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 […]
alzheimer’s disease
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 […]
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 […]
AC Immune tries to resurrect crenezumab with new data delve
In May, another amyloid targeting drug for Alzheimer’s disease – AC Immune and Roche’s crenezumab – missed the mark in another clinical trial and looked […]
Memory Health CEO shares approach to combating Alzheimer’s disease
Memory Health CEO Edward Shehab talked about taking a preventive approach to neurodegenerative conditions.
For neurological disease, solving measurement is the first and biggest hurdle to re-imagining treatment
Neurodegenerative diseases like Parkinson’s and Alzheimer’s affect millions of people worldwide, and their prevalence is only increasing, according to the World Health Organization. And while […]
AbbVie cuts Alzheimer’s alliance with Alector in half
AbbVie is pulling out of its collaboration with Alector on the development of Alzheimer’s disease candidate AL003, which aims to tackle the neurodegenerative disease by […]
AbbVie & Alector drop Alzheimer’s med from alliance, shifting focus to a 2nd drug
AbbVie paid Alector $205 million up front five years ago to begin an R&D partnership on two drugs intended to bring an immunotherapy approach to […]
Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan
The FDA has started an accelerated review of Eisai and Biogen’s a new amyloid-targeting antibody lecanemab for Alzheimer’s disease, with a 6 January deadline that […]
When It Comes to Digital Health, Experience Is Everything
Aniket Singh Rajput, Founder and CEO of Neuroglee Thanks to COVID-19 and numerous other factors, the adoption of digital health technologies used by patients in […]
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 […]
Single MRI-based brain scan could diagnose Alzheimer’s disease, says study
Alzheimer’s disease could be diagnosed from a single MRI brain scan, according to a new study by Imperial College London. Using machine learning technology, researchers […]
FDA panel turns down Acadia’s Nuplazid for Alzheimer’s psychosis
Acadia Pharma’s attempts to extend the indications of its Nuplazid drug in the US to include Alzheimer’s disease-related psychosis have suffered another major setback. Nuplazid […]
Trial of New Alzheimer’s Drug Reports Disappointing Results
The drug, crenezumab, failed to prevent early symptoms or slow cognitive decline, the latest setback in the long quest to find effective therapies for the […]
Trial of New Alzheimer’s Drug Reports Disappointing Results
The drug, crenezumab, failed to prevent early symptoms or slow cognitive decline, the latest setback in the long quest to find effective therapies for the […]
Trial of New Alzheimer’s Drug Reports Disappointing Results
The drug, crenezumab, failed to prevent early symptoms or slow cognitive decline, the latest setback in the long quest to find effective therapies for the […]
Another amyloid miss in Alzheimer’s as Roche’s crenezumab fails trial
The litany of failed trials of amyloid-targeting drugs for Alzheimer’s disease has added another verse, as Roche concedes that its crenezumab candidate was unable to […]
Cumulus puts its digital biomarkers for CNS diseases to the test
Cumulus Neuroscience has started a pair of clinical trials to gauge the value of a panel of physiological and digital biomarkers in tracking the course […]
Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go
Here we go again. With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer’s disease therapy lecanemab, which […]
FDA approves first in vitro test for early Alzheimer’s disease
The US FDA has authorised a new test that can detect amyloid plaques in early-stage Alzheimer’s disease without the use of PET scans, which expose […]
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, […]
Biogen C.E.O. to Step Down Following Launch of Alzheimer’s Drug, Aduhelm
The drug company will effectively give up on marketing Aduhelm, which comes with unproven benefits and serious safety risks.
Biogen C.E.O. to Step Down Following Launch of Alzheimer’s Drug, Aduhelm
The drug company will effectively give up on marketing Aduhelm, which comes with unproven benefits and serious safety risks.
Biogen C.E.O. to Step Down Following Launch of Alzheimer’s Drug, Aduhelm
The drug company will effectively give up on marketing Aduhelm, which comes with unproven benefits and serious safety risks.
Biogen C.E.O. to Step Down Following Launch of Alzheimer’s Drug, Aduhelm
The drug company will effectively give up on marketing Aduhelm, which comes with unproven benefits and serious safety risks.
Biogen C.E.O. to Step Down Following Launch of Alzheimer’s Drug, Aduhelm
The drug company will effectively give up on marketing Aduhelm, which comes with unproven benefit and serious safety risks.
Vounatsos heading for exit as Biogen sidelines Aduhelm
Biogen has announced a major revamp of its business that will see chief executive Michel Vounatsos depart the company, and all commercial activities related to […]
Sources of Oxidized Cholesterol
Chicken, fish, and egg powder in processed foods present greater risk from cholesterol oxidation byproducts, but there are things you can do to reduce exposure. […]
Oxidized Cholesterol and Alzheimer’s Disease
Oxidized cholesterol can be a hundred times more toxic than regular cholesterol, raising additional concerns about foods such as ghee, canned tuna, processed meat, and […]
Biogen pulls EU application for Alzheimer’s drug Aduhelm
Biogen has given up on seeking approval for its Alzheimer’s disease therapy Aduhelm in the EU, saying that discussions with EU regulators had made it […]
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 […]
Why a Focus on Behavioral Health is Key to Improving Quality Measures
Tom Zaubler, MD, Chief Medical Officer of NeuroFlow Since the passage of the Medicare Improvements for Patients & Providers Act in 2008, the U.S. healthcare […]
Scientists Question Data Behind an Experimental Alzheimer’s Drug
Studies linked to Cassava Sciences, once a stock market favorite, have been retracted or challenged by medical journals.
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.
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 […]
CMS decision on Aduhelm is in, and it’s bad news for Biogen
The US Centres for Medicare and Medicaid Services (CMS) has firmed up its draft decision to limit reimbursement of Biogen’s Alzheimer’s disease therapy Aduhelm to […]
Medicare Officially Limits Coverage of Aduhelm to Patients in Clinical Trials
Officials cited data showing the new Alzheimer’s drug has serious safety risks and may not help patients.
Inside a Campaign to Get Medicare Coverage for a New Alzheimer’s Drug
The Alzheimer’s Association has pushed relentlessly to get broad access to Aduhelm, despite safety risks and uncertain evidence that it helps patients.
Study uncovers new Alzheimer’s genes, links to immune disruption
The largest-ever study of genetics in Alzheimer’s disease patients has identified 42 new genes that appear to be linked to the neurodegenerative disorder. The new […]
Irish wearables firm Kinesis bought by Linus Health
University College Dublin spinout Kinesis Health Technologies, which has developed a range of wearable sensors to assess the physical capabilities of patients, has been bought […]
Biogen finally publishes its phase 3 Aduhelm data
After months of debate about the validity of its phase 3 clinical trials for Alzheimer’s therapy Aduhelm, Biogen has published the results in a peer-review […]
Pharma group seeks digital measure standards for Alzheimer’s
A group of pharma companies and academic groups have joined forces with the Digital Medicine Society (DiMe) to develop standardised, digital clinical measures that can […]
Eisai hands off responsibility for Aduhelm to Biogen
Japanese pharma Eisai has backed away from its 50:50 profit-sharing arrangement with Biogen for troubled Alzheimer’s therapy Aduhelm, handing over full responsibility to its US […]
Aetion and Cognito Team Up for Predictive Modeling in Alzheimer’s
What You Should Know: – Aetion, real-world evidence (RWE) tech and analytics provider, and Cognito Therapeutics, a pioneer in neuromodulation therapeutics for neurodegenerative diseases like Alzheimer’s, are partnering […]
Roche starts new four-year trial of Alzheimer’s drug gantenerumab
With prospects of an early, accelerated approval for Roche’s Alzheimer’s disease candidate gantenerumab looking diminished, the drugmaker has launched a new four-year trial in the […]
AbbVie adds to neuroscience pipeline with $1bn Syndesi buy
Four years after spinning out from Belgium’s UCB, Syndesi Therapeutics and its SV2A modulator programme has been bought by AbbVie for $130 million upfront. The […]
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 […]
MindMaze raises $105m to seek out new neurological DTx
Swiss digital health company MindMaze has raised $105 million to help take its digital therapeutics (DTx) for neurological diseases like stroke onto the global stage, […]
Eisai bites back against restricted coverage plan for Aduhelm
Japanese drugmaker Eisai has published comments filed with the US Centers for Medicare & Medicaid Services over its restrictive coverage proposal for beleaguered Alzheimer’s drug […]
Lilly defers Alzheimer’s drug filing after CMS’ ‘disappointing’ decision
Eli Lilly has backed away from plans to file Alzheimer’s drug donanemab in the first quarter of this year, saying the proposal to limit reimbursement […]
Preventing Alzheimer’s Disease with Diet
What evidence is there that our meat-sweet diets play a cause-and-effect role in dementia? What is behind the dramatic increase in dementia in Japan over […]
Eli Lilly plans €400m Irish plant that will create 800 jobs
Eli Lilly has said it is seeking permission to build a new biopharmaceutical manufacturing facility in Ireland that will be used to produce active ingredients […]
Biogen tweaks confirmatory trial of Alzheimer’s drug Aduhelm
Biogen and Eisai have increased the earning potential of their Alzheimer’s drug Aduhelm by expanding the post-marketing trial of the drug required by the FDA […]
FDA presses pause on test of Alzheimer’s drug from Denali before study even starts
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 […]
Medicare limits Aduhelm coverage to clinical trial participants
Biogen’s difficult launch of controversial Alzheimer’s therapy Aduhelm has been made even harder by a proposal by Medicare to cover the drug only for certain […]
Medicare Proposes to Sharply Limit Coverage of the Alzheimer’s Drug Aduhelm
If the preliminary decision is finalized this spring, it would restrict coverage to patients in randomized clinical trials.
Medicare Proposes to Sharply Limit Coverage of the Alzheimer’s Drug Aduhelm
If the preliminary decision is finalized this spring, it would restrict coverage to patients in randomized clinical trials.
CMS proposes limited coverage of Biogen Alzheimer’s drug, only in clinical trials
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 […]
Medicare Proposes to Cover Aduhelm Only for Patients in Clinical Trials
If the preliminary decision is finalized this spring, it would sharply limit the number of patients who use the expensive drug.
Alzheimer’s Drug Aduhelm Faces Crucial Medicare Decision
Medicare officials are trying to determine whether to cover Aduhelm, which the F.D.A. approved despite unclear evidence that it helps patients.
Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA
Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track […]
Biogen Slashes Price of Alzheimer’s Drug Aduhelm, as It Faces Obstacles
A group of Alzheimer’s experts and health advocates called on the F.D.A. to withdraw its approval of the drug, the latest of several setbacks for […]
Biogen Slashes Price of Alzheimer’s Drug Aduhelm, as It Faces Obstacles
A group of Alzheimer’s experts and health advocates called on the F.D.A. to withdraw its approval of the drug, the latest of several setbacks for […]
Biogen Slashes Price of Alzheimer’s Drug Aduhelm, as It Faces Obstacles
A group of Alzheimer’s experts and health advocates called on the F.D.A. to withdraw its approval of the drug, the latest of several setbacks for […]
Biogen Slashes Price of Alzheimer’s Drug Aduhelm, as It Faces Obstacles
A group of Alzheimer’s experts and health advocates called on the F.D.A. to withdraw its approval of the drug, the latest of several setbacks for […]
Biogen slashes price of Alzheimer’s drug by half as CMS coverage decision looms
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 […]
Biogen takes axe to Aduhelm price in a bid to drive take-up
Biogen has cut the list price of its Alzheimer’s disease therapy in half from $56,000 to $28,200 a year, before the outcome of an ongoing […]
Digital health’s ‘wow factor’ should focus on the patient
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 […]
Biogen’s Alzheimer’s drug Aduhelm is rejected by EU advisors
The EMA’s human medicines committee has said it cannot approve Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, saying it was unconvinced by the data submitted […]
Biogen updates on its confirmatory Aduhelm trial
Biogen and partner Eisai have said they will provide details next March for the confirmatory trial that will be needed to upgrade the drug’s accelerated […]
Biogen projects confirmatory study for Alzheimer’s drug will take four years
Six months after Biogen was awarded regulatory approval for its Alzheimer’s disease drug Aduhelm, the company the company is laying out a timeline for the […]
Alzheimer’s disease should be approached as white matter disease, not gray
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 […]
Viagra ‘should be tested as Alzheimer’s therapy’
Scientists in the US have found that people who use Viagra for erectile dysfunction seem to have a lower risk of developing Alzheimer’s disease – […]
GSK pumps £30m into a new Oxford University partnership
GlaxoSmithKline has formed a five-year partnership with Oxford University to set up a new institute that will apply machine learning and functional genomics to the […]
Eisai forges alliance with FCNT on digital tools for dementia
Japanese drugmaker Eisai has teamed up with Fujitsu spin-out FCNT, which makes smartphones aimed at older consumers, on digital tools to support people with dementia. […]
Trial of intranasal Alzheimer’s vaccine gets underway in US
The first patients are now being treated as part of a first-in-human trial of a vaccine, administered as a nasal spray, that aims to slow […]
Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many […]
Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many […]
Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many […]
Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many […]
Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many […]
Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug
Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many […]
The emerging golden era of neuroscience [Sponsored]
Bill Martin, the Global Therapeutic Area Head of Neuroscience at The Janssen Pharmaceutical Companies of Johnson & Johnson, shared some of the promising developments in […]
Biogen’s Alzheimer’s drug is unlikely to win E.U. approval.
The drug, Aduhelm, has been mired in controversy since it was in approved in the United States in June.
Biogen’s Alzheimer’s drug is unlikely to win E.U. approval.
The drug, Aduhelm, has been mired in controversy since it was in approved in the United States in June.
Biogen’s Alzheimer’s drug is unlikely to win E.U. approval.
The drug, Aduhelm, has been mired in controversy since it was in approved in the United States in June.
Biogen’s Alzheimer’s drug is unlikely to win E.U. approval.
The drug, Aduhelm, has been mired in controversy since it was in approved in the United States in June.
CHMP minded to turn down Alzheimer’s drug Aduhelm, says Biogen
Biogen and Eisai have said that the EMA’s human medicines committee looks unlikely recommended approval of their Alzheimer’s drug Aduhelm when it comes up for […]
With claims of potential Alzheimer’s edge, Vaxxinity squeaks out $88M IPO
Vaxxinity, a clinical-stage biotech with vaccine technology that gets the body to produce therapeutic or protective antibodies, raised $88 million from an IPO that priced […]
Lilly files Alzheimer’s drug donanemab as Cortexyme rival fails trial
Eli Lilly has followed through on its plan to file for approval of its Alzheimer’s disease candidate donanemab, and is planning to take on Biogen […]
FDA clears AI-powered digital test for early dementia
The FDA has approved an artificial intelligence-based test for early detection of dementia that can be carried out on an iPad in five minutes. The […]
Biogen’s Aduhelm rollout goes from bad to worse
Analysts were predicting sales of Biogen’s recently approved Alzheimer’s therapy Aduhelm may start to gather a little momentum in the third quarter, but the drug […]
Sales of Biogen’s Alzheimer’s Drug Fall Short of Expectations
The drug, Aduhelm, brought in $300,000 in revenue in its first full three months of availability. The company expects the drug to generate minimal revenue […]
Sales of Biogen’s costly new Alzheimer’s drug fall far short of expectations.
The drug, Aduhelm, brought in $300,000 in revenue in its first full three months of availability. The company expects the drug to generate minimal revenue […]
Eisai-backed trial will assess Altoida’s digital test for early Alzheimer’s
A software platform developed by Altoida that uses augmented reality and artificial intelligence to diagnose neurological diseases in their earliest stages is being tested in […]
Data dive finds cheap diuretic could be Alzheimer’s drug
A data-mining study conducted by researchers in the US has found that an already-approved diuretic drug could have potential as a treatment for some patients […]
Genentech’s Gantenerumab Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Alzheimer’s Disease
Shots: The designation is based on the data from an ongoing SCarlet RoAD, Marguerite RoAD OLE trials along with other studies evaluating gantenerumab (anti-amyloid beta […]
Could Pfizer’s Inlyta have a role in Alzheimer’s disease?
Pfizer’s tyrosine kinase inhibitor Inlyta is already a cornerstone of treatment for some forms of cancer, but could have potential as a therapy for Alzheimer’s […]
Another Eisai, Biogen Alzheimer’s drug is filed for speedy FDA review
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 […]
Biogen, Eisai double down on Alzheimer’s with lecanemab filing
Biogen and Eisai’s first Alzheimer’s disease drug Aduhelm is facing an uphill battle in the US market, but the partners are forging ahead with their […]
Biogen admits slow Aduhelm launch, as scientists question label again
Shares in Biogen have come under pressure after chief executive Michel Vounatsos admitted that the company is facing a much slower than anticipated rollout of […]
Startup Neuroglee raises $10m for virtual neurology clinics
A digital health company focusing on neurodegenerative disorders – Neuroglee Therapeutics – has raised $10 million in first-round funding to roll out a virtual neurology […]
House Committees Demand F.D.A. Records on Alzheimer’s Drug Approval
The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter.
House Committees Demand F.D.A. Records on Alzheimer’s Drug Approval
The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter.
House Committees Demand F.D.A. Records on Alzheimer’s Drug Approval
The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter.
AC Immune Report Results of Semorinemab in P-II Lauriet Study for the Treatment of Alzheimer’s Disease
Shots: The P-II Lauriet study evaluates the safety & efficacy of semorinemab (anti-tau mAb) vs PBO in 272 adult patients with AD across 43 centers […]
AC Immune claims half a win for tau drug in Alzheimer’s trial
Shares in AC Immune leaped today after the company said its tau-targeting Alzheimer’s disease candidate semorinemab hit one of its objectives in a phase 2 […]
Weekly Health Quiz: Covid, Aloe and Heartburn
Test your knowledge of this week’s health news.
Weekly Health Quiz: Covid, Aloe and Heartburn
Test your knowledge of this week’s health news.
That $56,000 Drug? Blame Medicare.
For an increasingly important set of drugs, Medicare has been driving up prices. It knows how to do better.
That $56,000 Drug? Blame Medicare.
For an increasingly important set of drugs, Medicare has been driving up prices. It knows how to do better.
Health insurer Excellus will not fund Alzheimer’s drug Aduhelm
Health insurer Excellus BlueCross BlueShield has said it will not cover treatment with Biogen and Eisai’s new Alzheimer’s disease drug Aduhelm because it has not […]
Cambridge team says AI could diagnose dementia with one scan
Researchers at Cambridge University in the UK are trialling an artificial intelligence system that they think could spot the signs of dementia after a single […]
Lilly sets out its stall on donanemab as filing approaches
The FDA’s approval of Biogen’s Aduhelm for Alzheimer’s disease emboldened Eli Lilly to move forward plans to file its own candidate donanemab later this year, […]
Biogen and Eisai unveil details for five-year, real-world Aduhelm clinical trial
Patients taking new Alzheimer’s disease drug Aduhelm will be evaluated in a real-world study lasting up to five years. Biogen announced plans for the observational […]
NIH digital tool aims to boost enrolment into Alzheimer’s studies
With a string of new drugs for Alzheimer’s disease making their way through late-stage clinical testing, the demand for suitable subjects to enrol into trials […]
Biogen adds real-world test for Aduhelm to its confirmatory trial
Biogen and partner Eisai have said they will run a large-scale observational study of Alzheimer’s drug Aduhelm in the US to build evidence for the […]
Biogen bites back at critics of Aduhelm after drug’s slow start
Biogen has reported $2m in sales for newly-launched Alzheimer’s therapy Aduhelm that came in below its expectations, prompting the company to issue a rebuke to […]
Biogen’s Aduhelm Sales Total $2 Million in Second Quarter
The drug from Biogen, called Aduhelm, is expected to generate billions in sales. It could also strain Medicare’s budget within a few years.
Merck, Evidation to test if smartphone data can be used to detect early Alzheimer’s
Merck and Evidation Health launched a study to see if data from smartphones and wearables could be used to detect and monitor the treatment of […]
Biogen’s Aduhelm Sales Total $2 Million in Second Quarter
The drug from Biogen, called Aduhelm, is expected to generate billions in sales. It could also strain Medicare’s budget within a few years.
Roche ‘talking to FDA’ as Alzheimer’s drug moves towards 2022 readout
Phase 3 results with Roche’s amyloid-targeting Alzheimer’s drug gantenerumab may not be due until the second half of last year, but the company is already […]
How Aduhelm, an Unproven Alzheimer’s Drug, Got Approved
Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.
How an Unproven Alzheimer’s Drug Got Approved
Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.
Cleveland Clinic Says It Won’t Administer Aduhelm to Patients
The major medical center’s rejection of the new Alzheimer’s drug is one of the starkest signs of concern over its effectiveness.
FDA staffers defend Aduhelm approval in JAMA editorial
Three FDA figures at the centre of the fallout over the approval Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm have defended their actions, arguing that […]
CMS considers coverage of Biogen’s costly new Alzheimer’s drug
CMS plans to review and determine coverage for Biogen’s Aduhelm, the first new Alzheimer’s disease treatment in decades. But the jury is still out on […]
How’s my driving? GPS tracking spots Alzheimer’s with 86% accuracy
Diagnosing Alzheimer’s disease is still a challenge, particularly in its earliest stages, but a new study suggests that subtle changes in behaviour whilst driving could […]
US starts review of Aduhelm coverage amid fears of Medicare hit
The US government has started a review of how Biogen and Eisai’s pricey new Alzheimer’s disease therapy Aduhelm will be covered by Medicare, to see […]
Aduhelm approval controversy dials up as FDA seeks probe
In another twist to the Aduhelm approval tale, FDA’s Janet Woodcock has called for an independent investigation into the relationship between agency staffers and Biogen […]
What Is Critical Race Theory?
And how to learn more about the issue dividing school districts across the country.
F.D.A. Requests Federal Investigation of Alzheimer’s Drug Approval
The agency’s acting head said a review should look into whether any interactions between agency staff and the drug developer, Biogen, broke F.D.A. rules.
FDA whittles back Aduhelm approval amid concern over broad label
One of the criticisms levelled at the FDA over its approval of Biogen and Eisai’s Alzheimer’s disease drug Aduhelm was its decision to clear use […]
A New Alzheimer’s Drug Offers More Questions Than Answers
The approval of Aduhelm to treat Alzheimer’s disease has raised hope among older adults, but many doctors wonder if it is warranted.
In Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug
The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. Now it recommends that the drug be given only to those with mild symptoms.
In a Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug
The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. The new label recommends that the drug be given only to patients with mild […]
A New Alzheimer’s Drug Offers More Questions Than Answers
The approval of Aduhelm to treat Alzheimer’s disease has raised hope among older adults, but many doctors wonder if it is warranted.
‘Some Hope Is Better Than Having No Hope’
The F.D.A. shocked the world of medicine when it approved a much-debated drug for Alzheimer’s. What does the decision mean for patients and their families?
A Divisive New Treatment for Alzheimer’s
The F.D.A. shocked the world of medicine when it approved a much-debated drug for the disease. What does the decision mean for patients and their […]
GSK adds neuro prospects, paying $700M to share R&D of Alector’s two lead drugs
GlaxoSmithKline is paying Alector $700 million up front to share in the development of the biotech’s two lead drugs, which offer potentially broad application in […]
The Underside of the Aducanumab Approval
I would like to recommend this piece at Stat about the details of the Biogen aducanumab approval. It’s behind the paywall, but it’s a deeply […]
All in on amyloid, Acumen Pharma’s IPO raises $160M for Alzheimer’s drug R&D
Acumen Pharmaceuticals’ IPO raised $160 million to fund clinical development of its Alzheimer’s disease drug candidate. Though that drug goes after the same target as […]
ICER revises its view of Aduhelm’s price – but not by much
The Institute for Clinical and Economic Review (ICER) was very damning of Biogen’s new Alzheimer’s disease therapy Aduhelm when it issued its first report on […]
ICER revises its view of Aduhelm’s price – but not by much
The Institute for Clinical and Economic Review (ICER) was very damning of Biogen’s new Alzheimer’s disease therapy Aduhelm when it issued its first report on […]
Many Alzheimer’s Experts Say Use of Aduhelm Should Be Sharply Limited
Even those who supported the F.D.A.’s approval of the controversial new drug said authorizing it for anyone with Alzheimer’s disease was much too broad.
Protein Aggregation Diseases
If you have occasion to study neurodegeneration, you will be struck by how many terrible high-profile diseases in this area seem to share a common […]
Open the Floodgates
It should be obvious, given previous posts here, that I think that the FDA approval of Biogen’s aducanumab for Alzheimer’s was a mistake. It is […]
Biogen abandons tau antibody for Alzheimer’s after phase 2 miss
Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been […]
Consumer group seeks resignation of top FDA staffers over Aduhelm okay
With the first patient set to receive Biogen’s new Alzheimer’s drug Aduhelm in Rhode Island today, US consumer advocacy organisation Public Citizen is deeply unhappy […]
The F.D.A.’s Approval of Biogen’s Alzheimer’s Drug Is a New Low
The F.D.A.’s approval of the Alzheimer’s drug aducanumab is inexplicable.
Aducanumab (Aduhelm) for Alzheimer’s Disease
Date: July 12, 2021 Issue #: 1628 Summary: Aducanumab-avwa (Aduhelm – Biogen/Eisai), an IV amyloid beta-directed monoclonal antibody, has received accelerated approval from the FDA […]
The F.D.A.’s Approval of Biogen’s Alzheimer’s Drug Is a New Low
The F.D.A.’s approval of the Alzheimer’s drug aducanumab is inexplicable.
And then there were three: another FDA adcomm member quits over Aduhelm
The fallout over the FDA’s decision to approved Biogen’s Alzheimer’s therapy Aduhelm continues to be felt, with a third member of its advisory committee resigning […]
Alzheimer’s Drug Is Bonanza for Biogen, Most Likely at Taxpayer Expense
Despite scant evidence that it works, the drug, Aduhelm, is predicted to generate billions of dollars in revenue, much of it from Medicare.
Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug
The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients.
Three F.D.A. Advisers Resign Over Approval of Alzheimer’s Drug
The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients.
Confirming benefit of Biogen Alzheimer’s disease drug will take 8 years
Biogen is still discussing with the FDA the clinical trial design to confirm the benefit offered by its newly approved Alzheimer’s disease drug, Aduhelm. According […]
The Aducanumab Approval
As the world knows, the FDA approved Biogen’s anti-amyloid antibody today, surely the first marketed drug whose Phase III trial was stopped for futility. I […]
F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works
Aducanumab, or Aduhelm, is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some experts say there’s […]
FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag
The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. […]
Alzheimer’s Drug Is Bonanza for Biogen, Most Likely at Taxpayer Expense
Despite scant evidence that it works, the drug, Aduhelm, is predicted to generate billions of dollars in revenue, much of it from Medicare.
FDA picks accelerated approval path to decide in favor of Biogen Alzheimer’s drug
A Biogen Alzheimer’s drug that clears amyloid plaque from the brain has been granted accelerated approved by the FDA. The drug, which will be marketed […]
F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works
Aducanumab, or Aduhelm, is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some prominent experts say […]
Jubilation for Biogen, Eisai as FDA says ‘yes’ to aducanumab
Biogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer’s […]
F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works
Aducanumab is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some prominent experts say there’s not […]
People Want an Alzheimer’s Drug. Aducanumab Isn’t the One.
An F.D.A. sign-off for aducanumab would make finding a good treatment harder.
Biogen’s Alzheimer’s Drug Poses a Dilemma for the F.D.A.
If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say […]
Alzheimer’s Drug Poses a Dilemma for the F.D.A.
If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say […]
Alzheimer’s Drug Poses a Dilemma for the F.D.A.
If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say […]
A Brief Note About Aducanumab
There’s a big FDA decision coming up in the next few days: whether or not to approve the Biogen antibody for Alzheimer’s (aducanumab). I’ve had […]
Saffron Put to the Test for Alzheimer’s
The spice saffron is pitted head-to-head against the leading drug for severe Alzheimer’s disease. What’s the latest on treating memory disorders with the spice saffron? […]
People Want an Alzheimer’s Drug. Aducanumab Isn’t the One.
An F.D.A. sign-off for aducanumab would make finding a good treatment harder.
People Want an Alzheimer’s Drug. Aducanumab Isn’t the One.
An F.D.A. sign-off for aducanumab would make finding a good treatment harder.
People Want an Alzheimer’s Drug. Aducanumab Isn’t the One.
An F.D.A. sign-off for aducanumab would make finding a good treatment harder.
Exscientia starts trials of AI-designed Alzheimer’s drug
Exscientia has advanced a drug candidate for Alzheimer’s disease into human testing, the third clinical-stage project for the UK specialist in artificial intelligence (AI) based […]
Can your typing patterns reveal if you have Alzheimer’s?
The neuroQWERTY technology can analyse people’s typing for signs of motor conditions like Parkinson’s disease – and now the team behind it is looking to […]
ISPOR Value Flower and Alzheimer’s Disease
Standard cost-effectiveness measures the value of a treatment based on the cost for an additional unit of health where units of health are measured in […]
Benefits of Turmeric for Arsenic Exposure
What happened when turmeric curcumin was put to the test to see if it could reverse DNA damage caused by arsenic exposure? Arsenic is a […]
Lilly’s Alzheimer’s Data
That’s a post title that I could have used eight or ten times over the lifetime of this blog – Eli Lilly has been hammering […]
Cognito looks to light, sound for potential Alzheimer’s treatment
Digital health startup Cognoa shared results of a Phase 2 trial of its device, intended to treat Alzheimer’s disease using gamma frequency light and sound. […]
AI platform says Olumiant could be repurposed for Alzheimer’s
With so many novel drug candidates for Alzheimer’s disease failing in clinical development, researchers in the US have started using artificial intelligence (AI) to screen […]
Gene and Cell Therapies in CNS Disorders: Miracle Cure? Opportunities Galore!
CNS disorders are a wide-ranging set of disorders in which the brain loses its normal functioning, limiting everyday ability to function. These may arise from […]
Aker BioMarine Collaborate with Université de Sherbrooke Department of Medicine for Alzheimer’s Disease
Shots: The alliance will investigate the effectiveness of LPC-bound EPA/DHA in preventing cognitive decline linked to AD. Aker BioMarine will supply the research team with […]
Alzheimer’s Research UK starts AI-based drug hunt with Exscientia
Medical charity Alzheimer’s Research UK has teamed up with artificial intelligence specialist Exscientia to find new drug treatments for the devastating neurodegenerative disease. The alliance […]
Early data back J&J and AC Immune’s Alzheimer’s jab
Shares in Swiss biotech AC Immune have risen sharply after it said a vaccine in development for Alzheimer’s disease (AD) hit the mark in a […]
Aurinia’s Lupkynis for Lupus; FDA Fast Track Designation for Toripalimab; Wren Therapeutics’ Financing; Merck’s Covid-19 Vaccine Program End
Hot on the heels, Aurinia launches its drug in the Lupus market after GSK Aurinia Pharmaceuticals has recently got the USFDA approval for its Lupkynis […]
Biohaven’s Troriluzole Failure; Daiichi/ AZ’s Enhertu; Fujifilm & Manufacturing Spree; J&J’s Darzalex Faspro
Biohaven’s Troriluzole Dwindles Again In Alzheimer’s After Anxiety Biohaven Pharmaceuticals had put too much faith in its third-generation prodrug, Troriluzole. The company has tested the […]
Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects?
When Eli Lilly reported results for donanemab in Alzheimer’s disease earlier this week it was hailed as a rare win for the amyloid hypothesis, although […]
Eli Lilly’s Alzheimer’s Drug Shows Promise in Small Trial
Participants with the disease still declined, but much more slowly than those receiving a placebo, investigators say.
Eli Lilly’s Alzheimer’s Drug Shows Promise in Small Trial
Participants with the disease still declined, but much more slowly than those receiving a placebo, investigators say.
Eli Lilly’s Alzheimer’s Drug Shows Promise in Small Trial
Participants with the disease still declined, but much more slowly than those receiving a placebo, investigators say.
How Care Coordination Technology Addresses Social Isolation in Seniors
Jenifer Leaf Jaeger, MD, MPH, Senior Medical Director, HealthEC Senior isolation is a health risk that affects at least a quarter of seniors over 65. […]
FDA panel unimpressed with data for Alzheimer’s drug aducanumab
The FDA may have been minded to approve Biogen and Eisai’s Alzheimer’s candidate aducanumab, but its clinical advisors have little doubt that the evidence for […]
FDA advisory panel vote against approving Biogen’s drug for Alzheimer’s
The nonbinding panel recommendation to reject the drug goes against what FDA scientists presented but they throw up another obstacle for the drug, which is […]
Trials and tribulations in Biogen’s Alzheimer’s drug reviews
Regulatory reviews of Biogen’s Alzheimer’s drug aducanumab are now ongoing on both sides of the Atlantic, but debate is still ongoing about whether the data […]
Topical Lemon Balm Lotion for Alzheimer’s
Improving cognitive performance with aromatherapy in young, healthy volunteers is one thing, but how about where it really matters? As I discuss in my video […]
Recent Advances in Alzheimer’s Disease Prevention
Recent Advances in Alzheimer’s Disease Prevention A prominent neurologist reviews what is known (and not known) about recent evidence-based advances in Alzheimer’s Disease prevention. The […]
Biogen to get speedy FDA review for Alzheimer’s drug despite not using voucher to request it
Biogen and Eisai said the FDA had accepted and given priority review to their application for aducanumab. The drug will undergo an advisory committee meeting […]
Roche doubles down on tau for Alzheimer’s, licensing UCB drug for $120m
Roche already has one Alzheimer’s candidate in its pipeline targeting tau, but has added a second via a deal with Belgian drugmaker UCB worth up […]
Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease
Shots: UCB to receive $120M and is eligible to receive $2B as cost reimbursement, development, and commercial milestones as well as royalties on sales of […]
Current Health, Dexcom Partner to Deliver Continuous, Remote Glucose Monitoring
What You Should Know: – Current Health has partnered with Dexcom to add continuous glucose monitoring (CGM) capabilities to its remote patient monitoring (RPM) platform […]
Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.
The FDA has 60 days to decide whether or not to accept the application. An analyst wrote that the agency accepting it with a priority […]
High Blood Pressure May Lead to Low Brain Volume
Having hypertension in midlife (ages 40 through 60) is associated with elevated risk of cognitive impairment and Alzheimer’s dementia later in life, even more so […]
