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 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 …

GSK pumps £30m into a new Oxford University partnership Read More »

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 …

Eisai forges alliance with FCNT on digital tools for dementia Read More »

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 …

Trial of intranasal Alzheimer’s vaccine gets underway in US Read More »

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 cases were asymptomatic.

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 cases were asymptomatic.

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 cases were asymptomatic.

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 cases were asymptomatic.

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 cases were asymptomatic.

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 cases were asymptomatic.

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 …

CHMP minded to turn down Alzheimer’s drug Aduhelm, says Biogen Read More »

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 …

Lilly files Alzheimer’s drug donanemab as Cortexyme rival fails trial Read More »

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, …

FDA clears AI-powered digital test for early dementia Read More »

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 …

Biogen’s Aduhelm rollout goes from bad to worse Read More »

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 for the rest of the year.

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 for the rest of the year.

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 …

Eisai-backed trial will assess Altoida’s digital test for early Alzheimer’s Read More »

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 …

Data dive finds cheap diuretic could be Alzheimer’s drug Read More »

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 Ab) in patients with AD, demonstrated a reduction in brain amyloid plaque The studies have been included in the optimized design of two ongoing P-III trials, GRADUATE 1 & 2 …

Genentech’s Gantenerumab Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Alzheimer’s Disease Read More »

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 …

Could Pfizer’s Inlyta have a role in Alzheimer’s disease? Read More »

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, Eisai double down on Alzheimer’s with lecanemab filing Read More »

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 …

Biogen admits slow Aduhelm launch, as scientists question label again Read More »

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 …

Startup Neuroglee raises $10m for virtual neurology clinics Read More »

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 globally. The therapy is being developed by Genentech The trial met its one co-1EPs i.e 43.6% reduction in cognitive decline from baseline as measured by ADAS-Cog11 @49wks. The 2EPs were …

AC Immune Report Results of Semorinemab in P-II Lauriet Study for the Treatment of Alzheimer’s Disease Read More »

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, …

AC Immune claims half a win for tau drug in Alzheimer’s trial Read More »

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 …

Health insurer Excellus will not fund Alzheimer’s drug Aduhelm Read More »

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 …

Cambridge team says AI could diagnose dementia with one scan Read More »

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 …

Lilly sets out its stall on donanemab as filing approaches Read More »

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 study, which is one of three post-marketing clinical programs planned to generate more data about the drug

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) – …

NIH digital tool aims to boost enrolment into Alzheimer’s studies Read More »

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 adds real-world test for Aduhelm to its confirmatory trial Read More »

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 …

Biogen bites back at critics of Aduhelm after drug’s slow start Read More »

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 …

Roche ‘talking to FDA’ as Alzheimer’s drug moves towards 2022 readout Read More »

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.

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 …

FDA staffers defend Aduhelm approval in JAMA editorial Read More »

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 …

How’s my driving? GPS tracking spots Alzheimer’s with 86% accuracy Read More »

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 …

US starts review of Aduhelm coverage amid fears of Medicare hit Read More »

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 …

Aduhelm approval controversy dials up as FDA seeks probe Read More »

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 …

FDA whittles back Aduhelm approval amid concern over broad label Read More »

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.

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 Biogen’s recently approved Aduhelm, Acumen says its antibody has potential dosing and safety advantages.

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 Read More »

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 Read More »

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 …

Protein Aggregation Diseases Read More »

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 …

Biogen abandons tau antibody for Alzheimer’s after phase 2 miss Read More »

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 …

Consumer group seeks resignation of top FDA staffers over Aduhelm okay Read More »

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 …

Aducanumab (Aduhelm) for Alzheimer’s Disease Read More »

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 …

And then there were three: another FDA adcomm member quits over Aduhelm Read More »

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 …

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag Read More »

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 …

Jubilation for Biogen, Eisai as FDA says ‘yes’ to aducanumab Read More »

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 …

Saffron Put to the Test for Alzheimer’s Read More »

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 …

Exscientia starts trials of AI-designed Alzheimer’s drug Read More »

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 …

Can your typing patterns reveal if you have Alzheimer’s? Read More »

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 …

ISPOR Value Flower and Alzheimer’s Disease Read More »

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 …

Benefits of Turmeric for Arsenic Exposure Read More »

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 …

AI platform says Olumiant could be repurposed for Alzheimer’s Read More »

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 …

Gene and Cell Therapies in CNS Disorders: Miracle Cure? Opportunities Galore! Read More »

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 its krill-based LPC EPA/DHA product (Lysoveta) The team will evaluate the link between genetic variations in lipid metabolism & transport of EPA/DHA across the BBB using knock-in mice for human …

Aker BioMarine Collaborate with Université de Sherbrooke Department of Medicine for Alzheimer’s Disease Read More »

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 …

Alzheimer’s Research UK starts AI-based drug hunt with Exscientia Read More »

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 …

Early data back J&J and AC Immune’s Alzheimer’s jab Read More »

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 …

Aurinia’s Lupkynis for Lupus; FDA Fast Track Designation for Toripalimab; Wren Therapeutics’ Financing; Merck’s Covid-19 Vaccine Program End Read More »

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 …

Biohaven’s Troriluzole Failure; Daiichi/ AZ’s Enhertu; Fujifilm & Manufacturing Spree; J&J’s Darzalex Faspro Read More »

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, …

Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects? Read More »

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, …

How Care Coordination Technology Addresses Social Isolation in Seniors Read More »

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 …

FDA panel unimpressed with data for Alzheimer’s drug aducanumab Read More »

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 …

Trials and tribulations in Biogen’s Alzheimer’s drug reviews Read More »

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 …

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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 at an undisclosed date. Biogen’s stock rose 10%, but analysts had mixed opinions.

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 doubles down on tau for Alzheimer’s, licensing UCB drug for $120m Read More »

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 …

Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease Read More »

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 …

Current Health, Dexcom Partner to Deliver Continuous, Remote Glucose Monitoring Read More »

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 or standard review may signal whether the agency is seriously considering approval or has continued reservations about the amyloid beta-targeting drug’s clinical benefit.

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 …

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