Latest news with #Leqembi
Yahoo
26-06-2025
- Health
- Yahoo
Eli Lilly receives FDA approval for Amyvid label update
The US Food and Drug Administration (FDA) has granted approval for a label update to Eli Lilly and Company's Amyvid (florbetapir F 18 injection) for use intravenously. The update revises the application of Amyvid in estimating amyloid plaque density, which is crucial for patients being evaluated for Alzheimer's disease and other causes of cognitive decline. Amyvid is available in multidose vials with 500-1900MBq/ml strength. The new label changes include revised usage guidelines to estimate plaque density, providing a fresh indication for selecting patients eligible for amyloid-targeting therapies. The update also allows quantification of amyloid plaques alongside visual understanding. The clinical studies section on the label acknowledges that amyloid beta positron emission tomography (PET) scans have helped assess plaque reduction during trials of certain amyloid-targeting treatments. Lilly neuroscience research and development group vice-president Mark Mintun stated: 'Nearly 80% of Americans would prefer to know if they have an Alzheimer's diagnosis before their memory and thinking symptoms disrupt daily life, highlighting the importance of advanced diagnostic tools like amyloid PET and blood biomarker testing. 'The modernisation of Amyvid's label is a significant step in advancing Alzheimer's care, enabling physicians to help patients make informed decisions, being evaluated for or to aid in the selection of patients who are indicated for amyloid-targeting therapy.' Amyvid is a radioactive diagnostic drug used for PET to assess the density of amyloid beta neuritic plaques in adults experiencing cognitive impairment for evaluation of Alzheimer's. The National Institute for Health and Care Excellence (NICE) recently decided against recommending Eli Lilly's Kisunla (donanemab) and Eisai's Leqembi (lecanemab) Alzheimer's drugs for NHS use. "Eli Lilly receives FDA approval for Amyvid label update" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
25-06-2025
- Health
- Yahoo
GE HealthCare's PET imaging agent gains Alzheimer's label expansion
The US Food and Drug Administration (FDA) has expanded the indications of an imaging agent developed by GE HealthCare, which will likely put it at the forefront of the Alzheimer's diagnostics arena. The updated label for GE HealthCare's positron emission tomography (PET) imaging agent Vizamyl (flutemetamol F 18 injection) now includes quantification of amyloid in the brain, meaning patients taking an anti-amyloid therapy can be monitored for the drug's effectiveness. There are currently two anti-amyloid therapies approved in the US, namely Eisai/Biogen's Leqembi (lecanemab) and Eli Lilly's Kisunla (donanemab). Despite reimbursement challenges for the two drugs, revenue for them is expected to surge in the coming decade. However, patients seeking to take them must meet stringent criteria, and the therapy's ongoing use comes with caveats – all of which must be diagnostically monitored with PET imaging. City of Hope National Medical Center's radiology professor Phillip Kuo said: 'The use of quantification in amyloid PET imaging has steadily moved from research to clinical practice, where it can aid in more confident and accurate diagnosis. 'Now quantification can also play a critical role in initiating and monitoring amyloid-targeted therapy for Alzheimer's disease and determining when it can be discontinued.' Vizamyl was first approved in 2013 to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment. Now, visual estimation has turned into quantification, opening further diagnostic avenues for the imaging agent in Alzheimer's. In another boost for patients, the label update also adds an explicit indication for the selection of patients eligible for therapy. Effectively, the expansion now allows for the diagnosis of Alzheimer's. This has been based on revised criteria from the Alzheimer's Association, indicating that an abnormal amyloid PET scan is sufficient to establish a diagnosis. The updated label also removes a previous restriction on predicting cognitive decline or progression to dementia, reflecting new evidence that links amyloid-positive scans with a higher risk of advancing from early mild cognitive impairment to Alzheimer's dementia. Whilst there are other available amyloid diagnostics such as Lilly's Amyvid (florbetapir), these do not have the same current range of label indications as Vizamyl. GE HealthCare also has some of the most advanced PET devices on the market. According to analysis by GlobalData, the company has the largest global market share of nuclear imaging equipment, of which PET scanners are a segment. 'The inclusion of quantification and removal of the therapy monitoring limitation from the Vizamyl label is good news for healthcare providers and their patients, further enabling timely and appropriate care decisions,' said GE HealthCare's pharmaceutical diagnostics division's chief medical officer Jit Saini. Research into Alzheimer's diagnosis is gaining momentum amid the revenue ceiling for anti-amyloid therapies. Last month, the FDA approved the Lumipulse G test, the first blood test to help diagnose the disease. The agency said the new tool could help reduce the number of PET scans, which are expensive and radiation-exposing. Developed by Fujirebio Diagnostics, the test measures the ratio between tau and amyloid proteins in the blood and ties its findings to the likelihood of finding plaque buildups in the brain. "GE HealthCare's PET imaging agent gains Alzheimer's label expansion" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error 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
Yahoo
02-06-2025
- Business
- Yahoo
BioArctic's Capital Markets Day 2025 - entering a new era of growth
STOCKHOLM, June 2, 2025 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) today welcomes investors, analysts and financial media to the company's Capital Markets Day. The event, which starts at 10:30 CET, will be broadcast live online. Over the past 20 years, BioArctic has built a thriving company based on a foundation of solid science and innovation, strong finances and an organization with well-educated staff and a value-driven corporate culture. At the Capital Markets Day, management will outline BioArctic's ambitions for 2030 which focuses on building Sweden's next major pharmaceutical company. This will be achieved by: building a balanced and broad pipeline with projects in all stages of development, adding additional successful global partnerships, and establishing Leqembi® as a treatment for Alzheimer's disease in the Nordics ensuring finances that allow for both investing in growth while giving recurring dividends to shareholders. To achieve this, the company will accelerate innovation into a broader area of severe brain diseases, proactively work with business development to maximize the value of each project, and work to ensure a successful launch of Leqembi in the Nordic region. The presentation for the Capital Markets Day can be found on A recording of the Capital Markets Day will be available later today on BioArctic's website. AGENDA 10:30 BioArctic today and tomorrow Precision neurology and severe brain disease experiencing unprecedented opportunities for innovation. Chief Executive Officer Gunilla Osswald will discuss how BioArctic is positioning itself to capture these global possibilities and outline the company's ambitions toward 2030. 11:00 FinancialsFollowing the recent license agreement with Bristol Myers Squibb and with continuous royalties from Leqembi sales, BioArctic expects to achieve profitability from this year onwards. Anders Martin-Löf, Chief Financial Officer, will outline what this strengthened financial position means for shareholders and BioArctic's future opportunities. 11:20 R&D StrategyBased on the same principle as Leqembi, BioArctic has built a project portfolio with selective antibodies targeting aggregated forms of misfolded proteins in the brain. Chief R&D Officer Johanna Fälting will outline the overarching research strategy and explain how BioArctic's integrated antibody and BrainTransporter™ platforms create opportunities across several disease areas. 11:50 Q&A 12:10 Lunch 13:00 LeqembiLeqembi is the first fully approved disease-modifying treatment for early Alzheimer's disease, marking a transformational shift in the treatment landscape. Anna-Kaija Grönblad, Chief Commercial Officer, will discuss this evolving paradigm, provide insights into global and European market developments, and outline BioArctic's preparations for the Nordic launch. 13:20 Key opinion leader: Disease modifying treatment for Alzheimer's disease in clinical useSince the initial approval of Leqembi in the United States in January 2023, clinicians have gained important real-world experience with this groundbreaking therapy for early Alzheimer's disease. Professor Lawrence S. Honig from Columbia University's Department of Neurology will present clinical insights from US practice and discuss the practical challenges and opportunities of implementing this new treatment paradigm. 14:00 Q&A 14:15 BrainTransporter-technologyBiological drugs hold enormous potential for treating brain diseases, but the blood-brain barrier has historically prevented their effective delivery. Chief Scientific Officer Per-Ola Freskgård will present how BioArctic's breakthrough BrainTransporter technology can deliver antibodies with up to 70 times greater brain exposure and superior distribution and discuss the commercial opportunities this proprietary platform creates. 14:55 ExidavnemabBioArctic's antibody exidavnemab targets alpha-synuclein, a key protein involved in multiple neurodegenerative conditions. Gabrielle Åhlberg Hillert, Chief Medical Officer, will provide an update on the Phase 2 program, explain how exidavnemab differentiates from other late-stage antibodies, and discuss how it could address significant unmet medical needs in alpha-synuclein diseases such as Parkinson's disease, Multiple System Atrophy, and Lewy body dementia. 15.15 Q&A 15.30 Concluding remarks Short summary by Gunilla Osswald, Chief Executive Officer The information was released for public disclosure, through the agency of the contact persons below, on June 2, 2025, at 10:30 CET. For further information, please contact: Oskar Bosson, VP Communications and Investor RelationsE-mail: +46 70 410 71 80 Charlotte af Klercker, Senior Director Sustainability and CommunicationsE-mail: Telephone: +46 73 515 09 70 About BioArctic ABBioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company is the originator of Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with Eisai. BioArctic has a broad research portfolio within Alzheimer's disease, Parkinson's disease, ALS and enzyme deficiency diseases. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which improves the transport of drugs into the brain. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For more information, please visit This information was brought to you by Cision The following files are available for download: BioArctic’s Capital Markets Day 2025 â€" entering a new era of growth View original content: SOURCE BioArctic
Yahoo
02-06-2025
- Business
- Yahoo
BioArctic's Capital Markets Day 2025 - entering a new era of growth
STOCKHOLM, June 2, 2025 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) today welcomes investors, analysts and financial media to the company's Capital Markets Day. The event, which starts at 10:30 CET, will be broadcast live online. Over the past 20 years, BioArctic has built a thriving company based on a foundation of solid science and innovation, strong finances and an organization with well-educated staff and a value-driven corporate culture. At the Capital Markets Day, management will outline BioArctic's ambitions for 2030 which focuses on building Sweden's next major pharmaceutical company. This will be achieved by: building a balanced and broad pipeline with projects in all stages of development, adding additional successful global partnerships, and establishing Leqembi® as a treatment for Alzheimer's disease in the Nordics ensuring finances that allow for both investing in growth while giving recurring dividends to shareholders. To achieve this, the company will accelerate innovation into a broader area of severe brain diseases, proactively work with business development to maximize the value of each project, and work to ensure a successful launch of Leqembi in the Nordic region. The presentation for the Capital Markets Day can be found on A recording of the Capital Markets Day will be available later today on BioArctic's website. AGENDA 10:30 BioArctic today and tomorrow Precision neurology and severe brain disease experiencing unprecedented opportunities for innovation. Chief Executive Officer Gunilla Osswald will discuss how BioArctic is positioning itself to capture these global possibilities and outline the company's ambitions toward 2030. 11:00 FinancialsFollowing the recent license agreement with Bristol Myers Squibb and with continuous royalties from Leqembi sales, BioArctic expects to achieve profitability from this year onwards. Anders Martin-Löf, Chief Financial Officer, will outline what this strengthened financial position means for shareholders and BioArctic's future opportunities. 11:20 R&D StrategyBased on the same principle as Leqembi, BioArctic has built a project portfolio with selective antibodies targeting aggregated forms of misfolded proteins in the brain. Chief R&D Officer Johanna Fälting will outline the overarching research strategy and explain how BioArctic's integrated antibody and BrainTransporter™ platforms create opportunities across several disease areas. 11:50 Q&A 12:10 Lunch 13:00 LeqembiLeqembi is the first fully approved disease-modifying treatment for early Alzheimer's disease, marking a transformational shift in the treatment landscape. Anna-Kaija Grönblad, Chief Commercial Officer, will discuss this evolving paradigm, provide insights into global and European market developments, and outline BioArctic's preparations for the Nordic launch. 13:20 Key opinion leader: Disease modifying treatment for Alzheimer's disease in clinical useSince the initial approval of Leqembi in the United States in January 2023, clinicians have gained important real-world experience with this groundbreaking therapy for early Alzheimer's disease. Professor Lawrence S. Honig from Columbia University's Department of Neurology will present clinical insights from US practice and discuss the practical challenges and opportunities of implementing this new treatment paradigm. 14:00 Q&A 14:15 BrainTransporter-technologyBiological drugs hold enormous potential for treating brain diseases, but the blood-brain barrier has historically prevented their effective delivery. Chief Scientific Officer Per-Ola Freskgård will present how BioArctic's breakthrough BrainTransporter technology can deliver antibodies with up to 70 times greater brain exposure and superior distribution and discuss the commercial opportunities this proprietary platform creates. 14:55 ExidavnemabBioArctic's antibody exidavnemab targets alpha-synuclein, a key protein involved in multiple neurodegenerative conditions. Gabrielle Åhlberg Hillert, Chief Medical Officer, will provide an update on the Phase 2 program, explain how exidavnemab differentiates from other late-stage antibodies, and discuss how it could address significant unmet medical needs in alpha-synuclein diseases such as Parkinson's disease, Multiple System Atrophy, and Lewy body dementia. 15.15 Q&A 15.30 Concluding remarks Short summary by Gunilla Osswald, Chief Executive Officer The information was released for public disclosure, through the agency of the contact persons below, on June 2, 2025, at 10:30 CET. For further information, please contact: Oskar Bosson, VP Communications and Investor RelationsE-mail: +46 70 410 71 80 Charlotte af Klercker, Senior Director Sustainability and CommunicationsE-mail: Telephone: +46 73 515 09 70 About BioArctic ABBioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company is the originator of Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with Eisai. BioArctic has a broad research portfolio within Alzheimer's disease, Parkinson's disease, ALS and enzyme deficiency diseases. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which improves the transport of drugs into the brain. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For more information, please visit This information was brought to you by Cision The following files are available for download: BioArctic’s Capital Markets Day 2025 â€" entering a new era of growth View original content: SOURCE BioArctic Sign in to access your portfolio
Yahoo
29-05-2025
- Business
- Yahoo
Helix releases pharmacogenomics tests for use in neurology and oncology
US-based genomics company Helix has released a new suite of pharmacogenomics (PGx) tests, widening its portfolio to offer personalised patient care in neurology and oncology. The suite includes a PGx Fluoropyrimidines DPYD test to detect individuals with dihydropyrimidine dehydrogenase (DPYD) gene variants at risk for side effects from certain chemotherapies, aligning with the recent guidelines from the National Comprehensive Cancer Network. The DPYD test provides insights into a patient's metabolism of cancer treatments. It targets therapies used in treating breast, pancreatic, head and neck, colorectal, and oesophageal cancers. Additionally, the suite includes the PGx APOE test to evaluate the status of apolipoprotein E (APOE) relevant to Alzheimer's drugs. It assesses the risk of serious adverse effects such as amyloid-related imaging abnormalities (ARIA) for individuals treated with Leqembi or Kisunla. These drugs have US Food and Drug Administration (FDA) boxed warnings for individuals with two copies of the APOE ε4 allele. With these tests, Helix now covers all neurology and oncology-associated PGx haplotypes cited in the agency's warnings. The company noted that its PGx tests offer accuracy across varied populations, utilising its Exome+ assay and comprehensive star allele caller. Its Sequence Once, Query Often model allows for exomes to be sequenced just once, with subsequent genetic tests not requiring additional samples. This facilitates rapid results, enabling genetic insights at the point of care. Helix's latest PGx tests encompass medications for cancer, cardiovascular diseases, pain management, gastrointestinal conditions, and anaesthesia guidance. These tests add to the company's existing PGx offerings for blood clotting, mental health, and immune suppression treatments. In addition, Helix has also developed the Helix Research Network in collaboration with its partners. This precision clinical research network comprises health systems focused on integrating genomics into routine care and advancing human health through genomics research. It also creates real-world evidence to support a wide range of initiatives, including studies showing the genomics' clinical use. Helix chief science officer Will Lee said: 'By focusing on patients with neurodegenerative conditions and cancer, and actively identifying those at higher risk for adverse outcomes, we can help providers treat vulnerable patients more precisely and effectively.' "Helix releases pharmacogenomics tests for use in neurology and oncology" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error 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
