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☆ Eli Lilly says FDA delays approval of Alzheimer's drug in surprise move
▼ + stars: | 2024-03-08 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

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

☆ Exclusive-Eisai Expects 1,500 Alzheimer's Patients in China Launch, Sees ‘Huge’ Growth
▼ + stars: | 2024-02-04 | by ( Feb. | At P.M. | ) www.usnews.com time to read: +5 min

“China is one of the fastest-aging countries in the world and is one of the most important countries in the area of Alzheimer’s disease for Eisai,” a company spokesperson said. “The potential growth for Leqembi in China is huge.”Eli Lilly, which is developing a similar treatment called donanemab, told Reuters it has filed for approval in China. The Indianapolis-based company is now testing its drug in a 1,500-person trial with volunteers in China, Taiwan, South Korea and the EU, a spokesperson said. Leqembi, which works by removing a toxic protein called beta amyloid from the brain, is the first Alzheimer's treatment proven to alter the course of the fatal, brain-wasting disease. Once on treatment, suitable patients undergo a series of MRI scans to monitor for potentially fatal swelling and bleeding in the brain.

Persons: Julie Steenhuysen, Andrew Silver CHICAGO, ” Eli Lilly, Biogen, Liu Zhou, Eisai, ”, Hidemaru Yamaguchi, Soeren Mattke, Mattke, Andrew Silver, Caroline Humer, Bill Berkrot Organizations: Reuters, EU, Leqembi, Guangdong Medical University, ” Citi, Psychiatry, Siemens Healthineers, University of Southern, University of Southern California Brain Health Locations: SHANGHAI, China, ”, Leqembi, The Indianapolis, Taiwan, South Korea, Eisai, United States, Japan, Europe, U.S, University of Southern California, Chicago, Shanghai

☆ Researchers return to Alzheimer's vaccines, buoyed by recent drug success
▼ + stars: | 2023-11-20 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +6 min

The renewed interest in Alzheimer's vaccines follows a promising first attempt more than 20 years ago that was abandoned after 6% of study volunteers developed life-threatening brain inflammation known as meningoencephalitis. Dr. Reisa Sperling, an Alzheimer's researcher at Mass General Brigham in Boston, said she believes vaccines will play an important role as researchers look to prevent Alzheimer's. She is considering vaccines for her next study in asymptomatic people with Alzheimer's proteins in their blood, but not enough to register on brain scans. Alzheimer's vaccines are still in the early stages and will require large, years-long trials to show they work. Generating a strong immune response is critical for such vaccines, which would typically be given to older individuals with weaker immune systems, he said.

Persons: Brian Snyder, Eli Lilly's, Reisa Sperling, Brigham, “, ” Sperling, Walter Koroshetz, Mei Mei Hu, Vaxxinity, Hu, Michael Rafii, Rafii, Andrea Pfiefer, Johnson, Prothena, Gene Kinney, Julie Steenhuysen, Caroline Humer, Bill Berkrot Organizations: Alzheimer Research, Brigham, Women's, REUTERS, Rights, U.S . Food, Drug Administration, Mass, National Institutes of Health, UB, University of Southern, Johnson, Bristol Myers Squibb, Thomson Locations: Boston , Massachusetts, U.S, Boston, Taiwan, University of Southern California

☆ More convenient form of breakthrough Alzheimer's drug Leqembi shows promising results in study
▼ + stars: | 2023-10-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Eisai on Wednesday said an injectable version of the Alzheimer's drug Leqembi showed promising initial results in a clinical trial, potentially paving the way for a new and more convenient option for administering the antibody treatment. Eisai and Biogen said in a release that they plan to apply for U.S. approval of subcutaneous Leqembi by the end of March. Eisai presented the preliminary results, from an extension to a late-stage trial that supported the approval of intravenous Leqembi, at the Clinical Trials on Alzheimer's Disease conference in Boston. The study specifically showed that the injectable form of Leqembi removed 14% more plaque than the approved intravenous formulation. Blood concentration levels of the drug were 11% higher with subcutaneous Leqembi than the other version.

Persons: Eisai, Leqembi, Biogen, – Organizations: Eisai, ARIA, Alzheimer's Association Locations: U.S, Boston

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

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

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

☆ 3 health-care stocks are in the headlines. How the news impacts our investments
▼ + stars: | 2023-07-13 | by ( Kevin Stankiewicz | In Kevinstankiewicz | ) www.cnbc.com time to read: +8 min

In April, alongside its first-quarter results, J & J raised its full-year sales guidance by about $1 billion and its earnings-per-share outlook by 15 cents. Clearing this overhang would help reduce the discount at which J & J shares to pharmaceutical peers, the firm said. The Club's take: JPMorgan's thinking on J & J aligns quite closely with our own. The dark cloud of talc lawsuits continues to keep a lid on J & J's stock price. Joaquin Duato, chief executive officer of Johnson & Johnson, at the company's headquarters in New Brunswick, New Jersey, U.S., on Thursday, April 21, 2022.

Persons: Johnson, Eli Lilly, J, Wells, Wells Fargo, Eli Lilly's, —, Eisai, Biogen, Bloomberg, we've, Jim Cramer's, Jim Cramer, Jim, Joaquin Duato, Amir Hamia Organizations: Johnson, JPMorgan, pharma, U.S ., Humana, UnitedHealth, Bloomberg, U.S, Mayo Clinic, Club, GE Healthcare, CNBC, Getty, & $ Locations: U.S, California, Wells Fargo, Rochester , Minnesota, New Brunswick , New Jersey

☆ Sales of Alzheimer’s drug Leqembi may be slow initially but could pick up in 2024
▼ + stars: | 2023-07-07 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Sales of the Alzheimer's drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts said after the groundbreaking treatment won approval in the U.S.Wall Street is chewing over the Food and Drug Administration's Thursday approval of Leqembi – a milestone in the treatment of the disease, even though the drug isn't a cure. Leqembi, from drugmakers Eisai and Biogen , is the first medicine proven to slow the progression of Alzheimer's in people at the early stages of the memory-robbing disease. Yee added that the firm's channel checks suggest doctors see the registry requirement "as a potential real-world challenge – at least in the initial phase." That includes navigating Medicare's registry requirement and coordinating PET scans and MRIs to screen for dangerous side effects of the drug. But Goodman, like other analysts, also noted that "we continue to expect a slow ramp in 2023 and acceleration moving into 2024."

Persons: Jay Reinstein, drugmakers, Yatin Suneja, Jefferies, Michael Yee, Yee, Paul Matteis, Marc Goodman, Goodman Organizations: Georgetown University Hospital, Wall, Food, Leqembi, FDA, National Institute, Aging, ARIA, SVB Securities Locations: Washington , DC, U.S

☆ Two health-care stocks are in the headlines. How the news impacts our investments
▼ + stars: | 2023-07-07 | by ( Kevin Stankiewicz | In Kevinstankiewicz | ) www.cnbc.com time to read: +9 min

Here's a deeper look at the headlines and their implications for our investment theses in these two health-care companies. The Club's take: The first-of-their-kind FDA and CMS actions came in generally as anticipated, and represent incremental positives for Eli Lilly. That's why some of the decline seen Friday in Eli Lilly shares – down over 2%, to around $453 each – could simply represent a sell-the-news situation. Eli Lilly has said donanemab could be approved by the FDA late this year or in early 2024. Our expectations around donanemab sales also are measured, and the drug is not the primary driver of our multiyear optimism for Eli Lilly.

Persons: Eli Lilly, Eli Lilly's donanemab, Leqembi —, Biogen, —, Lilly's, That's, Donanemab, Lilly, donanemab, that's, Lisa Gill, UnitedHealth, Humana, Gill, What's, We'll, Jim Cramer's, Jim Cramer, Jim Organizations: Club, Drug Administration, Medicare, Medicaid Services, FDA, GE Healthcare, Humana, JPMorgan, CNBC Locations: Massachusetts

☆ FDA approves Alzheimer’s drug Leqembi, paving way for broader Medicare coverage
▼ + stars: | 2023-07-06 | by ( Spencer Kimball | ) www.cnbc.com time to read: +8 min

Leqembi is the first Alzheimer's antibody treatment to receive full FDA approval. The antibody, administered twice monthly through intravenous infusion, targets a protein called amyloid that is associated with Alzheimer's disease. Medicare coverage is a crucial step to help older Americans with early Alzheimer's disease pay for the treatment. Costs may vary depending on whether the patient has supplemental Medicare coverage or other secondary insurance, according to the agency. Philipson and his colleagues at the University of Chicago estimated that delaying Medicare coverage of Alzheimer's antibody treatments by one year would result in $6.8 billion in increased spending.

Persons: Joanna Pike, Leqembi, Pike, David Knopman, Knopman, Anna Eshoo of, Nanette Barragan, There's, Tomas Philipson, Bush, Philipson, Sen, Bernie Sanders, Xavier Becerra, Sanders, Eisai Organizations: Drug Administration, Medicare, FDA, Alzheimer's Association, Mayo Clinic, Services, Health, University of Chicago, Senate Health, Human Services, Clinical Locations: U.S, Minnesota, Anna Eshoo of California

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

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

All six advisers on the panel voted in favor of Leqembi for treatment of the mind-wasting illness. That approval would also make Leqembi the first disease-modifying drug ever to achieve the regulatory milestone. Leqembi won accelerated approval by the FDA in January based on its ability to remove sticky amyloid plaques from the brain. Most U.S. Alzheimer's patients are Medicare-eligible. “We are in full agreement with the FDA Advisory Committee that Leqembi provides clinical benefit and that this benefit outweighs the risks."

Persons: Eisai, Leqembi, Tanya Simuni, Robert Alexander, Joanne Pike, Leroy Leo, Khushi, Julie Steenhuysen, Bill Berkrot Organizations: Food and Drug Administration, Alzheimer's Association, FDA, Northwestern University Feinberg School of Medicine, Banner Alzheimer's Institute, CAA, Medicare, Wall Street, Analysts, Alzheimer's, Thomson Locations: Leqembi, U.S, Bengaluru, Chicago

☆ Bernie Sanders says price of Alzheimer's treatment is unconscionable, calls on HHS to take action
▼ + stars: | 2023-06-07 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

Sen. Bernie Sanders on Wednesday called on the U.S. Health and Human Services Department to take action to ensure seniors can actually afford the expensive Alzheimer's treatment Leqembi. Sanders, who chairs the Senate Health Committee, in a letter to HHS Secretary Xavier Becerra called the $26,500 annual price tag for Leqembi set by drugmakers Eisai and Biogen "unconscionable." Sanders said the "outrageously high price" of Leqembi "will prevent seniors who need this drug from receiving treatment." Most Medicare patients suffering from Alzheimer's would not be able to afford the 20% co-payment of more than $5,000 a year for Leqembi, Sanders said. Co-payments, along with coinsurance and deductibles, are medication and health services costs that patients must personally pay for out of pocket, as opposed to being covered by their health insurance.

Persons: Sen, Bernie Sanders, Sanders, Xavier Becerra, drugmakers Eisai, Becerra, Mr Organizations: U.S, Capitol, U.S . Health, Human Services Department, Health, Medicare, HHS, Services, Leqembi, Democratic, Senate, Clinical Locations: Washington , DC, Vermont

☆ Alzheimer’s patients may wait years to get treated with new drugs, putting them at risk of more severe disease
▼ + stars: | 2023-04-30 | by ( Spencer Kimball | ) www.cnbc.com time to read: +17 min

But time spent waiting robs early patients of their memory and ability to live independently. This condition is often, though not always, a sign of early Alzheimer's disease. PET scans cumbersomeTwo types of tests can diagnosis Alzheimer's disease: PET scans and spinal taps. Early Alzheimer's disease can also be diagnosed with a spinal tap, in which fluid around the spinal cord is extracted with a catheter and tested. He believes big players like CVS will provide infusions for Alzheimer's disease on a major scale if they see there's a large and stable market.

☆ Eli Lilly jumps to all-time highs on Alzheimer's news. Here's what it means our investment
▼ + stars: | 2023-04-21 | by ( Kevin Stankiewicz | ) www.cnbc.com time to read: +6 min

LLY 1Y mountain Shares of Eli Lilly over the past 12 months. Still, a commercially successful Alzheimer's drug would be material for Eli Lilly and strengthen its long-term position. Mounjaro is the heart of our Eli Lilly investment case. Another catalyst looming for Eli Lilly shares is results from a study conducted by its competitor in the weight-loss category Novo Nordisk . Eli Lilly Pharmaceutical company logo SOPA Images | LightRocket | Getty Images

Piper Sandler said several positive catalysts are in sight for Biogen over the next several quarters. The firm named the foremost catalyst for Biogen as Alzheimer's treatment Leqembi , which it co-developed with Japanese pharmaceutical company Eisai. Specifically, while share today is minimal (0.7% of patients), docs project this share to almost quadruple within 6 months," Raymond wrote in a Monday note. Aduhelm is the controversial Alzheimer's treatment developed by Biogen and Eisai, whose sales fell below Wall Street's expectations as its efficacy was called into question. "For our part, we think Leqembi has set a high bar – especially with regard to safety," said Raymond.

☆ Club meeting recap: Jim Cramer says 'the existential threat is gone for J&J'
▼ + stars: | 2023-04-05 | by ( Paulina Likos | ) www.cnbc.com time to read: +3 min

Every weekday the CNBC Investing Club with Jim Cramer holds a "Morning Meeting" livestream at 10:20 a.m. Jim Cramer said Wednesday that J & J's proposal could mean, "the existential threat is gone for J & J." Watch Eli Lilly Club holding Eli Lilly (LLY) will report a key phase-3 data readout of its Alzheimer's drug Donanemab in the next one-to-two months. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER .

☆ Maker of promising Alzheimer's drug Leqembi expects full FDA approval this summer, expanded Medicare coverage
▼ + stars: | 2023-02-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +7 min

Early Alzheimer's typically hits people ages 65 and older, causing cognitive impairment and other issues. Medicare beneficiaries who agree to participate in CMS-backed research studies, which are broader than clinical trials, would get coverage if Leqembi receives full approval. Drug rollout will take yearsIf everything goes according to Eisai's expectations, the FDA would grant full approval and CMS would provide unrestricted coverage of Leqembi. In that scenario, Eisai anticipates that about 100,000 diagnosed early Alzheimer's patients will be eligible by year three of the drug's rollout. Private insurers are largely waiting for a CMS coverage decision though some may decide to make their coverage decisions earlier, he said.

☆ Biogen sees modest 2023 revenue from Alzheimer's disease drug
▼ + stars: | 2023-02-15 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

Feb 15 (Reuters) - Biogen Inc (BIIB.O) said on Wednesday that Alzheimer's disease drug Leqembi would bring in modest revenue for the year although it might not be enough to offset costs tied to its launch. Biogen has a 50% share of U.S. profits on Leqembi, which it developed with lead partner Eisai Co Ltd (4523.T). "Over the last couple of years, the company has lost its way somewhat and now it is in a declining revenue," Viehbacher said. Biogen expects full-year adjusted profit of $15 to $16 per share, compared with analysts' estimates of $15.72 per share. The company reported a Q4 adjusted profit of $4.05 per share, above Refinitiv IBES estimates of $3.48 per share.

☆ Here's where to look for the next developments in the fight against Alzheimer's disease
▼ + stars: | 2023-01-17 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +10 min

The Centers for Disease Control and Prevention estimates 5.8 million Americans were living with the disease in 2020 . BIIB 6M mountain Biogen's stock is trading well above its lows Leqembi treats Alzheimer's disease by targeting amyloid-beta plaques in the brain. Attention shifts to Eli Lilly Shares of other Alzheimer's drug developers have often mirrored Biogen's moves. Small drug developers Smaller Alzheimer's drug developers have also been boosted by research developments. Still in an early stage of its research, Prothena has traded as a proxy for developments in Alzheimer's treatment.

☆ Most Alzheimer’s patients would pay up to $26,500 per year for new treatment Leqembi
▼ + stars: | 2023-01-09 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

Few seniors with early Alzheimer's disease will have access to the new treatment Leqembi due to its high cost and very limited coverage by Medicare. "Even with Medicare coverage, beneficiaries would still be responsible for 20% coinsurance, and that's not a trivial amount." An investigation by lawmakers in the House concluded that the FDA approval process for Aduhelm was "rife with irregularities." "It's not going to be widely available even to people who are potentially eligible based on whether or not they have mild cognitive impairment related to Alzheimer's disease," Neuman said. CMS plans to provide broader coverage for Leqembi if the treatment receives full FDA approval under the traditional process, according to an agency statement.

The Food and Drug Administration on Friday approved an Alzheimer’s drug shown in clinical trials to slow cognitive decline in patients in the early stages of the illness. The FDA approved Leqembi for use in people with mild cognitive impairment or early Alzheimer’s disease. Most drugs approved by the FDA for Alzheimer’s are aimed at helping symptoms, not actually slowing the progression of the disease. Friday's announcement comes on the heels of a scathing congressional report released last week detailing the approval of a different Alzheimer’s drug, called Aduhelm. The Alzheimer's Association has said that based on the Eisai and Biogen phase 3 clinical trial results, the FDA should approve Leqembi for early-stage Alzheimer’s.

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