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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
A 0.25 mg injection pen of Novo Nordisk's weight-loss drug Wegovy is shown in this photo illustration in Oslo, Norway, August31, 2023. The U.S. Food and Drug Administration on Wednesday said Eli Lilly (LLY.N) could begin selling its drug tirzepatide for weight loss, making it the second obesity drug in a class known as GLP-1s. Studies of Novo's Wegovy showed that it led to 15% weight loss over 68 weeks, while Lilly's drug, which also targets a second hormone called GIP, demonstrated weight loss of more than 22% over 72 weeks. Drugstore chain Walgreens is seeing "enormous demand" for GLP-1s, said John Driscoll, president, U.S. healthcare at Walgreens Boots Alliance (WBA.O). Much has been made of the impact the new weight loss drugs might have on consumer habits such as snack food purchases, but Driscoll said Walgreens has not seen that yet.
Persons: Victoria Klesty, Eli Lilly, Novo, Novo's Wegovy, Lawrence Tabak, John Driscoll, Tabak, Driscoll, Walgreens, Julie Steenhuuysen, Caroline Stauffer, Deena Beasley, Jamie Freed Organizations: REUTERS, Rights, Reuters, Total Health, U.S . Food, Drug Administration, U.S . National Institutes of Health, Walgreens, Walgreens Boots Alliance, Thomson Locations: Oslo, Norway, August31, Victoria, Chicago, U.S, satiety
The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Eisai/Handout via REUTERS/File Photo Acquire Licensing RightsBOSTON, Oct 25 (Reuters) - An injected version of Eisai (4523.T) and Biogen's (BIIB.O) Alzheimer's drug Leqembi works as well as the current intravenous version at removing toxic brain plaques, according to an analysis presented by Eisai on Wednesday. The Japanese drugmaker's review compared data for 72 patients with early Alzheimer's given Leqembi by subcutaneous injection to prior pivotal trial results from 898 patients who received the drug by infusion. Blood concentration levels of the drug were 11% higher with subcutaneous Leqembi than the IV version. Roll-out of IV Leqembi, which has an annual list price of $26,500, has been slow.
Persons: Eisai, Leqembi, , Eric Reiman, Priya Singhal, Biogen, Michael Irizarry, Alzheimer's, Julie Steenhuysen, Deena Beasley, Bill Berkrot, Leslie Adler Organizations: Reuters, REUTERS, Rights, Banner Alzheimer's Institute, ARIA, Thomson Locations: Handout, Boston, Los Angeles
In an extended portion of Eisai’s main Leqembi trial, CAA was associated with one death. 'THE DIGNITY OF RISK'Hillerstrom said the groups are "very strongly" lobbying Eisai and Lilly to conduct the safety trials in Down syndrome, and said he has been meeting with the companies to push them to design such trials. Lilly declined to comment on whether it is considering either a safety trial or taking part in that study. An Eisai spokeswoman said the company "has no immediate plans" to conduct clinical trials of Leqembi in people with Down syndrome. The company is collaborating with LuMind in a study gathering data on how Alzheimer's manifests in people with Down syndrome.
Persons: Oskar Hillerstrom, Lianor, Hampus, Brian Snyder, Lianor da Cunha, Oskar, de Oeiras, Teresa, Oskar’s, Hampus Hillerstrom, Eli Lilly's, LuMind, Hillerstrom, Lilly, Emily Largent, Beau Ances, Louis, I've, Ances, I'm, Michael Rafii, William Mobley, Mobley, Dawn Brooks, donanemab, Margot Rhondeau, Hannah, Julie Steenhuysen, Caroline Humer, Bill Berkrot Organizations: REUTERS, Rights, Reuters, CAA, University of Pennsylvania Perelman School of Medicine, Medicare, U.S . Food, Drug Administration, Washington University, National Institute, Aging, University of Southern, UC San Diego School of Medicine, LuMind, Syndrome, Thomson Locations: Lexington , Massachusetts, U.S, Santo, Portugal, United States, St, University of Southern California
A few compounds picked by AI are now in development, but those bets will take years to play out. Reuters interviews with more than a dozen pharmaceutical company executives, drug regulators, public health experts and AI firms show, however, that the technology is playing a sizeable and growing role in human drug trials. The U.S. Food and Drug Administration (FDA) said it had received about 300 applications that incorporate AI or machine learning in drug development from 2016 through 2022. Without AI, Bayer said it would have spent millions more, and taken up to nine months longer to recruit volunteers. Finding real-world patients by mining electronic patient data can be done manually, but using AI speeds up the process dramatically.
Persons: Dado Ruvic, Jeffrey Morgan, Amgen, Badhri Srinivasan, Sameer Pujari, drugmaker Bayer, Bayer, Blythe Adamson, Roche, Richard Pazdur, Gen Li, John Concato, Natalie Grover, Martin Coulter, Julie Steenhuysen, Josephine Mason, David Clarke Organizations: Pharmaceutical Research, REUTERS, Pharmaceutical, Bayer, Novartis, Deloitte, U.S . Food, Drug Administration, Reuters, World Health, Flatiron Health, FDA, European Medicines Agency, FDA's Oncology, Excellence, Medical, FDA's Center, Drug, Research, Thomson Locations: U.S, Johannesburg, Texas, Finland, United States, London, Chicago
The updated shots are part of a push by public health officials to align the next COVID vaccines more closely with the actual circulating variant of the virus, similar to the way annual flu shots are designed. The U.S. Food and Drug Administration (FDA) on Monday authorized updated COVID vaccines made by Pfizer (PFE.N) and its German partner BioNTech SE (22UAy.DE) as well as by Moderna (MRNA.O). CDC Director Mandy Cohen is expected to approve the recommendations issued by the advisers, allowing Americans to get the updated vaccines. The first COVID vaccines in 2020 were monovalent, or single-target vaccines, aimed at the original strain of the virus. They were followed by bivalent COVID vaccine booster shots that targeted both the original and the Omicron strains.
Persons: Emily Elconin, BioNTech, Caitlin Rivers, Mandy Cohen, Rivers, bivalent, Daniel Kuritzkes, Eris, Kuritzkes, Novavax, Bhanvi, Julie Steenhuysen, Will Dunham, Caroline Humer Organizations: REUTERS, U.S . Centers for Disease Control, Prevention, U.S . Food, Drug Administration, Pfizer, Moderna, FDA, Johns Hopkins Center for Health Security, CDC, Omicron, Brigham, Women's Hospital, Vaccine, EG, Thomson Locations: Waterford , Michigan, U.S, United States, Baltimore, Europe, Asia, Boston, Moderna, Bengaluru, Chicago
Nicknamed "Pirola" on social media, the BA.2.86 Omicron subvariant is being tracked by both the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC). As of Aug. 30, CDC said the BA.2.86 variant was detected in at least four U.S. states in people or wastewater. Delaware on Tuesday said it had detected a BA.2.86 infection at a hospital. Moderna on Wednesday said clinical data showed that its retooled COVID vaccine generated a nearly 9-fold increase in human antibodies that can neutralize BA.2.86. Pfizer said on Wednesday that its updated COVID shot showed neutralizing activity against BA.2.86 and EG.5 in studies conducted on mice.
Persons: Emily Elconin, David Dowdy, Dowdy, Dan Barouch, David Ho, Deena Beasley, Julie Steenhuysen, Bill Berkrot Organizations: REUTERS, Moderna, Pfizer, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, CDC, EG, Omicron, East, Johns Hopkins Bloomberg School of Public Health, Center, Virology, Vaccine, Beth Israel Deaconess Medical, Columbia University, U.S . Food, Drug Administration, Thomson Locations: Waterford , Michigan, U.S, Europe, Asia, Delaware, East Coast, Boston, Sweden, China
REUTERS/Shannon Stapleton/File Photo Acquire Licensing RightsLONDON/CHICAGO, Aug 24 (Reuters) - A highly mutated COVID variant called BA.2.86 has now been detected in Switzerland and South Africa in addition to Israel, Denmark, the U.S. and the U.K., according to a leading World Health Organization official. It has since been detected in other symptomatic patients, in routine airport screening, and in wastewater samples in a handful of countries. That the known cases are not linked suggests it is already circulating more widely, particularly given reduced surveillance worldwide, she said. There have been nine such cases detected as of Aug. 23 and the variant was also found in wastewater in Switzerland. Jha and others, including the European public health agency and COVAX, the global program for getting vaccines to the world's poorest, said COVID surveillance and defenses could be reactivated in the event of a major infection wave.
Persons: Shannon Stapleton, Maria Van Kerkhove, Kerkhove, , Marion Koopmans, Nirav Shah, Van Kerkhove, Tyra Grove Krause, Ashish Jha, Jha, Jennifer Rigby, Julie Steenhuysen, Pratik Jain, Caroline Humer, Bill Berkrot Organizations: REUTERS, Health Organization, Omicron, WHO, U.S . Centers for Disease Control, Pharmacy, Walgreens, Rite, Reuters, Statens Serum, White, Thomson Locations: Harlem, New York City, U.S, CHICAGO, Switzerland, South Africa, Israel, Denmark, COVID, Dutch, Danish, Bengaluru
CHICAGO, July 31 (Reuters) - Quest Diagnostics (DGX.N) on Monday launched the first direct-to-consumer blood test to detect abnormal levels of beta amyloid, a key Alzheimer's protein which can appear years before dementia symptoms arise. The $399 test, called AD-Detect, uses the same technology as a blood test the company launched for use by doctors in early 2022. Users must first pay for the test on Quest's website. Quest will then arrange for an appointment with a telemedicine doctor to order it on their behalf. Quest's lab-developed test, created and performed in a single laboratory, has not undergone any FDA review.
Persons: Michael Racke, Biogen, Eli Lilly, Racke, Julie Steenhuysen, Richard Chang Organizations: Quest Diagnostics, Monday, U.S . Food, Drug Administration, Thomson Locations: Eisai, Alzheimer's
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
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
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
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
The hope is for "a completely new treatment paradigm in cancer that will be better tolerated and unique to individual patients' tumors," said Dr. Jane Healy, an executive overseeing in early cancer treatment development at Merck. The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. Aiming at these unique proteins allows the immune system to kill cancer cells while leaving healthy tissue unscathed. With standard treatment, 90% of pancreatic cancer patients die within five years of diagnosis. The approach first primes the immune system with an older technology called a chimpanzee adenovirus vaccine that targets patients' tumors.
Persons: Andrew Kelly, Keytruda, Jane Healy, Germany's BioNTech, Vinod Balachandran, we've, we're, Andrew Allen, Healy, Julie Steenhuysen, Caroline Humer, Bill Berkrot Organizations: Merck & Co, REUTERS, CHICAGO, Moderna Inc, American Society of Clinical Oncology, Merck, Moderna, Memorial Sloan Kettering Cancer Center, Thomson Locations: Kenilworth , New Jersey, U.S, Chicago, New York, Nature
Leqembi received accelerated approval from the FDA in January, based on limited evidence suggesting it would slow cognitive decline in early Alzheimer's patients. A panel of FDA advisers will discuss whether Leqembi should receive traditional approval next week, and a decision could come by early July. Medicare, the government health plan for Americans 65 and over, currently pays for Leqembi only if patients are enrolled in a clinical trial. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices rather than drugs. To receive Medicare coverage, people will need to be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer's and have a qualified physician participating in a registry.
Persons: Biogen, Leqembi, Eisai, Eli Lilly, Co's, Eli Lilly's, Alzheimer's, Sue Peschin, Manas Mishra, Leroy D'souza, Bill Berkrot Organizations: U.S, Eisai Co, FDA, Medicare, Centers, Medicaid Services, CMS, Alzheimer’s Association, Alliance for Aging Research, Thomson Locations: Bengaluru
"The end of the COVID-19 public health emergency marks a tremendous transition for our country, for public health, and in my tenure as CDC Director," Walensky wrote to President Joe Biden in her resignation letter. "We have all benefited from her service and dedication to public health, and I wish her the best in her next chapter," Biden said in a statement. "For 75 years, CDC and public health have been preparing for COVID-19, and in our big moment, our performance did not reliably meet expectations," she told CDC staff last summer. Public health experts said Walensky wrestled with political and technical challenges during her tenure. "Dr. Walensky was put into place at the CDC at a time when the agency was basically captive to politicians which clearly hampered her ability to lead," he said.
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.
Three decades ago, scientists discovered that the gene also plays a role in Alzheimer's risk, though exactly how is still not clear. APOE3 is the most common, and does not raise Alzheimer's risk. APOE4 increases Alzheimer's risk and is linked with an earlier onset of the disease. Some 25% of people have one copy of APOE4 and 2-5% have two copies. Children of a parent with two copies of the APOE4 variant are presumed to have at least one copy, increasing their own risk.
Lilly has not previously discussed its Medicare coverage optimism publicly. The U.S. Centers for Medicare & Medicaid Services (CMS) did not immediately respond to a request for comment. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices. Amyvid, Lilly's Alzheimer's imaging agent that can detect amyloid plaques on PET scans, has been subject to CMS' evidence development program for a decade. "It shuts out many patients," said Dr. Maria Carrillo, chief science officer of the Alzheimer’s Association, "especially minorities and rural patients."
CHICAGO, April 21 (Reuters) - Wendy Nelson watched her mother slowly die of Alzheimer's disease, unable to move or swallow at the end. When her father's memory began to fail a year later, one of her two sisters doubted it could be Alzheimer's, Nelson said. THE TESTING REVOLUTIONUntil recently, most doctors tended not to order genetic tests to determine Alzheimer's risk, because there were no effective treatments to slow or prevent the disease. US regulators recommend genetic testing before starting treatment with Leqembi. Some members of families with increased genetic risk of Alzheimer's say it might be better not to know at all.
The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. BioNTech SE (22UAy.DE) and Gritstone Bio Inc (GRTS.O) are working on competing cancer vaccines based on mRNA technology. Barr said it took about eight weeks to design a personalized mRNA vaccine for each patient. In the past, similar experimental cancer vaccines were developed targeting a single tumor mutation, or neoantigen. With mRNA technology in combination with Keytruda, "we can create this shotgun approach ... that can create a more potent immune response," Barr said.
The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. BioNTech SE (22UAy.DE) and Gritstone Bio Inc (GRTS.O) are working on competing cancer vaccines based on mRNA technology. Barr said it took Moderna about eight weeks to design a personalized mRNA vaccine for each patient. In the past, similar experimental cancer vaccines were developed targeting a single tumor mutation, or neoantigen. With mRNA technology in combination with Keytruda, "we can create this shotgun approach ... that can create a more potent immune response," Barr said.
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.
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