An anonymous reader shares a report: The Food and Drug Administration has refused to start a review of Moderna's application for its experimental flu shot, the company announced Tuesday, in another sign of the Trump administration's influence on tightening vaccine regulations in the U.S. Moderna said the move is inconsistent with previous feedback from the agency from before it submitted the application and started phase three trials on the shot, called mRNA-1010. The drugmaker said it has requested a meeting with the FDA to "understand the path forward."

Moderna noted that the agency did not identify any specific safety or efficacy issues with the vaccine, but instead objected to the study design, despite previously approving it. The company added that the move won't impact its 2026 financial guidance. Moderna's jab showed positive phase three data last year, meeting all of the trial goals. At the time, Moderna said the stand-alone flu shot was key to its efforts to advance a combination vaccine targeting both influenza and Covid-19.

Scientists from Spain and China have successfully repaired the blood-brain barrier in Alzheimer's-model mice, enabling the brain to naturally clear amyloid-beta plaques and reverse cognitive decline. "After just three drug injections, mice with certain genes that mimic Alzheimer's showed a reversal of several key pathological features," adds ScienceAlert. From the report: Within hours of the first injection, the animal brains showed a nearly 45 percent reduction in clumps of amyloid-beta plaques, a hallmark of Alzheimer's disease. The mice had previously shown signs of cognitive decline, but after all three doses, the animals performed on par with their healthy peers in spatial learning and memory tasks. The benefits lasted at least six months.

These preclinical results don't guarantee success in humans, but they're an encouraging start, which the authors say "heralds a new era" in drug research. "The therapeutic implications are profound," claim the international team of researchers, co-led by scientists at the Institute for Bioengineering of Catalonia (IBEC) and the West China Hospital Sichuan University (WCHSU). The findings have been published in Signal Transduction and Targeted Therapy.

An anonymous reader quotes a report from the Associated Press: U.S. health officials on Friday endorsed the first blood test that can help diagnose Alzheimer's and identify patients who may benefit from drugs that can modestly slow the memory-destroying disease. The test can aid doctors in determining whether a patient's memory problems are due to Alzheimer's or a number of other medical conditions that can cause cognitive difficulties. The Food and Drug Administration cleared it for patients 55 and older who are showing early signs of the disease.

The new test, from Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a key marker for Alzheimer's. Previously, the only FDA-approved methods for detecting amyloid were invasive tests of spinal fluid or expensive PET scans. The lower costs and convenience of a blood test could also help expand use of two new drugs, Leqembi and Kisunla, which have been shown to slightly slow the progression of Alzheimer's by clearing amyloid from the brain. Doctors are required to test patients for the plaque before prescribing the drugs, which require regular IV infusions. [...]

A number of specialty hospitals and laboratories have already developed their own in-house tests for amyloid in recent years. But those tests aren't reviewed by the FDA and generally aren't covered by insurance. Doctors have also had little data to judge which tests are reliable and accurate, leading to an unregulated marketplace that some have called a "wild west." Several larger diagnostic and drug companies are also developing their own tests for FDA approval, including Roche, Eli Lilly and C2N Diagnostics. The tests can only be ordered by a doctor and aren't intended for people who don't yet have any symptoms.

San Francisco-based biotech startup Loyal says a drug it developed to increase dogs' lifespan "has passed a significant milestone on the way to regulatory approval," reports the Washington Post: The Food and Drug Administration certified the daily pill as having a "reasonable expectation of effectiveness" at extending senior dogs' lifespans. The regulator's Center for Veterinary Medicine still has to certify that the drug is safe and that Loyal can manufacture it at scale before vets can prescribe the pill to dogs 10 years or older that weigh 14 pounds or more. Loyal's CEO, Celine Halioua, estimates that the process should be complete by the end of 2025 and called the FDA's initial recognition "a key step" to extending dogs' lives...

In the past decade, a subculture of tech entrepreneurship has focused on helping people stave off death, hawking custom-made dietary supplements and $2,500 full-body MRIs and investing in the development of antiaging drugs, among many other efforts. According to data firm Pitchbook, about $900 million in venture capital has been poured into antiaging and longevity start-ups in the past 12 months. Loyal has raised more than $150 million in venture funding since its 2019 founding to develop lifespan-extending drugs initially focused on canines.

Launching veterinary drugs is in some ways easier than winning approval for human treatments. Because dogs and humans have evolved alongside one another, Halioua hopes to eventually apply her findings about pets to help prolong their owners' lives. "If we can successfully delay the onset and severity of age-related diseases in dogs, it's extremely compelling evidence that it will also do that in humans," Halioua said. The biological processes of aging unfold faster in dogs because they live such short lives, she said, helping researchers and entrepreneurs probe how they work.
"Loyal's pill is a result of research into how to mimic the life-extending benefit of caloric restriction without the appetite suppression," according to the article, "and without the need for an owner to restrict their dog's food.

"The drug aims to improve a dog's metabolic fitness, or the body's ability to convert nutrients into energy and regulate hormones, which declines in humans and canines with age..."

Bruce66423 shares a report from the Associated Press: Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose associated with opioid medications such as Vicodin and OxyContin. "It's the first new pharmaceutical approach to treating pain in more than 20 years, offering an alternative to opioids and over-the-counter medications such as ibuprofen and acetaminophen. But the medication's modest effectiveness and lengthy development process underscore the challenges of finding new ways to manage pain.

Studies in more than 870 patients with acute pain due to foot and abdominal surgeries showed Vertex's drug provided more relief than a dummy pill but didn't outperform a common opioid-acetaminophen combination pill. "It's not a slam dunk on effectiveness," said Michael Schuh of the Mayo Clinic, a pharmacist and pain medicine expert who was not involved in the research. "But it is a slam dunk in that it's a very different pathway and mechanism of action. So, I think that shows a lot promise." The new drug will carry a list price of $15.50 per pill, making it many times more expensive than comparable opioids, which are often available as generics for $1 or less. [...]

Opioids reduce pain by binding to receptors in the brain that receive nerve signals from different parts of the body. Those chemical interactions also give rise to opioids' addictive effects. Vertex's drug works differently, blocking proteins that trigger pain signals that are later sent to the brain. "In trying to develop medicines that don't have the addictive risks of opioid medicines, a key factor is working to block pain signaling before it gets to the brain," Vertex's Dr. David Altshuler, told The Associated Press last year. Commonly reported side effects with the drug were nausea, constipation, itching, rash and headache.

An anonymous reader shares a report: A lawyer defending an alleged distributor of Anom, the encrypted phone company for criminals that the FBI secretly ran and backdoored to intercept tens of millions of messages, is pushing to learn the identity of the confidential human source (CHS) who first created Anom and provided it to the FBI starting the largest sting operation in history, according to recently filed court records. The government says it will provide that identity under discovery, but the CHS may also be revealed in open court if they testify.

The move is significant in that the CHS, who used the pseudonym Afgoo while running Anom, is a likely target for retaliation from violent criminals caught in Anom's net. The Anom case, called Operation Trojan Shield, implicated hundreds of criminal syndicates in more than 100 countries. That includes South American cocaine traffickers, Australian biker gangs, and kingpins hiding in Dubai. Anom also snagged specific significant drug traffickers like Hakan Ayik, who authorities say heads the Aussie Cartel which brought in more than a billion Australian dollars in profit annually. Court records say, however, that if this defendant's case goes to trial, the lawyer believes Afgoo will be the "government's key witness."

The Wall Street Journal visits scientists at Harvard University's Wyss Institute for Biologically Inspired Engineering who are researching a "sugar-to-fiber" enzyme (normally used by plants to create stalks). They're testing a version they've "encased in spherical nanoparticles — tiny mesh-like cages made of pectin that allow the enzyme to be added to food without being activated until it reaches the intestine.

"Once there, a change in pH causes the cage to expand, freeing the enzyme to float through its holes and start converting sugar to fiber." The Wyss Institute's goal for its enzyme product was to reduce the sugar absorbed from food by 30%, though it has the potential to remove even more than that, says Sam Inverso, director of business development partnerships at the Wyss Institute. The enzyme's ability to turn sugar into fiber is also key, as most Americans don't get nearly enough fiber in their diet, says Adama Sesay, a senior engineer at the Wyss Institute who worked on the project...

The Wyss Institute is now licensing the technology to a company to help bring its enzyme product to market, a process that entails additional testing and work to secure regulatory approval. Inverso says that the aim is for the product to be available to U.S. food manufacturers within the next two years, and that other encapsulated enzymes could follow: products that reduce lactose absorption after drinking milk, or cut gluten after eating bread. For now the enzyme works better in solid food than in a liquid. Producing it in large quantities and at low cost is still a ways off — currently it's 100 times more expensive than raw sugar, Inverso says.
And the Journal notes they're not the only ones working on the problem: San Francisco-based startup Biolumen recently launched a product called Monch Monch, a drink mix made of fibrous, microscopic sponges designed to soak up sugar and prevent it from reaching the bloodstream. At mealtime consumers can blend a teaspoon of Monch Monch, which has no taste, smell or color, into drinks from water to wine. Once it has reached the stomach, the sponges start to swell and sequester sugar, reducing its burden on the body, says Dr. Robert Lustig, Biolumen's co-founder and chief medical officer... One gram of Monch Monch can sequester six grams of sugar, says Lustig... The product, introduced as a dietary supplement, can also be used as a food ingredient under a Food and Drug Administration principle known as "generally recognized as safe." Packets of Monch Monch are available for purchase online, and Biolumen says it is in talks with U.S. food manufacturers it declined to name about its use in other products...

Food companies are betting on other solutions for now. Cereal startup Magic Spoon uses allulose, a natural sugar found in figs and raisins that is growing in popularity, helped by FDA guidance that allows it to be excluded from sugar or added-sugar totals on nutrition labels. Ingredient company Tate & Lyle, which makes allulose from corn kernels, says the sweetener tastes like sugar and adds bulk and caramel color, but passes through the body without being metabolized... Chicago-based Blommer Chocolate recently launched a line of reduced-sugar chocolate and confectionery products made with Incredo, a sugar that has been physically altered to taste sweeter using a mineral carrier that dissolves faster in saliva and targets the sweet-taste receptors on the tongue. Incredo's use enables manufacturers to use up to 50% less sugar, the company says.
The article even notes that "researchers still working to reduce sugar are peddling new technologies, like individual sugar crystals modified to dissolve more quickly in the mouth, making food taste sweeter."

An anonymous reader quotes a report from The Verge: The Senate passed the Kids Online Safety Act (KOSA) and the Children and Teens' Online Privacy Protection Act (also known as COPPA 2.0), the first major internet bills meant to protect children to reach that milestone in two decades. A legislative vehicle that included both KOSA and COPPA 2.0 passed 91-3. Senate Majority Leader Chuck Schumer (D-NY) called it "a momentous day" in a speech ahead of the vote, saying that "the Senate keeps its promise to every parent who's lost a child because of the risks of social media." He called for the House to pass the bills "as soon as they can."

KOSA is a landmark piece of legislation that a persistent group of parent advocates played a key role in pushing forward -- meeting with lawmakers, showing up at hearings with tech CEOs, and bringing along photos of their children, who, in many cases, died by suicide after experiencing cyberbullying or other harms from social media. These parents say that a bill like KOSA could have saved their own children from suffering and hope it will do the same for other children. The bill works by creating a duty of care for online platforms that are used by minors, requiring they take "reasonable" measures in how they design their products to mitigate a list of harms, including online bullying, sexual exploitation, drug promotion, and eating disorders. It specifies that the bill doesn't prevent platforms from letting minors search for any specific content or providing resources to mitigate any of the listed harms, "including evidence-informed information and clinical resources." The legislation faces significant opposition from digital rights, free speech, and LGBTQ+ advocates who fear it could lead to censorship and privacy issues. Critics argue that the duty of care may result in aggressive content filtering and mandatory age verification, potentially blocking important educational and lifesaving content.

The bill may also face legal challenges from tech platforms citing First Amendment violations.

OpenAI CEO Sam Altman and businesswoman Arianna Huffington have announced they're working on an "AI health coach" via Thrive AI Health. According to a Time magazine op-ed, the two executives said that the bot will be trained on "the best peer-reviewed science" alongside "the personal biometric, lab, and other medical data you've chosen to share with it." The Verge reports: The company tapped DeCarlos Love, a former Google executive who previously worked on Fitbit and other wearables, to be CEO. Thrive AI Health also established research partnerships with several academic institutions and medical centers like Stanford Medicine, the Rockefeller Neuroscience Institute at West Virginia University, and the Alice L. Walton School of Medicine. (The Alice L. Walton Foundation is also a strategic investor in Thrive AI Health.) Thrive AI Health's goal is to provide powerful insights to those who otherwise wouldn't have access -- like a single mother looking for quick meal ideas for her gluten-free child or an immunocompromised person in need of instant advice in between doctor's appointments. [...]

The bot is still in its early stages, adopting an Atomic Habits approach. Its goal is to gently encourage small changes in five key areas of your life: sleep, nutrition, fitness, stress management, and social connection. By making minor adjustments, such as suggesting a 10-minute walk after picking up your child from school, Thrive AI Health aims to positively impact people with chronic conditions like heart disease. It doesn't claim to be ready to provide real diagnosis like a doctor would but instead aims to guide users into a healthier lifestyle. "AI is already greatly accelerating the rate of scientific progress in medicine -- offering breakthroughs in drug development, diagnoses, and increasing the rate of scientific progress around diseases like cancer," the op-ed read.

Slashdot reader quonset writes: After decades of study and testing, a potential vaccine for cancer may be on the horizon. Dr. Thomas Wagner, founder of Orbis Health Solutions, is using the body's own immune system to fight the disease, with each shot personalized to the patient, according to ABC News.
From the article: Typically, cancer cells evade a person's immune system because it is recognized as that person's cells. Wagner developed a tumor lysate particle only (TLPO) vaccine that uses a person's tumor cells to identify particular parts that are then presented back in the body using the vaccine in a way that can stimulate their immune system to gain the ability to detect these cancer cells like an infection, allowing the immune system to fight the cancer itself.

"People used to ask me the question, 'When will there be a cure for cancer?' And I've been doing this for 60 years and I could never answer that question," Wagner said. "Until recently, until the last three or four or five years." Wagner believes this type of cancer treatment could be a key to finding the long-awaited cure for cancer, all cancers, if paired with early detection.

Wagner's TLPO cancer vaccine has been tested in hundreds of patients with advanced forms of melanoma in Phase 2 clinical trials. The most recent data presented at an academic conference showed nearly 95% of people given only the vaccine were still alive three years after starting treatment and 64% were still disease-free. Among the most advanced forms of melanoma, disease-free survival after three years for people with stage III disease was 60% in the vaccine-only group, compared to about 39% in the placebo group. Disease-free survival for those with stage IV disease was about 68% in the vaccine-only group, and zero in the placebo group.

The most common side effects were redness or pain at the injection site, fever and fatigue after the injection – similar to other vaccines that stimulate an immune response.

Based on this data and other studies, the U.S. Food and Drug Administration has greenlit Wagner's vaccine to start a Phase 3 clinical trial. It will be a three-year endeavor with a goal to enroll 500 people and is planned to launch sometime this year, Riley Polk, president of Orbis Health Solutions, told WLOS, an ABC News affiliate in Asheville, North Carolina.
Polk's own father was told there were no treatment options left for his lung cancer, according to the article. That was more than 10 years ago, and "His father opted to try Wagner's cancer vaccine and lived 10 more years before dying from something unrelated to cancer." Polk gives ABC News this quote.

"You can tell me a lot of things, but you can't tell me [the vaccine] doesn't work."

"It's ridiculous just how virulent some of these bacteria get over time," says Dwayne Roach, assistant professor of bacteriophages, infectious disease and immunology at San Diego State University.

But now CNN says doctors are fighting multi-drug-resistant superbugs with "nature's oldest predators — tiny tripod-looking viruses called phages designed to find, attack and gobble up bacteria." The microscopic creatures have saved the lives of patients dying from superbug infections and are being used in clinical trials as a potential solution to the growing problem of antibiotic resistance...

In labs around the country, phage scientists are taking research and discovery to the next level... [Yale scientists] are busy mapping which phages and antibiotics are most symbiotic in the fight against a pathogen. Roach's San Diego State lab is investigating the body's immune response to phages while developing new phage purification techniques to prepare samples for intravenous use in patients. Currently, clinical trials are underway to test the effectiveness of phages against intractable urinary tract infections, chronic constipation, joint infections, diabetic foot ulcers, tonsillitis and the persistent, reoccurring infections that occur in patients with cystic fibrosis. The chronic infections common in cystic fibrosis are typically due to various strains of drug-resistant Pseudomonas aeruginosa — the same pathogen responsible for Horton's ear infection and the artificial tears outbreak.

A number of labs are developing libraries of phages, stockpiled with strains found in nature that are known to be effective against a particular pathogen. In Texas, a new facility is taking that a step further — speeding up evolution by creating phages in the lab. "Rather than just sourcing new phages from the environment, we have a bioreactor that in real time creates billions upon billions of phages," said Anthony Maresso, associate professor at Baylor College of Medicine in Houston. "Most of those phages won't be active against the drug-resistant bacteria, but at some point there will be a rare variant that has been trained, so to speak, to attack the resistant bacteria, and we'll add that to our arsenal," Maresso said. "It's a next-generation approach on phage libraries." Maresso's lab published a study last year on the treatment of 12 patients with phages customized to each patient's unique bacterial profile. It was a qualified success: The antibiotic-resistant bacteria in five patients were eradicated, while several more patients showed improvements.

"There's a lot of approaches right now that are happening in parallel," Roach said. "Do we engineer phages? Do we make a phage cocktail, and then how big is the cocktail? Is it two phages or 12 phages? Should phages be inhaled, applied topically or injected intravenously? There's a lot of work underway on exactly how to best do this...." Genetically engineering phages would allow scientists to target each person's unique mix of antibiotic-resistant pathogens instead of searching sewage, bogs, ponds, the bilge of boats and other prime breeding grounds for bacteria to find just the right phage for the job.

Along with phage libraries, genetic engineering is also a key to churning out phages in mass, to distribute on a wider scale. In Russia and the country of Georgia, where phage therapy has been used for decades, patients can buy phage cocktails off the shelf in pharmacies.

"I'm optimistic about the world's climate progress," Bill Gates wrote this week — but he also explained why.

"In 2024 and beyond, I predict we will see lots of new innovations coming into the marketplace — even in very complicated areas like nuclear. The climate crisis can feel overwhelming, but I find it easier to stay optimistic when you focus on all the progress we're making. If the world continues to prioritize funding innovation, I'm hopeful we can make good progress on our climate goals."

And elsewhere Gates writes that "AI is about to supercharge the innovation pipeline." My work has always been rooted in a core idea: Innovation is the key to progress. It's why I started Microsoft, and it's why Melinda and I started the Gates Foundation more than two decades ago. Innovation is the reason our lives have improved so much over the last century. From electricity and cars to medicine and planes, innovation has made the world better. Today, we are far more productive because of the IT revolution. The most successful economies are driven by innovative industries that evolve to meet the needs of a changing world.

My favorite innovation story, though, starts with one of my favorite statistics: Since 2000, the world has cut in half the number of children who die before the age of five. How did we do it? One key reason was innovation. Scientists came up with new ways to make vaccines that were faster and cheaper but just as safe. They developed new delivery mechanisms that worked in the world's most remote places, which made it possible to reach more kids. And they created new vaccines that protect children from deadly diseases like rotavirus.

In a world with limited resources, you have to find ways to maximize impact. Innovation is the key to getting the most out of every dollar spent. And artificial intelligence is about to accelerate the rate of new discoveries at a pace we've never seen before.

One of the biggest impacts so far is on creating new medicines. Drug discovery requires combing through massive amounts of data, and AI tools can speed up that process significantly. Some companies are already working on cancer drugs developed this way. But a key priority of the Gates Foundation in AI is ensuring these tools also address health issues that disproportionately affect the world's poorest, like AIDS, TB, and malaria. We're taking a hard look at the wide array of AI innovation in the pipeline right now and working with our partners to use these technologies to improve lives in low- and middle-income countries...

I feel like a kid on Christmas morning when I think about how AI can be used to get game-changing technologies out to the people who need them faster than ever before. This is something I am going to spend a lot of time thinking about next year.
Gates notes that researchers are already exploring questions like "Can AI combat antibiotic resistance?"

As detailed in a paper published in Cell Chemical Biology, researchers have developed a "cancer-killing pill" capable of destroying solid tumors while leaving healthy cells unaffected. The new drug has been in development for 20 years and is now undergoing pre-clinical research in the U.S.. Derek Lowe, a medicinal chemist and freelance writer on science and pharmaceutical topics, writes about the new paper via Science Magazine: It's about a molecule designated AOH1996, which seems to have a unique mode of action in tumor cells, one that might make it more more selective for those as compared to normal ones. The key target here is a protein called PCNA (from its old name of "proliferating cell nuclear antigen"). [...] The current molecule is a traditional direct small molecule binder that is selective for caPCNA over the regular type, which is a very attractive advantage to explore. The team behind it has been working on it for several years now to validate that mechanism, and the new paper linked first above is their report of going all the way into animal models. AOH1996 is a very unremarkable-looking molecule - to be honest, it looks like the sort of stuff that you used to see in old combinatorial chemistry libraries in the late 90s and early 2000s, a couple of aryl-rich groups strung together with amide bonds. It's certainly not going to be the most soluble stuff in the world, but they seem to have been able to formulate it. But I'm definitely not going to make fun of any chemical structure that works! [...]

The new paper shows preclinical toxicity testing in two species (mice and dogs), which is what you need to get to human trials. It seems to pass those very well, with no signs of trouble at 6x the effective dose in either species. And if you were throwing DSBs all over the place in normal tissues, believe me, you'd see tox. It is clean in an Ames test, for example. As for efficacy, in cell assays the concentration needed for 50% growth inhibition across 70 different cancer cell lines averaged around 300nM, while it showed no toxic effects on various non-cancer lines up to 10 micromolar (at least a 30x window). The affected cells show cell-cycle arrest, replication stress, apoptosis, and so on. And application of AOH1996 along with other known chemotherapy agents made the cells much more sensitive to those, presumably because they couldn't deal with those on top of the problems that AOH1996 was already causing.

It also shows growth arrest in xenograft tumors in mouse models, with a no-effect dose at least six times its effective dose, and combination therapy with a topoisomerase inhibitor showed even more significant effects. The compound has entered a Phase I trial in humans on the basis of the above data, and I very much look forward to seeing it advance to Phase II, where it will doubtless be used in combination with several existing therapies. I hope that human cancers will prove vulnerable to this new mode of attack in the clinic, and that they are not able to mutate around it with new forms of caPCNA too quickly, either. The comparison with the peptide agent mentioned above will be especially interesting, too. There's only one way to find out - good luck to everyone involved!

A bill requiring social media companies, encrypted communications providers and other online services to report drug activity on their platforms to the U.S. Drug Enforcement Administration (DEA) advanced to the Senate floor Thursday, alarming privacy advocates who say the legislation turns the companies into de facto drug enforcement agents and exposes many of them to liability for providing end-to-end encryption. From a report: The bipartisan Cooper Davis Act -- named for a Kansas teenager who died after unknowingly taking a fentanyl-laced pill he bought on Snapchat -- requires social media companies and other web communication providers to give the DEA users' names and other information when the companies have "actual knowledge" that illicit drugs are being distributed on their platforms.

Many privacy advocates caution that, if passed in its current form, the bill could be a death blow to end-to-end encryption services because it includes particularly controversial language holding companies accountable for conduct they don't report if they "deliberately blind" themselves to the violations. Officials from the DEA have spent several months honing the bill with key senators, Judiciary Committee Chairman Dick Durbin (D-IL) said Thursday. Providers of encrypted services would face a difficult choice should the bill pass, said Greg Nojeim, Senior Counsel & Director of Security and Surveillance Project at the Center for Democracy and Technology. "They could maintain end-to-end encryption and risk liability that they had willfully blinded themselves to illegal content on their service and face the music later," Nojeim said. "Or they could opt to remove end-to-end encryption and subject all of their users who used to be protected by one of the best cybersecurity tools available to new threats and new privacy violations."

Roger Thomas Clark, also known as Variety Jones, will spend much of the rest of his life in prison for his key role in building the world's first dark web drug market. Wired: Nearly ten years ago, the sprawling dark web drug market known as the Silk Road was torn offline in a law enforcement operation coordinated by the FBI, whose agents arrested that black market's boss, Ross Ulbricht, in a San Francisco library. It would take two years for Ulbricht's second-in-command -- an elusive figure known as Variety Jones -- to be tracked down and arrested in Thailand. Today, a decade after the Silk Road's demise, Clark has been sentenced to join his former boss in federal prison.

In a Manhattan courtroom on Monday, Roger Thomas Clark -- also known by his online handles including Variety Jones, Cimon and Plural of Mongoose -- was sentenced to 20 years behind bars for his role in building and running Silk Road. Clark, a 62-year-old Canadian national, will now likely spend much of the rest of his life incarcerated for helping to pioneer the anonymous, cryptocurrency-based model for online illegal sales of drugs and other contraband that still persists on the dark web today. The sentence is the maximum Clark faced in accordance with the plea agreement he made with prosecutors.

Clark "misguidedly turned his belief that drugs should be legal into material assistance for a criminal enterprise," Judge Sidney Stein said in his sentencing statement. "These beliefs crossed over into patently illegal behavior." Stein added that Clark was "clear-eyed and intentional" in his work as Ulbricht's "right-hand man" in the Silk Road's operations. "The sentence must reflect the vast criminal enterprise of which he was a leader," Stein said.

An artificial-intelligence tool has shown promise at helping doctors fight aggressive brain tumors by identifying characteristics that help guide surgery. From a report: The tool -- called the Cryosection Histopathology Assessment and Review Machine, or CHARM -- studies images to quickly pick out the genetic profile of a kind of tumor called glioma, a process that currently takes days or weeks, said Kun-Hsing Yu, senior author of a report released Friday in the journal Med. Surgeons use detailed diagnoses to guide them while they operate, Yu said, and the ability to get them rapidly could improve patients' outcomes and spare them from multiple surgeries. While glioma varies in severity, an aggressive form called glioblastoma can lead to death in less than six months if untreated. Only 17% of people with glioblastoma survive their second year after being diagnosed, according to the American Association of Neurological Surgeons.

Surgeons use information about the genetic profile of a glioma tumor when deciding how much tissue to remove from a patient's brain, as well as whether to implant wafers coated in a cancer-fighting drug. Getting that information, however, currently requires time-consuming testing. Yu and his team of researchers trained a machine-learning algorithm to do the work by showing it pictures of samples gathered during brain surgery, and then checking its work against those patients' diagnoses. CHARM learned to match or outperform other AI systems at identifying the genetic profile of a tumor.

A Phase 1 trail of a universal mRNA-based influenza vaccine is under way at Duke Unversity in Durham, North Carolina. It's being developed by the National Institute of Allergy and Infectious Diseases' (NAID) Vaccine Research Center (VRC). New Atlas reports: Some 50 participants aged 18-49 will be split into three groups and given 10, 25 and 50 micrograms of the active drug, respectively. When optimal dosage is then determined, another 10 participants will get this measured jab. There will also be an additional group who will receive a current quadrivalent seasonal flu shot, so researchers have a comparative dataset that takes into account the immune response and safety of readily available influenza vaccines. Those in the trial will then be regularly evaluated over 12 months to see how the drug's immune response has fared and to assess its short-term and long-term safety.

This trial comes after the initial NIAID's Vaccine Research Center study on the safety and immune response of the H1ssF (H1 hemagglutinin stabilized stem ferritin) nanoparticle vaccine. The Phase 1 trial, from April 2019 to March 2020, delivered broad antibody responses in the 52 participants aged 18-70. The results of the trial were published last month in the journal Science Translational Medicine.

The H1ssF vaccine targets the flu protein hemagglutinin. One section of this protein -- the 'head' -- changes as the virus evolves into different strains, but the stem of the protein is much slower to be altered and remains fairly constant throughout influenza mutations. The researchers believe herein lies the key to a long-lasting, effective universal preventative vaccine. The new trial combines the H1ssF nanoparticle vaccine with messenger RNA (mRNA) as the platform, with the end goal that it'll deliver a more efficient, targeted immune response.

An anonymous reader quotes a report from Ars Technica: A team of researchers at the Italian Institute of Technology (IIT) in Milan recently created a fully rechargeable battery using nontoxic edible components. This is probably the world's first battery that is safe to ingest and entirely made of food-grade materials. "Given the level of safety of these batteries, they could be used in children's toys, where there is a high risk of ingestion," said Mario Caironi, a senior researcher at IIT. However, this isn't the only solution the edible battery could provide. Apart from serving as an alternative to conventional toxic toy batteries, the edible battery from IIT could also play a key role in making health care applications safer than ever. For instance, doctors have to be cautious regarding the use of miniature electronic devices (such as drug-delivery robots, biosensors, etc.) inside the human body, as they come equipped with batteries made of toxic substances. An edible battery could solve this problem. There are also more mundane applications, like replacing batteries in pet toys.

Ivan K. Ilic, first author of the study and a postdoctoral researcher at IIT, told Ars Technica, "Two main ways a battery damages human tissue when it's inside the body is by doing water electrolysis and by the toxicity of its materials. Water electrolysis is a phenomenon where electricity with a voltage higher than 1.2 V (virtually all commercial batteries) breaks water into oxygen and hydrogen (an explosive gas), and it is very dangerous if it occurs in the stomach. Our battery is way below this voltage, around 0.65 V, so water electrolysis cannot occur. On the other hand, we used only food materials, so nothing is toxic!" Before the battery is useful, however, the researchers will need to first enhance the battery's power capacity. Currently, the edible battery can supply 48 microamperes of current for a bit over 10 minutes. So it can easily meet the power demand of a miniature medical device or a small LED. "These batteries are no competition to ordinary batteries -- they will not power electric cars -- but they are meant to power edible electronics and maybe some other niche applications, so their main advantage is non-toxicity," said Ilic. Here's a list of what makes these edible batteries work, as mentioned by Ars:

- "Quercetin, a pigment found in almonds and capers, serves as the battery cathode, whereas riboflavin (vitamin B2) makes up the battery anode.
- The researchers used nori (edible seaweed that is used in the wrapping of sushi rolls) as the separator and a water-based solution (aqueous NaHSO4) as the electrolyte.
- Activated charcoal is employed to achieve high electrical conductivity in the battery.
The battery electrodes come covered in beeswax and connect to a gold foil (used to cover pastries) that laminates a supporting structure made of ethyl cellulose."

The research has been published in the journal Advanced Materials.

An experimental Alzheimer's medication slowed declines in patients' ability to think clearly and perform daily tasks by more than a third in a large clinical trial, drugmaker Eli Lilly said Wednesday. From a report: Based on the results, in people with early symptomatic Alzheimer's disease, Lilly said it plans to file for approval from the US Food and Drug Administration by the end of June. The medicine, donanemab, works by removing plaque buildups in the brain known as amyloid that are a hallmark of Alzheimer's disease. However, there were some side effects reported; there were three deaths in the trial among people taking the drug, two of which were attributed to adverse events such as brain swelling or microhemorrhages, known as amyloid-related imaging abnormalities or ARIA. The trial was run in more than 1,700 patients for 18 months.

"For every medicine, for every disease, there are potential risks and potential benefits," said Lilly's chief scientific and medical officer, Dr. Daniel Skovronsky. But he noted that almost half of the participants taking the drug, 47%, showed no decline on a key measure of cognition over the course of a year, compared with 29% of people taking a placebo. That's "the kind of efficacy that's never been seen before in Alzheimer's disease," Skovronsky said. Alzheimer's affects more than 6 million Americans, with an estimated 1.7 million to 2 million people over 65 in the early stages of the disease, according to Lilly. Drug development for Alzheimer's has been riddled with failures, but Lilly's drug is among a new group showing promise. The first, Eisai and Biogen's Leqembi, received accelerated FDA approval in January.

For half a century, Geoffrey Hinton nurtured the technology at the heart of chatbots like ChatGPT. Now he worries it will cause serious harm. From a report: Geoffrey Hinton was an artificial intelligence pioneer. In 2012, Dr. Hinton and two of his graduate students at the University of Toronto created technology that became the intellectual foundation for the A.I. systems that the tech industry's biggest companies believe is a key to their future. On Monday, however, he officially joined a growing chorus of critics who say those companies are racing toward danger with their aggressive campaign to create products based on generative artificial intelligence, the technology that powers popular chatbots like ChatGPT. Dr. Hinton said he has quit his job at Google, where he has worked for more than decade and became one of the most respected voices in the field, so he can freely speak out about the risks of A.I. A part of him, he said, now regrets his life's work.

"I console myself with the normal excuse: If I hadn't done it, somebody else would have," Dr. Hinton said during a lengthy interview last week in the dining room of his home in Toronto, a short walk from where he and his students made their breakthrough. Dr. Hinton's journey from A.I. groundbreaker to doomsayer marks a remarkable moment for the technology industry at perhaps its most important inflection point in decades. Industry leaders believe the new A.I. systems could be as important as the introduction of the web browser in the early 1990s and could lead to breakthroughs in areas ranging from drug research to education. But gnawing at many industry insiders is a fear that they are releasing something dangerous into the wild. Generative A.I. can already be a tool for misinformation. Soon, it could be a risk to jobs. Somewhere down the line, tech's biggest worriers say, it could be a risk to humanity. "It is hard to see how you can prevent the bad actors from using it for bad things," Dr. Hinton said.