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First new Alzheimer’s drug in decades receives controversial FDA approval

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A new Alzheimer’s disease treatment has been controversially approved for use in the United States despite an independent Food and Drug Administration (FDA) advisory panel reporting last year the drug’s Phase 3 trial results were inconclusive. The approval marks the first new treatment for Alzheimer’s in almost 20 years.

The ongoing story of aducanumab is turning into a twisty tale worthy of a Hollywood screenplay. Early clinical trials for this novel treatment were promising, removing accumulations of the toxic amyloid proteins thought to be one of the major damaging factors behind Alzheimer’s disease.

In early 2019 pharmaceutical company Biogen unexpectedly announced it was discontinuing its two large Phase 3 trials for aducanumab. An independent data monitoring committee had looked at the early results and concluded the drug didn’t seem to be working. The failure of these aducanumab trials followed the failure of a number of other anti-amyloid Alzheimer’s drugs, raising doubts over the veracity of the one hypothesis that dominated Alzheimer’s research for decades.

Then, later in 2019, something strange happened. Biogen suddenly revealed it had re-analyzed the aducanumab trial data and discovered the prior analysis was premature. It was claimed further investigations revealed significantly positive results from patients exposed to higher doses of the drug for longer periods of time. So, despite one of the two large Phase 3 trials finding no difference between aducanumab and placebo, the drug still potentially slowed cognitive decline in some patients.

The company claimed it was entering discussions with the FDA for market approval but many experts were concerned the evidence was simply not there to justify broad clinical use. An independent advisory committee convened by the FDA overwhelmingly recommended against the market approval of aducanumab in late 2020, claiming the clinical trials did not deliver clear evidence for the drug’s efficacy.

Now, in a rare instance of the FDA going against the advice of its own advisory panel, aducanumab has been conditionally approved for use in the United States. The FDA’s approval was granted under what is called Accelerated Approval, which means the drug meets such a serious unmet need it can be allowed to be administered to patients while Biogen undertakes another large clinical trial to confirm efficacy. Biogen has been given until 2030 to complete this additional trial.

“Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s,” says Patrizia Cavazzoni, from the FDA’s Center for Drug Evaluation and Research. “As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”

The approval of aducanumab is broad, authorizing its use for all Alzheimer’s patients from mild to severe. In approving aducanumab, the FDA has focused solely on the drug’s apparent ability to reduce the build-up of amyloid plaques in the brain. Whether this slows cognitive decline in late-stage Alzheimer’s or is more effective at preventing neurodegeneration in early-stage patients is yet to be determined.

However, what does seem clear is how unusual this particular approval is, considering the clinical data presented is below what would usually be necessary for FDA authorization. Caleb Alexander, a scientist on the FDA advisory panel who recommended against aducanumab’s approval, says he is surprised the drug has been authorized.

“The most compelling argument for approval was the unmet need but that cannot, or should not, trump regulatory standards,” Alexander said to StatNews. “It’s hard to find any scientist who thinks the data are persuasive. Unmet need is an important contextual factor but it’s not an evidentiary threshold.”

Robert Howard, a dementia researcher from University College London went even further, claiming the FDA has ignored the data, meaning it will take a decade of high healthcare costs before questions of efficacy can be resolved by the extra confirmatory trial.

“I consider the approval of aducanumab represents a grave error that will have only negative impact on patients and their families and that could derail the ongoing search for meaningful dementia treatments for a decade,” says Howard.

Biogen has priced the drug at US$56,000 per year, under the name Aduhelm, vowing to not increase the cost for at least four years. It is administered via monthly intravenous infusions and it’s unclear how much of the cost health insurers will cover.

“Price and access are sensitive matters for all groundbreaking innovations,” says Michel Vounatsos, CEO of Biogen. “We have engaged extensively with health economists, public health experts, and payers about Aduhelm – and we have examined other recent biologic drug innovations. Consistent with our pricing principles, we have established a price for Aduhelm that reflects the overall value this treatment brings to patients, caregivers and society – and one that will enable continuous innovation.”

Source: FDA

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Source: https://newatlas.com/health-wellbeing/aducanumab-aduhelm-alzheimers-controversial-fda-approval/

NEWATLAS

Personalized therapy for aggressive brain cancer shows promising results

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Newly announced results from a preliminary clinical trial testing a novel kind of brain cancer drug have revealed incredibly promising responses in a particular subset of patients. A larger Phase 2 trial is now underway targeting patients with a specific biomarker.

Glioblastoma is an aggressive and often deadly form of brain cancer, with around only five percent of patients surviving longer than five years after initial diagnosis. Lisavanbulin is one of several new drugs in development designed to inhibit tumor growth and treat this devastating form of cancer.

Long-term data from a recently completed Phase 1 human trial initially revealed mixed results, with only two of 20 patients showing significant improvement. However, looking more closely at the data the researchers discovered those two successful cases shared a particular characteristic.

Those two patients were found to have high expression of a particular protein called end-binding protein 1 (EB1) in their tumor tissue. Three out of the 20 subjects in this early trial showed strong EB1 expression.

“EB1 plays a pivotal role in the regulation of microtubule dynamics during cell division and has been shown to interact with microtubule-targeting agents, such as lisavanbulin, inhibiting tumor growth,” reports Basilea, the company developing the new drug.

Preclinical studies also found EB1 positivity was a strong predictor of efficacy. Following these findings a Phase 2 trial is now underway specifically focusing on glioblastoma patients with EB1-positive tumors.

“We are in a new era of personalized medicine, with markers in cancer cells offering vital clues to what treatment could target an individual’s disease,” says Juanita Lopez, from the Institute of Cancer Research. “This encouraging early study suggests some patients with advanced brain cancer who are EB1-positive could be treated with lisavanbulin, a targeted drug which blocks the growth of cancer cells.”

New findings presented at the recent American Society of Clinical Oncology (ASCO) Annual Meeting indicate EB1 expression can be found in approximately five percent of glioblastoma cases. The research also looked at EB1 expression in a number of other cancer samples, finding it in low levels in some metastatic melanoma, lung cancer and breast cancer tissue.

“We are looking forward to the interim results in our phase 2 study, which is enrolling patients with recurrent glioblastoma that is EB1-positive, towards the end of 2021,” says Marc Engelhardt, Basilea’s chief medical officer. “A clinical proof-of-concept in glioblastoma based on positive interim results would support exploring the selection of patients based on EB1-positivity in other tumor types as well, such as melanoma, breast, colorectal and lung cancers or rare cancer types such as medulloblastomas or neuroblastomas.”

Paul Nicholson, one of the patients in this early trial, saw his cancer shrink by more than 80 percent. Three years later his scans are still looking positive.

Lopez points out this novel targeted treatment may not work for all glioblastoma patients but it could offer new hope to those with EB1-positive cancers. Initial results from the international Phase 2 trial are expected later this year.

“We believe that our findings could be a key step in the development of the world’s first targeted brain cancer treatment, offering hope to some patients with aggressive glioblastoma,” says Lopez. “People with brain cancer currently have very poor survival rates and lack treatment options, so this could be a very welcome addition to our limited arsenal of tools to combat the disease.”

Source: ICR, Basilea

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Source: https://newatlas.com/health-wellbeing/personalized-therapy-glioblastoma-cancer-early-trial-results/

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NEWATLAS

Hyundai buys Boston Dynamics, maker of Spot the robotic dog

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Hyundai Motor Group has made a major move into the world of mobile robotics, announcing that it has acquired a majority stake in Boston Dynamics from Japanese technology firm Softbank. Most famous for its ever-impressive robotic dog named Spot, Boston Dynamics will now work together with the automaker on technologies that advance human mobility.

Boston Dynamics first put Spot on sale in June of last year, and among its stable of agile machines the dog-like quadruped is undoubtedly the star of the show. We’ve seen it go to work herding sheep in New Zealand, tracking the vital signs of COVID-19 patients and inspecting construction sites, to list just a few of its responsibilities.

But Boston Dynamics is no one-trick pony. It has also developed a back-flipping humanoid robot called Atlas, a leaping, wheeled robot called Handle and an advanced version of Handle called Stretch, which is optimized for warehouse work and is expected to go on sale next year.

All of this appears to have caught the eye of the Hyundai Motor Group, which reportedly entered talks last year with owner Softbank to buy the robot-maker. The deal has now been made official and values Boston Dynamics at US$1.1 billion, with Hyundai now holding an 80-percent controlling stake and leaving Softbank with the remaining 20 percent.

Hyundai describes this as another step in its transformation into a “Smart Mobility Solution Provider,” to go alongside its other investments in autonomous driving, AI, urban aircraft and robotics. The two will work together on robots for wide-ranging applications, from logistics to manufacturing, while also continuing to expand Boston Dynamic’s lineup of mobile machines.

The promo video for the announcement can be viewed below.

Hyundai x Boston Dynamics | As mobility evolves so does humanity

Source: Hyundai

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Source: https://newatlas.com/robotics/hyundai-boston-dynamics-spot-robotic-dog/

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NEWATLAS

New method converts carbon into graphene or diamond in a flash

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Researchers at Rice University have developed a way to turn carbon from a variety of sources straight into useful forms such as graphene or diamond. The technique uses a “flash” of electricity to heat the carbon, converting it into a final form that’s determined by the length of the flash.

The technique is known as flash joule heating (FJH), and the team first described it in January 2020. An electrical current is passed through carbon-containing materials, heating them to about 2,727 °C (4,940 °F), which converts the carbon into pristine, turbostratic graphene flakes.

Now the researchers have refined the process to create other materials. The original flashes lasted 10 milliseconds, but the team found that by changing the duration between 10 and 500 milliseconds they could also guide the carbon to convert into other forms, too. That includes nanodiamond, and “concentric carbon” where carbon atoms form a shell around a nanodiamond core.

An electron microscope image of concentric carbon, where carbon atoms form a shell around a nanodiamond core
An electron microscope image of concentric carbon, where carbon atoms form a shell around a nanodiamond core

Tour Group

To help the process along, organic fluorine compounds and precursors are now added to the mix at the beginning. Previous studies have shown that fluorine helps carbon atoms stick together more strongly, allowing the nanodiamonds to be made under gentler conditions – normally it would take very high pressures.

The team says that the new FJH process can help produce these new forms in bulk, which is traditionally tricky to do. That includes fluorinated nanodiamonds, which are more useful in electronic components such as semiconductors but normally need to undergo a separate doping process.

“In industry, there has been a long-standing use for small diamonds in cutting tools and as electrical insulators,” says James Tour, lead researcher on the study. “The fluorinated version here provides a route to modifications of these structures. And there is a large demand for graphene, while the fluorinated family is newly produced here in bulk form. The concentric-shelled structures have been used as lubricant additives, and this flash method might provide an inexpensive and fast route to these formations.”

The team says that the next steps are to experiment with using other additives such as boron, phosphorus and nitrogen.

The research was published in the journal ACS Nano.

Source: Rice University

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Source: https://newatlas.com/materials/carbon-graphene-diamond-flash-joule-heating/

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Durable concrete uses graphene particles to fend off water and cracks

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As scientists work to shore up the strength and durability of concrete, it mightn’t come as a huge surprise that the wonder material graphene is proving to be a promising additive. As the world’s strongest artificial material, it may have a lot to offer the world of construction, and the latest example of this comes from Northwestern University researchers, who have developed a novel form of graphene-infused cement that is highly resistant to water and cracks.

As the key ingredient in the production of concrete, the world’s most widely used material, cement has a massive environmental footprint, accounting for around eight percent of global greenhouse gas emissions. One way researchers hope to reduce this burden this is by developing forms of concrete that last for longer, which reduces the need for further concrete to replace compromised structures.

One of the reasons concrete structures fail is the formation of cracks, which start out as tiny ruptures. Once water infiltrates these ruptures, they can cause them to grow in size until the entire thing needs repairing or replacing. We’ve seen some interesting ways scientists may be able to intervene in this process, through “self-healing” concrete that patches up its own cracks with help from blood enzymes, fungus and special glues.

Graphene might also play a part in this. We’ve seen promising concrete prototypes that use flakes of graphene to decrease water permeability, and even how old tires can be converted into graphene for the production of stronger concrete. And the technology is starting to make its way into the real world, with engineers recently pouring the world’s first graphene-enhanced concrete slab in England.

The Northwestern University researchers have been cooking up yet another supercharged cement recipe, where tiny particles of the wonder material are incorporated to make concrete more resistant to water. The team experimented with a range of particle types, including carbon nanotubes, carbon nanofibers and graphene nanoplatelets, and then tested their performance through an advanced technique known as scratch testing. This subjects the microscopic bits of the material to conical probes to test their fracture response.

“I was able to look at many different materials at the same time,” says lead author of the study, Ange-Therese Akono. “My method is applied directly at the micrometer and nanometer scales, which saves a considerable amount of time. And then based on this, we can understand how materials behave, how they crack and ultimately predict their resistance to fracture.”

These experiments also allowed the scientists to tweak the makeup of the cement to enhance its performance. Through this process, the team landed on graphene nanoplatelets as the winning ingredient, which they found could be incorporated in small amounts to improve the fracture resistance of the finished product. This was achieved by lowering the material’s porosity and therefore water penetration, which decreased by 78 percent.

“The role of nanoparticles in this application has not been understood before now, so this is a major breakthrough,” Akono says. “As a fracture mechanics expert by training, I wanted to understand how to change cement production to enhance the fracture response.”

The research was published in the journal Philosophical Transactions of the Royal Society A.

Source: Northwestern University

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Source: https://newatlas.com/materials/durable-concrete-graphene-particles-water-cracking/

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