New analysis of official records from the National Institute of Health (NIH) have revealed that just 365,000 people took part in a clinical trial for Type 2 Diabetes in 2021, despite 37.3 million people in the US living with the condition – or more than 11% of the population. By taking part in a clinical trial, people affected by conditions like diabetes can access innovative new treatments and drugs and help bring the medicines to market much faster, benefiting millions of others. The new findings were uncovered by Lindus Health, a clinical trials start-up, who analyzed the official clinical trial records across multiple diseases and found that diabetes was clearly being under-represented – with the equivalent of fewer than 1% of people affected by the disease being involved in a trial. Despite the number of people affected by diabetes, the condition is frequently overlooked in clinical trials. This is despite ...
Scientists at City of Hope have developed universal donor stem cells that could one day provide lifesaving therapy to children with lethal brain conditions, such as Canavan disease, as well as to people with other degenerative diseases, such as Alzheimer’s and multiple sclerosis. The study was recently published in Advanced Science. “The off-the-shelf approach City of Hope is taking can easily be extended to improve the quality of life of cancer patients who are experiencing cognitive impairment or impaired motor function as a side effect of chemotherapy or radiation,” said Yanhong Shi, Ph.D., chair of the Department of Neurodegenerative Diseases and the Herbert Horvitz Professor in Neuroscience at Beckman Research Institute of City of Hope. Shi has been working on this research for 12 years. This is the first time stem cells have been engineered to become universal donors for cell therapy targeting diseases of the central nervous system, Shi ...
By Tristan Manalac Pictured: A Biogen building/courtesy of PictureDesignSwiss/shutterstock Biogen announced Monday that three of its directors—Alexander Denner, William Jones and Richard Mulligan—will not stand for re-election at the company’s annual stockholder meeting Wednesday. Instead, Susan Langer will be up for election to Biogen’s board of directors. This latest shake-up comes after board chair Stelios Papadopoulos announced he was stepping down from his post after the annual meeting. Papadopoulos will be succeeded by Caroline Dorsa, a long-standing member of Biogen’s board who had previously served for more than two decades at Merck. Meanwhile, Langer is currently serving as president of Souffle Therapeutics, a privately held start-up that has most recently scored $50 million in investments, according to PitchBook. Before that, Langer was also the founding president of Kojin Therapeutics and the founding chief business officer of Paratus Sciences. She also previously worked at Biogen in posts of increasing responsibility. Endpoints ...
Researchers from The University of Texas at El Paso’s School of Pharmacy will explore the viability of a new treatment for vascular dementia, thanks to a $2.2 million grant from the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS). The grant builds on work that’s previously been done by the team and their collaborators. Vascular dementia -; the second most common type of dementia worldwide -; is caused by reduced or blocked blood flow in the brain. Similar to Alzheimer’s disease, vascular dementia causes memory loss and cognitive problems such as confusion, slowed thinking, and difficulty with problem solving and speaking. Mohammad Iqbal Bhuiyan, Ph.D., assistant professor in the UTEP School of Pharmacy, is the project’s principal investigator. His NINDS-funded research will focus on better understanding the biological triggers behind vascular dementia and investigating a new candidate drug, known as “ZT-1a,” to counteract the condition. ...
By Rosemary Scott Pictured: Three side-by-side scans of a human brain/iStock, semnic The FDA released briefing documents Wednesday that signal it is likely to grant Eisai and Biogen’s Leqembi (lecanemab) full approval to treat Alzheimer’s disease on its decision date in July. The documents come just two days before an advisory committee is scheduled to vote on whether to recommend the drug’s approval. The FDA has asked the six members of the advisory committee to answer the following question: Do the results of a pivotal trial dubbed Study 301 (CLARITY AD) verify the clinical benefit of lecanemab for the treatment of AD? But it appears the agency may have already decided for itself. Both the briefing documents and the committee’s decision will be based on the Study 301results. In the documents, the FDA stated that the data from the trial showed “consistently favorable results for the primary and secondary endpoints,” ...
As Alzheimer’s disease partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. Wednesday, that vision came into better focus as the FDA released a document showing how the agency views the drug.In advance of a highly anticipated FDA advisory committee set for Friday, the agency released a briefing document that appears to support a full FDA approval for Leqembi. On efficacy, the agency said the drug’s treatment effect in its pivotal trial, called Study 301, is “supported by the consistently favorable results for the primary and secondary endpoints across the prespecified subgroups of interest.” In the study, investigators tested Leqembi against placebo in patients with mild cognitive impairment due to Alzheimer’s or mild Alzheimer’s dementia. The study measured the drug’s efficacy on an endpoint called the Clinical Dementia Rating-Sum of Boxes at 18 months of treatment. On ...
Nicole DeFeudis Editor Biogen is calling it quits on a late-stage Parkinson’s trial as part of an ongoing R&D reorganization. The Cambridge, MA-based biotech announced Monday morning that it’s discontinuing a Phase III program evaluating BIIB122 as a treatment for patients with Parkinson’s disease related to LRRK2 mutations with partner Denali Therapeutics. The study, dubbed LIGHTHOUSE, kicked off in September; it was slated for completion in 2031. Biogen said the decision was made in consideration of the study’s “complexity including the long timeline.” “These modifications are not based on any safety or efficacy data from studies of BIIB122,” the company said in a statement. “Denali and Biogen have a strategic collaboration to jointly develop and commercialize small molecule inhibitors of LRRK2 and remain committed to advancing the development of BIIB122.” Back in 2020, Biogen shelled out more than $1 billion upfront — including $560 million in cash and $465 million ...
University of Queensland researchers have used artificial intelligence to build a 3D map of key cell components to better understand dementia and infectious diseases including COVID-19. Professor Brett Collins from UQ’s Institute for Molecular Bioscience and Professor Pete Cullen from the University of Bristol led a team that modeled the 16 subunit Commander complex, a bundle of proteins that act as ‘postal workers’ in cells. Just as the postal system has processes to transport and sort cargo, cells in our bodies have molecular machines that transport and sort proteins. This protein transport system is implicated in many diseases including heart disease, Alzheimer’s disease and infections. “Knowing the 3D shape of these proteins helps us understand how they function, why mutations cause disease, and how to design drugs to target them in the future,” Professor Collins said. “Viruses such as SARS-CoV-2 – which causes COVID-19 – and human papilloma virus ...
Biogen has stopped or paused several drug programs as part of a larger effort to cut costs and prioritize certain research. The decision, disclosed Tuesday in the company’s latest earnings report, comes as sales of its marketed medicines for brain and nervous system disorders continue to fall. Biogen recorded $2.46 billion in total revenue between January and March, a 3% decline from the same period a year prior. Revenue was down across most business segments, with the company’s flagship multiple sclerosis franchise taking the biggest hit, decreasing by 19%. Christopher Viehbacher, the former chief executive at Sanofi and the recently minted CEO of Biogen, is now trying to reshape a research and development organization that, for many years, revolved around high-risk, high-reward neuroscience programs. ““Having a few of those projects in our pipeline is good,” he said in February, “having 100% … is challenging.” On Tuesday, Biogen ...
Magnetic resonance imaging (MRI) is how we visualize soft, watery tissue that is hard to image with X-rays. But while an MRI provides good enough resolution to spot a brain tumor, it needs to be a lot sharper to visualize microscopic details within the brain that reveal its organization. In a decades-long technical tour de force lead by Duke’s Center for In Vivo Microscopy with colleagues at the University of Tennessee Health Science Center, University of Pennsylvania, University of Pittsburgh and Indiana University, researchers took up the gauntlet and improved the resolution of MRI leading to the sharpest images ever captured of a mouse brain. Coinciding with the 50th anniversary of the first MRI, the researchers generated scans of a mouse brain that are dramatically crisper than a typical clinical MRI for humans, the scientific equivalent of going from a pixelated 8-bit graphic to the hyper-realistic detail of a Chuck Close painting. A single ...
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