu, which it plans to launch in 2026. On Thursday, Novavax said it will settle a bitter arbitration dispute with Gavi, a nongovernmental global vaccine organization, over a canceled Covid vaccine purchase agreement.
Persons: Novavax, John Jacobs, Jacobs, Gavi Organizations: LSEG, CNBC, CNBC PRO
Shares of Viking Therapeutics soared more than 80% in premarket trading Tuesday after the company's experimental weight loss drug showed promising initial results in a mid-stage trial. Viking Therapeutics is one of several small obesity drugmakers hoping to enter the budding weight loss drug industry, which analysts say could grow into a $100 billion market by the end of the decade. Separately, the company said it expects to release early-stage trial data on an oral version of its weight loss drug. Viking Therapeutics' drug targets GLP-1 and another hormone called GIP. Those are the same hormones that Eli Lilly's weight loss and diabetes drugs, Zepbound and Mounjaro, target.
Persons: Brian Lian, Eli Lilly's Organizations: Viking Therapeutics, Viking, Food and Drug Administration
A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands. Novavax on Thursday said it will settle a bitter arbitration dispute with Gavi, a nongovernmental global vaccine organization, over a canceled Covid vaccine purchase agreement. In 2022, Novavax terminated a purchase agreement with Geneva-based Gavi. Under the settlement, Novavax has paid an initial $75 million to Gavi and will make deferred payments of $80 million each year through Dec. 31. Analysts had previously told CNBC that Novavax could "be in trouble" if the arbitration forced it to pay the full $700 million to Gavi in 2023.
Persons: Novavax, Gavi, bode, David Marlow Organizations: Dutch Health Service Organization, CNBC Locations: The Hague, Netherlands, Geneva, Novavax
Moderna on Thursday posted a surprise quarterly profit, in part boosted by deferred revenue, even as the company saw slumping sales from its Covid vaccine, its only marketable product. The biotech company booked fourth-quarter sales of $2.81 billion, with sales of its Covid shot dropping 43% from the same period a year ago. That includes charges related to the company's efforts to scale back manufacturing of its Covid shot and write-downs of unused doses of the vaccine. Still, the deferred revenue boosted Moderna's full-year Covid vaccine sales to $6.7 billion, an amount the company first unveiled in January. It booked $18 billion in revenue in 2022 and expects sales from the shot to drop even further in 2024.
Persons: Jamey Mock, Moderna, Mock Organizations: Moderna, LSEG, Revenue, CNBC, Food, Drug, Merck Locations: Gavi
Test tubes are seen in front of a displayed AbbVie logo in this illustration taken on May 21, 2021. AbbVie on Tuesday said longtime executive Robert Michael will become the company's new CEO, replacing Richard Gonzalez. Michael, who is AbbVie's president and chief operating officer, will become the company's second-ever CEO on July 1. Gonzalez, who has led the company since it spun out from Abbott Laboratories in 2013, will retire and become AbbVie's executive chairman. Now is the opportune time to hand the CEO role over to Rob," Gonzalez said in a release.
Persons: AbbVie, Robert Michael, Richard Gonzalez, Michael, Gonzalez, Rob Organizations: Abbott Laboratories, AbbVie, CNBC PRO Locations: Humira
They are group purchasing organizations, which broker drug purchases for hospitals and other health-care providers, and drug wholesalers, which buy medicines from manufacturers and distribute them to providers. But the Biden administration is zeroing in on other players in the drug supply chain to uncover the "root causes and potential solutions" to ongoing shortages. The Federal Trade Commission on Wednesday said it is examining the role that drug wholesalers and companies that purchase medicines for U.S. health-care providers play in shortages of generic drugs, which account for the majority of Americans' prescriptions. Group purchasing organizations and wholesalers have gotten limited attention on Capitol Hill, even as reining in high drug costs has become a key priority among lawmakers in both chambers. PBMs contend that manufacturers are responsible for high drug prices, while drugmakers say rebates and fees collected by those middlemen force them to increase list prices for products.
Persons: Biden, Doug Farrar, Cencora Organizations: FTC, Department of Health, Human Services, Federal Trade Commission, Public Affairs, CNBC, HHS, Cardinal Health, Group, Capitol, CNBC PRO Locations: U.S
Biogen on Tuesday reported fourth-quarter revenue and profit that shrank from a year ago, as it recorded charges related to dropping its controversial Alzheimer's drug Aduhelm and as sales slumped in its multiple sclerosis therapies, the company's biggest drug category. Biogen booked sales of $2.39 billion for the quarter, down 6% from the same period a year ago. Revenue from multiple sclerosis products fell 8% to $1.17 billion as the therapies face competition from cheaper generics. Adjusting for one-time items, the company reported $2.95 per share. But the company expects its pharmaceutical revenue, which includes product revenue and its 50% share of Leqembi sales, to be flat this year compared to 2023.
Persons: Biogen, LSEG, Biogen's, Leqembi Organizations: LSEG, Biogen, Food and Drug, Reata Pharmaceuticals, FDA Locations: U.S
CVS, which owns health insurer Aetna, on Wednesday slashed its full-year profit outlook, citing the potential for higher medical costs to bite into its profits. Last month, Humana said it saw an even bigger jump in medical costs in the fourth quarter. Higher medical costs may be a larger problem for Humana than they are for CVS and other insurers. They added that there is no other part of Humana's business that could meaningfully dampen the hit from higher medical costs on the insurance side. Another insurance giant that has been seeing higher medical costs, UnitedHealth Group, also has large health-care services and pharmacy operations that diversify its earnings streams.
Persons: Humana Organizations: CVS, Aetna, Medicare, Elevance, Humana, UBS, UnitedHealth
The decision is an early win for the Biden administration as it grapples with a flurry of other legal challenges that drugmakers have filed against the Medicare drug price negotiations. The judge's ruling won't end the legal battle over the policy, which could end up at the Supreme Court. A slate of major companies with drugs selected for negotiations, including J&J, Merck , and Bristol Myers Squibb , have filed separate lawsuits challenging the constitutionality of the price talks. The suit also argued that the price talks violate the Eighth Amendment because they include a "crippling" excise tax aimed at forcing drugmakers to accept the government-dictated price of medicines. The groups also argued that the price talks violate due process by denying pharmaceutical companies and the public input on how Medicare negotiations will be implemented.
Persons: Biden, drugmakers, Judge David Ezra of, Ezra, NICA's, Nicole Longo, PhRMA, Eli Lilly, Johnson, NICA Organizations: U.S . Department of Health, Human Services, Supreme, Medicare, Western, Western District of Texas, Pharmaceutical Research, Manufacturers of America, Global Colon Cancer Association, National, Center Association, CNBC, Pfizer, Johnson, Merck, Bristol Myers Squibb, Chamber of Commerce, Department of Health, Department of Justice Locations: Washington ,, Western District, PhRMA, Ohio
Victoria Klesty | ReutersThe insatiable demand for weight loss drugs is trouncing supply, leaving many patients struggling to find the injectable treatments. The dominant weight loss drugmakers, Novo Nordisk and Eli Lilly , have said supply woes likely won't go away anytime soon, as the popularity of those medicines continues to soar. Some Wall Street analysts project that the weight loss drug market could be worth $100 billion by the end of the decade. But both Novo Nordisk and Eli Lilly gave updates on positive supply developments to investors over the last week. Other forms of weight loss drugs could helpAlternative forms of weight loss drugs could also help alleviate supply constraints in the future.
Persons: Victoria Klesty, Eli Lilly, Cantor Fitzgerald, Louise Chen, Nordisk's Wegovy, Eli Lilly's Zepbound, Goldman Sachs, Jeff Friedman, Novo, Mike Segar, Eli, Catalent, Yves Herman Yves Herman, TD Cowen, Michael Nedelcovych, Anat Ashkenazi, Cantor Fitzgerald's Chen, Morgan Stanley, Eli Lilly's, George Frey Organizations: Novo Nordisk, CNBC, Nordisk's, University of Florida, Pfizer, AstraZeneca, Roche, Food, Nordisk, Company, FDA, Novo Holdings, Wegovy, REUTERS, Reuters, U.S Locations: Oslo, Norway, Novo, U.S, Branchburg , New Jersey, Brussels, Belgium, Catalent, Concord , North Carolina, North, Germany, Indiana, Denmark, France
Senators will question the CEOs of Johnson & Johnson , Merck and Bristol Myers Squibb on U.S. drug prices at a hearing Thursday, as lawmakers on both sides of the aisle work to rein in high health-care costs for Americans. Prescription drug prices in the U.S. are also more than 2.5 times as high as those in other high-income nations, another federal report showed. The Senate Health, Education, Labor and Pensions Committee says that's especially true for some of the top drugs from J&J, Merck and Bristol Myers Squibb. ET and include testimony from J&J CEO Joaquin Duato, Merck CEO Robert Davis and Bristol Myers Squibb CEO Chris Boerner. A spokesperson for Bristol Myers Squibb did not immediately respond to a request for comment ahead of the hearing.
Persons: Sen, Bernie Sanders, Ed Markey, Joaquin Duato, Robert Davis, Chris Boerner, Duato, Davis, Bristol Myers, Eli Lilly's, J Organizations: Capitol, Johnson, Merck, Bristol Myers Squibb, U.S, Health, Education, Labor, Pensions, Bristol Myers, CNBC, J, Bristol Locations: U.S
CVS Health on Wednesday reported fourth-quarter revenue and adjusted earnings that topped expectations, but the company cut its full-year profit outlook, citing higher medical costs that are dogging the broader insurance industry. The company lowered its 2024 adjusted earnings forecast to at least $8.30 per share, down from a previous guidance of at least $8.50 per share. Analysts surveyed by LSEG were expecting full-year adjusted earnings of $8.49 per share. CVS also cut its unadjusted earnings guidance to $7.06 per share, down from at least $7.26 per share. Excluding certain items, such as amortization of intangible assets and capital losses, adjusted earnings per share were $2.12 for the quarter.
Persons: LSEG Organizations: CVS Health, CVS, Aetna, LSEG, Oak Street Health
Still, Eli Lilly and Novo Nordisk appear to be making some encouraging progress. Eli Lilly wasn't the only weight loss drug producer to see positive supply developments in the last week. Novo Holdings, which owns almost 77% of the voting shares in Novo Nordisk, said Monday it will acquire drug manufacturer Catalent in a $16.5 billion deal. Novo Nordisk will then buy three of Catalent's manufacturing plants from Novo Holdings for $11 billion. Tema in November launched an ETF whose key holdings include companies benefiting from the hype around weight loss drugs.
Persons: Eli Lilly, Anat Ashkenazi, Incretin, Eli Lilly's, Ashkenazi, Eli Lilly wasn't, Yuri Khodjamirian, Danish drugmaker Organizations: Novo Nordisk, Holdings, Wegovy, Novo Holdings, CNBC, Tema, Nordisk, Reuters Locations: North Carolina, Novo, Tema, Brussels, Danish, U.S
Eli Lilly logo is shown on one of the company's offices in San Diego, California, U.S., September 17, 2020. Eli Lilly on Tuesday reported fourth-quarter revenue and adjusted earnings that topped expectations on the strong launch of its new weight loss drug, Zepbound, and higher prices for its blockbuster diabetes drug, Mounjaro. Zepbound, which won approval from U.S. regulators in early November, raked in $175.8 million in sales for the fourth quarter. Shares of Eli Lilly were up 5% in premarket trading Tuesday. With a market cap of roughly $673 billion, Eli Lilly is the largest pharmaceutical company based in the U.S.Eli Lilly will hold an earnings call with investors at 10:00 a.m.
Persons: Eli Lilly, Eli Lilly's, Mounjaro Organizations: LSEG, FactSet Locations: San Diego , California, U.S
Eli Lilly on Tuesday said its highly popular drug used for weight loss and diabetes showed promise as a treatment for fatty liver disease in a mid-stage trial. The condition is characterized by excess fat build-up and inflammation in the liver and can lead to liver scarring, also known as fibrosis. The trial followed around 190 adults with MASH with severe stages of liver scarring, Eli Lilly executives said on an earnings call Tuesday. It was less clear how much the drug reduced liver scarring, which was the second aim of the trial. Eli Lilly is "equally encouraged" by tirzepatide's results in reducing liver scarring, the company's chief scientific officer Dan Skovronsky said on the call.
Persons: Eli Lilly’s, Eli Lilly, tirzepatide, Dan Skovronsky, David Risinger, Eli Lilly's Organizations: Leerink, Novo Nordisk Locations: New York City, U.S
Novo Nordisk will then buy three of Catalent's manufacturing sites from Novo Holdings for $11 billion. Novo Holdings owns almost 77% of the voting shares in Novo Nordisk. Novo Nordisk and Novo Holdings said they expect the acquisition of the plants and the broader deal to buy Catalent to close at the end of 2024. Novo Nordisk added that it expects its purchase to gradually help increase its filling capacity beginning in 2026. Under the terms of the deal, Novo Holdings will buy Catalent for $63.50 a share in cash, a premium of 16.5% to Catalent's closing price on Friday.
Persons: Catalent, Eli Lilly Organizations: Nordisk, Novo Holdings, Novo Nordisk's Wegovy, Novo Nordisk, Novo, Elliott Investment Management, U.S ., Reuters, CNBC PRO Locations: Novo, Italy, Belgium, Bloomington , Indiana, Denmark, France, U.S, Brussels
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