Drugmakers can keep making off-brand weight-loss drugs as FDA backpedals

FDA is reviewing its decision to remove tirzepatide drugs from the shortage list.

Facing a lawsuit, the Food and Drug Administration has decided to reconsider its decision to take popular weight-loss and diabetes drugs off of the national shortage list, which will allow compounding pharmacies to continue selling cheaper copycat versions—at least for now.

A trade organization representing compounding pharmacies sued the agency last week over its October 2 announcement that there was no longer a shortage of tirzepatide drugs, branded as Mounjaro for diabetes and Zepbound for weight loss. The products, members of the extremely popular and effective class of GLP-1 drugs, had been on the shortage list since December 2022.

Being on the list meant that compounding pharmacies were legally allowed to make "essentially copies" of the products; the only time these pharmacies—also called outsourcing facilities—can make imitation versions of approved drugs, such as tirzepatide, is when the products appear on the shortage list. So, with the FDA's announcement, compounders were immediately barred from making any more of the lucrative drugs and had 60 days to fulfill existing orders.

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FCC Republican opposes regulation of data caps with analogy to coffee refills

Republican commissioner: You wouldn’t require free coffee refills, would you?

The Federal Communications Commission is taking a closer look at how broadband data caps affect consumers, and is considering whether it has authority to regulate how Internet service providers impose such caps. Democrats are spearheading the effort over the opposition of the FCC's Republican minority.

FCC Chairwoman Jessica Rosenworcel floated a plan to open a formal inquiry into data caps in June 2023, and the FCC is finally moving ahead. A Notice of Inquiry announced today "explores how broadband data caps impact competition and consumers," the FCC said.

"During the last year, nearly 3,000 people have gotten so aggravated by data caps on their Internet service that they have reached out the Federal Communications Commission to register their frustration," Rosenworcel said in a statement issued today. "We are listening. Today, we start an inquiry into the state of data caps. We want to shine a light on what they mean for Internet service for consumers across the country."

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North Korean hackers use newly discovered Linux malware to raid ATMs

Once, FASTCash ran only on Unix. Then came Windows. Now it can target Linux, too.

In the beginning, North Korean hackers compromised the banking infrastructure running AIX, IBM’s proprietary version of Unix. Next, they hacked infrastructure running Windows. Now, the state-backed bank robbers have expanded their repertoire to include Linux.

The malware, tracked under the name FASTCash, is a remote access tool that gets installed on payment switches inside compromised networks that handle payment card transactions. The US Cybersecurity and Infrastructure Security Agency first warned of FASTCash in 2018 in an advisory that said the malware was infecting AIX-powered switches inside retail payment networks. In 2020, the agency updated its guidance to report FASTCash was now infecting switches running Windows as well. Besides embracing Windows, FASTCash had also expanded its net to include not just switches for retail payments but those handled by regional interbank payment processors as well.

Tampering with transaction messages on the fly

Over the weekend, a researcher reported finding two samples of FASTCash for switches running on Linux. One sample is compiled for Ubuntu Linux 20.04 and was likely developed sometime after April 21, 2022. The other sample was likely not used. As of the time this post went live, only four anti-malware engines detected each sample. The number of detections as of Sunday was zero. The Linux version was uploaded to VirusTotal in June 2023.

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Sustainable building effort reaches new heights with wooden skyscrapers

Wood offers architects an alternative to carbon-intensive steel and concrete.

At the University of Toronto, just across the street from the football stadium, workers are putting up a 14-story building with space for classrooms and faculty offices. What’s unusual is how they’re building it — by bolting together giant beams, columns, and panels made of manufactured slabs of wood.

As each wood element is delivered by flatbed, a tall crane lifts it into place and holds it in position while workers attach it with metal connectors. In its half-finished state, the building resembles flat-pack furniture in the process of being assembled.

The tower uses a new technology called mass timber. In this kind of construction, massive, manufactured wood elements that can extend more than half the length of a football field replace steel beams and concrete. Though still relatively uncommon, it is growing in popularity and beginning to pop up in skylines around the world.

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Discord Disputes DMCA Subpoena, Rejects Role as ‘Anti-Piracy’ Partner

Korean game publisher Nexon is using the U.S. legal system to address online copyright infringement. The company obtained a DMCA subpoena that requires Discord to hand over the personal details of suspected pirates. While Discord has shared information in the past, it doesn’t plan to cooperate any longer, refusing to play the role of ‘anti-piracy police’.

From: TF, for the latest news on copyright battles, piracy and more.

doscordUnder U.S. law, rightsholders have an option to identify alleged copyright infringers, without directly having to file a lawsuit.

Instead, they can request a DMCA subpoena. These documents are typically signed by a court clerk and don’t require any judicial oversight. Specifically, they allow rightsholders to obtain the personal details of anonymous alleged infringers through third-party service providers.

Foreign companies are also aware of this discovery ‘shortcut’. For example, Korean game publisher Nexon previously used it to identify people who allegedly shared pirated content, including the games MapleStory and Sudden Attack, through Discord, .

Nexon Targets Discord with DMCA Subpoenas

When Nexon obtained a DMCA subpoena last October, Discord initially objected, deeming it “overbroad and unduly burdensome.” After the parties got together, an agreement was reached to confidentially disclose basic subscriber information related to 64 Discord User IDs.

Discord was clearly hesitant to cooperate but, faced with a motion to compel, it eventually chose to do so. However, the company did not envision that Nexon would return to court with similar requests a few months later.

In May, Nexon obtained a new DMCA subpoena, which again requires Discord to share the personal details of alleged copyright infringers. This time, the legal paperwork targets roughly two dozen users who allegedly shared copyrighted material related to the MapleStory game.

subpoena

When the subpoena was issued, Discord had yet to send over the user details from the first request, which it eventually shared mid-June. However, going forward, the company doesn’t intend to adopt the role of anti-piracy data provider.

Discord Draws a Line

In July, Discord sent a letter to Nexon, informing the game company that it has no intention of cooperating with the latest request, describing it as improper.

“Now, you appear to be demanding additional information for yet more User IDs, which you allege infringe one of the same copyrights you have already asserted. You are attempting to renegotiate a deal that has already been struck and fulfilled. Your actions are improper,” Discord’s attorney wrote.

The letter outlined a broad list of objections and makes it clear that Discord doesn’t plan to invest substantial resources to help Nexon catch online pirates.

“Discord is committed to fulfilling its obligations under the law, but acting as your copyright assertion partner is not one of them. Your firm continues to make improper and overly burdensome demands […] including immediate threats of motion practice in non-existent legal matters.”

Prepared to Fight

The messaging platform wrote that it is prepared to file a motion to quash the subpoena, if needed. It further urged Nexon to withdraw their demands, and cease sending any similar ‘defective’ subpoenas going forward.

To support its stance, Discord made a list of twenty-two general objections and reservations. Among other things, the company wants to protect user privacy and their first amendment right to anonymous speech.

“Discord objects to the Requests as infringing its users’ decisions to remain anonymous, an aspect of their freedom of speech protected by the First Amendment. The Requests improperly seek to unmask anonymous speakers and consequently compel disclosure of material protected by the First Amendment,” it reads.

This strongly-worded letter didn’t have the desired result, however. Instead of backing off, Nexon doubled down, filing a motion to compel at a Texas federal court late last week.

compel motion

The game company refutes Discord’s objections and asks the court to enter an order requiring Discord to produce the requested user data. Nexon says that it needs this information to protect its copyrights.

“Discord’s failure to cooperate discovery has impeded Nexon’s ability to discover relevant, non-privileged information that will support its potential claims against the users who have provided access to the infringing material,” Nexon writes.

maple

While the court has yet to rule on the matter, Discord is expected to file a formal motion to quash the subpoena in response, as indicated in its earlier communications.

The dispute is yet another classic example of the clash between copyrights and user privacy, with online service providers in the middle. The fact that Discord’s compliance requires operational (time and money) resources, makes it even more complex.

This isn’t just an isolated issue that affects these two companies. The outcome of this brewing legal dispute could have a direct impact on similar DMCA subpoena efforts in the future.

A copy of the motion to compel, filed at the Texas federal court by Nexon Korea Corporation, is available here (pdf)

From: TF, for the latest news on copyright battles, piracy and more.

Lilbits: Using an eGPU with a Raspberry Pi 5, Android 15 is rolling out for Pixel devices

More than a month after releasing the source code for Android 15, Google is beginning to roll out the latest version of its mobile operating system to Pixel phones and tablets. But many of the new features Google is highlighting aren’t necessaril…

More than a month after releasing the source code for Android 15, Google is beginning to roll out the latest version of its mobile operating system to Pixel phones and tablets. But many of the new features Google is highlighting aren’t necessarily coming to all Android phones. They’re Pixel-specific apps and services. Here’s a roundup of […]

The post Lilbits: Using an eGPU with a Raspberry Pi 5, Android 15 is rolling out for Pixel devices appeared first on Liliputing.

SpaceX claims Starlink can offer gigabit speeds if FCC approves new plan

SpaceX: “Small-but-meaningful updates” can boost speed from about 100Mbps to 1Gbps.

SpaceX is seeking approval for changes to Starlink that the company says will enable gigabit-per-second broadband service. In an application submitted to the Federal Communications Commission on October 11, SpaceX claims the requested "modification and its companion amendment will enable the Gen2 system to deliver gigabit-speed, truly low-latency broadband and ubiquitous mobile connectivity to all Americans and the billions of people globally who still lack access to adequate broadband."

SpaceX said it is seeking "several small-but-meaningful updates to the orbital configuration and operational parameters for its Gen2 space station authorization to improve space sustainability, better respond to evolving demand, and more efficiently share spectrum with other spectrum users."

SpaceX wants to lower the altitudes of satellites "at 525 km, 530 km, and 535 km to 480 km, 485 km, and 475 km altitude, respectively." The reconfiguration will increase the "potential maximum number of orbital planes and satellites per plane" while keeping the planned total number of second-generation satellites at 29,988 or less. The FCC has so far approved 7,500 Gen2 satellites.

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24H2: Windows-11-Update kappt das Netz

Das jüngste Windows-11-Update 24H2 hat Berichten zufolge bei einer Reihe von Benutzern Probleme mit der Internetverbindung verursacht. (Windows 11, Microsoft)

Das jüngste Windows-11-Update 24H2 hat Berichten zufolge bei einer Reihe von Benutzern Probleme mit der Internetverbindung verursacht. (Windows 11, Microsoft)

Reports: Tesla’s prototype Optimus robots were controlled by humans

But the prototypes used “artificial intelligence” to control their walking.

After Elon Musk provided his "long-term" vision for autonomous, humanoid robots at last week's "We, Robot" event, we expressed some skepticism about the autonomy of the Optimus prototypes sent out for a post-event mingle with the assembled, partying humans. Now, there's been a raft of confirmation that human teleoperators were indeed puppeting the robot prototypes for much of the night.

Bloomberg cites unnamed "people familiar with the matter" in reporting that Tesla "used humans to remotely control some capabilities" of the prototype robots at the event. The report doesn't specify which demonstrated capabilities needed that human assistance, but it points out that the robots "were able to walk without external control using artificial intelligence" (the lack of a similar AI call-out for any other robot actions that night seems telling).

That lines up with reporting from tech blogger Robert Scoble, who posted on social media that he had "talked with an engineer" who confirmed that "when it walked, that is AI running Optimus." For other tasks—like pouring drinks from a tap, playing Rock Paper Scissors, or chatting with nearby attendees—Scoble noted that "a human is remote assisting."

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