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Gilead 's twice-yearly shot reduced HIV infections by 96% in a second large study, the company said Thursday. The positive phase three trial data on lenacapavir sets the stage for likely approval by the U.S. Food and Drug Administration for HIV prevention. The company said 99.9% of participants who received lenacapavir did not acquire HIV, with two cases among 2,180 people. Gilead in June also said lenacapavir was 100% effective at preventing HIV in another late-stage trial with cisgender women. The trial results should lead to an FDA approval and launch in the market by 2025, Yee said.
Persons: Gilead, Daniel O'Day, lenacapavir, Michael Yee, Yee Organizations: U.S . Food, Drug Administration, PrEP, Centers for Disease Control, Jefferies, CNBC, YouTube Locations: Gilead
In this article ESALY4523.T-JPBIIB Follow your favorite stocks CREATE FREE ACCOUNTHannah Yoon | The Washington Post | Getty ImagesLeqembi, an Alzheimer's drug from Biogen and Eisai , isn't a cure for the mind-damaging disease. The drug works in part by clearing toxic plaques in the brain called amyloid, a hallmark of Alzheimer's, according to its manufacturers. The Mayo Clinic's center, which began screening patients for Leqembi in October, has 50 to 60 patients currently taking the drug, according to Petersen. The Mayo Clinic's Alzheimer's center similarly stops dosing patients if ARIA appears on an MRI, according to Petersen. Meeks' neurologist, Dr. Wendell Helveston, said a follow-up MRI picked up one small area of bleeding in her brain that didn't cause any symptoms.
Persons: Hannah Yoon, Missie Meeks, Meeks, Leqembi, I'm, haven't, Julio Rojas, Patricia Waldrup, Biogen's, Alzheimer's, Brian B, Bettencourt, Tracey Collins, Collins, Alex Scott, Scott, Medicare enrollees, Neurologists, Ronald Petersen, Jay Reinstein, Michael Robinson Chávez, Petersen, Michael Irizarry, Eisai's, Eisai, Biogen, Eisai's Scott, It's, Rojas, Wendell Helveston, Bobby Pugh, Bessie Pugh, Karen Pulfer Focht Organizations: Washington Post, Getty, CNBC, University of California, San, San Francisco Health, Toronto Star, Medicare, Mayo Clinic Alzheimer's Disease Research, Georgetown University Hospital, Washington , D.C, Mayo, Leqembi, Mayo Clinic, Reuters, ARIA, Hattiesburg Clinic, Ave Locations: Biogen, Ellisville , Mississippi, U.S, San Francisco, Portland , Maine, Boston, South Mississippi, Washington ,, Mayo, Portland, South Portland, Mississippi, Eisai, Bartlett , Tennessee
The Biden administration on Friday said it will resume offering free at-home Covid-19 tests to American households in late September as the virus has gained a stronger foothold in the U.S. this summer. Americans will soon be able to use COVIDtests.gov to request four free tests, administration officials told reporters during a briefing. The tests will be able to detect the Covid variants that are currently circulating, most of which are descendants of the highly contagious omicron variant JN.1. The government's program has provided more than 1.8 billion free over-the-counter Covid tests to Americans since it started in 2021, according to O'Connell. But the government decided to reopen the program in late September because it's when more Americans begin to travel and gather indoors with loved ones.
Persons: Biden, Dawn O'Connell, Harris, O'Connell Organizations: Health, Human Services Department, Biden, Centers for Disease Control Locations: U.S
The direct-to-consumer health-care startup Ro launched a new free tool Tuesday to help patients determine whether their insurance covers a buzzy class of weight loss and diabetes drugs called GLP-1s. Ro said nearly half of the company's patients have some form of insurance coverage for a GLP-1, according to its customer data. Ro said it hopes its new tool can help patients understand their coverage options so they can decide how to pursue weight loss. The digital health company may benefit too, as it could drive some patients to join the company's GLP-1 program. It includes 24/7 messaging, one-on-one coaching with nurses and help with navigating insurance coverage.
Persons: Ro, Zachariah Reitano Organizations: Novo Nordisk, CNBC Locations: U.S
Shares of Eli Lilly closed more than 9% higher on Thursday. That has forced Eli Lilly and its rival Novo Nordisk to invest heavily to boost manufacturing. "We just see unbelievable demand, and we're not even trying that hard to promote this drug," Eli Lilly CEO David Ricks told CNBC in an interview. Eli Lilly said sales were largely driven by higher demand for Mounjaro and Zepbound as production increases improved supply in the U.S. With a market cap of more than $730 billion, Eli Lilly is the largest pharmaceutical company based in the U.S.
Persons: Eli Lilly, Eli Lilly's, we're, David Ricks, Ricks, Zepbound, Mounjaro, Wegovy Organizations: U.S, Novo Nordisk, Food, CNBC, LSEG Locations: U.S, United States, Novo
The CVS pharmacy logo is displayed on a sign above a CVS Health Corp. store in Las Vegas, Nevada on Feb. 7, 2024. CVS Health on Wednesday slashed its full-year profit outlook again and announced a new plan to cut $2 billion in expenses over several years as higher medical costs squeeze the company and the broader U.S. insurance industry. CVS also cut its unadjusted earnings guidance to a range of $4.95 to $5.20 per share, down from at least $5.64 per share. Those ratings help Medicare patients compare the quality of Medicare health and drug plans. Medicare Advantage, a privately run health insurance plan contracted by the federal Medicare program, has long been a driver of growth and profits for the insurance industry.
Persons: Brian Kane, Karen Lynch, Thomas Cowhey, Katerina Guerraz, Lynch, LSEG, CVS, Cowhey, Caremark Organizations: CVS Health Corp, CVS Health, Aetna, CVS, Affordable, Medicare, UnitedHealth, Humana, Elevance, LSEG Locations: Las Vegas , Nevada
The first round of Medicare drug price negotiations has come to an end – but we still don't know the final prices that the U.S. government and pharmaceutical companies have agreed on. They all maintain that Medicare drug price negotiations are a long-term threat to the pharmaceutical industry's drug innovation and profits, but the immediate dust has somewhat settled. That's based on executive commentary during the recent quarterly earnings calls of Bristol Myers Squibb and Johnson & Johnson , among other companies. Novartis CEO Vasant Narasimhan said on July 18 that the short-term impact from Medicare drug price negotiations "might be manageable on our first set of drugs." Executives at each of the drugmakers similarly emphasized their opposition to Medicare drug price negotiations on their respective earnings calls.
Persons: Joe Biden, Johnson, Joe Biden's, Christopher Boerner, Bristol Myers, Robert Michael, We've, Michael, Jennifer Taubert, Vasant Narasimhan, Narasimhan, Bristol Myers Squibb's Boerner, Boehringer Ingelheim, Annika Organizations: National Institutes of Health, Medicare, Bristol Myers Squibb, Johnson, Pfizer, J, Novartis, Merck, Novo Nordisk, AstraZeneca Locations: Bethesda , Maryland, U.S, annikakim.constantino@nbcuni.com
An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City on Dec. 11, 2023. All doses of Eli Lilly's highly popular weight loss injection Zepbound and diabetes drug Mounjaro are now available in the U.S., according to an update on the U.S. Food and Drug Administration's drug shortage database on Friday. The FDA's update comes one day after Eli Lilly CEO David Ricks told Bloomberg that the shortages of Mounjaro and Zepbound would end "very soon." A spokesperson for Eli Lilly did not immediately respond to CNBC's request for comment on the FDA's update on Friday. Meanwhile, the FDA said some doses of Novo Nordisk's weight loss drug Wegovy have limited supply.
Persons: Eli Lilly’s, Eli Lilly's, Zepbound, Eli Lilly, David Ricks Organizations: U.S . Food, Novo Nordisk, Bloomberg, FDA Locations: New York City, U.S
It's Moderna's second-ever commercially available product after its Covid vaccine, which has seen demand plunge as the world emerges from the pandemic and relies less on protective shots and treatments. He added that "we've been having quite intense discussions with governments across Europe" to get Covid vaccine supply from Moderna. He is referring to the European Union's massive renegotiated Covid vaccine supply contract with Pfizer and its German partner BioNTech . Its shares are up nearly 20% this year on increasing confidence around its pipeline and messenger RNA platform, which is the technology used in its Covid vaccine and RSV shot. Moderna is also developing a stand-alone flu shot, a personalized cancer vaccine with Merck and shots for latent viruses, among other products.
Persons: It's Moderna's, Stephane Bancel, we've, Bancel, BioNTech, Moderna, I'm Organizations: Moderna Inc, Moderna, Pfizer, GSK, LSEG, Wall, Research, Merck Locations: Cambridge , Massachusetts, Europe, U.S, Moderna, Ukraine
Biogen on Thursday reported second-quarter earnings and revenue that topped estimates and hiked its full-year guidance, as the company's cost cuts showed progress and sales of its breakthrough Alzheimer's drug, Leqembi, and other new products beat expectations. Leqembi, which Biogen shares with Eisai, became the second drug proven to slow the progression of Alzheimer's to win approval in the U.S. last summer. That's above the $31 million analysts had expected, according to estimates compiled by StreetAccount. Tecfidera, for example, booked $252.2 million in revenue in the second quarter, which is relatively flat from the year-earlier period. Analysts had expected the once-blockbuster drug to rake in $233.3 million in revenue for the quarter, according to StreetAccount.
Persons: Biogen, StreetAccount, Leqembi, Drug Administration greenlit Skyclarys, Biogen's Organizations: Eisai, LSEG, Reata Pharmaceuticals, Drug Administration, Sage Therapeutics Locations: U.S, Europe
An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024. Eli Lilly 's weight loss drug Zepbound showed benefits in patients with a common type of heart failure and obesity, according to late-stage trial data the company released Thursday. Eli Lilly said it plans to submit the results from the phase three trial to regulators in the U.S. and other agencies starting later this year. Zepbound also significantly improved heart failure symptoms and physical limitations, Eli Lilly said in a release. Eli Lilly will present the data at an upcoming medical meeting and submit it to a peer-reviewed journal.
Persons: Eli Lilly, Zepbound Organizations: Centers for Disease Control, Novo Nordisk, Drug Administration Locations: Brooklyn, New York, U.S
Pfizer on Thursday reported second-quarter revenue and adjusted earnings that blew past expectations and raised its full-year outlook, benefiting from its broad cost-cutting program, better-than-expected sales of its Covid antiviral pill Paxlovid and strong non-Covid product sales. Pfizer now expects to book adjusted earnings of $2.45 to $2.65 per share for the fiscal year, up from its previous guidance of $2.15 to $2.35 per share. Pfizer also hiked its revenue outlook to a range of $59.5 billion to $62.5 billion, up from a previous revenue forecast of between $58.5 billion and $61.5 billion. 60 cents adjusted vs. 46 cents expected. Revenue: $13.28 billion vs. $12.96 billion expected.
Organizations: Pfizer, LSEG, Revenue Locations: U.S, Seagen
The newly FDA approved Alzheimer's treatment Leqembi is prepared at Abington Neurological Associates in Abington, PA., on Tuesday, November 7, 2023. The breakthrough Alzheimer's drug Leqembi slowed disease progression in patients over three years, demonstrating the need for them to stay on the treatment long term, according to new data released Tuesday by Japanese drugmaker Eisai. The study results on Leqembi, which Eisai shares with Biogen , also found that a patient's Alzheimer's disease worsens after they stop treatment. The results are a first glimpse at what Alzheimer's patients' future could look like on therapies such as Leqembi, which is currently taken twice a month through an infusion. By 2050, the number of Alzheimer's patients is projected to rise to almost 13 million in the U.S.
Persons: Lynn Kramer, Leqembi, Eisai, Kramer Organizations: FDA, Abington Neurological Associates, Biogen, CNBC, Alzheimer's Association International Conference, Alzheimer's Association Locations: Abington, Abington , PA, U.S, Philadelphia
George Frey | ReutersAn older, once-daily drug for diabetes and obesity from Novo Nordisk called liraglutide may slow the progression of Alzheimer's disease by protecting patients' brains, according to data from a mid-stage trial released on Tuesday. Novo Nordisk sells liraglutide as a diabetes and obesity drug under the brand names Victoza and Saxenda, respectively. Alzheimer's disease often causes the brain to shrink as the illness progresses because crucial nerve cells break down and stop working properly. By 2050, the number of Alzheimer's patients is projected to rise to almost 13 million in the U.S. The ongoing EVOKE is examining semaglutide, the active ingredient in Wegovy and Ozempic, in nearly 2,000 Alzheimer's patients.
Persons: George Frey, Eli Lilly, liraglutide, Brian B, Bettencourt, Heather Snyder, Leqembi, Snyder, Dr, Paul Edison, Edison, Bobby Pugh, Bessie Pugh, Karen Pulfer Focht Organizations: Novo Nordisk Pharmaceutical, Reuters, Novo Nordisk, Imperial College London, Alzheimer's Association International Conference, Toronto Star, Getty, Alzheimer's Association, U.S, CNBC, Alzheimer's, Novo Nordisk's, Ave Locations: Provo , Utah, Danish, Philadelphia, Biogen, Novo, Bartlett , Tennessee, U.S
Merck on Tuesday reported second-quarter revenue and adjusted earnings that topped Wall Street's expectations as it saw strong sales from its blockbuster cancer drug Keytruda as well as other treatments in its oncology and vaccines portfolios and a newly launched cardiovascular drug. The pharmaceutical giant also raised its full-year sales forecast to a range of $63.4 billion to $64.4 billion on increased demand for key products, particularly its oncology treatments. That's only slightly higher than the $63.1 billion to $64.3 billion guidance the company provided in April. Merck reported $16.11 billion in revenue for the quarter, up 7% from the same period a year ago. Some analysts expect that worldwide sales of Winrevair could reach $5 billion by 2030.
Persons: Keytruda, Merck Organizations: Merck, Harpoon Therapeutics, LSEG, Prometheus Biosciences Locations: Rahway , New Jersey, U.S
European drug regulators on Friday rejected the Alzheimer's treatment Leqembi from Biogen and Eisai , creating another hurdle for the companies as they scramble to boost uptake of the therapy in the U.S. But it almost always follows the drug regulator's recommendations. The European Medicines Agency's human medicines committee recommended against granting marketing authorization for Leqembi. Leqembi and Kisunla are milestones in the treatment of Alzheimer's after three decades of failed efforts to develop medicines that can fight the fatal disease. In 2021, the European Medicines Agency rejected Aduhelm.
Persons: Eisai, Leqembi, Eli Lilly, Kisunla, Aduhelm Organizations: U.S, European Commission, U.S . Food, Drug Administration, Medicines, European Medicines Agency, Alzheimer's Locations: Biogen, U.S, Japan, South Korea, China, Israel, Europe, Alzheimer's Europe
The Bristol Myers Squibb research and development center at Cambridge Crossing in Cambridge, Massachusetts, on Dec. 27, 2023. Bristol Myers Squibb on Friday reported second-quarter earnings and revenue that topped expectations and raised its full-year guidance as the drugmaker moves to slash costs. The results come as Bristol Myers moves to cut $1.5 billion in costs by 2025 and reinvest that money into key drug brands and research and development programs. Bristol Myers posted net income of $1.68 billion, or 83 cents per share, for the second quarter. Revenue from Bristol Myers' blood cancer drug Revlimid also topped analysts' estimates for the period despite facing competition from cheaper generics.
Persons: Bristol Myers, Revlimid, Joe Biden's Organizations: Bristol Myers Squibb, LSEG, Revenue Locations: Cambridge, Cambridge , Massachusetts, Bristol, Revlimid
Shares of Viking Therapeutics jumped more than 30% on Thursday after the biotech company a day earlier announced plans to advance its experimental weight loss injection into a late-stage trial earlier than expected. Viking is one of several small and large drugmakers hoping to compete in the space against Novo Nordisk and Eli Lilly , whose weight loss and diabetes GLP-1s have skyrocketed in demand over the last two years. During the call, Lian added that Viking expects to test VK2735 as a monthly injection in a future study. Viking Therapeutics' drug promotes weight loss by targeting a GLP-1 and another hormone called GIP. That pill caused 3.3% weight loss when compared to a placebo in an early-stage trial.
Persons: Eli Lilly, Viking, Brian Lian, Lian, Justin Zelin, Zelin, Eli Lilly's Zepbound Organizations: Viking Therapeutics, San, Novo Nordisk, Food and Drug Administration, FDA, Novo Nordisk's Wegovy Locations: San Diego
Pfizer on Wednesday said its experimental gene therapy for a rare genetic blood-clotting disorder succeeded in a large late-stage trial, paving the way for a potential approval. Without enough of that protein, the blood cannot clot properly, increasing the risk of spontaneous bleeding and severe bleeding after surgery. Pfizer said its one-time treatment significantly cut the number of annual bleeding episodes in patients with moderately severe to severe hemophilia A after 15 months. If approved, Pfizer's therapy will compete with BioMarin Pharmaceutical 's one-time treatment Roctavian. BioMarin is reportedly considering whether to divest its hemophilia A therapy, which costs $2.9 million.
Persons: Andrew Leavitt, Pfizer Organizations: Pfizer, Sangamo Therapeutics, BioMarin Locations: U.S
Bipartisan lawmakers introduced a new bill on Tuesday that aims to crack down on the business practices of drug supply chain middlemen who are widely accused of inflating prescription medication prices and harming U.S. patients and pharmacies. The legislation aims to ensure community pharmacies can provide care to patients enrolled in federal health-care programs while being reimbursed "fairly and transparently" by so-called pharmacy benefit managers, or PBMs. Those middlemen also create lists of medications, also known as formularies, that are covered by insurance and reimburse pharmacies for prescriptions. Auchincloss said those practices have allowed PBMs to trap $300 billion in revenue in the middle of the drug supply chain between manufacturers and patients. Legislation targeting PBMs advanced through House and Senate committees with bipartisan support last year, and one proposal overwhelmingly passed the House in December.
Persons: Jake Auchincloss, Diana Harshbarger, Auchincloss, Biden Organizations: Medicare, CVS, PBMs, House, Federal Trade Commission, CNBC
Pfizer on Thursday said it will move forward with a once-daily version of its weight loss pill, danuglipron, after it saw "encouraging" data in an ongoing early-stage trial. Pfizer is one of several drugmakers racing to win a slice of the market for a highly popular class of weight loss and diabetes drugs called GLP-1 agonists. At the time, the pharmaceutical giant said phase one trial data on the once-daily version would "inform a path forward." Pfizer's danuglipron is a GLP-1 that promotes weight loss in the same way as Novo Nordisk' s injection Wegovy and diabetes treatment Ozempic. But he said Pfizer was looking for potential licensing deals or earlier-stage weight loss drugs.
Persons: Albert Bourla, Pfizer's, Eli Lilly, Bourla, Mikael Dolsten, Dolsten Organizations: Pfizer, Novo Nordisk, U.S
Joe Raedle | Getty ImagesAn Express Scripts spokesperson said the "prices of insulin and other medicines are set by their manufacturers, who have raised list prices repeatedly." They also create lists of medications — or formularies — that are covered by insurance and reimburse pharmacies for prescriptions. The investigation into insulin prices also examines drugmakers, but it is unclear whether they will be named in the upcoming lawsuits, Politico reported, citing people familiar with the matter. Eli Lilly , French drugmaker Sanofi and Danish pharmaceutical company Novo Nordisk control roughly 90% of the U.S. insulin market. Pharmacist Thomas Jensen looks over a prescription drug at the Rock Canyon Pharmacy in Provo, Utah, on May 9, 2019.
Persons: Lina Khan, Tom Williams, Joe Raedle, PBMs, Eli Lilly, Sanofi, Thomas Jensen, George Frey Organizations: Trade, Financial Services, General Government, CQ, Inc, Getty, Federal Trade Commission, CNBC, UnitedHealth, CVS, FTC, Politico, Novo Nordisk, Pharmacy Locations: Miami, U.S, Danish, Provo , Utah
Joe Raedle | Getty ImagesAn Express Scripts spokesperson said "the prices of insulin and other medicines are set by their manufacturers, who have raised list prices repeatedly." The FTC's investigation into insulin prices also examines drugmakers, but it is unclear whether they will be named in the upcoming lawsuits, Politico reported, citing sources. Eli Lilly , French drugmaker Sanofi and Danish pharmaceutical company Novo Nordisk control roughly 90% of the U.S. insulin market. They also create lists of medications – or formularies – that are covered by insurance and reimburse pharmacies for prescriptions. Pharmacist Thomas Jensen looks over a prescription drug at the Rock Canyon Pharmacy in Provo, Utah, on May 9, 2019.
Persons: Lina Khan, Tom Williams, Joe Raedle, Eli Lilly, Sanofi, Thomas Jensen, George Frey Organizations: Trade, Financial Services, General Government, CQ, Inc, Getty, Federal Trade Commission, CNBC, UnitedHealth, CVS, Politico, Novo Nordisk, Pharmacy Locations: Miami , Florida, Danish, U.S, Provo , Utah
A sign with the company logo sits outside of the headquarters campus of Eli Lilly and Company on March 17, 2024 in Indianapolis, Indiana. The Food and Drug Administration on Tuesday approved Eli Lilly 's Alzheimer's drug donanemab, expanding the limited treatment options for the mind-wasting disease in the U.S. The agency approved the treatment, which will be sold under the brand name Kisunla, for adults with early symptomatic Alzheimer's disease, according to the company. "Having multiple treatment options is the kind of advancement we've all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease." It's a long-awaited win for Eli Lilly after donanemab faced obstacles in its path to market.
Persons: Eli Lilly, Joanne Pike, donanemab Organizations: Company, The, Drug Administration, U.S, Alzheimer's Association, FDA Locations: Indianapolis , Indiana, U.S
But other current employees are dissatisfied with where the strategy shift has left them. In January 2023, Pfizer forecast a steep drop in annual revenue, to between $67 billion and $71 billion. Pfizer's 2023 revenue ultimately came in at $58.5 billion, including $11.22 billion from its Covid vaccine and $1.28 billion from Paxlovid. Faith in executive leadership also plunged among some workers, according to most of the current and former employees who spoke with CNBC. Some current workers said that hasn't appeared to change after the town hall on May 2.
Persons: Albert Bourla, Wall, they're, Bourla, I'm, drugmaker Seagen, Irfan Khan, hasn't, Pfizer, renegotiating, John Thys, Payal Sahni Becher, Becher, Kena, Mike McDermott, Bourla's Organizations: Corbis, Getty, Pfizer, Wall, CNBC, Los Angeles Times, Moderna, Centers for Disease Control, U.S ., GSK, Bristol Myers Squibb, Pfizer wasn't, . Biotech, Companies, Biotech, BioNtech, Reuters, Human, View Press, Global, APEC, Summit, Tech, Google Locations: U.S, Covid, Eagle Rock , California, Durham , North Carolina, Puurs, Belgium, New York City, Peapack , New Jersey, Kena
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