Latest news with #AmyotrophicLateralSclerosis


Business Standard
3 days ago
- Health
- Business Standard
Zydus Lifesciences' Usnoflast receives USFDA fast track designation for ALS Treatment
Zydus Lifesciences announced that the U.S. Food and Drug Administration (USFDA) has granted Fast Track Designation to Usnoflast (ZYIL1), a novel oral NLRP3 inhibitor, for the treatment of Amyotrophic Lateral Sclerosis (ALS). The fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs. Drugs granted this designation are eligible for benefits such as accelerated approval, priority review, and more frequent interactions with the USFDA during the drug development process. The company stated that people living with ALS have an average survival of approximately two to five years from diagnosis, with most ALS patients dying from respiratory failure. ALS patients experience neuroinflammation and rapid neurodegeneration. Axonal neurodegeneration leads to the formation of neurofilaments, which first accumulate in the cerebrospinal fluid (CSF) of ALS patients and then slowly enter the bloodstream. Due to rapid neurodegeneration, steady loss of the ability to move, speak, eat, and eventually breathe, paralysis and death are common outcomes in ALS patients. ALS affects approximately 32,000 people in the U.S., with an average of 5,000 new patients diagnosed every year, according to statistics from the Centers for Disease Control and Prevention (CDC). More than 30,000 people are estimated to be living with ALS in Europe (European Union and United Kingdom), while India has an estimated 75,000 people living with ALS. Usnoflast, a novel chemical entity (NCE), had earlier received Orphan Drug Designation (ODD) from the USFDA, which offers development incentives including tax credits for clinical testing, waiver of certain FDA fees, and a potential seven-year marketing exclusivity upon USFDA approval. Usnoflast (ZYIL1) is a novel oral small molecule NLRP3 inhibitor studied in preclinical models of neuroinflammation, Parkinsons disease, inflammatory bowel disease (IBD), and multiple sclerosis (MS). Zydus has completed a Phase 2(a) randomized, double-blind, placebo-controlled trial in 24 ALS patients across seven sites in India and recently received USFDA approval to initiate a Phase 2(b) randomized, double-blind, placebo-controlled trial in ALS patients. Chairman of Zydus Lifesciences Limited, Pankaj Patel, said, This Fast Track Designation in addition to the previous Orphan Drug Designation granted by the USFDA, underlines the urgent need to develop treatments to address Amyotrophic Lateral Sclerosis (ALS), which is a fatal neurodegenerative disease. Zydus is committed to unlocking new frontiers in neuroscience and develop Usnoflast for patients with ALS. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 16.96% YoY to Rs 5,269.1 crore during the quarter. The counter shed 0.30% to Rs 915.22 on the BSE.


Hans India
23-05-2025
- Health
- Hans India
Experimental drug shows promise of treatment for young patients with rare form of ALS
Treatment with an experimental drug has shown significant improvements in young patients with a rare form of Amyotrophic Lateral Sclerosis (ALS) -- a progressive neurodegenerative disorder, said a team of US researchers on Friday. ALS, also known as Lou Gehrig's disease, is a rare disorder that affects nerve cells in the brain and spinal cord, leading to the loss of motor neurons causing difficulty with movement, balance, coordination, and potentially even breathing. While experimental therapies have so far slowed down the disease or halted its progression, the new treatment using ulefnersen (previously known as jacifusen) -- showed that functional losses in young patients can be reversed. "When testing new drugs for ALS, we do not expect to see clinical improvement," said neurologist and scientist Neil Shneider at Columbia University. But, "what we've seen in one patient is really unprecedented functional recovery. It's surprising and deeply motivating for us, the ALS research community, but also the community of ALS patients," he added. Data from 12 patients -- all treated with the novel therapy for a rare form of ALS caused by a genetic mutation in a gene called FUS -- were presented in a case series published by Shneider online in The Lancet. Though these gene mutations are responsible for only 1-2 per cent of ALS cases, they cause some of the most aggressive forms of ALS that begin in adolescents and young adults. In patients with these mutations, toxic FUS proteins accumulate in the motor neurons that control the patient's muscles, eventually killing the neurons. Two of the patients in the published case series showed a remarkable response to the experimental therapy, ulefnersen developed by Shneider in collaboration with California-based Ionis Pharmaceuticals. One young woman, who has received injections of the therapy since late 2020, recovered the ability to walk unaided and to breathe without the use of a ventilator, both previously lost to ALS. She has lived longer with this disease than any other known patient with this juvenile-onset form of FUS ALS. The second patient, a man in his mid-30s, was asymptomatic when he began treatment, but tests of electrical activity in his muscles indicated that symptoms would likely emerge soon. In three years of continuous treatment with the experimental drug, the man has yet to develop any symptoms of FUS-ALS and the abnormal electrical activity in his muscles has improved. Overall, after six months of treatment, patients in the series experienced up to an 83 per cent decrease in a protein called neurofilament light, a biomarker of nerve damage. "These responses show that if we intervene early enough and go after the right target at the right time in the course of the disease, it's possible to not only slow disease progression but actually reverse some of the functional losses," Shneider said. Though most of the other symptomatic patients in the series did not survive their aggressive disease, Shneider said "Several apparently benefited from the treatment. The progression of their disease slowed, and they lived a longer life as a consequence." The case series also showed that the drug is safe and well tolerated, with no serious adverse events related to the drug. Following the results from the first of these patients, a global clinical trial of the drug is now in progress. "Now we are eagerly awaiting those results, which we hope will lead to the approval of ulefnersen," Shneider said.


Al Etihad
22-05-2025
- Health
- Al Etihad
NYUAD showcases cutting-edge innovations - all made in the Emirates
23 May 2025 00:45 MAYS IBRAHIM (ABU DHABI)New York University Abu Dhabi (NYUAD) showcased a suite of homegrown innovations at Make it in the Emirates in Abu Dhabi, including brain-controlled prosthetics, one-of-a-kind UAVs (unmanned aerial vehicles), and sustainable building materials. Mind-Controlled Prosthetics for Neurodegenerative ConditionsSpeaking with Aletihad, Abdul Basit, a research engineer at NYUAD, explained how a brain-controlled prosthetic arm developed at the university's eBRAIN Lab works. Using EEG (electroencephalogram) signals collected through electrodes placed on the scalp, the team is developing AI-driven systems that interpret brain activity and translate it into precise movements in a robotic arm. "This technology is primarily aimed at patients suffering from ALS (Amyotrophic Lateral Sclerosis) and MS (Multiple Sclerosis), paralysis or other neurodegenerative conditions for whom traditional EMG-based systems are not viable," Basit said. "We're also integrating gaze-tracking to make the interface more intuitive – allowing users to simply look at an object and think about an action to initiate it."The project is currently in the research and development phase. Basit noted that the team is currently working on optimising signal interpretation, reducing hardware complexity, and enabling real-time performance on edge added that the eBRAIN Lab is also developing AI-based MRI analysis for detecting MS lesions and brain tumours, which leverages multi-modal large language models to assist radiologists with diagnostic recommendations. Omni-Directional Drones and Humanoid Telepresence Robots At the Centre for Artificial Intelligence and Robotics (CAIR), Postdoctoral Associate Mahmoud Hamandi and his team developed the OmniOcta UAV – the world's first fully functional battery-powered omnidirectional drone using only fixed, unidirectional thrusters. Unlike traditional drones that tilt to manoeuvre, the OmniOcta can hover, rotate and fly at extreme angles, such as a 90° roll, thanks to its eight precisely angled thrusters calculated via a custom optimisation algorithm."This makes it ideal for inspection in confined spaces, as well as for physical interaction tasks like pushing objects or even unscrewing a lightbulb," Hamandi explained. "It's also entirely self-contained and robust, requiring no external power or mechanical tilting." Sustainable Construction Material From NYUAD's Advanced Materials and Building Efficiency Research Laboratory (AMBER Lab), research scientist Inderjeet Singh presented two game-changing sustainable construction materials. This includes SaltCrete, a magnesium-based cement developed at the AMBER Lab using reject brine from desalination and calcium carbide slag. This process not only reuses industrial waste but also captures carbon dioxide during curing, making it a potential carbon sink, according to other material is Limestone Calcined Clay Cement (LC3), which combines calcined clay and limestone to reduce emissions by 40% compared to traditional cement. "SaltCrete reduces emissions by around 50% and supports waste valorisation, while LC3 is currently being tested in marine environments to build eco-friendly sea walls that preserve biodiversity," Singh said.


Cision Canada
22-05-2025
- Business
- Cision Canada
AbbVie and U of T Mississauga's SpinUp Announce Neuropeutics Inc as First AbbVie Biotech Innovators Award Recipient Français
Following a national competition, AbbVie and SpinUp – the University of Toronto's lab-based, life sciences accelerator – announce Neuropeutics Inc as recipient of first AbbVie Biotech Innovators Award Neuropeutics Inc receives a year of laboratory space and equipment at no cost, as well as access to support and mentorship TORONTO, May 22, 2025 /CNW/ - AbbVie (NYSE: ABBV) in partnership with the University of Toronto's SpinUp, are pleased to announce Neuropeutics Inc as the recipient of the AbbVie Biotech Innovators Award, a national prize to help foster innovation and support growth in Canada's life sciences sector. Following a competitive selection process, the award, funded by AbbVie, has been granted to Neuropeutics Inc for developing small molecules preventing and reversing protein aggregation as therapeutics for neurodegenerative diseases. "We are delighted to have this opportunity to collaborate with a global biopharmaceutical company such as AbbVie, and the University of Toronto's SpinUp, to advance Neuropeutics' therapeutic research and development across multiple neurodegenerative diseases. At Neuropeutics, we are committed to developing targeted therapies to extend neurodegenerative disease patients' survival and improve their quality of life. This award allows us to pursue that mission with greater momentum," said Dr. Marc Shenouda, CEO & Co-Founder of Neuropeutics Inc. Neuropeutics Inc's scientific entrepreneurial spirit directly aligns with the mandate of the AbbVie Biotech Innovators Award to foster research, innovation and growth within Canada's life sciences sector. A hallmark of neurodegenerative diseases is protein aggregation. One such protein is TDP-43, a normally nuclear DNA/RNA binding protein, which in disease conditions becomes mislocalized and forms cytoplasmic aggregates causing neuronal toxicity. Neuropeutics Inc has developed a novel strategy to address diseases such as: Amyotrophic Lateral Sclerosis (ALS), Frontotemporal dementia, Alzheimer's disease, Huntington's disease and Parkinson's disease. "It was impressive and motivating to see the variety of entries and the calibre of early-stage biotech companies who applied for the Award. We thank all who participated in this life science competition," said Rami Fayed, Vice President and General Manager of AbbVie Canada. "After a rigorous evaluation process, it is with great pleasure that we are announcing that Neuropeutics has been named the recipient of the AbbVie Biotech Innovators Award for its pioneering work in neurodegenerative diseases. We look forward to supporting the journey of Neuropeutics, in collaboration with SpinUp, to accelerate their efforts to deliver life-changing innovation to patients." "Congratulations to Neuropeutics on being the first AbbVie Biotech Innovators Award recipient, and welcome to SpinUp – the University of Toronto's wet lab incubator," said France Gagnon, Vice-Principal, Research and Innovation at the University of Toronto Mississauga. "This is the place where the potential of Neuropeutics' work in neurodegenerative diseases can be realized and the impact on life sciences can be game changing. We are pleased to collaborate with AbbVie, a global leader in the biopharmaceutical industry, to offer this unique opportunity to this competitively chosen startup." The AbbVie Biotech Innovators Award was launched in 2024 in collaboration with SpinUp, a purpose-built laboratory for chemistry and biological work – or wet lab – incubator at the University of Toronto. The Award is to support early-stage Canadian biotechnology startup companies with the potential to generate transformational therapies in areas that align with AbbVie's therapeutic areas of focus: immunology, oncology, neuroscience, and eye care. Neuropeutics Inc will receive a year of laboratory space at no cost, in addition to access to SpinUp's core equipment, services, entrepreneurship programming, and research talent community at the University of Toronto. Neuropeutics Inc will also benefit from mentorship by AbbVie's scientific and business executives. For more information on the AbbVie Biotech Innovators Award, please visit: About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow AbbVie Canada on Instagram or find us on LinkedIn. About SpinUp SpinUp is the first wet lab startup incubator at the University of Toronto, Canada's leading centre for learning and discovery and one of the world's top-two universities for health science productivity. SpinUp is purpose built to drive life science innovation. It offers early-stage start-ups access to outstanding and highly subsidized wet lab space, equipment, entrepreneurship programming and expertise at a brand new, state-of-the-art research facility at U of T's Mississauga campus. Visit our website at and connect with us on Instagram and LinkedIn. SpinUp is proudly part of U of T Entrepreneurship, a network of 12 accelerators across three campuses. Over the past 10 years, this network has supported more than 1,200 capital-backed companies, which have created 17,000 jobs and raised $12 billion in external investment. U of T now launches more research-based start-ups than any university in North America outside of MIT. The AbbVie Biotech Innovators Award is part of U of T Mississauga's Blue Ticket program at SpinUp, which provides a one-year SpinUp membership. About Neuropeutics Inc Neuropeutics is a for-profit Canadian pharmaceutical company developing targeted therapies to extend neurodegenerative disease patients' survival and improve their quality of life. To learn more, please visit us at contact us at [email protected], and connect with us on LinkedIn.
Yahoo
22-05-2025
- Business
- Yahoo
AbbVie and U of T Mississauga's SpinUp Announce Neuropeutics Inc as First AbbVie Biotech Innovators Award Recipient
Following a national competition, AbbVie and SpinUp – the University of Toronto's lab-based, life sciences accelerator – announce Neuropeutics Inc as recipient of first AbbVie Biotech Innovators Award Neuropeutics Inc receives a year of laboratory space and equipment at no cost, as well as access to support and mentorship TORONTO, May 22, 2025 /CNW/ - AbbVie (NYSE: ABBV) in partnership with the University of Toronto's SpinUp, are pleased to announce Neuropeutics Inc as the recipient of the AbbVie Biotech Innovators Award, a national prize to help foster innovation and support growth in Canada's life sciences sector. Following a competitive selection process, the award, funded by AbbVie, has been granted to Neuropeutics Inc for developing small molecules preventing and reversing protein aggregation as therapeutics for neurodegenerative diseases. "We are delighted to have this opportunity to collaborate with a global biopharmaceutical company such as AbbVie, and the University of Toronto's SpinUp, to advance Neuropeutics' therapeutic research and development across multiple neurodegenerative diseases. At Neuropeutics, we are committed to developing targeted therapies to extend neurodegenerative disease patients' survival and improve their quality of life. This award allows us to pursue that mission with greater momentum," said Dr. Marc Shenouda, CEO & Co-Founder of Neuropeutics Inc. Neuropeutics Inc's scientific entrepreneurial spirit directly aligns with the mandate of the AbbVie Biotech Innovators Award to foster research, innovation and growth within Canada's life sciences sector. A hallmark of neurodegenerative diseases is protein aggregation. One such protein is TDP-43, a normally nuclear DNA/RNA binding protein, which in disease conditions becomes mislocalized and forms cytoplasmic aggregates causing neuronal toxicity. Neuropeutics Inc has developed a novel strategy to address diseases such as: Amyotrophic Lateral Sclerosis (ALS), Frontotemporal dementia, Alzheimer's disease, Huntington's disease and Parkinson's disease. "It was impressive and motivating to see the variety of entries and the calibre of early-stage biotech companies who applied for the Award. We thank all who participated in this life science competition," said Rami Fayed, Vice President and General Manager of AbbVie Canada. "After a rigorous evaluation process, it is with great pleasure that we are announcing that Neuropeutics has been named the recipient of the AbbVie Biotech Innovators Award for its pioneering work in neurodegenerative diseases. We look forward to supporting the journey of Neuropeutics, in collaboration with SpinUp, to accelerate their efforts to deliver life-changing innovation to patients." "Congratulations to Neuropeutics on being the first AbbVie Biotech Innovators Award recipient, and welcome to SpinUp – the University of Toronto's wet lab incubator," said France Gagnon, Vice-Principal, Research and Innovation at the University of Toronto Mississauga. "This is the place where the potential of Neuropeutics' work in neurodegenerative diseases can be realized and the impact on life sciences can be game changing. We are pleased to collaborate with AbbVie, a global leader in the biopharmaceutical industry, to offer this unique opportunity to this competitively chosen startup." The AbbVie Biotech Innovators Award was launched in 2024 in collaboration with SpinUp, a purpose-built laboratory for chemistry and biological work – or wet lab – incubator at the University of Toronto. The Award is to support early-stage Canadian biotechnology startup companies with the potential to generate transformational therapies in areas that align with AbbVie's therapeutic areas of focus: immunology, oncology, neuroscience, and eye care. Neuropeutics Inc will receive a year of laboratory space at no cost, in addition to access to SpinUp's core equipment, services, entrepreneurship programming, and research talent community at the University of Toronto. Neuropeutics Inc will also benefit from mentorship by AbbVie's scientific and business executives. For more information on the AbbVie Biotech Innovators Award, please visit: About AbbVieAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow AbbVie Canada on Instagram or find us on LinkedIn. About SpinUpSpinUp is the first wet lab startup incubator at the University of Toronto, Canada's leading centre for learning and discovery and one of the world's top-two universities for health science productivity. SpinUp is purpose built to drive life science innovation. It offers early-stage start-ups access to outstanding and highly subsidized wet lab space, equipment, entrepreneurship programming and expertise at a brand new, state-of-the-art research facility at U of T's Mississauga campus. Visit our website at and connect with us on Instagram and LinkedIn. SpinUp is proudly part of U of T Entrepreneurship, a network of 12 accelerators across three campuses. Over the past 10 years, this network has supported more than 1,200 capital-backed companies, which have created 17,000 jobs and raised $12 billion in external investment. U of T now launches more research-based start-ups than any university in North America outside of MIT. The AbbVie Biotech Innovators Award is part of U of T Mississauga's Blue Ticket program at SpinUp, which provides a one-year SpinUp membership. About Neuropeutics IncNeuropeutics is a for-profit Canadian pharmaceutical company developing targeted therapies to extend neurodegenerative disease patients' survival and improve their quality of life. To learn more, please visit us at contact us at info@ and connect with us on LinkedIn. SOURCE AbbVie Canada View original content to download multimedia: Sign in to access your portfolio