Category: alzheimer’s disease

  • 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 the home has skyrocketed. Accenture reported in 2021, for example, that remote patient monitoring technology adoption tripled among patients. Whether it is streaming video telehealth appointments with a provider, a […]

  • 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 were able to examine structural features of the brain, including regions that are not traditionally associated with Alzheimer’s. The simplicity of this process, scientists suggest, could aid clinicians in identifying […]

  • 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 (pimavanserin) is already FDA-approved to treat psychosis caused by Parkinson’s disease, but Acadia’s hope to expanding that use to the Alzheimer’s population were shot down by a complete response letter […]

  • 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 slow cognitive decline in patients with an inherited form of the disease. The result isn’t a big surprise – Roche terminated two phase 3 trials of crenezumab in people with […]

  • 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 of neurodegenerative diseases, including Alzheimer’s. The hope is that the toolkit will improve on current measurement tools for dementia and other neurological conditions that have serious limitations, according to the […]

  • 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 is now fully filed with the FDA. The two partners have also requested a priority review for the Biologics License Application (BLA) for lecanemab, which if granted by the FDA […]

  • 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 patients to radiation. Fujirebio Diagnostics’ Lumipulse G β-Amyloid Ratio (1-42/1-40) test has been cleared for use in adult patients aged 55 years and older who have cognitive impairment and are […]

  • 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 troubled Alzheimer’s therapy Aduhelm cease. Michel Vounatsos The headline news in the company’s first-quarter results statement (PDF) was Vounatsos’ departure, although he will remain at the helm of Biogen until […]

  • 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. “A significant body of evidence indicates that oxidized cholesterol, in the form of oxysterols, is one of the main triggers of AD [Alzheimer’s disease].” But, that’s not all. Cholesterol oxidation […]

  • 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 parmesan cheese. Too much cholesterol in the blood “has long been considered to act as a primary risk factor for developing Alzheimer’s disease and, possibly, Parkinson’s disease.” Striking images on […]

  • 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 clear the current data for the drug is not sufficient to get it past the EMA’s Committee for Medicinal Products for Human Use (CHMP). The decision does not come as […]

  • 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 system has been moving towards value-based care (VBC) which encourages health providers to improve care quality by reimbursing them based on successful outcomes rather than individual medical services. The overarching […]

  • 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 a few thousand patients enrolled in clinical trials. The final verdict from the CMS dashes any remaining hopes that Biogen may have held that it would be able to build […]

  • 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 genes takes the total number associated with Alzheimer’s to 75, opening up new avenues for research of ways to diagnose and treat the conditions, and suggest that immunological dysfunction may […]

  • 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 by US company Linus Health for an undisclosed sum. The merger brings together Kinesis’ gait analysis tools with Linus’ digital brain health monitoring technologies, designed to spot diseases like Alzheimer’s […]

  • 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 journal, allowing physicians to look at the data and make their own judgment on its efficacy and safety. The choice of journal looks like it could however add to the […]

  • 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 be used in the development of therapies for Alzheimer’s disease and related dementias. According to the consortium – which includes drugmakers Biogen, Eisai, Eli Lilly and Merck & Co – […]

  • 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 counterpart. The changes to the terms of their longstanding collaboration on Aduhelm (aducanumab) means that Eisai’s profit-share converts to a simple royalty rate on revenues from 1 January next year. […]

  • 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 to develop an AI-driven predictive model to help payers and providers identify patients with rapidly progressing mild cognitive impairment (MCI) and Alzheimer’s who may benefit from earlier treatment.  Impact of MCI […]

  • 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 hope of building its case for the drug. The new placebo-controlled SKYLINE study will enrol 1,250 people aged 60 to 80 with the earliest biological signs of Alzheimer’s – in […]

  • 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 total value of the deal could rise to $1 billion, dependent on whether Syndesi’s SV2A drugs – headed by early-stage clinical candidate SDI-118 – progress in development and reach the […]

  • 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, and fund the development of therapies for other diseases like Alzheimer’s and Parkinson’s. MindMaze takes a gaming approach to its DTx platform, but goes well beyond the use of a […]

  • 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 Aduhelm, saying it undermines well-established FDA processes. The letter to CMS’ director of coverage ad analysis Tamara Syrek Jensen said the decision to impose a coverage with evidence development (CED) […]

  • 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 of Biogen’s first-to-market Aduhelm has made going down the accelerated approval route all-but pointless. The company has planned to filed for speedy approval of donanemab based on the results of […]

  • 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 recent decades? As you can see at the start of my video How to Prevent Alzheimer’s with Diet, rates have climbed significantly. Is it due to rising obesity rates or […]

  • 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 for its biologic medicines, including its new Alzheimer’s candidates. The pharma group has said the total investment in the proposed facility in Limerick would be more than €400 million ($445 […]

  • 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 – which could be the primary source of income for the drug. If the provisional reimbursement decision by the Centre for Medicare and Medicaid Services (CMS) is finalised, Aduhelm (aducanumab) […]

  • 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 patients enrolled in clinical trials. Biogen and partner Eisai had been hoping for good news from the review of Aduhelm (aducanumab) by the Centre for Medicare and Medicaid Services (CMS), […]

  • 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 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 […]

  • 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 designation to lecanemab, their follow-up to recently approved Aduhelm. The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of […]

  • 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 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 […]

  • 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 reimbursement review of the drug by the US government. The price reduction for Aduhelm (aducanumab) comes into play from 1 January and comes on the back of the “feedback of […]

  • 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 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 […]

  • 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 for the drug. The companies had already indicated that the CHMP looked likely to turn down their marketing application for Aduhelm (aducanumab), but the decision nevertheless is a heavy blow, […]

  • 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 approval for controversial Alzheimer’s drug Aduhelm to a full one. Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians […]

  • 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 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.

  • 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 – a link that they say should be examined more closely in clinical trials. Viagra (sildenafil) – originally developed by Pfizer – is now widely available as a generic and can […]

  • 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 discovery of new medicines. The Oxford-GSK Institute of Molecular and Computational Medicine – based at Oxford’s Nuffield Department of Medicine – is being set up with £30 million (around $40 […]

  • 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. Eisai has licensed rights to a cognition-checking algorithm developed by Australian digital health company Cogstate, which it uses in an app – called NouKNOW – that allows people to check […]

  • 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 down the progression of Alzheimer’s disease (AD). Researchers at Brigham and Women’s Hospital in Boston, US, hope that the vaccine will stimulate the immune system to clear the amyloid plaques […]

  • 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 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.

  • 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 discussion next month. The CHMP had a “negative trend vote” on the drug at a meeting last week which included an “oral explanation” of Aduhelm (aducanumab), which was approved in […]

  • 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 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.

  • 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 and Eisai with a head-to-head trial against their recently-approved Aduhelm drug. Lilly has also picked up an accelerated review for donanemab from the FDA, which is assessing the drug under […]

  • 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 CognICA Integrated Cognitive Assessment (ICA) test developed by London, UK-based company Cognetivity Neurosciences has been approved by the FDA as an alternative to traditional pen-and-paper tests with some key advantages, […]

  • 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 seems to be going into reverse. As it turned out, Aduhelm (aducanumab) made just $300,000 in the three-month period from July to September, against analysts’ estimates of $12 million, suggesting […]

  • 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 a five-year trial involving thousands of patients. The trial – which will be supported by pharma company Eisai and Ionian University in the US – will see if the test […]

  • 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 with Alzheimer’s disease. The research by a team of National Institutes of Health (NIH) scientists found that people who took bumetanide, a generic drug usually used to treat heart failure […]

  • 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 disease as well, according to scientists in Canada. The team – from the University of British Columbia – are particularly excited about their findings because the drug could represent an […]

  • 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 second candidate lecanemab, starting a rolling submission to the FDA. Like Aduhelm (aducanumab) lecanemab – also known as BAN2401 – is another amyloid-directed antibody but has a slightly different mechanism, […]

  • 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 its controversial Alzheimer’s disease therapy Aduhelm. Speaking at a Morgan Stanley conference yesterday, Vounatsos said Biogen may have to revisit its sales forecasts for Aduhelm (aducanumab), which were already “very […]

  • 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 clinics for people with cognitive problems caused by dementia. The Singapore startup, which is partnering with the Mayo Clinic on the clinics, said the cash injection will also go towards […]

  • 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 trial, although it missed another. The Swiss biotech’s Nasdaq-listed shares were up around 66% shortly after the announcement of data from the LAURIET study in patients with mild-to-moderate Alzheimer’s disease, […]

  • 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 been shown to be medically effective. The company – said to be the largest health insurer in New York – said in a statement that Aduhelm (aducanumab) remains an investigational […]

  • 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 brain scan. The team – led by Prof Zoe Kourtzi of the university and Alan Turing Institute – told the BBC that the AI could make it possible to start […]

  • 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, although it has acknowledged it will have to overcome reservations about anti-amyloid drugs. Lilly’s chief scientific officer Dan Skovronsky said on the company’s second-quarter results call that the results of […]

  • 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 is running at an all-time high – and threatens to outstrip supply. Now, the National Institute on Aging (NIA) – part of the US National Institutes of Health (NIH) – […]

  • 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 drug’s efficacy following its controversial approval. The ICARE AD-US study will provide information on the long-term effectiveness and safety of Aduhelm (aducanumab) as prescribed in routine clinical practice within 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 what it says is “extensive misinformation and misunderstanding” about the drug. In an open letter, R&D chief Al Sandrock tackled a number of the criticisms levelled at the FDA’s decision […]

  • 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 in discussions with the FDA about a route to approval. There has been speculation since the unexpected approval of Biogen and Eisai’s Aduhelm (aducanumab) last month that other amyloid therapies […]

  • 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 to do otherwise would have left millions of patients in limbo for years. The trio say that the decision to approve Aduhelm (aducanumab) was extremely challenging as “evidence was strongly […]

  • 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 the drug’s effectiveness. Not to mention, its hefty price tag — $56,000 — could drive up Medicare spending.

  • 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 serve as an early warning system. The researchers used GPS logging devices and machine learning as “digital biomarkers” to compare the driving of people who have preclinical Alzheimer’s but are […]

  • 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 if a national strategy needs to be adopted. At the moment, the coverage for $56,000-a-year Aduhelm (aducanumab) is currently determined at the local level by Medicare administrative contractors representing 12 […]

  • 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 executives. The acting FDA commissioner has sent a letter to the Department of Health and Human Services (HHS) inspector general Christi Grimm on Friday, asking for a review of the […]

  • 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 of the drug in a broader group of patients than was included in clinical trials. Now, it has backtracked on that decision. The updated label for Aduhelm (aducanumab) says it […]

  • 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 treating neurological disorders. Alector’s approach addresses the role immune cell dysfunction plays in neurodegenerative disorders such as Alzheimer’s and Parkinson’s disease.

  • 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 reported piece from Adam Feuerstein, Matthew Herper, and Damian Garde about how in 2019 Biogen launched an effort to get their apparently failed drug approved by the FDA anyway. They […]

  • 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 the drug last month, and a swift update to its deliberations won’t be much comfort to the company. The cost-effectiveness watchdog has revised its calculation of a fair price range […]

  • 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 the drug last month, and a swift update to its deliberations won’t be much comfort to the company. The cost-effectiveness watchdog has revised its calculation of a fair price range […]

  • 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 theme. Alzheimer’s, ALS, progressive supranuclear palsy, Parkinson’s, Lewy body dementia, some types of frontotemporal dementia, Huntington’s, prion diseases such as BSE and more all feature abnormal protein aggregates that appear […]

  • 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 a mistake for a whole list of reasons, and we’re about to see another one of those in action. Eli Lilly has been attacking Alzheimer’s for decades now, in what […]

  • 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 canned. The decision comes on the back of the phase 2 TANGO study of gosuranemab (also known as BIIB092), which showed that the antibody was unable to show a benefit […]

  • 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 about the FDA’s approval of the drug – and it wants the scalps of those responsible. In a letter to Secretary of Health and Human Services Xavier Becerra, the director […]

  • 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 for treatment of Alzheimer’s disease. The approval was based on the surrogate endpoint of reduction in amyloid beta plaques in the brain. The manufacturer is required to conduct an additional […]

  • 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 in protest.  The latest to depart the FDA’s Peripheral and Central Nervous System Drugs panel is Aaron Kesselheim of Harvard Medical School, joining fellow committee members Joel Perlmutter and David […]

  • 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 think this is one of the worst FDA decisions I have ever seen, because – like the advisory committee that reviewed the application, and like the FDA’s own statisticians – […]

  • 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. That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s […]

  • 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 disease. The accelerated approval from the US regulator has been given even though its own advisory committee comprehensively voted down the main study filed in support of the drug last […]

  • 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 there isn’t enough evidence it works.

  • 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 there isn’t enough evidence it works.

  • 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 several people ask me what I think about this, and I can only refer them to what I said in 2019 and what I said late last year as well. Given […]

  • 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? As I discuss in my video Saffron Versus Memantine (Namenda) for Alzheimer’s, “saffron has been widely used in the Persian traditional medicine for memory problems,” but it wasn’t put to […]

  • 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 drug discovery.  The new molecule – called DSP-0038 – is being developed by Japan’s Sumitomo Dainippon Pharma (DSP), which is now starting a phase 1 trial in the US as […]

  • 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 expand into the notoriously-difficult area of dementia. Teresa Arroyo-Gallego tells us about the science behind the technology and how the team hopes to reshape cognitive screening.  While many disease areas […]

  • 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 quality-adjusted life years (QALYs). For Alzheimer’s disease, however, this approach may be limited. A paper by Garrison et al. (2021) identifies the petals of the value flower that are particularly […]

  • 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 carcinogenic heavy metal, and the major mechanism of arsenic-related damage appears to be oxidative stress. It’s the arsenic-induced accumulation of free radicals that can kill off cells and damage our […]

  • 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 away at Alzheimer’s for a long time now. They have yet another anti-amyloid antibody study out this week, and (as has happened over and over in this area) it as […]

  • 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 already-approved therapies for activity against the neurodegenerative disorder.  A team based at Massachusetts General Hospital and Harvard Medical School has come up with an AI algorithm – called DRIAD (Drug […]

  • 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 various reasons-some are inherited, some result from damage, and some from infections. It contributes to the highest disability-adjusted life years. The current treatment options are minimal. Most of the disorders […]

  • 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 will see Exscientia work with the charity’s Oxford Drug Discovery Institute (ODDI) to find therapeutics that target the neuroinflammation associated with Alzheimer’s disease (AD), focusing in particular on the NLRP3 […]

  • 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 phase 1/2 trial.  ACI-35.030, partnered with Johnson & Johnson, is designed to stimulate the body to generate antibodies against tau protein, one of the factors though to play a role […]

  • 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 (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active Lupus nephritis (LN). Lupkynis is the first oral therapy to receive FDA nod for Lupus […]

  • 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 efficacy of the drug in more than one indication, including generalized anxiety disorder (GAD), obsessive-compulsive disorder, spinocerebellar ataxia and Alzheimer’s disease (AD). However, it seems the drug continues to disappoint […]

  • 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 there’s no shortage of candidates that have failed despite positive mid-stage trial results. Some analysts have intimated that given the small size of the study at just over 270 patients, […]

  • 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. It has become recognized over the past decade as a risk factor for poor aging outcomes including cognitive decline, depression, anxiety, Alzheimer’s disease, obesity, hypertension, heart disease, impaired immune function, […]

  • 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 the drug is lacking. The much-anticipated advisory committee meeting held on Friday to discuss the marketing application for aducanumab proved to be a fractious affair, with both the companies’ data […]

  • 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 behind the drug is strong enough to support approval. The EMA has just kicked off its review of the anti-amyloid therapy, following in the footsteps of the FDA in the […]

  • 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 Best Aromatherapy Herb for Alzheimer’s, a group of Japanese researchers had a pie-in-the-sky notion that certain smells could lead to “nerve rebirth” in Alzheimer’s patients. Twenty years ago, even simply […]

  • 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 Doctor Weighs In

  • 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 to $2 billion. The Swiss pharma group is paying $120 million upfront for exclusive global rights to UCB0107, an anti-tau antibody that is in a phase 1 trial in another […]

  • 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 the therapies, if Roche proceeds the clinical development. Roche to get an exclusive license to develop and commercialize UCB0107 for AD UCB to fund and perform a POC study in […]

  • 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 – enhancing care and improving outcomes for diabetics. – Dexcom CGM data will transmit directly into the Current Health wearable and platform for review by the care management and clinical […]

  • 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 than having the so-called Alzheimer’s gene. “It is clear that cerebral vascular disease”—that is, hardening of the arteries inside our brain—“and cognitive decline travel hand in hand,” something I’ve addressed […]