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Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer's disease
Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer's disease

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Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer's disease

Elecsys pTau181 is the first In Vitro Diagnostic Regulation (IVDR) certified test to rule out Alzheimer's associated amyloid pathology. The minimally invasive, blood-based test can serve as a rule out for Alzheimer's pathology, reducing the need for confirmatory testing with a negative result. Data from clinical study supports use in primary care for people with varying signs of cognitive decline. Basel, 23 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received CE Mark for its Elecsys® pTau181 test to measure phosphorylated Tau (pTau) 181 protein which is an indicator of amyloid pathology, a hallmark of Alzheimer's disease. The test, which has been developed in collaboration with Eli Lilly and Company, can be used by clinicians in conjunction with other clinical information to rule out Alzheimer's disease as the cause of cognitive decline. This could avoid the need for further confirmatory investigation for patients testing negative. 'The burden of Alzheimer's disease on society and healthcare systems is increasing as the world's population ages,' said Matt Sause, CEO of Roche Diagnostics. 'With Elecsys pTau181, doctors can give patients and their caregivers the clarity they need when establishing the cause of cognitive decline. By enabling an earlier and less invasive diagnosis, this test has the potential to improve patient outcomes and decrease costs for healthcare systems worldwide.' Barriers to early and accurate diagnosis of Alzheimer's disease exist across the world. Up to 75% of people living with symptoms are not diagnosed, and those who have received a diagnosis waited nearly three years on average after symptom onset.1 The identification of amyloid pathology is critical for Alzheimer's diagnosis and treatment. Current methods to confirm amyloid pathology - including positron emission tomography (PET) and cerebrospinal fluid (CSF) assessment - can be expensive, difficult to access and invasive. With a negative Elecsys pTau181 blood test, people can avoid further unnecessary investigations for Alzheimer's using CSF or PET and can identify the care pathway that is right for them. Clinical study results support that the test can be implemented effectively across care settings, including primary care, where most patients first seek help for cognitive concerns. Those with positive results are then able to undergo further testing, supporting earlier identification of Alzheimer's pathology. This is key to accessing new treatments that are most effective when used early in the disease progression, enabling patients to make informed decisions about their future care. Clinical data support the Elecsys pTau181 test for varying signs of cognitive declineThe CE Mark for the Elecsys pTau181 blood test was based on data from a prospective, multicentre study, which included 787 patients across the US, Europe and Australia. The study showed the test was able to rule out Alzheimer's disease with a high negative predictive value (NPV) of 93.8% based on a 22.5% prevalence of amyloid positivity according to positron emission tomography (PET) scans, with 83.6% sensitivity. The rule out performance of the test was only minimally impacted by the patients' age, gender, body mass index or impaired kidney function. This global, prospectively-collected, diagnostic registrational clinical study was the first of its kind in the industry to investigate the test's clinical performance in a diverse patient population, aged 55-80 years old that reflects as closely as possible the patients who could benefit from the test. It involved a subset of patients from a wider study looking at a highly diverse set of patients with broad inclusion criteria, to ensure the test could be used effectively across different geographies and ethnicities. Elecsys pTau217 blood testRoche is also developing the Elecsys pTau217 blood test, an in-vitro diagnostic immunoassay for the quantitative determination of the protein Phospho-Tau (217P) in human plasma for use as an aid in identifying amyloid pathology. Recent data presented on Elecsys pTau217 showed that it was able to accurately detect amyloid pathology and was more stable than a pTau217/Aβ42 ratio in blood and plasma samples at room and refrigerator temperatures. Together with the high throughput and full automation of the assay, these data support the potential of Elecsys pTau217 as an accurate standalone test that could be scaled up for broad implementation in routine clinical practice worldwide across Roche's unmatched installed base. About Roche in Alzheimer'sWith more than two decades of scientific research in Alzheimer's disease, Roche is working towards a day when we can detect and treat the disease early, in order to stop or even prevent its progression to preserve what makes people who they are. Today, the company's Alzheimer's disease portfolio spans investigational medicines for different targets, types and stages of the disease, including trontinemab. On the diagnostics side, it also includes approved and investigational tools, including digital, blood-based tests and CSF assays, aiming to more effectively detect, diagnose and monitor the disease. Yet the global challenges of Alzheimer's disease go well beyond the capabilities of science, and making a meaningful impact requires collaboration both within the Alzheimer's community and outside of healthcare. Roche will continue to work together with numerous partners with the hope to transform millions of lives. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by Alzheimer's Disease International. World Alzheimer Report 2022 [Internet; cited April 2025]. Available from: Last accessed: April 2025 Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: Dr Sabine BorngräberPhone: +41 61 68-88027e-mail: Dr Birgit MasjostPhone: +41 61 68-84814e-mail: Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: Attachment Media Investor Release Elecsys pTau181 CE Mark English

NewAmsterdam Pharma to Present Alzheimer's Biomarker Data from BROADWAY Trial at AAIC 2025
NewAmsterdam Pharma to Present Alzheimer's Biomarker Data from BROADWAY Trial at AAIC 2025

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NewAmsterdam Pharma to Present Alzheimer's Biomarker Data from BROADWAY Trial at AAIC 2025

– NewAmsterdam to host conference call at 10:00 a.m. ET on Wednesday, July 30th – NAARDEN, the Netherlands and MIAMI, July 22, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or 'NewAmsterdam' or the 'Company'), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that it will present full data from the prespecified Alzheimer's Disease (AD) biomarker analyses in the BROADWAY clinical trial (NCT05142722) in a late-breaking oral presentation at the Alzheimer's Association International Conference (AAIC), being held July 30, 2025 in Toronto, Canada. Details of the presentation are as follows: Presentation Title: Effects of Obicetrapib, a Potent Oral CETP Inhibitor, on Alzheimer's Disease Biomarkers in 1727 Patients with Cardiovascular DiseaseSession Title: Developing Topics on Innovative Therapeutic ApproachesPresentation Date and Time: Wednesday, July 30, 2025, 8:21-8:28 AM ETPresenter: Philip Scheltens M.D., Room 718 Conference Call and Webcast Information NewAmsterdam will host a live webcast and conference call at 10:00 a.m. ET on July 30, 2025 to review the full AD biomarker data presented at AAIC. The call will include remarks from featured speakers including: Philip Scheltens, M.D., Ph.D., professor of Neurology at the Vrije Universiteit Amsterdam and partner and head of EQT Life Sciences Dementia Fund; Kellyann Niotis, M.D., director of Parkinson's and Lewy Body Dementia Research at The Institute for Neurogenerative Diseases - Parkinson's and Alzheimer's Research Education Foundation; and Nathaniel Chin, M.D., medical director and Clinical Core Co-Leader for the Wisconsin Alzheimer's Disease Research Center (ADRC) and medical director for the Wisconsin Registry for Alzheimer's Prevention (WRAP). To access the live webcast, participants may register here. The live webcast will be available under the 'Events & Presentations' section of the Investor Relations page of the Company's website at To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. An archived replay of the webcast will be available on NewAmsterdam's website following the live event. About ObicetrapibObicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company's Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company's Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company. About NewAmsterdamNewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage, clinical biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple Phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. Company ContactMatthew PhilippeP: Media ContactReal Chemistry on behalf of NewAmsterdamChristian EdgingtonP: 1-513-310-6410cedgington@ Investor ContactPrecision AQ on behalf of NewAmsterdamAustin MurtaghP: in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Biogen to Highlight Scientific Progress Across Alzheimer's Disease at the Alzheimer's Association International Conference 2025
Biogen to Highlight Scientific Progress Across Alzheimer's Disease at the Alzheimer's Association International Conference 2025

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Biogen to Highlight Scientific Progress Across Alzheimer's Disease at the Alzheimer's Association International Conference 2025

Lecanemab presentations to include long-term Clarity AD data, real-world treatment insights, and a subcutaneous formulation for continued care Presentations on tau to explore its biological role, the development of targeted therapies and biomarkers, and the future integration of these innovations into clinical practice CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced upcoming scientific presentations at the 2025 Alzheimer's Association International Conference (AAIC), taking place July 27-31 in Toronto, Canada. Data on LEQEMBI® (lecanemab) will include 48-month results from the Clarity AD open-label extension, real-world evidence, and new insights into a subcutaneous formulation for maintenance dosing. Presentations on tau will explore tau-targeted therapies and biomarkers, including baseline characteristics of participants from CELIA, a Phase 2 trial evaluating the efficacy, safety, and tolerability of BIIB080, an investigational antisense oligonucleotide (ASO) therapy that targets tau. 'At AAIC, we are sharing data that underscore our ongoing efforts to advance both how Alzheimer's is treated and how care is delivered, including 48-month findings from the LEQEMBI Clarity AD open-label extension and new insights into the potential of subcutaneous maintenance dosing for LEQEMBI. We are also excited to share baseline characteristics from CELIA, our Phase 2 study of BIIB080, an investigational ASO therapy targeting tau,' said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. 'As we deepen our understanding of this complex disease, we remain committed to pushing the science forward and evolving care to better meet the needs of patients and families.' Key Scientific Sessions and Presentations: Lecanemab Clarity AD OLE in Early AD: Initial Findings from 48-Month AnalysisWednesday, July 30, 8:00–8:45 AM ET Lecanemab Subcutaneous Formulation for Maintenance Dosing: The Potential of a New and Convenient Option for Ongoing Treatment in Early Alzheimer's DiseaseWednesday, July 30, 9:00–10:30 AM ET Patient, Care Partner, and Health Care Professional Opinion of the Lecanemab Autoinjector for Subcutaneous DeliverySunday, July 27, 8:00–8:45 AM ET Lecanemab Two Years Post-Approval: Real-World Case Series and Patient Pathway LearningsSunday, July 27, 9:00–10:30 AM ET Indirect Treatment Comparison of ARIA Outcomes for Lecanemab Compared to Donanemab Based on Reported ResultsSunday, July 27, 4:14–5:45 PM ET Innovations in Tau Therapies and Biomarkers for Alzheimer's Disease: Bridging Research and Clinical PracticeWednesday, July 30, 2:00–3:30 PM ET Baseline Characteristics from CELIA: A Phase 2 Study to Evaluate BIIB080 in Participants with Early Alzheimer's DiseaseMonday, July 28, 7:30 AM–4:15 PM ET Educational Program on Tau in Alzheimer's Disease At AAIC, Biogen will host an interactive booth offering an immersive journey into the role of tau in Alzheimer's disease, from pathology to clinical presentation. Biogen is also expanding its educational efforts with a new e-learning module on building on the resources already available. For more information, please see the AAIC 2025 program and visit the Biogen AAIC booth. About BIIB080BIIB080 is an investigational antisense oligonucleotide (ASO) therapy designed to target microtubule-associated protein tau (MAPT) mRNA to reduce the production of tau protein. Abnormal accumulation of tau in the brain is a hallmark of Alzheimer's disease and is associated with neurodegeneration and cognitive decline. BIIB080 is currently being evaluated in a Phase 2 clinical study (NCT05399888) in individuals with early Alzheimer's disease. In December 2019, Biogen exercised a license option with Ionis Pharmaceuticals and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB080 (tau ASO). BIIB080 was discovered by Ionis. About LEQEMBI ® (lecanemab)LEQEMBI (lecanemab) is the result of a strategic research alliance between Eisai and BioArctic. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). LEQEMBI is an amyloid beta-directed antibody for the treatment for Alzheimer's disease (AD) in the U.S. The U.S. Food and Drug Administration (FDA) granted LEQEMBI traditional approval on July 6, 2023. LEQEMBI is indicated for the treatment of Alzheimer's disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. Please see full U.S. Prescribing Information for LEQEMBI, including Boxed WARNING and Medication Guide. About BiogenFounded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term routinely post information that may be important to investors on our website at Follow us on social media - Facebook, LinkedIn, X, YouTube. Biogen Safe Harbor This news release contains forward-looking statements, including about the potential clinical effects of lecanemab and BIIB080; the potential benefits, safety and efficacy of lecanemab and BIIB080; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated risks, benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab and BIIB080; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as 'aim,' 'anticipate,' 'assume,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'guidance,' 'hope,' 'intend,' 'may,' 'objective,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'prospect,' 'should,' 'target,' 'will,' 'would,' and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; risks associated with third party collaborations; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; risks of unexpected costs or delays or other unforeseen hurdles; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned 'Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. MEDIA CONTACT:BiogenMadeleine Shin+ 1 781 464 INVESTOR CONTACT:BiogenTim Power+1 781 464 2442IR@ Error al recuperar los datos Inicia sesión para acceder a tu cartera de valores Error al recuperar los datos Error al recuperar los datos Error al recuperar los datos Error al recuperar los datos

The cancer drugs that could lower the risk of Alzheimer's disease
The cancer drugs that could lower the risk of Alzheimer's disease

The Independent

timea day ago

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The cancer drugs that could lower the risk of Alzheimer's disease

Scientists at the University of California, San Francisco, have identified two existing cancer drugs that may help lower the risk of Alzheimer's disease. Researchers screened over 1,300 candidate drugs, narrowing them down to five that showed potential for reducing Alzheimer's risk in human patients, including two cancer drugs. The selected drugs, letrozole (for breast cancer) and irinotecan (for colon and lung cancer), were tested on mice and appeared to improve memory and brain function. This finding is significant because developing new drugs for Alzheimer's is extremely costly and time-consuming, whereas repurposing existing ones could accelerate clinical trials. The study, published in the medical journal Cell, offers a promising new direction for treatment given that Alzheimer's affects millions and care costs are projected to rise substantially.

These two cancer drugs may help lower your risk of Alzheimer's disease, study shows
These two cancer drugs may help lower your risk of Alzheimer's disease, study shows

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These two cancer drugs may help lower your risk of Alzheimer's disease, study shows

Scientists have identified two cancer drugs that may also lower the risk of Alzheimer's disease as they search for some way to lower its impact on an aging population. In a study published on Monday in the medical journal Cell, researchers from the University of California, San Francisco, combed through more than 1,300 candidate drugs — from antipsychotics to antibiotics — for anything that could help alleviate the incurable condition. Only 90 of those drugs targeted the brain cell genes thought to influence Alzheimer's, and of those only five showed evidence of actually reducing the risk of Alzheimer's in human patients. The scientists then chose letrozole, designed to fight breast cancer, and irinotecan, intended for treating colon and lung cancer, to test on mice. 'We didn't expect cancer drugs to come up," study co-author Marina Sirota told NBC News. In fact, the two drugs used in combination did appear to improve memory and brain function in aging mice who had begun to show signs of dementia. The effects still need to be proven in human studies (PA Wire) That result still needs to be tested in humans, and the drugs may prove less effective in humans. Still, the finding is significant because pharmaceutical companies have so far struggled to develop purpose-built drugs for the disease. "Developing a new drug can take hundreds of millions, or even billions, of dollars, on average take more than ten years," said study co-author Dr. Yadong Huang. "For this repurposed drug, usually it just takes two or three years, and then you can go to the clinical trial and the cost is much, much lower. "We still haven't generated or produced any very effective drugs that can really slow dramatically the cognitive decline," he added. Over seven million Americans live with Alzheimer's disease, according to the Alzheimer's Association, including 1 in 9 people aged over 65. The number is only likely to grow as the average age of the U.S. population continues to climb, with care costs for people with dementia projected to grow from $384 billion in 2025 to nearly $1 trillion by 2050.

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