An Alzheimer’s disease drug from Athira Pharma has failed a Phase 2 clinical trial and the biotech has a surprising theory why. Athira says standard of care drugs Alzheimer’s patients are already taking may diminish the effect of its small molecule and this finding could inform how the company proceeds with an ongoing Phase 3 clinical trial.
The tests could prove useful in screening patients that coud benefit from therapies being tested for Alzheimer's. But uptake will depend, in part, on reimbursement, according to doctors surveyed by Quest.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Biogen withdrew an application seeking approval in Europe for Alzheimer’s disease drug Aduhelm, a move that follows a negative opinion on the therapy issued by a European Medicines Commission committee last December. The company was unable to persuade European regulators to change their minds about the drug.
New technologies for quantifying behavioral information and tracking neurological patterns have the potential to change treatment—but we must connect the data.
Biogen’s Alzheimer’s disease drug Aduhelm will only be covered for Medicare beneficiaries participating in a clinical trial. The final coverage determination will have the effect of limiting use of the drug, but the agency said its decision provides clarity on what drug companies need to show in order to secure Medicare coverage.
AbbVie has acquired Syndesi Therapeutics, an early clinical neuroscience startup developing drugs that have potential applications in a range of cognitive disorders. Syndesi is based on research from Belgian pharmaceutical company UCB.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The FDA placed a clinical hold on Denali Therapeutics’ application to begin Phase 1 testing of an antibody drug for Alzheimer’s disease. The Denali drug uses the biotech’s proprietary technology to deliver therapeutic cargo across the protective blood-brain barrier.
The Center for Medicare and Medicaid Services proposes covering Biogen Alzheimer’s disease drug Aduhelm only for people enrolled in a clinical trial. In explaining this proposal, the agency cited the unclear benefit to patients as well as the documented safety risks associated with the drug, which can be best monitored within the context of a clinical trial.
The price of Biogen Alzheimer’s disease drug Aduhelm will be cut in half at the start of 2022, a move that comes as a Medicare recommendation on coverage is expected early next year. Meanwhile, Biogen is preparing corporate measures projected to save $500 million annually, cost-cutting made necessary in part due to slow market uptake of Aduhelm.
While the era of using digital health tools to manage MCI and perhaps prevent greater cognitive decline is just beginning, it is a promising new therapeutic direction for a very complex condition. The more these solutions are developed and studied, it seems clear, however, that the most effective technology will be the systems that individuals with MCI and their caregivers consistently enjoy using over the long term.
This eBook, in collaboration with Care Logistics, details how hospitals and health systems can facilitate more effective decision-making by operationalizing elevated awareness.
Six months after Biogen was awarded regulatory approval for its Alzheimer’s disease drug Aduhelm, the company is laying out a timeline for the post-marketing study to confirm whether the drug works. The projected four-year study will enroll more than 1,300 patients and will include a placebo control arm.
We now know how important white matter is to our overall brain health and cognitive ability, as well as how declines in white matter structure are correlated with impairments in brain function.
Bill Martin, the Global Therapeutic Area Head of Neuroscience at The Janssen Pharmaceutical Companies of Johnson & Johnson, shared some of the promising developments in the neuroscience space, such as the rise of neuro-immunology and the industry’s embrace of digital health tools to support drug development in a recent interview.
Vaxxinity, a clinical-stage biotech with vaccine technology that gets the body to produce therapeutic or protective antibodies, raised $78 million from an IPO that priced below the targeted price range. In addition to its lead Alzheimer’s disease program, Vaxxinity’s pipeline includes product candidates for Parkinson’s disease, migraine, and Covid-19.
Eisai is seeking accelerated FDA approval of lecanemab, an Alzheimer’s disease drug that is part of a research alliance with Biogen. The drug is following the same path blazed earlier this year with FDA approval of Biogen Alzheimer’s drug Aduhelm.