Tag: European Union

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The Download: South Korea’s hottest bachelors, and advancing eye transplants

This is today’s edition of The Download, our weekday newsletter that provides a daily dose of what’s going on in the world of technology.

South Korea’s hottest new bachelors are chip workers

Baek, a 35-year-old manager at the South Korean semiconductor titan SK Hynix, was enrolled in a matchmaking company a year ago. In a move typical of anxious South Korean parents, his mother signed him up, hoping to find a good wife for her son.

Lately, says Baek, he and his coworkers are having better luck finding dates—perhaps because of the dazzling bonuses they just got. Flush with eye-popping profits from the AI chip boom, SK Hynix agreed to pay 10% of operating profits to employees, which translates to an extra $476,000 per employee this year. Samsung workers received a similar deal this May.

With their newfound wealth, chip workers like Baek have become the most sought-after bachelors and bachelorettes in South Korea. 

Discover how AI chip profits are transforming South Korea’s dating market—and stoking anxieties.

—Michelle Kim

A device that revives eyeballs from dead donors could make eye transplants possible

It’s not easy to transplant a whole human eye. The surgery is difficult, and eyes start to degenerate as soon as they’ve left the body. When surgeons attempted it a few years ago, the newly transplanted eye couldn’t see.

But researchers believe they might have a solution: a device that maintains and revives freshly removed eyeballs using a technique called perfusion. Treated eyes don’t degrade as quickly and appear to retain the ability to transmit electrical signals—and potentially see. 

The device could one day make whole-eye transplants a viable possibility. Here’s how it works.

—Jessica Hamzelou

The must-reads

I’ve combed the internet to find you today’s most fun/important/scary/fascinating stories about technology.

1 The UN’s chief has warned that AI is outpacing global rules
He’s called for globally harmonised guardrails. (Reuters $)
+ The UN also said AI could worsen global inequality. (Guardian)

2 An Israeli battlefield system identified 850,000 targets in Gaza and Lebanon
Elbit Systems says it detected targets in real time. (Guardian)
+ Congress wants to permanently integrate US and Israeli defence tech. (Intercept) 
+  How AI turned the Iran conflict into theater. (MIT Technology Review) 

3 EU transparency rules have exposed Microsoft’s tax haven tactics
A new report shows how it shifts profits around to reduce tax bills. (NYT $)
+ Other US companies will soon need to provide similar reports. (Engadget)

4 A spacecraft has launched an audacious mission to rescue a NASA telescope
LINK will try to tug the SWIFT observatory to a higher orbit. (New Scientist $)
+ It will attempt to grab the telescope with three robotic arms. (BBC)
+ The observatory studies gamma-ray bursts. (NBC News)
+ We’re putting more stuff into space than ever. (MIT Technology Review)

5 Chinese tech giants are disabling humanlike AI due to new regulations
ByteDance and Alibaba have shut down the features. (SCMP)
+ Beijing is tightening its AI regulations. (Nikkei Asia)

6 Anthropic wants to develop its own drugs
The company says it will pursue treatments for “neglected” diseases. (Verge)
+ It’s also got a new AI for science product. (MIT Technology Review)

7 India is testing an alternative to Silicon Valley’s AI playbook
It’s based on small, offline, multilingual, open-source AI. (Rest of World)
+ India’s AI infrastructure is also attracting investors. (CNBC)

8 Big Tech has suddenly flipped on the AI jobs wipeout scenario
Negative public opinion has sparked a more optimistic public stance. (WSJ $)
+ The AI jobs hysteria needs a reality check. (MIT Technology Review)

9 Midjourney has accused Hollywood studios of covertly using AI
It’s escalated its legal fight with Disney, Universal, and Warner. (Gizmodo)

10 A martian rock has lots of carbon on it, and it’s not clear why
Scientists cannot yet tell whether biology played a role. (Ars Technica)

Quote of the day

“It’s just his AI and my AI going back and forth.” 

—An anonymous employee explains why she’s struggling to develop a good working relationship with her boss, Fortune reports.

One More Thing


The AI relationship revolution is already here

AI is everywhere, and it’s starting to alter our relationships with our spouses, kids, colleagues, friends—and even ourselves. 

Although the technology remains unpredictable and sometimes baffling, individuals from all across the world and from all walks of life are finding it useful, supportive, and comforting too. 

People are using large language models to seek validation, mediate marital arguments, and help navigate interactions with their community. They’re using it for parenting support, self-care, and even to fall in love.

Explore how AI is changing our relationships.

—Rhiannon Williams

We can still have nice things

A place for comfort, fun, and distraction to brighten up your day. (Got any ideas? Drop me a line.)

+ Radiohead’s seminal album “OK Computer” has been reimagined as a Nintendo 64 soundtrack.
+ Graphic design history meets stamp collecting in this beautifully curated archive of postage stamp design.
+ As Lionel Messi lights up another World Cup, his former coach breaks down his style of play in this fascinating analysis.
+ Armchair engineers will enjoy the brilliant product teardowns of everyday items like clicky pens and lighters on Mechanical Pencil.

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The Download: a smoking “endgame” and a new Elizabeth Bear story

This is today’s edition of The Download, our weekday newsletter that provides a daily dose of what’s going on in the world of technology.

The UK’s generational tobacco ban might not work. I’m supporting it anyway.

—Jessica Hamzelou

As the parent of two little girls, I often think about how their childhood is different from mine. The seven-year-old is learning about AI at school. The five-year-old is given internet-based homework every week. And they are both absolutely repulsed by the idea of smoking.

That was not the prevailing sentiment when I was young. Smoking was a central part of our culture. Which is why the UK’s recent passing of a generational sales ban on tobacco products feels like such a big deal.

This is what’s described as an “endgame” approach. While many tobacco control strategies—such as taxation or gory imagery—aim to reduce consumption, policies like the UK’s are designed to eliminate it entirely. It’s a new approach, and no one knows whether it will work. But it’s an enticing prospect—and it’s starting to look a lot less radical.

Find out why generational tobacco bans are gaining support.

This story is from The Checkup, our weekly biotech newsletter. Sign up to receive it in your inbox every Thursday.

You do your own time

—You do your own time is a short story by Elizabeth Bear, an award-winning speculative fiction author.

There we were, a regular murderers’ row of librarians. Turning around in the nave of our library to greet the sound of footsteps, pistols leveled in case whoever was coming in didn’t respect sanctuary.

I pulled down a solid-state drive full of biographies and case studies of people who had spent time—and sometimes their whole lives—in labor camps or chattelhood. It was illegal to possess, and the feds used smart agents to track down and obliterate any copies. Which was why we were sending one to the stars.

What’s left behind when a name is erased from the system? No legacy, no memory—that is the point of media and narrative control. So that was our plan: to preserve it, for later generations, or just as a silent record of our existence.

Read the rest of this short story in full. 

—Elizabeth Bear

This story is from the latest edition of our magazine, which is all about engineering. Subscribe now to get a copy, plus all our other issues and a range of subscriber-only content.

The must-reads

I’ve combed the internet to find you today’s most fun/important/scary/fascinating stories about technology.

1 An EU lawmaker investigating spyware was hacked by that spyware
Citizen Lab found Pegasus spyware on Stelios Kouloglou’s phone. (Wired $)
+ It said the EU “looks the other way” on spyware abuses. (Guardian)
+ Meet the director of Citizen Lab. (MIT Technology Review)
 
2 Anthropic is closing loopholes that allow Chinese access to Claude
It’s targeting VPNs, relay services, and overseas accounts. (FT $)
+ Users in China keep finding new workarounds. (Wired $)
 
3 A Tesla driver has been charged with manslaughter after a fatal crash
Court records show he was using automated driver-assistance. (WSJ $)
+ Tesla sales have surged 25% after a rebound in Europe. (NYT $)
 
4 Trump bought lots of tech stock the day he unveiled his AI Action Plan
He acquired up to $5 million in stock from Amazon and others. (Engadget)
+ His AI Action Plan was a distraction. (MIT Technology Review)
 
5 Companies are throttling employees’ AI use because it’s too expensive
They’re pleading with workers to use less powerful models. (404 Media)
+ Tesla has capped their AI spending at $200 per week. (The Information $)

6 The Energy Dept wants data centers on backup power in heat waves
It wants them to free up power for AC. (NYT $)
+ People near data centers are dreading heat wave pollution. (Politico $)
+ No one wants a data center in their backyard. (MIT Technology Review)
 
7 A Meta glasses feature just went from free to a subscription service
“Conversation Focus” will now cost $19.99 per month. (BBC)
+ The move heralds a new era of consumer tech subscriptions. (Wired $)

8 Random wobbles in time could solve gravity’s greatest mystery
A new idea could reconcile gravity and quantum mechanics. (New Scientist $)
 
9 Peter Thiel claims the pope is “working for the Chinese Communists”
By pushing for stricter AI rules that may benefit Chinese interests. (CNN)
+ Pope Leo XIV said AI must be “disarmed” in his first major teaching. (BBC)
+ His encyclical offered a template for steering AI. (MIT Technology Review) 
 
10 Supersonic flight over land could finally be legal again
Regulators want to lift a ban—so long as the planes are quiet. (Ars Technica)

Quote of the day

“We don’t have robots that are nearly as good at understanding the physical world as a rat.”

—Yann LeCun, the founder of AMI Labs and Meta’s former chief AI scientist, tells the BBC that AI isn’t as smart as many think.

One More Thing

MARCO GIANNAVOLA

How two brothers became go-to experts on America’s “mystery drone” invasion 

On a Friday evening in December, every tier of US law enforcement was dispatched to a military research installation outside Boston after a squadron of 15 to 20 drones was spotted violating restricted airspace. The culprits could not be found.

It was the latest in a series of purported drone sightings along the US East Coast. Lacking coordination or clarity from the White House, the Pentagon, and the intelligence community, law enforcement officers turned to an unlikely source: twin brothers from Long Island who hunt UFOs.

The Tedescos have built a mobile field lab to investigate unexplained aerial phenomena. Now members of the FBI want their support.

Discover how the brothers are helping law enforcement investigate UFOs.

—Matthew Phelan

We can still have nice things

A place for comfort, fun, and distraction to brighten up your day. (Got any ideas? Drop me a line.)

+ This record-breaking drone show is a mind-bending display of aerial light.
+ A Paris bakery is taking a bite out of food waste by repurposing croissants.
+ Relive your childhood with a classic episode from the Mister Rogers archive.
+ See graffiti through new eyes with this project that prettifies tags and makes them legible.

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Cytiva Completes Doubling of Utah Site’s Liquid Media Production Capacity

Cytiva has completed an expansion of its Logan, UT, facility that effectively doubles its liquid media production capacity, a project designed to support supply chain continuity for customers relying on the company for their cell culture needs.

The company has completed its animal-derived component-free (ADCF) liquid media expansion facility (A1X), Pierre-Alain Ruffieux, Cytiva group executive, bioprocess, told GEN in an interview conducted from the company’s booth during the Biotechnology Innovation Organization (BIO) International Convention recently held in San Diego. He said the completion was celebrated with a ceremony on the site.

Cytiva detailed the expansion project in a May 12 post on its website: The ADCF liquid media expansion facility (A1X) has larger mixing tanks than the existing facility, supporting batch sizes from 700 L up to 13,000 L—compared with batch sizes of 100 L to 10,000 L supported by Cytiva’s existing facility.

Also, the A1X facility uses mixing tanks and liquid media transfer lines comprised of AL6XN and 316 L stainless steel. This differs from the existing facility equipment, which is comprised solely of 316 L stainless steel. AL6XN is a low-carbon, high-purity stainless-steel alloy that is more resistant to wear and corrosion than 316 L, representing an upgrade to the product contact layer versus the existing facility equipment.

The expanded site’s added liquid capacity comes from the addition of three manifold fill lines, three filling manifolds, six mixing tanks, six formulation booths, and a utility building to support large volume liquid media production. Housed in the utility building are a 45,000 L tank and process water system, a 55,000 L tank and water for injection system, a clean steam generator, and additional supporting utilities.

“In addition to the added capacity, Cytiva has updated several aspects of the manufacturing floor layout and equipment, improvements designed to shorten production cycle time, improve safety, and minimize product risk,” the company explained. “The updates also establish closed systems for cleaning and a controlled environment for the transport and handling of raw materials and finished goods.”

Previously, Cytiva completed expanding its dry powder and liquid media manufacturing capacity for large-volume customers and added high-speed bottle filling for smaller-volume users. The company also opened an expanded staging area for finished goods, as well as a new centralized 10,000-square-foot quality control lab to support increased manufacturing.

AI’s “two major impacts”

Pierre-Alain Ruffieux, Cytiva group executive, bioprocess

During a wide-ranging interview, Ruffieux discussed Cytiva’s approach to AI and several recent Cytiva announcements.

“We see two major impacts from AI on what we are doing,” Ruffieux explained. “The first one, and I always like to start with the customers because it’s really our focus: We see our customers accelerating and increasing the number of targets they are doing. AI is helping them to have more targets and in a faster time,” Ruffieux said. “It’s putting pressure on the CMC folks, and I think it’s where we play: They ask us to provide innovative solutions to go faster.”

Cytiva’s focus on AI is two-fold, he continued.

“One, we are developing intelligent equipment which is using AI to be easier for customers to use and which are more functional; that is one aspect. It’s also delivering more experience in a shorter time frame,” Ruffieux said. “It’s a kind of next level of DoE [design of experiments], but it’s also delivering a productivity aspect because the goal is to have equipment which requires either fewer people or fewer people with less specific knowledge of the equipment.”

Like a growing number of companies in and outside biopharma, Ruffieux said, Cytiva has fully embraced AI “to make our product better, to make the customer experience better, but also to improve our internal processes.”

“Faster and better”

“We see AI helping us to develop software, writing new software to go faster and better. AI is very powerful for reviewing documents and doing things,” he explained. “It’s amazing what we can do both in writing code, but also perhaps as importantly, as we validate the code and we test everything, the use of AI is allowing our people to work in a much more comprehensive way, in a much faster way.”

AI also adds a layer, he said, to the continuous improvement ethos that Cytiva and other Danaher-owned companies practice through the Danaher Business System (DBS). Since the mid-1980s, Danaher has carried out an ongoing company-wide Kaizen or continuous improvement effort based on lean manufacturing and anchored on DBS, a common culture and operating system focused on people, plans, processes, and performance.

“AI is an additional pillar to this system, really helping the company to be more efficient and to drive business,” Ruffieux said.

Cytiva’s customers, he continued, have not specifically asked about AI. So what are customers telling the company that they want?

“What customers want is Cytiva delivering solutions which help them to innovate, produce drugs, and accelerate these processes. And AI is one of the attributes, but they don’t have a specific task on AI,” Ruffieux replied. “In discussing with senior customers, people are interested in the outcome, not in the product itself. So it’s not AI for AI, it’s AI for a business outcome. And in life science, the business outcome is quality. It’s reliability. It’s speed. It’s customers asking, can we help them to be better?”

AMT designation

Last month, Cytiva hailed the FDA’s granting its Advanced Manufacturing Technology (AMT) designation to the company for its Elevecta™ transient cell line for adeno-associated virus (AAV) manufacturing, one of the first gene therapy manufacturing technologies to receive the designation. Customers using the Elevecta transient cell line will benefit, according to Cytiva, from a clear, predictable regulatory and quality framework for gene therapy development.

Through its AMT designation, the FDA recognizes drug manufacturing technologies that it deems to have elevated the reliability, quality, and robustness of advanced therapeutics manufacturing. By enabling a streamlined Chemistry, Manufacturing, and Controls (CMC) review and frequent communication with the FDA, designees count on the AMT designation to help accelerate their manufacturing-related development timelines and create a meaningful advantage through faster time to market.

“This recognition by the FDA is giving confidence and trust for our customers: If they use this cell line to produce AAV, they know that the agency has seen the technical advantage and it’s confidence on the regulatory pathway,” Ruffieux said. “This recognition by that regulatory body is giving trust to the work of the company in helping customers develop drugs, which is really where we position ourselves as true partners.”

Elevecta is designed to significantly reduce the formation and encapsidation of host cell DNA (hcDNA).

“What is beautiful with that is, we get a reduction of 99% of the host cell DNA. You don’t have to worry any more about the host cell DNA which is coming with your product. Again, that is a huge advantage for the customer using that,” Ruffieux said. “This is the kind of innovation we are really proud to bring to our customers.”

Operating from hubs in Marlborough, MA, Amersham, U.K., Uppsala, Sweden, and Shanghai, Cytiva is a unit of Danaher that was re-launched in 2020 after Danaher spent $21.4 billion for the former biopharma business of GE Healthcare Life Sciences. Danaher oversees a global family of more than 20 operating companies focused on biotech and life sciences, as well as diagnostics, water quality, and product identification.

Bringing “the entire workflow”

Earlier this month, the company said that eight of its 2,000 L single-use Xcellerex bioreactors were among equipment contained in the new GMP-2 manufacturing facility inaugurated in Wuhan, China, by Chime Biologics, a decade-long customer that has used equipment made by Cytiva and its predecessor company.

“I want to put that in a larger context: At Cytiva, we really bring to the customers the entire workflow, which is really exciting for small to mid-sized customers. Coming to us, they really get a full facility that is working, really, from A−Z,” Ruffieux said. “It’s starting from an expansion of the cell line, to freezing the drug substance. It’s about a fully integrated solution that helps the customer to have that. And we have multiple facilities like that, that we are building every year for customers across the world.”

“We make significant investments to be able to supply our customers with what they need into different regions, in-region-for-region,” Ruffieux said.

In-region-for-region refers to Cytiva’s ongoing effort to satisfy customer demand for manufacturing tools and services usable within their regions of the world.

“This is really helping us and the customer to secure supply independent of any disruption,” he added. “Since COVID-19, we have seen multiple disruptions worldwide. And really, our original presence is giving confidence to customers that they will get what they need, independent of whatever crisis is happening across the world.”

Worldwide, the United States and European Union have championed “reshoring” efforts by drug developers and tools/technology providers across biopharma to manufacture more of their products within their regions rather than in China or elsewhere in Asia.

“When there is investment, it’s definitely always a tailwind,” Ruffieux said. “We welcome investment, and we are happy to support all customers to put up new facilities, and for the opportunity these facilities offer to position our equipment.”

The post Cytiva Completes Doubling of Utah Site’s Liquid Media Production Capacity appeared first on GEN – Genetic Engineering and Biotechnology News.

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The Download: Europe’s heat wave hits the grid, and IBM’s chip targets Moore’s Law

This is today’s edition of The Download, our weekday newsletter that provides a daily dose of what’s going on in the world of technology.

Europe’s extreme heat is shutting down power plants

Europe is in the middle of a record-breaking heat wave, and the grid is being pushed to its limits as people turn to fans and air-conditioning to try to stay cool. But some power plants won’t be online to help handle the load.

The main source of stress is increased demand, largely driven by cooling. And the challenges are only expected to worsen as climate change brings more frequent and intense heat waves.

Find out how rising temperatures are stretching power supplies—and how utilities can adapt.

—Casey Crownhart

What Europe’s heat wave means for the power grid

Grid planning in the age of climate change generally means that we need a lot more supply, and quickly. But one interesting facet to this challenge is that in some places, seasonal patterns are shifting, compounding the difficulty of meeting demand. 

Europe has historically seen its grid peak in the winter when electric heating is widespread. So some planned outages happen in the spring and into the summer, which is affecting the supply right now. But a growing need for air-conditioning will alter the balance.

Read the full story on how climate change is reshaping electricity demand.

—Casey Crownhart

This story is from The Spark, our weekly newsletter giving you the inside track on all things climate. Sign up to receive it in your inbox every Wednesday.

IBM unveils chip technology that could help extend Moore’s Law another decade

IBM has built a new prototype chip with around 100 billion transistors on an area the size of a fingernail. That’s twice the density of the company’s previous state-of-the-art technology announced in 2021. And the design could pave the way for faster and more energy-efficient computers for years to come.

In the last fifteen years, transistors have been shrunk close to their limits. They can’t get smaller without their function deteriorating. IBM’s new chip resolves this with an approach familiar to urban planners: building up.

Here’s how the strategy is bringing new hope to the technology industry. 

—Sophia Chen

The must-reads

I’ve combed the internet to find you today’s most fun/important/scary/fascinating stories about technology.

1 Anthropic says Alibaba “illicitly” extracted Claude’s capabilities 
It claims the Chinese firm ran a “brazen” campaign to access the model. (BBC)
+ It says it’s the “largest known distillation attack” on the company. (CNBC)
+ The technique trains a weaker model on a stronger one’s outputs. (FT $)
+ Anthropic previously accused other Chinese rivals of using it. (CNN)
+ But it’s still feuding with the White House. (MIT Technology Review)

2 NASA has detected possible chemical signatures of ancient life on Mars
The Perseverance rover spotted complex carbon on rocks. (New Scientist $)
+ The molecules are typically associated with dead organisms. (Guardian)
+ The US has lost its lead in the hunt for alien life. (MIT Technology Review)

3 The EU has joined a US pact to stop relying on Chinese AI
Much of the rest of the world seems to still be a battleground for control. (FT $)
+ China is expanding its AI push in the Global South to counter the US. (The Wire China)
+ Chinese AI experts are freaking out about the AI arms race. (Wired $)

4 OpenAI and Broadcom have unveiled their first jointly designed AI chip
Jalapeño is built to power large-scale AI systems like ChatGPT. (NYT $)
+ It’s part of OpenAI’s push to “build the full stack.” (CNBC)

5 A new report shows ICE has built a vast hi-tech surveillance system
It includes facial recognition, drones, and data scraping.(Guardian)
+ Is the Pentagon allowed to surveil citizens with AI? (MIT Technology Review)

6 Electronics can now be printed onto living tissue
Which could enable smart implants and ingestible diagnostics. (The Economist $)

7 The data center boom is sparking a third wave of inflation 
Demand for memory chips is pushing prices higher.(WSJ $)

8 Companies are scrambling to curb spending on AI token “chewing”
Accenture data shows non-technical staff are draining budgets. (404 Media)

9 Claude Design is creating a bland wave of website uniformity
The AI tool is homogenizing the internet’s aesthetic. (The New Yorker $)

10 Elon Musk has lost his trillionaire status
Thanks to SpaceX stock coming back to Earth. (Business Insider)

Quote of the day

“Tom Brown is not being a weirdo like Dario and can actually engage.” 

—A person directly familiar with calls between the Trump administration and Anthropic tells Wired that they’ve improved since cofounder Tom Brown replaced CEO Dario Amodei in the talks.

One More Thing

TONY LUONG


The quest to learn if our brain’s mutations affect mental health

For years, scientists searching for the roots of conditions like schizophrenia, autism, and Alzheimer’s have focused on single genes. But the real source may lie in a more complex genetic puzzle inside the brain.

Mike McConnell has spent decades exploring the idea that neurons do not all share identical DNA, and that these differences could help explain psychiatric disease. His work has contributed to evidence that brain cells can form a “genetic mosaic,” with mutations that vary across the brain.

Discover how this could reshape our understanding of mental illness.

—Roxanne Khamsi

We can still have nice things

A place for comfort, fun, and distraction to brighten up your day. (Got any ideas? Drop me a line.)

+ This classical reimagining of the Super Mario soundtrack is exquisite.
+ At long last, we can calculate the fuel efficiency of launching our enemies into the Sun.
+ Before CGI, explosions were an art form. This compilation of classic practical effects is pure action-movie nostalgia.
+ Cambridge botanists lovingly recreated a 336-year-old garden to honor the “father of natural history.” (Big thanks to reader Peter Ryan for the find!) 

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The emergence of the web data infrastructure layer for AI

AI is booming. New use cases are emerging each day. To capitalize on the technology’s potential, enterprises require data at scale. In many cases, though, the relevant information is blocked or unstructured, which limits its use by AI models. 

To understand this challenge, consider the foundation of the web itself. The web was not designed for the automated discovery and retrieval that new AI applications demand. Overcoming this inherent design constraint requires infrastructure.

The next frontier in AI may depend on a new web data infrastructure layer that can enable models to discover and map this ever-expanding digital realm. This layer must be able to navigate hundreds of millions of existing web domains and billions of new URLs created each week, delivering real-time information and overcoming technical barriers.

“The data suggests there’s far more data out there,” says Or Lenchner, CEO of Bright Data, a web data collection platform. “Think of the universe: It’s out there, but you don’t know what you don’t know.”

Enabling access to fresh, relevant, and trustworthy data

While early AI breakthroughs were driven by scaling training data and model size, organizations are now encountering a fundamental bottleneck: They need to keep pace with the dynamic, unstructured, and constantly evolving nature of web data in order to ground outputs in current and verifiable information. AI performance increasingly depends not just on model architecture but on a system’s compute, networking, retrieval, and data engineering capabilities—that is, the system’s ability to quickly and reliably retrieve data that is fresh, relevant, and trustworthy.

Traditional model training relies on snapshots of information collected at a particular point in time. Training AI on such static data is no longer sufficient. To track fluctuations such as competitor pricing, consumer sentiment, and market trends, companies need a constant feed of new information, pulling data in real time along with relevant context. Their infrastructure must therefore be able to handle millions of simultaneous interactions across websites that vary by geography, language, format, and access rules.

“If it can’t retrieve real-time information, it lacks context,” Lenchner says. “In a business setting, that’s not acceptable anymore. Stale answers lead to bad decisions and disappointed consumers.”

Speed is not merely a matter of convenience; it’s a matter of necessity. Today’s organizations operate in environments where prices, inventory, markets, security threats, and customer behavior change continuously. Delayed data retrieval can reduce the usefulness of an otherwise sophisticated model.

Using live, high-quality web data can also reduce AI hallucinations because the model has a more relevant knowledge base. This builds user trust. In fact, one survey found that 56% of AI practitioners said businesses need access to real-time web data to improve trust in AI outputs. To ensure the model runs efficiently and effectively, the information must also be pared down to the appropriate essentials. 

Despite the introduction of retrieval-augmented generation (RAG), where models pull in external data at the moment of a query, many AI systems still struggle to deliver outputs that are current, contextually relevant, and trustworthy in operational settings. According to Gartner, 60% of AI projects that are not supported by AI-ready data—accurate, structured, organized, and contextualized—will be abandoned by the end of the year. 

This is because large-scale retrieval alone does not solve the problem. As Lenchner puts it, “You need to retrieve data at scale, but also in real time. Latency becomes an issue because of the end user who is waiting for the output.” 

Accessing fresh, AI-ready data at scale introduces technical and structural challenges. In practice, many enterprise systems combine public web retrieval with APIs, licensed datasets, and proprietary internal data in their AI applications. Integrating these fragmented sources into a timely and usable knowledge layer requires specialized capabilities. Some research has found that 97% of AI organizations depend on real-time web data infrastructure, but 90% feel boxed in by various restrictions. Companies are increasingly developing technical approaches to navigate these constraints.

Lenchner draws this metaphor: “Think of the trained model as intelligence and relevant data as knowledge. A powerful intelligence layer sitting on top of a hollow knowledge layer is like a genius who knows nothing—useless in practice. Intelligence and knowledge have to come together.”

The promise of new infrastructure

A new layer of web data infrastructure can address this developing need for stronger AI inputs by enabling discovery of data, real-time access, and tailoring to a specific context. As Lechner describes it, “It’s all about collecting data at scale, super-low latency, without being blocked.”

Rather than relying on increased computing power, this type of platform emulates human browsing behavior to access available content and transform raw code into structured data feeds. It can work with websites that might not interact with traditional scraping tools, such as those heavy in JavaScript, or with aggressive antibot software. 

As Lenchner explains, “It’s basically having infrastructure that can mimic a web user with identifying information—IP address, location, and 1,000 more parameters. And at scale. Think of doing that 80 billion times a day for millions of websites. And every single time, you are looking exactly as the website expects you to look.”

Of course, continuous retrieval introduces new data governance challenges. To address them, platforms can enforce strict compliance protocols aligned with global privacy frameworks, such as the EU’s General Data Protection Regulation (GDPR) and the California Consumer Privacy Act (CCPA). They can also be limited to openly accessible, public information, avoiding paywalls or private logins. Any networks used can be vetted and consent-based, and incentives can be provided to owners of IP addresses. In this way, systems can be designed to comply with tightening regulation.

Such complex capabilities do not come easy. “When this is critical infrastructure for a company,” Lenchner says, “doing it in-house becomes a full-time engineering problem that competes with the actual AI work.” Addressing this complexity requires organizations to commit significant resources, leading many to seek specialized platforms designed specifically for data retrieval, orchestration, and observability.

Infrastructure for the real world

Real-time data retrieval is changing what AI systems can do inside organizations. For example, a retail company can use public information to enable a dynamic pricing engine, and global brands can track trademark infringements. 

As the ecosystem matures, organizations that invest in this emerging data infrastructure layer will be better positioned to build AI systems that are more responsive, reliable, and aligned with real-world conditions—AI systems that can continuously adapt using current web data. Over time, the distinction between AI models and the infrastructure that feeds them may even begin to disappear.

As Lenchner says, “The world is changing. And everything that is happening in the world is being uploaded to the public web. The amount of new data that is being generated is growing and accelerating.”

To learn more from Bright Data, read the Data for AI 2026 report.

This content was produced by Insights, the custom content arm of MIT Technology Review. It was not written by MIT Technology Review’s editorial staff. It was researched, designed, and written by human writers, editors, analysts, and illustrators. This includes the writing of surveys and collection of data for surveys. AI tools that may have been used were limited to secondary production processes that passed thorough human review.

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AbbVie to Acquire Apogee Therapeutics for $10.9B

SAN DIEGO — AbbVie has agreed to acquire Apogee Therapeutics for $10.9 billion, the companies said today, in a deal designed to bolster the buyer’s pipeline with an atopic dermatitis (AD) candidate set to advance to Phase III trials during the second half of this year, and being positioned as a potential challenger to a top-selling drug.

Apogee’s lead candidate zumilokibart, an IL-13 inhibitor also called APG777, is a long-acting treatment that according to the company holds “pipeline-in-a-product potential” because of the opportunity it has for treating a variety of immunology and inflammation (I&I) diseases for which the drug is under study.

“We continue to believe that Apogee’s zumilokibart is one of the more attractive assets in the I&I space, and its current valuation proves this out,” Edward Nash, a managing director and senior biotechnology analyst with Canaccord Genuity, wrote this morning in a research note. “The company, since its 2022 inception, has continued to deliver strong clinical results for zumilokibart in atopic dermatitis. The BIG [emphasis in original] differentiator for the drug is its potential to be dosed once every three or six months, which was just demonstrated in recently announced updates from the Phase II trial.”

Last month, Apogee announced positive 16-week data from Part B of its Phase II APEX trial (NCT06395948) assessing zumilokibart in moderate-to-severe AD. The trial met its primary and secondary endpoints with high statistical significance, as 65.9% of patients treated with mid-dose zumilokibart achieved EASI-75 (41.9% placebo adjusted).

Based on these results and subject to positive regulatory feedback, Apogee said it planned to move forward in its Phase III trials with the mid-dose, which achieved the best clinical activity of the three doses tested and was well-tolerated.

To support those Phase III trials and continued late phase development and potential commercialization of zumilokibart, Apogee last month entered into a strategic financing for up to $1.3 billion in flexible, non-dilutive total capital.

The capital includes up to $800 million of synthetic royalty funding and access of up to $500 million in senior corporate debt available by mutual consent of Blackstone and Apogee. Blackstone agreed to provide the synthetic royalty funding in exchange for low-to-mid single digit tiered royalties for 15 years on worldwide annual sales of zumilokibart. The royalties decrease with increasing sales, with zero royalties paid out on global annual sales exceeding $8 billion.

Third-largest deal, so far

The $10.9 billion Apogee acquisition is the new third largest biopharma merger-and-acquisition (M&A) deal announced so far this year, behind the €10.7 billion ($12.268 billion) cash buyout offer for Italian-based Recordati being pursued by CVC Capital Partners and Groupe Bruxelles Lambert, which aim to take the company private; and Sun Pharmaceutical Industries’ planned $11.75 billion purchase of Organon, the women’s health drug developer spun out of Merck & Co., in a deal expected to close in early 2027.

The previous third-largest M&A deal this year, now fourth-largest, is GlaxoSmithKline (GSK)’s planned $10.6 billion buyout of Nuvalent,  announced June 9 and expected to close in the third quarter.

For AbbVie, the deal for Apogee adds to its pipeline in I&I, a category the biopharma giant dominated when its multi-indication blockbuster Humira® (adalimumab) was the world’s best-selling drug, before it lost patent exclusivity in the European Union in 2018 and the U.S. in 2023—after which it slipped from the top of GEN’s annual A-Lists of Top 10 Best-Selling Drugs.

However, AbbVie has developed two successful I&I drugs in recent years, Skyrizi® (risankizumab)  and Rinvoq® (upadacitinib)—with Skyrizi ranking No. 6 on GEN’s latest best-selling drugs A-List, generating $17.562 billion in sales last year (up 49.9% from 2024) and $4.483 billion in Q1 2026, up 30.9% from Q1 2025.

“For more than two decades, AbbVie has led and shaped the field of immunology bringing the science, scale and expertise needed to address some of the most complex diseases,” Robert A. Michael, AbbVie’s chairman and CEO, said in a statement. “The acquisition of Apogee further builds on our existing leadership, strengthening our ability to deliver innovative medicines to patients who need better options while also creating significant long-term value for shareholders.”

Apogee investors signaled support for the buyout with a surge of stock buying that sent the company’s shares soaring 47% in early day trading from $90.38 to $132.65 as of 10:21 am ET. AbbVie shares rose 4.5% from $216.49 to $226.24.

Potential Dupixent® challenger

Apogee is positioning zumilokibart as a potential challenger to Dupixent® (dupilumab), the blockbuster drug for AD and other indications that is co-marketed by Sanofi, which records global net sales, and Regeneron Pharmaceuticals.

Dupixent ranked No. 5 among “Top 10 Best-Selling Drugs” as ranked by GEN in a recent A-List, with $18.124 billion (€15.714 billion) in 2025 sales, up 20.2% from the $15.077 billion (€13.072 billion) that the drug racked up in 2024. Dupixent carried that momentum into the first quarter of this year, garnering $4.9 billion (€4.2 billion) in sales as recorded by Sanofi, up 33% from a year earlier. 

However, Dupixent is set to lose key U.S. patent exclusivity in 2031, giving Apogee and other AD drug developers time, they hope, to bring new treatments to market that can successfully compete when Dupixent loses its IP protection.

In addition to AD, zumilokibart is also being developed to treat asthma and eosinophilic esophagitis (EoE). The EoE program is set to advance into mid-stage clinical study as Apogee plans to launch the Phase IIb ELEVATE trial in the second half of this year.

Apogee has generated positive Phase Ib data for zumilokibart in asthma, and is on course to advance that program into the Phase IIb ASPIRE trial, set to launch in the first half of 2027.

Two other programs, both of them combination therapies that include zumilokibart, round out Apogee’s pipeline. APG279, a combination of zumilokibart and APG990, an OX40L inhibitor, is an AD candidate now in a Phase I trial (NCT07027527) comparing the the safety, tolerability, and pharmacokinetic (PK) parameters of the combination vs. Dupixent in adults with moderate-to-severe atopic dermatitis (AD).

Apogee cites preclinical studies showing that APG279 has driven closer to JAK-like inhibition of Type 1, 2, and 3 signaling compared to approved or in-development biologics, with the potential for best-in-class dosing and better tolerability in AD and a variety of other I&I diseases.

One-two punch

Apogee reasons that its chances of treating AD are enhanced by a proverbial one-two punch combining deep and sustained inhibition of Type 2 inflammation through zumilokibart’s inhibition of IL-13 with broader inhibition of Type 1-3 inflammation through APG990’s inhibition of OX40L.

The other combination program, APG273, is a preclinical combination of zumilokibart with APG333, a TSLP (thymic stromal lymphopoietin) that is being developed to treat asthma and COPD. Apogee has said it plans to announce additional plans for clinical studies later this year.

“Apogee’s pipeline adds highly differentiated clinical-stage assets, further expanding our robust immunology portfolio in areas of significant patient need, including atopic dermatitis and asthma,” Michael added. With our deep scientific expertise and proven capabilities, we are uniquely positioned to rapidly advance these programs and continue to transform the standard of care in inflammatory diseases.”

AbbVie has agreed to acquire all outstanding shares of Apogee for $135.11 per share cash, a 49.5% premium from the stock’s closing price on Friday.

The boards of AbbVie and Apogee have unanimously approved the transaction, which is expected to close in the third quarter subject to customary closing conditions, including Apogee shareholder approval and receipt of regulatory approvals.

“This transaction reflects the strength of Apogee’s vision, our team’s dedication and the significant progress we’ve made advancing zumilokibart and our differentiated pipeline,” stated Apogee CEO Michael Henderson, MD. “Since our founding, we’ve focused on developing transformative therapies for patients with inflammatory diseases while creating value for shareholders. This transaction delivers substantial shareholder value and positions our programs to reach their full potential.”

“We believe AbbVie can advance zumilokibart and our portfolio while expanding their impact for patients worldwide,”  Henderson added.

The post AbbVie to Acquire Apogee Therapeutics for $10.9B appeared first on GEN – Genetic Engineering and Biotechnology News.

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STAT+: European Union inks a draft deal to boost local production of medicines and avoid shortages

The European Union reached a provisional deal to strengthen the supply of essential medicines — such as antibiotics, insulin, vaccines, and painkillers — and avoid shortages by ‌boosting domestic production and reducing reliance on imports.

Known as the Critical Medicines Act, the initiative seeks to avoid the kinds of withering drug shortages that were seen during the Covid-19 pandemic. Specifically, the proposal targets supply-chain weaknesses for more than 200 medicines that are considered critical ​to the region’s health security, including treatments for rare diseases.

“With today’s agreement, we are taking practical action to reduce our vulnerabilities, diversify supply chains and strengthen Europe’s capacity to produce critical medicines and their ingredients closer to home,” said Neophytos Charalambides, the health minister for Cyprus, in a statement.

Continue to STAT+ to read the full story…

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Gene Therapy Briefs: Regeneron Wins FDA Approval for First Neurosensory Gene Therapy

The FDA has granted accelerated approval to Regeneron Pharmaceuticals’ Otarmeni™ (lunsotogene parvec-cwha) as the first gene therapy designed to restore a neurosensory function to normal levels.

Otarmeni is an adeno-associated virus vector-based gene therapy indicated for treating children and adults with severe-to-profound and profound sensorineural hearing loss, defined as any frequency >90 decibel hearing level [dB HL], associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear.

Otarmeni (formerly DB-OTO) is the first and only in vivo gene therapy indicated for OTOF-related hearing loss. Regeneron said it will make Otarmeni available for free in the U.S.

The FDA based its accelerated approval decision on the improvement of hearing sensitivity as measured by average pure tone audiometry (PTA) at week 24 during the Phase I/II CHORD trial (NCT05788536). Twenty participants ages 10 months to 16 years received a single dose of Otarmeni via intracochlear infusion—10 patients in one ear, the other 10 in both ears. Data from CHORD showed:

  • 80% of participants (16 of 20) reported hearing improvements per pure tone audiometry assessments at ≤70 dB HL at 24 weeks, achieving the trial’s primary endpoint, while one additional participant achieved the threshold by week 48.
  • 70% (14 of 20) showed an auditory brainstem response (ABR) at ≤90 decibels at 24 weeks, achieving the trial’s key secondary endpoint.
  • Among participants followed to 48 weeks, all prior responders maintained a response to therapy, and 42% of all participants (five of 12) achieved normal hearing that included whispers (≤25 dB HL).

“This unprecedented breakthrough in gene therapy has already proven to be life-changing for many of the children in our clinical trial and their families,” said George D. Yancopoulos, MD, PhD, board co-chair, president and chief scientific officer of Regeneron. 1

The FDA said its accelerated approval may hinge upon verification and description of clinical benefit in the confirmatory portion of the CHOIRD trial, a first-in-human, multicenter, open-label trial designed to assess the safety, tolerability and preliminary efficacy of DB-OTO in infants, children, and adolescents with otoferlin variants.

Otarmeni is the first gene therapy, and second new molecular entity, to win FDA approval under the agency’s Commissioner’s National Priority Voucher (CNPV) pilot program.

Launched in October by FDA Commissioner Martin A. Makary, MD, CNPV awards vouchers to drug developers whose work is deemed to address a health crisis in the U.S., deliver more innovative cures, address unmet public health needs, and increase domestic drug manufacturing as a national security issue. The vouchers entitle companies to reviews of their final applications within a target timeframe of 1–2 months rather than the standard 10–12 months.

Intellia’s Lonvo-Z begins rolling BLA following positive Phase III data

Intellia Therapeutics has launched a rolling Biologics License Application (BLA) submission to the FDA seeking regulatory approval of lonvoguran ziclumeran (lonvo-z), after announcing positive topline results from the global Phase III HAELO trial (NCT06634420) in hereditary angioedema (HAE)—the first Phase III data reported for an in vivo gene editing therapy.

HAELO is a randomized, double-blind, placebo-controlled Phase III trial designed to evaluate the efficacy and safety of a one-time 50 mg dose of lonvo-z in adults and adolescents aged 16 years and older with Type I or Type II HAE. The trial’s key endpoints focused on the number of HAE attacks experienced by patients, quality of life, safety and tolerability. Eighty patients were enrolled with 52 receiving lonvo-z and 28, placebo.

HAELO met its primary endpoint. For the six-month efficacy evaluation period (weeks 5 to 28), a one-time infusion of lonvo-z reduced attacks by 87% vs. placebo, with a mean monthly attack rate of 0.26 in the lonvo-z arm vs. 2.10 in the placebo arm.

Other key findings from HAELO:

  • The trial met all key secondary endpoints with statistical significance (p<0.0001). These included a 62% rate of patients who were entirely attack free and therapy free in the lonvo-z arm for the six-month efficacy evaluation period, vs. 11% of patients in the placebo arm.
  • Lonvo-z showed favorable safety and tolerability data. The most common treatment emergent adverse events (TEAEs) during the primary observation period (infusion through week 28) were infusion-related reactions, headache and fatigue. All TEAEs reported as of the data cutoff (February 10, 2026) were mild or moderate, with no serious adverse events observed in the lonvo-z arm.
  • As of the data cutoff, all patients who received lonvo-z at baseline or in crossover after week 28 remained long-term prophylaxis (LTP) free.

“Today’s HAELO results represent a profound milestone for Intellia, the broader CRISPR and precision medicine fields and, most importantly, the HAE community,” said John Leonard, MD, Intellia’s president and CEO. “These data affirm lonvo-z’s potential, with one dose, to offer prolonged freedom from both attacks and the need for ongoing therapy.” 2

Intellia said researchers plan to present additional clinical data from HAELO at the 2026 European Academy of Allergy and Clinical Immunology Congress (EAACI), set for June 12-15 in Istanbul, Turkey (Abstract #100217).

Lonvo-z is designed to inactivate the kallikrein B1 (KLKB1) gene in order to permanently lower kallikrein and bradykinin levels. Lonvo-z is designed as a one-time treatment that is administered in an outpatient setting.

Intellia said it is preparing for a potential U.S. launch of lonvo-z in the first half of 2027.

J. Craig Venter Dies: Pioneer in gene discovery, genomics, and synthetic biology

Craig Venter, PhD, a pioneer in gene discovery, human genomics, and synthetic biology, died April 29 in San Diego after a brief hospitalization for unexpected side effects that arose from treatment of recently diagnosed cancer. He was 79.

Venter was founder, board chair, and CEO of the institute that bears his name in La Jolla, CA. Earlier at the National Institutes of Health (NIH), he helped pioneer gene discovery using expressed sequence tags (ESTs), enabling rapid identification of large numbers of human genes and accelerating genome mapping efforts.

He went on to lead efforts that produced the first draft sequences of the human genome. He and colleagues later published the first high-quality diploid human genome, a scientific milestone that demonstrated the importance of capturing genetic variation inherited from both parents.

Venter’s work helped define and advance modern genomics, as well as launched the field of synthetic biology, where he and his teams constructed the first self-replicating bacterial cell controlled by a chemically synthesized genome—proof that genomes could be designed digitally, built from chemical components, and like a computer, booted up to run a living cell.

Through the Sorcerer II Global Ocean Sampling Expedition, Venter and his teams used metagenomics to reveal microbial diversity, reporting the discovery of millions of new genes and expanding the known universe of protein families—work that added to knowledge and insight of the ocean microbiome and its role in planetary systems.

“Venter was controversial and often challenged the scientific orthodoxy, with critics accusing him of hype and going overboard on privatization,” said John Sterling, Editor in Chief of Genetic Engineering & Biotechnology News, who has known and worked editorially with Venter over the past 35 years. “To many, he was a visionary focusing on technological acceleration and blending academic science with the zeal of an entrepreneur. Supporters saw him as a pioneer who sped up genomics by years.” 3

In addition to founding the J. Craig Venter Institute (JCVI), Venter was a serial entrepreneur who co-founded Synthetic Genomics, Human Longevity, and most recently Diploid Genomics, advancing efforts designed to translate genomics and synthetic biology into tools for health and society.

He was also a fierce advocate for robust federal science funding, as well as for partnerships that accelerate progress across government, academia, and industry.

“Craig believed that science moves forward when people are willing to think differently, move decisively, and build what doesn’t yet exist,” said Anders Dale, president of JCVI. “His leadership and vision reshaped genomics and helped ignite synthetic biology. We will honor his legacy by continuing the mission he built—advancing genomic science, championing the public investments that make discovery possible, and partnering broadly to turn knowledge into impact.” 4

Rocket Pharma selling Priority Review Voucher for Kresladi™ for $180M

Rocket Pharmaceuticals has agreed to sell for $180 million the Rare Pediatric Disease Priority Review Voucher (PRV) it was awarded by the FDA after the agency granted accelerated approval of Kresladi™ (marnetegragene autotemcel).

Kresladi is an autologous hematopoietic stem cell-based gene therapy indicated to treat children with severe leukocyte adhesion deficiency-I (LAD-I) due to biallelic variants in ITGB2 without an available human leukocyte antigen-matched sibling donor for allogeneic hematopoietic stem cell transplant.

The indication was approved in March under accelerated approval based on increase in neutrophil CD18 and CD11a surface expression. The accelerated approval of Kresladi is subject to confirmation of its clinical benefit, to be based on an evaluation of longer-term follow-up data of treated patients in the ongoing Phase I/II trial (NCT03812263) and through a post-marketing registry. The study generated positive topline data showing 100% overall survival at 12 months post-infusion (and for the entire duration of follow-up) for all nine LAD-I patients with 18 to 42 months of available follow-up.

The accelerated approval followed a resubmission of Rocket’s Biologics License Application for Kresladi. The original submission was rejected by the FDA in 2024 through a Complete Response Letter that requested additional Chemistry, Manufacturing, and Controls (CMC) information, but did not raise safety or efficacy issues about the gene therapy.

Rocket said it plans to use proceeds from the PRV sale toward advancing its prioritized cardiovascular gene therapy pipeline, including clinical-stage programs in Danon disease, PKP2-associated arrhythmogenic cardiomyopathy (PKP2-ACM), and BAG3-associated dilated cardiomyopathy (BAG3-DCM).

“The monetization of our PRV, following the FDA approval of Kresladi, provides meaningful non-dilutive capital and extends our cash runway into the second quarter of 2028,” said Gaurav Shah, MD, Rocket Pharmaceuticals CEO. “This strengthens our ability to advance key clinical milestones across our cardiovascular gene therapy pipeline, with all programs on track.” 5

Passage Bio cuts staff 75%, launches strategic review

Passage Bio said it will eliminate 75% of its staff in a cost-cutting restructuring that is part of the company’s effort to review strategic alternatives.

“The Company expects that the aggregate severance and exit costs for the Restructuring Plan will be approximately $3.3 million, which will be recorded primarily in the second quarter of 2026,” Passage Bio said in a regulatory filing. 6

Passage Bio has said it plans to review strategic alternatives that may include merger or acquisition transactions, a reverse merger, a sale of assets of the company, strategic partnerships, licensing opportunities, or other potential paths.

The restructuring followed Passage Bio receiving feedback during a Type C meeting with officials at the FDA that indicated that the company will be required to complete a randomized controlled registrational trial evaluating its lead pipeline candidate PBFT02 as a treatment for frontotemporal dementia (FTD) with granulin (GRN) mutations.

PBFT02 is a gene replacement therapy that uses an adeno-associated virus serotype 1 (AAV1) viral vector to deliver, through intra cisterna magna (ICM) administration, a functional GRN gene that encodes the progranulin protein (PGRN).

The 75% workforce cut amounts to approximately 18 people, based on the 24 full-time employees it reported as of December 31, 2025, according to its annual report.

LEO Pharma acquires Replay for $50M upfront, milestones

LEO Pharma has agreed to acquire Replay, a developer of gene therapies for rare genetic dermatological conditions, in a deal that the buyer said will add deep expertise and a next-generation gene therapy platform to its pipeline, namely Replay’s high‑payload herpes simplex virus (HSV) delivery vector.

LEO Pharma plans to acquire Replay for $50 million upfront, plus milestone payments and tiered single-digit royalties.

Replay’s gene therapy platform is designed to leverage HSV’s capacity to deliver large genes, which according to LEO makes it well suited for addressing rare, genetically driven dermatological conditions. The genetically modified HSV therapy is formulated as a topical gel that targets the deficient gene when applied directly to the skin.

“Replay’s HSV gene therapy platform holds significant promise for patients with rare genetic skin diseases, and realizing its full potential requires focused expertise in medical dermatology—an area where LEO Pharma brings decades of leadership, scale and proven execution,” LEO Pharma CEO Christophe Bourdon said. “The acquisition aligns with our strategy of investing in the most impactful opportunities in dermatology and positions LEO Pharma at the forefront of next‑generation gene therapy.” 7

LEO Pharma agreed to acquire Replay after identifying Replay as a high‑potential opportunity using its artificial intelligence (AI) scouting platform, Innoviewer™. Replay’s lead pipeline drug program is a preclinical phase candidate designed to treat dystrophic epidermolysis bullosa (DEB).

MeiraGTx buys rights to XLRP treatment from J&J for $25M upfront

MeiraGTx Holdings has agreed to acquire from Johnson & Johnson (J&J) all interests in botaretigene sparoparvovec (bota-vec), a gene therapy being developed to treat X-linked retinitis pigmentosa (XLRP).

Under the companies’ asset purchase agreement, MeiraGTx agreed to pay J&J $25 million cash upfront, a one-time regulatory and commercial milestone payment tied to U.S. approval and U.S. sales performance of bota-vec for the treatment of XLRP, plus what MeiraGTx called a high double-digit royalty on global net sales starting in mid-2029.

The sale comes nearly a year after bota-vec failed the 95-patient, Phase III LUMEOS trial (NCT04671433)  by missing the study’s primary endpoint of demonstrating statistically significant vision-guided mobility in patients with XLRP, as measured by a Visual Mobility Assessment (VMA) or maze.

However, MeiraGTx has emphasized results showing that subjects treated with bota-vec were 2.4x more likely to respond than untreated subjects. A Low Luminance Questionnaire – Patient-Reported Outcome (LLQ PRO) showed significant benefit in mobility and dim light function, qualities tested by the VMA—thus indication, according to MeiraGTx, that the maze was not sensitive enough to capture these benefits.

The company characterized data from the LUMEOS trial’s secondary endpoints as very strong, with clinically meaningful and statistically significant improvements shown in each of three domains of vision.

MeiraGTx is the commercial manufacturer of bota-vec and had collaborated in its development with J&J from Phase I development onward. The FDA has granted Fast Track and Orphan Drug Designations to bota-vec, while the European Medicines Agency has granted Priority Medicines (PRIME), Advanced Therapy Medicinal Product (ATMP), and Orphan Drug designations to bota-vec.

“This is a unique opportunity to gain an asset at this stage in development with data supporting a meaningful benefit in patients with no alternative treatment, many of whom are waiting for this life changing therapy and hoping for expeditious approval,” said Alexandria Forbes, PhD, MeiraGTX’s president and CEO. 8

She added that MeiraGTx intends to start filing a Biologics License Agreement (BLA) with the FDA and applications for regulatory approval in the European Union and Japan as soon as possible.

 

References

1. Regeneron Pharmaceuticals. Otarmeni™ (lunsotogene parvec-cwha) Approved by FDA as First and Only Gene Therapy for Genetic Hearing Loss; Regeneron to Provide Otarmeni for Free in the U.S. April 23, 2026. (Last accessed May 1, 2026)

2. Intellia Therapeutics. Intellia Therapeutics Reports Positive Phase 3 Results in Hereditary Angioedema, Marking a Global First for In Vivo Gene Editing. April 27, 2026. (Last accessed May 1, 2026).

3. Genetic Engineering & Biotechnology News. Genomics Pioneer and Life Sciences Entrepreneur J. Craig Venter Dies at 79. April 30, 2026. (Last accessed May 1, 2026)

4. Craig Venter Institute. J. Craig Venter, genomics pioneer and founder of JCVI and Diploid Genomics, Inc., dies at 79. April 29, 2026. (Last accessed May 1, 2026)

5. Rocket Pharmaceuticals. Rocket Pharmaceuticals Announces $180 Million Sale of Priority Review Voucher. April 28, 2026. (Last accessed May 3, 2026)

6. Passage Bio. Form 8-K, filed April 28, 2026. (Last accessed May 5,2026)

7. LEO Pharma. LEO Pharma bolsters rare skin disease focus through acquisition of Replay gene therapy platform. April 30, 2026. (Last accessed May 3, 2026)

8. MeiraGTx Holdings. MeiraGTx Announces the Acquisition of Botaretigene Sparoparvovec (bota-vec) for the Treatment of X-linked Retinitis Pigmentosa (XLRP). April 16, 2026. (Last accessed May 3, 2026)

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