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☆ What Eli Lilly investors can learn from the slow launch of a competitor's drug
▼ + stars: | 2024-02-15 | by ( Kevin Stankiewicz | ) www.cnbc.com time to read: +8 min

Club holding Eli Lilly is expecting to get approval for its Alzheimer's treatment in the coming weeks, but investors looking for immediate financial success should temper their expectations. The FDA's decision on Lilly's drug, known as donanemab, is expected by the end of March. In the meantime, Eli Lilly's diabetes and obesity drugs, the heart of our investment thesis, should continue to fuel the lion's share of the company's topline growth. About 2,000 patients are currently taking Leqembi, Biogen said Tuesday, up from 800 at the time of the company's third-quarter report in November. LLY YTD mountain Eli Lilly's stock performance so far in 2024.

Persons: Eli Lilly, drugmaker Biogen, Eli Lilly's, —, Lilly, Biogen, Japan's, Chris Viehbacher, Viehbacher, Morgan Stanley, Lilly's, Donanemab, Mounjaro, Jim Cramer, Leqembi, Jim Cramer's, Jim Organizations: Food and Drug Administration, Drug Administration, Alzheimer's Association, FDA, Club, GE Healthcare, FactSet, Pharmaceutical, CNBC Locations: Indianapolis

☆ Bobby Knight, legendary Indiana Hoosiers basketball coach, dies at 83
▼ + stars: | 2023-11-01 | by ( Phil Helsel | ) www.cnbc.com time to read: +1 min

BLOOMINGTON, INDIANA - FEBRUARY 08: Former Indiana Hoosiers Head coach Bob Knight on the court during halftime of the game against the Purdue Boilermakers at Assembly Hall on February 08, 2020 in Bloomington, Indiana. (Photo by Justin Casterline/Getty Images)Bobby Knight, the Indiana University basketball coach who guided the Hoosiers to three NCAA championships, has died at 83, his family said. The Hall of Fame coach died Wednesday surrounded by his family at his home in Bloomington, Indiana, his family said in a statement. Knight was called "a legend among coaches" by the Basketball Hall of Fame, where he was inducted in 1991. Knight was Big Ten coach of the year five times and a four-time national coach of the year.

Persons: Bob Knight, Justin Casterline, Bobby Knight, Knight, Big, Knight's Organizations: Former Indiana Hoosiers, Purdue Boilermakers, Hall, Indiana University, Hoosiers, NCAA, of Fame, Basketball Hall of Fame, Ohio State Buckeyes, Indiana Hoosiers, U.S, Summer Games, NIT, Alzheimer's Association, Marian University Locations: BLOOMINGTON, INDIANA, Bloomington , Indiana, Los Angeles, Massillon , Ohio

☆ 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

☆ Blood tests needed for widespread Alzheimer's diagnosis on the way
▼ + stars: | 2023-10-11 | by ( Deena Beasley | ) www.reuters.com time to read: +6 min

Several Alzheimer's blood tests are in the works – and one is already being sold to consumers – but none have been established as accurate, formally approved by regulators or reimbursed by insurers. Researchers have been working for years on blood tests for Alzheimer's that can replicate these diagnostic tools. The need for blood tests has become more pressing since the FDA approved Leqembi in July. Accurate blood tests are expected to help identify which dementia patients actually have Alzheimer’s, the most common but not the only cause of dementia. "When there are widely available, scalable, sensitive and specific blood tests it will be an absolute game changer for Alzheimer's patients."

Persons: Denis Balibouse, Eli Lilly, Dr, Sarah Kremen, Eliezer Masliah, Eisai, Michael Irizarry, Roche, Bruce Jordan, Russ Paulsen, Deena Beasley, Caroline Humer, Bill Berkrot Organizations: Memory Centre, of Readaptation, University Hospital, REUTERS, FDA, Sinai Medical Center, Wednesday, Quest Diagnostics, National Institute, Aging, U.S . National Institutes of Health, C2N Diagnostics, Roche Diagnostics, Alzheimer's Association, RAND, Thomson Locations: Geneva, Switzerland, Leqembi, Eisai, Los Angeles, U.S

☆ Lilly drug slows Alzheimer's by 60% for mildly impaired patients in trial
▼ + stars: | 2023-07-17 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

Lilly expects the U.S. Food and Drug Administration to decide by the end of this year whether to approve donanemab. The company had previously reported that 24% of the overall donanemab treatment group had brain swelling. The deaths of three trial patients were linked to the treatment, researchers reported. For high tau patients, donanemab was shown to slow disease progression by about 17%, while the benefit was 35% for those with low-to-intermediate tau levels. Both medications are also being studied in large trials to see if they have an impact on delaying onset of Alzheimer's disease symptoms.

Persons: Seth Gale, Brian Snyder, Eli Lilly, Anne White, Lilly, Susan Kohlhaas, Liana Apostolova, White, Liz Coulthard, donanemab, Deena Beasley, Ludwig Burger, Will Dunham, Bill Berkrot, Caroline Humer Organizations: Alzheimer Research, Brigham, Women’s, REUTERS, Alzheimer's Association International, U.S . Food, Drug Administration, Alzheimer’s Research, Indiana University School of Medicine, Doctors, University of Bristol, JAMA, FDA, Alzheimer's Association, Health Organization, New York Stock Exchange, Thomson Locations: Boston , Massachusetts, U.S, Amsterdam, Eisai

☆ Acumen's Alzheimer's drug passes initial safety test
▼ + stars: | 2023-07-16 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +2 min

CHICAGO, July 16 (Reuters) - An experimental Alzheimer's disease drug developed by Acumen Pharmaceuticals (ABOS.O) targeting a novel form of the toxic protein beta amyloid in the brain passed an early safety test and will advance to a larger trial, the company said on Sunday. The drug, ACI193, was well tolerated in the first trial testing it in people, the company said. Results of the randomized, placebo-controlled study of 62 patients with early Alzheimer's disease were presented at the Alzheimer's Association's International Conference in Amsterdam. In the Acumen trial, 10.4% of treated participants (5 people) developed a brain swelling condition known as ARIA-E associated with amyloid-targeting treatments. Acumen said the study suggests the drug can be given as a monthly intravenous infusion.

Persons: Eric Siemers, Leqembi, Julie Steenhuysen, Bill Berkrot Organizations: Pharmaceuticals, Thomson Locations: Amsterdam, Alzheimer's

☆ Alzheimer's diagnosis revamp embraces rating scale similar to cancer
▼ + stars: | 2023-07-16 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +4 min

July 16 (Reuters) - Alzheimer's disease experts are revamping the way doctors diagnose patients with the progressive brain disorder - the most common type of dementia - adopting a seven-point rating scale based on cognitive and biological changes in the patient. "Stage 1a is really the beginning of evidence that someone has the disease," Jack said. The new scale also includes a Stage 0 for people who carry genes that guarantee they will develop Alzheimer's. Noting the new system's similarity to cancer stages, Jack said, "There's no such thing as mild breast cancer. Jack also noted that many other conditions can cause dementia but not all dementia is Alzheimer's disease.

Persons: Clifford Jack, Eli Lilly's, Maria Carrillo, Jack, Julie Steenhuysen, Will Dunham Organizations: Alzheimer's Association, Mayo Clinic, National Institute of Aging, government's National Institutes of Health, Drug Administration, FDA, Down, Thomson Locations: Amsterdam, Rochester , Minnesota, Chicago

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

☆ 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

☆ Medicare offers details on reimbursement for new Alzheimer's drugs
▼ + stars: | 2023-06-22 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +4 min

CHICAGO, June 22 (Reuters) - The U.S. Medicare health plan on Thursday offered details of plans to collect patient data as a condition for reimbursement for Eisai Co Ltd (4523.T) and Biogen Inc's (BIIB.O) new Alzheimer's drug Leqembi, should it win traditional U.S. approval as expected by July 6. If it wins traditional FDA approval, Leqembi would be the first disease-modifying drug ever to achieve the regulatory milestone. Current treatments only treat symptoms but do not change the course of the disease, which affects 6 million Americans, according to the Alzheimer's Association. On that basis, CMS said it would only pay for Leqembi if patients were enrolled in a clinical trial. The CMS data requirements apply to all Alzheimer's treatments that reduce beta amyloid from the brain, including Eli Lilly and Co's donanemab, which recently reported positive results from its late-stage trial.

Persons: Biogen, Eisai's Leqembi, Leqembi, Eli Lilly, Co's, “, Robert Egge, Julie Steenhuysen, Daniel Wallis Organizations: U.S, Eisai Co, Centers, Medicare, Medicaid Services, CMS, Alzheimer's Association, U.S . Food, Drug Administration, FDA, Alzheimer’s Association, Thomson Locations: U.S

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

☆ Eli Lilly Alzheimer’s treatment donanemab slowed disease progression in clinical trial
▼ + stars: | 2023-05-03 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

The Alzheimer's treatment donanemab, which is made by Eli Lilly , significantly slowed progression of the mind-robbing disease, according to clinical trial data released Wednesday by the company. Patients who took donanemab were 39% less likely to progress to the next stage of the disease during the study, according to the trial results. Dr. Daniel Skovronsky, Lilly's chief scientific and medical officer, said donanemab demonstrated the highest level of efficacy of any Alzheimer's treatment in a clinical trial. In a separate measure, patients who received donanemab showed 40% less decline in their ability to conduct daily activities at 18 months. "These are the strongest phase 3 data for an Alzheimer's treatment to date.

The drug, donanemab, met all goals of the trial. "These are the strongest phase 3 data for an Alzheimer's treatment to date," said Maria Carrillo, chief science officer for the Alzheimer's Association. In the donanemab treatment group, Lilly said brain swelling, a known side effect of drugs of this type, occurred in 24% of the participants, with 6.1% experiencing symptoms. In the Leqembi Phase 3 trial, the drug was associated with brain swelling in nearly 13% of its study participants. It also said 47% of donanemab patients in the 18-month trial had no disease progression at 12 months, compared with 29% of the placebo group.

☆ Bipartisan attorneys general call on Medicare to cover Alzheimer's treatments
▼ + stars: | 2023-05-01 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Democratic and Republican attorneys general in nearly half of U.S. states are calling on Medicare to provide unrestricted coverage of antibody treatments for Alzheimer's disease, according to a letter released Monday. "We ask that CMS provide unrestricted Medicare coverage for FDA-approved Alzheimer's treatments, consistent with its decades-long practice of covering FDA-approved prescription drugs for Medicare beneficiaries," the attorneys general, led by Oklahoma's Gentner Drummond, told CMS Administrator Chiquita Brooks-LaSure and Health Secretary Xavier Becerra. More than 70 House lawmakers and 18 senators called on Medicare to provide unrestricted coverage of Alzheimer's treatments in February. The push by members of Congress and state attorneys general comes after Medicare rejected a request by the Alzheimer's Association to cover Leqembi without any conditions.

☆ 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.

☆ Biogen isn't concerned about competing with Eli Lilly in the Alzheimer’s drug space, CEO says
▼ + stars: | 2023-04-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Biogen isn't worried about competing with Eli Lilly as they both attempt to bring an Alzheimer's drug to the market, Biogen's CEO said Tuesday. Researchers argue that the accumulation of amyloid plaque is a crucial first step toward the cognitive decline observed in Alzheimer's disease. Eli Lilly didn't immediately respond to a request for comment. He said that will likely require Eli Lilly and Biogen to roll out maintenance doses that will keep plaque levels low. Biogen is banking on the success of its drug leqembi after the disastrous approval and rollout of its old Alzheimer's drug aduhelm last year.

☆ Alzheimer’s patients retain the benefits of Leqembi even when they stop the drug, Eisai says
▼ + stars: | 2023-04-06 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Alzheimer's patients who take Leqembi retain the benefits of the treatment even when they stop taking it, new research by Eisai shows. The findings also come as Eisai and Biogen try to regain their footing after the polarizing approval and disastrous rollout of its other Alzheimer's disease therapy, aduhelm, last year. In the analysis, Alzheimer's patients stopped taking Leqembi after 18 months in a phase two clinical trial and later resumed the treatment in an extension trial. Amyloid is a protein that builds up on the brain in Alzheimer's patients and disrupts cell function. That means Alzheimer's disease progressed at a slower rate in patients who received Leqembi compared to those who took the placebo during the clinical trial.

☆ Eli Lilly says experimental Alzheimer's drug reduces brain plaque in early study
▼ + stars: | 2023-04-05 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Eli Lilly 's experimental Alzheimer's drug lowered levels of brain plaque in patients who are in the earliest stages of the devastating disease, initial data shows. Researchers have argued that accumulation of amyloid plaque is a crucial first step toward the cognitive decline observed in Alzheimer's disease. The early data comes as Eli Lilly continues its decades-long bid to bring an Alzheimer's drug to the market. Eli Lilly found the drug caused a "rapid and robust" clearance of amyloid plaque, the presentation said. But Tewari said it's unclear if clearing amyloid plaque will lead to clinical benefits like a reduction in cognitive decline.

☆ Exclusive: US to build $300 mln database to fuel Alzheimer's research
▼ + stars: | 2023-04-03 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +4 min

The platform will draw on data from medical records, insurance claims, pharmacies, mobile devices, sensors and various government agencies, they said. The database could help identify healthy people at risk for Alzheimer's, which affects about 6 million Americans, for future drug trials. The U.S. Medicare health plan for older adults will likely require such tracking in a registry as a condition of reimbursement for Leqembi. Silverberg said the data platform could also help researchers working in other disease areas understand which patients are most at risk and the impact of medications. The system would be built in a secure computing environment with a number of restrictions to ensure the privacy of people's health data, Silverberg said.

☆ Lilly says experimental Alzheimer's drug reduces amyloid in small study
▼ + stars: | 2023-03-31 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

The higher the dose of the antibody drug, which was given by subcutaneous injection, the larger the effect, Lilly said. The Indianapolis-based drugmaker is launching a Phase III study of the experimental antibody, remternetug, but declined to comment on which doses will be selected for larger, later-stage trials. Lilly, at a medical conference in Gothenburg, Sweden, presented interim data from 41 study participants. Trial results published last year showed that, in patients with early Alzheimer's, Leqembi reduced the rate of cognitive decline by 27% compared with a placebo. Brooks said that sharing its early remternetug data "reinforces Lilly's commitment and investment in the Alzheimer's disease space ...

The Alzheimer's Association and the pharmaceutical industry say the drug companies are not directly involved in the campaign. But the Alzheimer's Association says patients simply don't have the time to spare. The agency did not address the Alzheimer's Association campaign. Association members have met 30 times with staffers for the state's 20 members of Congress, Ryan Schiff, the chapter's public policy manager, said. Spokespeople for all three companies said they do not work with the Association on its campaign to expand Medicare coverage of the drugs.

☆ FDA will review Eisai and Biogen's Alzheimer's treatment Leqembi with decision on full approval expected in early July
▼ + stars: | 2023-03-06 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

The Food and Drug Administration will make a decision on whether to fully approve Eisai and Biogen 's Alzheimer's treatment Leqembi by July 6, the companies announced Monday. It is administered intravenously twice a month and slowed the progression of early Alzheimer's disease by 27% in clinical trials. Although the FDA approved Leqembi on an expedited basis in January, access to the treatment is virtually nonexistent right now. Learn more and register today: http://bit.ly/3DUNbRoThe Alzheimer's Association called on CMS in December to provide unrestricted coverage of treatments like Leqembi. "As defined in statute, to provide coverage nationally, CMS is required to examine whether a medication is reasonable and necessary," the agency said in its statement.

☆ Medicare rejects Alzheimer's Association request for unrestricted coverage of treatments like Leqembi
▼ + stars: | 2023-02-23 | by ( Spencer Kimball | ) www.cnbc.com time to read: +6 min

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Due to the drug's high price and Medicare's coverage restrictions, seniors are unable to access the treatment. The letter the Alzheimer's Association sent to CMS in December calling for unrestricted coverage was signed by more than 200 researchers and experts. CMS said it would provide broader coverage of Leqembi on the same day should the FDA fully approve the treatment. Medicare adopted the coverage restrictions after controversy over the Alzheimer's antibody treatment Aduhelm, which was also developed by Eisai and Biogen.

☆ 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.

☆ Senators call on Medicare to offer broad coverage of Alzheimer's treatments as public pressure grows
▼ + stars: | 2023-02-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

U.S. senators on Friday called for Medicare to offer broad coverage of Alzheimer's treatments approved by the Food and Drug Administration, warning that current restrictions cost patients precious time as their disease progresses. The 20 senators told CMS that Alzheimer's will cost the nation $1 trillion by 2050 if the U.S. does not take decisive action. As a consequence, Medicare coverage for the expensive drug is basically nonexistent. The Alzheimer's Association wrote CMS in December calling for the agency to provide unrestricted Medicare coverage for Leqembi. "We believe Medicare beneficiaries should have unimpeded access, broad and simple access to Leqembi because the data fulfill those criteria."

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