Author name: Shannon Garcia

drug-makers-can’t-make-knockoff-weight-loss-drugs-anymore—and-they’re-mad

Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad

Compounding pharmacies are suing the Food and Drug Administration so they can keep making imitation versions of popular—and lucrative—tirzepatide drugs, namely knockoffs of Mounjaro for diabetes and Zepbound for weight loss.

Generally, compounding pharmacies make customized formulations of drugs for patients with specific needs, like when a patient has an allergy to a filler ingredient or if a child needs a liquid version of a drug that normally comes as a capsule. But larger compounding operations are also legally allowed to make imitations of branded drugs if those drugs are in short supply, acting as a stopgap for patients.

Tirzepatide has certainly been in short supply in recent years. Given the high prevalence of diabetes and obesity in America and the drug’s effectiveness, demand for tirzepatide and other drugs in the new GLP-1 class have skyrocketed, and many patients have struggled to fill prescriptions. The FDA placed tirzepatide on its drug shortage list in December of 2022—and that’s where it remained until last week.

On October 2, the FDA announced that the tirzepatide shortage had been resolved and that the nation’s supply of GLP-1 drugs was stabilizing, though other drugs in the class, including semaglutide, remain in short supply.

“FDA confirmed with the drug’s manufacturer [Eli Lilly] that their stated product availability and manufacturing capacity can meet the present and projected national demand,” the agency said in its announcement. However, it cautioned that patients and prescribers “may still see intermittent localized supply disruptions” as the drugs move through the supply chain.

End of an era

With the resolution, compounding pharmacies are no longer able to produce tirzepatide. And the FDA highlighted the point to the drug makers, writing in bold that the agency “reminds compounders of the legal restrictions on making copies of FDA-approved drugs.”

Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad Read More »

samsung-quits-updating-galaxy-z-fold-2-that-came-out-in-2020-for-$2,000

Samsung quits updating Galaxy Z Fold 2 that came out in 2020 for $2,000

In February 2022, Samsung started promising up to four generations of Android OS and One UI upgrades to “select” Galaxy devices, as well as “up to five years of security updates.” And in January, it announced moving to seven years of security and OS updates, matching a move from Google. However, the Fold 2 wasn’t included in Samsung’s list of “select” Galaxy devices.

Thus, one could have estimated that the Fold 2 might stop receiving OS and security updates by 2024, four years after its debut. But it’s still hard to reconcile with paying four figures for a phone that became a security risk after four years, despite functioning properly otherwise. Apple, by comparison, now promises at least five years of security updates. Apple only started making that promise in 2023 with the iPhone 15 series. However, the current-generation iOS 18 is supported by iPhones released in 2020, like the second-generation iPhone SE, and even older ones, like the iPhone XR that came out in 2018. Arguably short-lived expensive devices like the Fold 2 are part of the reason some activists are pushing for the FTC to require that smart devices state on their packaging how long they’ll receive updates.

However, unlike iPhones, Samsung phones aren’t all powered by a proprietary chip, making promises of upgrades require commitments from third-party vendors, like Qualcomm. With Qualcomm known for being resistant to longer chip life cycles in the past, seven years of updates is progress for Samsung users—just not those who invested in the Z Fold 2.

Samsung quits updating Galaxy Z Fold 2 that came out in 2020 for $2,000 Read More »

alien:-isolation-sequel-bursts-into-existence,-10-years-after-original

Alien: Isolation sequel bursts into existence, 10 years after original

The Alien franchise is about uncaring monsters, unfeeling corporations, and horrific, claustrophobic terror. Given this setting, it almost made sense, what happened to the original Alien: Isolation.

The game was released to positive reviews, is now considered one of the best games ever made, and sold more than 2 million copies within its first few months. Despite this, Isolation only got “close to break-even or just about in the black,” then-Creative Assembly studio director Tim Heaton told GamesIndustry.biz a year after release. With the rapid evolution of AAA game development, that wasn’t enough. And so, like a salvage team diverted to a bio-weapon recovery mission, Isolation and its momentum were seemingly abandoned.

Gameplay and review accolades for Alien: Isolation, released 10 years ago today.

Abandoned, that is, until today, the 10th anniversary of that game’s 2014 release. The appropriately named Al Hope, creative director of Isolation studio Creative Assembly, posted on X (formerly Twitter) that his team had “heard your distress calls loud and clear,” and could confirm that “a sequel to Alien: Isolation is in early development.”

The original game stands out to this day for its bold yet entirely appropriate take on making an Alien game. You play as Amanda Ripley, daughter of iconic heroine Ellen Ripley, working for Weyland-Yutani in a welding job. You get a chance to find out more about what happened to your mother, but—you’ll never believe it—things go terribly wrong, and now you are hunted.

Alien: Isolation sequel bursts into existence, 10 years after original Read More »

report:-first-wave-of-m4-macs,-including-smaller-mac-mini,-coming-november-1

Report: First wave of M4 Macs, including smaller Mac mini, coming November 1

Reliable rumors have suggested that M4 Macs are right around the corner, and now Bloomberg’s Mark Gurman is forecasting a specific launch date: November 1, following a late-October announcement that mirrors last year’s Halloween-themed reveal for the first M3 Macs.

This date could be subject to change, and not all the products announced in October would necessarily launch on November 1—lower-end Macs are more likely to launch early, and higher-end models would be more likely to ship a bit later in the month.

The list of what to expect is the same as it has been for a while: refreshed 14- and 16-inch MacBook Pros with M4, M4 Pro, and M4 Max chips, a new M4 version of the 24-inch iMac, and an M4 update to the Mac mini that leapfrogs the M3 entirely. These will all be the first Macs to get the M4, following its unexpected introduction in the iPad Pro earlier this year.

The refreshed Mac mini is the most interesting of the new models—it’s said to come with a fully revamped design for the first time since the aluminum unibody version was released in 2010. The new Mac mini is said to be closer in size to an Apple TV box, but it will retain an internal power supply that doesn’t require a bulky external brick. The Mac mini lineup should still be split between two slightly different machines: one entry-level model with a basic M4 chip, and a higher-end M4 Pro version that bridges the gap between the Mac mini and the Mac Studio.

Report: First wave of M4 Macs, including smaller Mac mini, coming November 1 Read More »

meta’s-new-“movie-gen”-ai-system-can-deepfake-video-from-a-single-photo

Meta’s new “Movie Gen” AI system can deepfake video from a single photo

On Friday, Meta announced a preview of Movie Gen, a new suite of AI models designed to create and manipulate video, audio, and images, including creating a realistic video from a single photo of a person. The company claims the models outperform other video-synthesis models when evaluated by humans, pushing us closer to a future where anyone can synthesize a full video of any subject on demand.

The company does not yet have plans of when or how it will release these capabilities to the public, but Meta says Movie Gen is a tool that may allow people to “enhance their inherent creativity” rather than replace human artists and animators. The company envisions future applications such as easily creating and editing “day in the life” videos for social media platforms or generating personalized animated birthday greetings.

Movie Gen builds on Meta’s previous work in video synthesis, following 2022’s Make-A-Scene video generator and the Emu image-synthesis model. Using text prompts for guidance, this latest system can generate custom videos with sounds for the first time, edit and insert changes into existing videos, and transform images of people into realistic personalized videos.

An AI-generated video of a baby hippo swimming around, created with Meta Movie Gen.

Meta isn’t the only game in town when it comes to AI video synthesis. Google showed off a new model called “Veo” in May, and Meta says that in human preference tests, its Movie Gen outputs beat OpenAI’s Sora, Runway Gen-3, and Chinese video model Kling.

Movie Gen’s video-generation model can create 1080p high-definition videos up to 16 seconds long at 16 frames per second from text descriptions or an image input. Meta claims the model can handle complex concepts like object motion, subject-object interactions, and camera movements.

AI-generated video from Meta Movie Gen with the prompt: “A ghost in a white bedsheet faces a mirror. The ghost’s reflection can be seen in the mirror. The ghost is in a dusty attic, filled with old beams, cloth-covered furniture. The attic is reflected in the mirror. The light is cool and natural. The ghost dances in front of the mirror.”

Even so, as we’ve seen with previous AI video generators, Movie Gen’s ability to generate coherent scenes on a particular topic is likely dependent on the concepts found in the example videos that Meta used to train its video-synthesis model. It’s worth keeping in mind that cherry-picked results from video generators often differ dramatically from typical results and getting a coherent result may require lots of trial and error.

Meta’s new “Movie Gen” AI system can deepfake video from a single photo Read More »

faulty-samsung-update-leaves-owners-of-bricked-galaxy-phones-with-few-options

Faulty Samsung update leaves owners of bricked Galaxy phones with few options

Samsung issued a software update on October 2 that bricked some older Galaxy smartphones. While Samsung has stopped the update from rolling out further, those with broken phones have received a harsh reminder of the importance of data backups.

On Wednesday, numerous people online started complaining about their Samsung phones being stuck in a bootloop (you can see examples here, here, and in newer comments here).

A Samsung spokesperson confirmed to Ars Technica that an update to Samsung’s SmartThings Framework app for managing smart devices caused the problems:

We are aware that a limited number of Galaxy smartphones running on Android 12 are rebooting continuously during an update to the latest version of the SmartThings app.

Samsung “immediately suspended the update” after learning of the problem and is “working to resolve the issues,” the company’s spokesperson said. According to user reports online, Samsung has issued a new update that people can download without their phones breaking.

However, owners of older affected phones, namely the Galaxy S10 series, Galaxy Note 10 series, Galaxy M51, and Galaxy A90, have been unable to power their devices on to roll back the update. Many users who already manually or automatically installed the update are still dealing with bricked devices.

A harsh reminder

Users with bricked Galaxy phones were initially met with a difficult choice: Go without their phone or perform a data-erasing factory reset.

Samsung’s statement to Ars advised customers to “contact the Samsung Contact Center” for support, but it’s unclear if a fix can be employed that doesn’t wipe the phone.

Faulty Samsung update leaves owners of bricked Galaxy phones with few options Read More »

helene-ravaged-the-nc-plant-that-makes-60%-of-the-country’s-iv-fluid-supply

Helene ravaged the NC plant that makes 60% of the country’s IV fluid supply

Hurricane Helene’s catastrophic damage and flooding to the Southeastern states may affect the country’s medical supply chain.

Hospitals nationwide are bracing for a possible shortage of essential intravenous fluids after the cataclysmic storm inundated a vital manufacturing plant in North Carolina.

The plant is Baxter International’s North Cove manufacturing facility in Marion, which is about 35 miles northeast of Asheville. Helene unleashed unprecedented amounts of rain throughout the western part of the state, killing dozens and ravaging numerous communities, homes, and other structures, including the plant.

The North Cove plant produces 60 percent of the country’s supply of IV solutions, typically producing 1.5 million bags per day, according to the American Hospital Association. The dozens of sterile solutions Baxter makes at the facility are used for everything from intravenous rehydration and drug delivery to peritoneal dialysis used to treat kidney failure.

“Our hearts and thoughts are with all those affected by Hurricane Helene,” Baxter CEO José Almeida said in a statement on September 29. “The safety of our employees, their families, and the communities in which we operate remains our utmost concern, and we are committed to helping ensure reliable supply of products to patients. Remediation efforts are already underway, and we will spare no resource—human or financial—to resume production and help ensure patients and providers have the products they need.”

Critical supply

On October 2, Mass General Brigham, Massachusetts’ largest hospital and health care system, warned employees via email of a “serious and immediate IV fluid shortage,” according to the Boston Globe.

Helene ravaged the NC plant that makes 60% of the country’s IV fluid supply Read More »

youtube-fixes-glitch-that-wrongly-removed-accounts,-deleted-videos

YouTube fixes glitch that wrongly removed accounts, deleted videos

As a message highlighted above the thread warned YouTube users that there were “longer than normal wait times” for support requests, YouTube continually asked for “patience” and turned off the comments.

“We are very sorry for this error on our part,” YouTube said.

Unable to leave comments, thousands of users mashed a button on the support thread, confirming that they had “the same question.” On Friday morning, 8,000 users had signaled despair, and as of this writing, the number had notched up to nearly 11,000.

YouTube has not confirmed how many users were removed, so that’s likely the best estimate we have for how many users were affected.

On Friday afternoon, YouTube did update the thread, confirming that “all channels incorrectly removed for Spam & Deceptive Practices have been fully reinstated!”

While YouTube claims that all channels are back online, not all the videos mistakenly removed were reinstated, YouTube said. Although most of the users impacted were reportedly non-creators, and therefore their livelihoods were likely not disrupted by the bug, at least one commenter complained, “my two most-viewed videos got deleted,” suggesting some account holders may highly value the videos still missing on their accounts.

“We’re working on reinstating the last few videos, thanks for bearing with us!” YouTube’s update said. “We know this was a frustrating experience, really appreciate your patience while we sort this out.”

It’s unclear if paid subscribers will be reimbursed for lost access to content.

YouTube did not respond to Ars’ request to comment.

YouTube fixes glitch that wrongly removed accounts, deleted videos Read More »

openai’s-canvas-can-translate-code-between-languages-with-a-click

OpenAI’s Canvas can translate code between languages with a click

Coding shortcuts in canvas include reviewing code, adding logs for debugging, inserting comments, fixing bugs, and porting code to different programming languages. For example, if your code is JavaScript, with a few clicks it can become PHP, TypeScript, Python, C++, or Java. As with GPT-4o by itself, you’ll probably still have to check it for mistakes.

A screenshot of coding using ChatGPT with Canvas captured on October 4, 2024.

A screenshot of coding using ChatGPT with Canvas captured on October 4, 2024.

Credit: Benj Edwards

A screenshot of coding using ChatGPT with Canvas captured on October 4, 2024. Credit: Benj Edwards

Also, users can highlight specific sections to direct ChatGPT’s focus, and the AI model can provide inline feedback and suggestions while considering the entire project, much like a copy editor or code reviewer. And the interface makes it easy to restore previous versions of a working document using a back button in the Canvas interface.

A new AI model

OpenAI says its research team developed new core behaviors for GPT-4o to support Canvas, including triggering the canvas for appropriate tasks, generating certain content types, making targeted edits, rewriting documents, and providing inline critique.

An image of OpenAI's Canvas in action.

An image of OpenAI’s Canvas in action.

An image of OpenAI’s Canvas in action. Credit: OpenAI

One key challenge in development, according to OpenAI, was defining when to trigger a canvas. In an example on the Canvas blog post, the team says it taught the model to open a canvas for prompts like “Write a blog post about the history of coffee beans” while avoiding triggering Canvas for general Q&A tasks like “Help me cook a new recipe for dinner.”

Another challenge involved tuning the model’s editing behavior once canvas was triggered, specifically deciding between targeted edits and full rewrites. The team trained the model to perform targeted edits when users specifically select text through the interface, otherwise favoring rewrites.

The company noted that canvas represents the first major update to ChatGPT’s visual interface since its launch two years ago. While canvas is still in early beta, OpenAI plans to improve its capabilities based on user feedback over time.

OpenAI’s Canvas can translate code between languages with a click Read More »

apple-couldn’t-tell-fake-iphones-from-real-ones,-lost-$2.5m-to-scammers

Apple couldn’t tell fake iPhones from real ones, lost $2.5M to scammers

Two men involved in an elaborate scheme duping Apple into replacing about 6,000 counterfeit iPhones with genuine iPhones were sentenced to prison this week, the US Department of Justice announced Thursday.

Together with their co-conspirators, the 34-year-old scammers, Haotian Sun and Pengfei Xue, squeezed Apple for about $2.5 million, as employees for years failed to detect what the DOJ described as a rather “sophisticated” scheme between 2017 and 2019.

Now Sun has been sentenced to 57 months in prison and must pay more than $1 million to Apple in restitution. For his part, Xue was sentenced to 54 months and ordered to pay $397,800 in restitution, the DOJ said. Additionally, both men must also serve three years of supervised release and forfeit thousands more following the judgment.

The scheme depended on tricking Apple into accepting bogus phones during returns by spoofing serial numbers or International Mobile Equipment Identity (IMEI) numbers linked to real customers’ iPhones that were still under warranty. (Apple provides a one-year warranty for new iPhones discovered to have defects and sells insurance plans to extend the warranties.)

The scammers were caught and convicted of mail fraud and conspiracy to commit mail fraud after an Apple investigator tipped law enforcement off, a 2019 affidavit from postal inspector Stephen Cohen said.

Law enforcement intercepted packages and confirmed that thousands of counterfeit phones were being shipped from China, then submitted to Apple for repairs either by mail or in person. These counterfeit phones, Cohen said, were either out of warranty or contained counterfeit parts, but Apple “wrongly” believed that they were real phones under real warranties, often replacing dozens of fake phones fraudulently returned in a single shipment, Cohen said.

Apple couldn’t tell fake iPhones from real ones, lost $2.5M to scammers Read More »

human-case-of-h5n1-suspected-in-california-amid-rapid-dairy-spread

Human case of H5N1 suspected in California amid rapid dairy spread

California’s infections bring the country’s total number of affected herds to 255 in 14 states, according to the USDA.

In a new release Thursday, California health officials worked to ease alarm about the human case, emphasizing that the risk to the general public remains low.

“Ongoing health checks of individuals who interact with potentially infected animals helped us quickly detect and respond to this possible human case. Fortunately, as we’ve seen in other states with human infections, the individual has experienced mild symptoms,” Tomás Aragón, director of California’s Department of Public Health, said. “We want to emphasize that the risk to the general public is low, and people who interact with potentially infected animals should take prevention measures.”

The release noted that in the past four months, the health department has distributed more than 340,000 respirators, 1.3 million gloves, 160,000 goggles and face shields, and 168,000 bouffant caps to farm workers. The state has also received 5,000 doses of seasonal flu vaccine earmarked for farm workers and is working to distribute those vaccines to local health departments.

Still, herd infections and human cases continue to tick up. Influenza researchers and other health experts are anxiously following the unusual dairy outbreak—the first time an avian influenza is known to have spilled over to and caused an outbreak in cattle. The more opportunities the virus has to spread and adapt to mammals, the more chances it could begin spreading among humans, potentially sparking an outbreak or even a pandemic.

Human case of H5N1 suspected in California amid rapid dairy spread Read More »

strange-“biotwang”-id’d-as-bryde’s-whale-call

Strange “biotwang” ID’d as Bryde’s whale call

In 2014, researchers monitoring acoustic recordings from the Mariana Archipelago picked up an unusual whale vocalization with both low- and high-frequency components. It seemed to be a whale call, but it sounded more mechanical than biological and has since been dubbed a “biotwang.”

Now a separate team of scientists has developed a machine-learning model to scan a dataset of recordings of whale vocalizations from various species to help identify the source of such calls. Combining that analysis with visual observations allowed the team to identify the source of the biotwang: a species of baleen whales called Bryde’s (pronounced “broodus”) whales. This should help researchers track populations of these whales as they migrate to different parts of the world, according to a recent paper published in the journal Frontiers in Marine Science.

Marine biologists often rely on a powerful tool called passive acoustic monitoring for long-term data collection of the ocean’s acoustic environment, including whale vocalizations. Bryde’s whale calls tend to be regionally specific, per the authors. For instance, calls in the eastern North Pacific are pretty well documented, with frequencies typically falling below 100 Hz, augmented by harmonic frequencies as high as 400 Hz. Far less is known about the sounds made by Bryde’s whales in the western and central North Pacific, since for many years there were only three known recordings of those vocalizations—including a call dubbed “Be8” (starting at 45 Hz with multiple harmonics) and mother-calf calls.

That changed with the detection of the biotwang in 2014. It’s quite a distinctive, complex call that typically lasts about 3.5 seconds, with five stages, starting at around 30 Hz and ending with a metallic sound that can reach as high as 8,000 Hz. “It’s a real weird call,” co-author Ann Allen, a scientist at NOAA Fisheries, told Ars. “Anybody who wasn’t familiar with whales would think it was some sort of artificial sound, made by a naval ship.” The 2014 team was familiar with whale vocalizations and originally attributed the strange sound to baleen whales. But that particular survey was autonomous, and without accompanying visual observations, the scientists could not definitively confirm their hypothesis.

Strange “biotwang” ID’d as Bryde’s whale call Read More »