$158,000 ALS drug pulled from market after failing in large clinical trial

The drug is now unavailable to new patients; its maker to lay off 70% of employees.

$158,000 ALS drug pulled from market after failing in large clinical trial

Enlarge (credit: Amlyx)

Amylyx, the maker of a new drug to treat ALS, is pulling that drug from the market and laying off 70 percent of its workers after a large clinical trial found that the drug did not help patients, according to an announcement from the company Thursday.

The drug, Relyvrio, won approval from the Food and Drug Administration in September 2022 to slow the progression of ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease). However, the data behind the controversial decision was shaky at best; it was based on a study of just 137 patients that had several weaknesses and questionable statistical significance, and FDA advisors initially voted against approval. Still, given the severity of the neurogenerative disease and lack of effective treatments, the FDA ultimately granted approval under the condition that the company was working on a Phase III clinical trial to solidify its claimed benefits.

Relyvrio—a combination of two existing, generic drugs—went on the market with a list price of $158,000.

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Apple now allows retro game emulators on its App Store—but with big caveats

It’s probably not the Wild West of game emulation you’re hoping for. Here’s why.

A screenshot of Sonic the Hedgehog on an iPhone

Enlarge / The classic Sega Genesis game Sonic the Hedgehog running on an iPhone—in this case, as a standalone app. (credit: Samuel Axon)

When Apple posted its latest update to the App Store's app review and submission policies for developers, it included language that appears to explicitly allow a new kind of app for emulating retro console games.

Apple has long forbidden apps that run code from an external source, but today's announced changes now allow "software that is not embedded in the binary" in certain cases, with "retro game console emulator apps can offer to download games" specifically listed as one of those cases.

Here's the exact wording:

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Apple now allows retro game emulators on its App Store—but with big caveats

It’s probably not the Wild West of game emulation you’re hoping for. Here’s why.

A screenshot of Sonic the Hedgehog on an iPhone

Enlarge / The classic Sega Genesis game Sonic the Hedgehog running on an iPhone—in this case, as a standalone app. (credit: Samuel Axon)

When Apple posted its latest update to the App Store's app review and submission policies for developers, it included language that appears to explicitly allow a new kind of app for emulating retro console games.

Apple has long forbidden apps that run code from an external source, but today's announced changes now allow "software that is not embedded in the binary" in certain cases, with "retro game console emulator apps can offer to download games" specifically listed as one of those cases.

Here's the exact wording:

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Roku has patented a way to show ads over anything you plug into your TV

System would detect paused content on external devices and show ads on top.

A promotional image for a Roku TV.

Enlarge / A promotional image for a Roku TV. (credit: Roku)

Roku TV sets come with ads. Generally, these are restricted to Roku's home and menu screens, its screensavers, and its first-party video channels, and once you start playing video, the only ads you'll see are the ones from the service you're streaming from. That said, Roku TVs have shown ads atop live TV before.

Now, the company is apparently experimenting with ways to show ads over top of even more of the things you plug into your TV. A patent from spotted by Lowpass describes a system for displaying ads over any device connected over HDMI, a list that could include cable boxes, game consoles, DVD or Blu-ray players, PCs, or even other video streaming devices. Roku filed for the patent in August 2023 and it was published in November 2023, though it hasn't yet been granted.

The technology described would detect whether content was paused in multiple ways—if the video being displayed is static, if there's no audio being played, if a pause symbol is shown anywhere on screen, or if (on a TV with HDMI-CEC enabled) a pause signal has been received from some passthrough remote control. The system would analyze the paused image and use metadata "to identify one or more objects" in the video frame, transmit that identification information to a network, and receive and display a "relevant ad" over top of whatever the paused content is.

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Roku has patented a way to show ads over anything you plug into your TV

System would detect paused content on external devices and show ads on top.

A promotional image for a Roku TV.

Enlarge / A promotional image for a Roku TV. (credit: Roku)

Roku TV sets come with ads. Generally, these are restricted to Roku's home and menu screens, its screensavers, and its first-party video channels, and once you start playing video, the only ads you'll see are the ones from the service you're streaming from. That said, Roku TVs have shown ads atop live TV before.

Now, the company is apparently experimenting with ways to show ads over top of even more of the things you plug into your TV. A patent from spotted by Lowpass describes a system for displaying ads over any device connected over HDMI, a list that could include cable boxes, game consoles, DVD or Blu-ray players, PCs, or even other video streaming devices. Roku filed for the patent in August 2023 and it was published in November 2023, though it hasn't yet been granted.

The technology described would detect whether content was paused in multiple ways—if the video being displayed is static, if there's no audio being played, if a pause symbol is shown anywhere on screen, or if (on a TV with HDMI-CEC enabled) a pause signal has been received from some passthrough remote control. The system would analyze the paused image and use metadata "to identify one or more objects" in the video frame, transmit that identification information to a network, and receive and display a "relevant ad" over top of whatever the paused content is.

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Will there be a Dune: Part Three? Yes… with caveats on timing

Timing of a big-screen return to Arrakis mostly depends on director Denis Villeneuve.

Legendary Pictures has confirmed that it plans to make <em>Dune: Part Three</em> with director Denis Villeneuve.

Enlarge / Legendary Pictures has confirmed that it plans to make Dune: Part Three with director Denis Villeneuve. (credit: YouTube/Warner Bros.)

Dune: Part Two is still raking in the moolah at the box office, and deservedly so. But judging by my various feeds, fans are already swooning over the prospect of director Denis Villeneuve extending his vision into a trilogy by adapting Frank Herbert's 1969 sequel, Dune Messiah, for the next installment. Will there be a Dune: Part Three? Most signs currently point to yes, with a couple of caveats. Exactly how soon we'll be seeing a return to Arrakis depends a lot on Villeneuve.

Variety confirmed that Legendary Pictures is working with the director on developing Dune: Part Three, although it remains unclear from the wording of the plethora of news items whether the project has officially been greenlit. ("Development" can mean a lot of things.) Naturally, the studio is eager, as are we: the film is the biggest hit of 2024 thus far, with global earnings of $630 million (although the hotly anticipated Deadpool and Wolverine this summer might give it a run for its money).

That confirmation sent fresh frissons of excitement across the Internet, although Villeneuve had been talking about the prospect as far back as September 2021. Those plans always depended on the success of Part Two, and that hurdle has obviously been cleared. By August 2023, the director was on record saying there were "words on paper" for a third film. And we learned just last month that composer Hans Zimmer was already working on the score for Dune: Part Three.

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Will there be a Dune: Part Three? Yes… with caveats on timing

Timing of a big-screen return to Arrakis mostly depends on director Denis Villeneuve.

Legendary Pictures has confirmed that it plans to make <em>Dune: Part Three</em> with director Denis Villeneuve.

Enlarge / Legendary Pictures has confirmed that it plans to make Dune: Part Three with director Denis Villeneuve. (credit: YouTube/Warner Bros.)

Dune: Part Two is still raking in the moolah at the box office, and deservedly so. But judging by my various feeds, fans are already swooning over the prospect of director Denis Villeneuve extending his vision into a trilogy by adapting Frank Herbert's 1969 sequel, Dune Messiah, for the next installment. Will there be a Dune: Part Three? Most signs currently point to yes, with a couple of caveats. Exactly how soon we'll be seeing a return to Arrakis depends a lot on Villeneuve.

Variety confirmed that Legendary Pictures is working with the director on developing Dune: Part Three, although it remains unclear from the wording of the plethora of news items whether the project has officially been greenlit. ("Development" can mean a lot of things.) Naturally, the studio is eager, as are we: the film is the biggest hit of 2024 thus far, with global earnings of $630 million (although the hotly anticipated Deadpool and Wolverine this summer might give it a run for its money).

That confirmation sent fresh frissons of excitement across the Internet, although Villeneuve had been talking about the prospect as far back as September 2021. Those plans always depended on the success of Part Two, and that hurdle has obviously been cleared. By August 2023, the director was on record saying there were "words on paper" for a third film. And we learned just last month that composer Hans Zimmer was already working on the score for Dune: Part Three.

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Tesla scraps its plan for a $25,000 Model 2 EV

Musk says that “Reuters is lying (again)” over reports that the Model 2 is dead.

In this photo illustration the American electric car manufacturing company brand Tesla logo is seen on an Android mobile device with a computer key which says cancel and cancelled

Enlarge (credit: Budrul Chukrut/SOPA Images/LightRocket via Getty Images)

Tesla has abandoned plans to develop an affordable electric Model 2, according to a report in Reuters. The news organization says it has reviewed company messages that say the affordable Model Y, which Tesla CEO Elon Musk claimed would sell for $25,000 or less, has been axed.

Musk has been talking about an affordable Tesla Model 2 for some time now. An affordable mass-market EV was supposedly always key to the company's long-range "master plans," and in December 2023 he said the company was working on a "low-cost electric vehicle that will be made at very high volume." Then, this March, Musk told Tesla workers that the Model 2 would go into production at the company's factory in Berlin, Germany.

In light of this news, that statement certainly raises eyebrows—Reuters reports that one of its three unnamed sources told it that the decision to scrap the Model 2 was made in late February. Instead, Musk is allegedly "all in on robotaxi," Tesla's plan to create an autonomous driving system that could allow its cars to compete with Uber or Lyft without a driver in the equation.

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German state gov. ditching Windows for Linux, 30K workers migrating

Schleswig-Holstein looks to succeed where Munich failed.

many penguins

Enlarge (credit: Getty)

Schleswig-Holstein, one of Germany’s 16 states, on Wednesday confirmed plans to move tens of thousands of systems from Microsoft Windows to Linux. The announcement follows previously established plans to migrate the state government off Microsoft Office in favor of open source LibreOffice.

As spotted by The Document Foundation, the government has apparently finished its pilot run of LibreOffice and is now announcing plans to expand to more open source offerings.

In 2021, the state government announced plans to move 25,000 computers to LibreOffice by 2026. At the time, Schleswig-Holstein said it had already been testing LibreOffice for two years.

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Danish Torrent Tracker Crackdown Leads to Another ‘Mild’ Sentence

As part of a widespread torrent tracker crackdown in Denmark, the National Unit for Special Crime investigated and prosecuted more than two dozen suspects. The most recent defendant, a 48-year-old man from East Jutland, pleaded guilty to his involvement in the Asgaard tracker and was handed a conditional prison sentence. According to local anti-piracy group Rights Alliance, the punishment should have been much tougher.

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

asgaard downPrivate torrent trackers with Danish roots have long been the go-to place for file-sharers in Denmark. Not anymore.

Starting in the fall of 2020, Danish law enforcement toppled several thriving torrent communities.

With help from local anti-piracy group Rights Alliance, DanishBits, NordicBits, ShareUniversity, Asgaard and others were systematically dismantled.

Sting Operation

When the first trackers fell, preparations for the operation had been ongoing for years. It all started when a former lawyer working for Rights Alliance went undercover at the private tracker DanishBits in 2016. As a quiet user, the infiltrator mapped the site’s internal relationships and identified key individuals in the wider Danish tracker ecosystem.

The details of this sting operation read like a film script but for many involved, it turned into a real-life drama. Not only were several trackers subsequently shut down, a number of community members were prosecuted too. More than two dozen people, from prolific uploaders to ringleaders, all had their day in court.

After the tracker dominoes fell, more than two dozen suspects were investigated and taken to court. This resulted in a wide range of sentences, with most of the tracker admins receiving conditional prison sentences of a few months. Some were ordered to carry out community service.

Conditional Prison Sentence

This week, the National Unit for Special Crimes (NSK) announced the final sentence related to the ‘Asgaard’ tracker. The Court in Horsens sentenced a 48-year-old man from East Jutland, who pleaded guilty to copyright infringement, to a suspended prison sentence of 60 days.

The defendant was the last of seven Asgaard tracker administrators to go before the court. The man helped to get the torrent site off the ground in 2019 and served as an admin of NordicBits before that; both offenses were accounted for in the conviction.

Asgaard became immensely popular in Denmark toward the end of 2020, after DanishBits and NordicBits shut down. The site had an estimated 1.5 million monthly visits at its height, making it the biggest pirate site in the country for a while.

Harsher Punishment Wanted

The guilty verdict is good news for Rights Alliance, but a bittersweet victory. While the crackdown effectively decimated the torrent tracker problem, the sentences handed down have been relatively ‘mild’. The tracker operator and many other “ringleaders” don’t have to serve time in prison, as the sentences are conditional.

Rights Alliance Director Maria Fredenslund notes that copyright and IP-related crimes are historically not viewed as severe crimes in Denmark, adding that a tougher sentence would be more effective.

“Sentences for IP crime are in general too low in Denmark, to have a sufficient deterrent effect. We believe the sentences in many cases should have been much harder,” Fredenslund informs TF.

“The reality is that IP crime has not been seen as a severe crime in Denmark historically, so we are starting from a low point and building from there to obtain adequate sentencing that will keep others from committing similar crimes.”

NSK prosecutor Hans Bohn Sørensen is content with the verdict, however, which marks the end of the Asgaard prosecution.

“I am satisfied with the verdict, which now ends the proceedings against the founders and administrators behind one of the largest illegal file sharing services we have had in Denmark,” Sørensen says.

Threat Neutralized?

The recent sentence and those that were handed down earlier are not the harshest on a global scale and unlikely to spook hardened criminals. However, deterrence is not solely determined by the harshness of a punishment.

Another factor that plays a key role is the likelihood of getting caught. With a multi-year crackdown on several trackers, Danish police and NSK have shown that this risk is, perhaps, higher than ever.

Commenting on this aspect, Fredenslund praises the authorities’ invaluable efforts, which helped to ensure that Danish file-sharing services no longer pose a significant threat to Danish rights holders.

Of course, new trackers will always emerge but Rights Alliance sees these as marginal problems in the grander scheme.

“The current trackers only harbor the very hardcore illegal users in Denmark. They don’t pose a threat that’s comparable to Asgaard, ShareUniversity, DanishBits, etc.,” Fredenslund notes.

With the final conviction of the last Asgaard admin, all cases related to the tracker are closed. Cases against other trackers are still pending, however. In the meantime, Rights Alliance maintains its focus on emerging threats, including those related to Artificial Intelligence.

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