alzheimer’s disease
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Eisai Alzheimer’s Drug Data Show Slowing of Decline But Safety Questions Linger
Eisai has presented and published full data from the Phase 3 clinical trial for its Alzheimer’s disease drug lecanemab, with results showing a statistically significant slowing decline associated with the neurodegenerative disorder. While an accelerated approval decision is expected in early 2023, the latest trial data are key because they represent the confirmatory study that could support an application for full FDA approval.
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Mental health startup for seniors rakes in $32M from General Catalyst, Mass General Brigham Ventures, others
There is a dearth of professionals with licenses and training to provide care for seniors’ mental and behavioral health challenges — such as Alzheimer’s and other dementias, anxiety and depression. Seattle-based Rippl Care is seeking to change this. The startup just closed a $32 million seed funding round led by ARCH Venture Partners and General Catalyst.
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Jorie Healthcare CEO Shares Why Automation is Critical to Revenue Cycle Management
The revenue cycle management business is using AI tools to automate cumbersome tasks to help hospitals operate more efficiently. It’s beginning to attract the attention of major healthcare organizations.
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Eisai, Biogen beat expectations with data that support Alzheimer’s drug approval
Eisai Alzheimer’s disease drug candidate lecanemab now has data from a pivotal study showing a statistically significant reduction in cognitive decline. Lecanemab is already under FDA review for potential accelerated approval but the agency has said that results from this larger study could support full approval of the antibody drug.
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Devices & Diagnostics, Health Tech, Startups, SYN
uMETHOD, Getlabs partner to make personalized cognitive decline care plans accessible in Arizona
uMETHOD, which provides precision medicine software to treat cognitive decline, tapped at-home diagnostics provider Getlabs to supply mobile phlebotomies for its patients in Arizona. Blood tests are an essential part of the personalized care plans that uMETHOD provides, and the partnership seeks to make these tests accessible to patients with cognitive decline.
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Aduhelm’s loss is a win for value-based drug pricing
Value-based pricing could have shown us with more certainty the real level of effectiveness of Aduhelm. Maybe it is worth paying something for; and value-based contracts are the only way to figure that out.
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Merck turns to biotech Cerevance to feed neuro pipeline with Alzheimer’s drugs
Merck is paying $25 million to kick off a research partnership with Cerevance, a startup that analyzes donor brain tissue to find novel targets for new neurological disorder drugs. While Cerevance’s lead program is a Parkinson’s disease drug, Merck is wants to see if the startup’s technology can help it discover and develop new Alzheimer’s disease drugs.
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FDA turns down Acadia Pharma drug for Alzheimer’s psychosis; new trial needed
Acadia Pharmaceuticals drug Nuplazid failed to win FDA approval for the treatment of psychosis in Alzheimer’s disease patients. The regulator said that the data submitted were not from an adequate and well-controlled study and the company must run another clinical trial.
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Memory Health CEO shares approach to combating Alzheimer’s disease
Memory Health CEO Edward Shehab talked about taking a preventive approach to neurodegenerative conditions.
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AbbVie & Alector drop Alzheimer’s med from alliance, shifting focus to a 2nd drug
AbbVie paid Alector $225 million up front five years ago to begin an R&D partnership on two drugs intended to bring an immunotherapy approach to the treatment of Alzheimer’s disease. One of the drugs has reached Phase 2 testing but the pharmaceutical giant has terminated the alliance on a program in Phase 1.
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Navigating Healthcare’s Data Revolution: Priorities, Opportunities, and Challenges for Health Systems
Arcadia recently partnered with HIMSS Market Insights to survey executives, IT, technology, and clinical leaders. Here’s what we found.
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Athira Alzheimer’s drug fails mid-stage, but the biotech still eyes a Phase 3 path
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.
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New Quest Alzheimer’s blood test can help clinical trial sponsors identify patients easily
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.
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Biogen pulls Alzheimer’s drug application in Europe as EMA calls data insufficient
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.
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MedCity Influencers, Health Tech
Without brain data, we won’t improve outcomes for patients who have neurological diseases
New technologies for quantifying behavioral information and tracking neurological patterns have the potential to change treatment—but we must connect the data.
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Final CMS decision limits coverage of Biogen’s Aduhelm to those in clinical trials
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.
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AbbVie makes neuro drug connection with $130M Syndesi Therapeutics acquisition
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.