GSK again pulls application for leucovorin, touted by FDA as potential autism treatment

 

GSK discontinued Wellcovorin in 1999, but the FDA in September last year asked the pharma to refile an application, pointing to its potential to treat cerebral folate deficiency with “autistic features.”

GSK has withdrawn an approval application for Wellcovorin, a decades-old drug that late last year gained renewed attention after the members of the Trump administration publicly suggested it has the potential to treat autism symptoms.

The pharma requested to terminate the new drug application because “the drug products were no longer marketed,” according to a Federal Register notice on Thursday. The withdrawal of the application was procedural and not linked to any safety or efficacy issues, a GSK spokesperson told The Wall Street Journal on Thursday, noting that the company had never intended to revive the drug.

Wellcovorin (generic name: leucovorin) was first approved in 1983 as a treatment to counter the toxic side effects of methotrexate, a common chemotherapeutic agent. GSK eventually discontinued the drug in 1997, though generic versions are on the market.

These generics will be unaffected by the pharma’s petition to pull the approval application for Wellcovorin, a spokesperson for the Department of Health and Human Services confirmed to WSJ. “GSK’s action does not affect the availability of generic leucovorin . . . or the labeling of leucovorin products,” the spokesperson said.

Wellcovorin re-entered the public’s consciousness in September 2025 after the FDA asked GSK to refile an application for the drug as a potential medicine for cerebral folate deficiency (CFD)—a highly unusual move for the regulator. At the time, the agency linked the rare disorder to “developmental delays with autistic features” and positioned leucovorin as a treatment.

Shortly after, GSK said that it would comply with the FDA’s request and file an application to update the drug’s label. This led to an approval last month, allowing the drug’s use in CFD caused by certain genetic anomalies.

In a press call, however, the agency admitted that there is not enough evidence to support the approval of leucovorin for autism more broadly, WSJ reported on Thursday. The American Academy of Pediatrics notes that “current evidence is insufficient to support prescribing leucovorin for autism in the absence of CFD.”

In September, alongside FDA Commissioner Marty Makary’s effort to paint leucovorin as an autism treatment, the agency also updated the label of products containing acetaminophen, such as Tylenol, to reflect a purported link to autism in children when used during pregnancy. These drugs, the FDA claimed at the time, could lead to “increased risk of neurological conditions such as autism and ADHD in children.”

However, the agency itself at the time conceded that “a causal relationship has not been established,” pointing to “contrary studies in the scientific literature.” Indeed, scientists have many times over rejected a causal link between acetaminophen during pregnancy and autism in children. As recently as 2024, a population study looking at 2.5 million children born from 1995 to 2019 found no such link.

https://www.biospace.com/business/gsk-again-pulls-application-for-leucovorin-touted-by-fda-as-potential-autism-treatment

Boehringer transfers schizophrenia DTx selling rights to Click

 Boehringer Ingelheim has amended its partnership with Click Therapeutics on a digital therapeutic (DTx) for schizophrenia, transferring commercial rights to the programme to the digital health specialist.

The changes to their longstanding alliance on the DTx, called CT-155, come a few months after it hit the target in the phase 3 CONVOKE schizophrenia trial, with the results showing that the smartphone app was able to help users achieve a reduction in negative symptoms when added to standard schizophrenia treatment.

Boehringer has sweetened the changes to the deal by making a $50 million Series D investment in Click, and has promised "dedicated commercial funding" to help the digital health company launch the DTx if it is approved by the FDA.

CT-155 is one of several DTx apps Boehringer and Click are working on under a $500 million partnership, first formed in 2020 and expanded two years later to include a second app for schizophrenia (CT-156), with an additional $460 million in potential milestones. The amendment signals that Boehringer may be shifting towards a more strategic investor role in DTx.

Boehringer is, however, continuing to take the lead on the phase 3 ENSPIRUS trial, which is putting the app through its paces in a real-world setting and also gauging how it can affect the use of healthcare services. Results from that are due later this year.

Click's chief executive, David Benshoof Klein, said the transfer of commercial rights is a "powerful validation of our vision and the capabilities we have spent over a decade building."

CT-155 has breakthrough device designation from the FDA, which reflects its potential to treat schizophrenia symptoms that are hard to address using pharmacological therapies for the disorder.

At the moment, there are no therapies approved by the FDA specifically to treat negative symptoms of schizophrenia, so CT-155 has a shot at becoming a first-in-class, adjunctive treatment with antipsychotics.

The app delivers interactive psychosocial intervention sessions that provide a digital alternative to face-to-face cognitive behavioural therapy (CBT), which can often be hard to access even in countries with well-developed healthcare systems.

The CONVOKE results, presented at last year's European College of Neuropsychopharmacology (ECNP) congress, showed that CT-155 achieved a 4.2-point improvement in negative symptoms, measured using the CAINS-MAP scale from baseline to 16 weeks, compared with a control app.

According to the investigators, it was the first pivotal trial to show a statistically significant reduction in experiential negative symptoms of schizophrenia as an adjunct to standard of care.

https://pharmaphorum.com/news/boehringer-transfers-schizophrenia-dtx-selling-rights-click

'Pro-China Party Of Socialism & Liberation Plans General Strike On U.S. Economy'

 The Party for Socialism & Liberation (PSL) is promoting a May 1 "general strike" aimed at disrupting economic activity across the U.S., framing it as a coordinated effort to pressure the Trump administration.

"The prospect of a nationwide shutdown terrifies the billionaire class, and it is what can really stop Trump in his tracks," PSL wrote on X.

PSL added that recent nationwide protests demonstrated opposition, and said left-wing nonprofits are now mobilizing for a larger action on May 1.

General strike threats come amid broader scrutiny of left-wing nonprofits pushing for a color revolution against Trump.

A 2023 report by The New York Times noted that Marxist billionaire Neville Roy Singham has been linked to PSL and is aligned "with the Chinese government media machine and is financing its propaganda worldwide."

From a national security perspective, a coordinated general strike to crash the economy - or, really, destroy capitalism, because that's the intended end goal - could create localized disruptions across critical logistics networks, including transportation, ports, energy systems, and manufacturing. In more extreme scenarios, prolonged strikes on critical logistical nodes could disrupt supply chains critical to defense and infrastructure.

Nationwide strike threats come as ongoing conflicts across Eurasia, including the Russia-Ukraine war and the ongoing US-Iran conflict, have transformed these areas of the world into warzones, in which the U.S. is a critical supplier of weapons.

Who benefits in a general strike if the U.S. economy comes to a halt? 

The prospect of a large-scale domestic work stoppage may suggest that China is waging asymmetric warfare through the Singham nonprofit network, as Beijing is furious about the energy shock at the Hormuz chokepoint following the Gulf conflict.

https://www.zerohedge.com/political/terrifies-billionaire-class-pro-china-party-socialism-liberation-plans-crash-us-economy

Xi Hosts Taiwan Opposition Leader In Rare Meet: 'Will Not Become Chessboard For External Intervention'

 All eyes remain fixated on the impending US-Iran talks in Islamabad, but big things are also happening Friday in Beijing, and they have direct impact on another potential global flashpoint: Taiwan.

While Washington potentially gets bogged down in another Middle East quagmire (if talks don't go well and there's no offramp), Chinese leader Xi Jinping has welcomed the leader of Taiwan’s main opposition party for a rare direct meeting in the Chinese capital.

The symbolism of the timing can't be missed, as Xi invited Nationalist Party Chairwoman Cheng Li-wun to China ahead of the planned big mid-May summit with President Trump in which the Chinese leader could continue a push to dilute Washington's support for Taiwan.

This is all about steering self-ruled Taiwan into China's orbit, and Beijing asserting political power to do so in the face of the Trump administration, after China has long stated its official policy of reunification to the mainland through political means.

By hosting Cheng, Xi is also presenting himself as a force for stability who can be entrusted with ensuring peace - the WSJ has commented - and we might add with the image of 'Taiwan's willing participation' - at a moment the Middle East is on fire largely as a result of American policy and quickness to result to force and surprise attacks.

Xi and Cheng expressed a desire for a "peaceful" resolution to the many decades-long Taiwan crisis, and posed for photos at the Great Hall of the People. They engaged in public remarks but also held a private, closed-door meeting.

Cheng emphasized in words to reporters that Chinese and Taiwanese officials should work to "transcend political confrontation and mutual hostility." She stated, "Instead, it should become a strait that connects family ties, civilization and hope – a symbol of peace jointly safeguarded by Chinese people on both sides."

Her rhetoric was tinged with familiar Chinese Communist Party talking points as she heralded China's supposed eradicating of absolute poverty while seeking to achieve the "great rejuvenation of the Chinese nation".

Among the more notable points were related to 'external intervention' - a not so stealthy reference to American power projection in southeast Asia:

"It is hoped that through the tireless efforts of our two parties, the Taiwan Strait will no longer be a focus of potential conflict, nor will it become a chessboard for external intervention," she said.

Xi and Cheng both agreed that her Kuomintang party is ready to work with Beijing to achieve peace across the Taiwan Strait.

According to a backgrounder:

Cheng is the highest-ranking Taiwanese leader to meet Xi since President Ma Ying-jeou talked with the Chinese leader in Singapore in 2015. They met again in China two years ago when Ma was a private citizen.

Both Cheng and Ma are members of the Kuomintang, the conservative-leaning Taiwanese political party that advocates for greater engagement with China by Taiwan’s self-ruled democratic government.

As for Xi, he held up Taiwan and China's shared history and culture, stating that "people of all ethnic groups, including Taiwanese compatriots," had "jointly written the glorious history of China."

Xi stressed, "All sons and daughters of China share the same Chinese roots and the same Chinese spirit. This originates from blood ties and is deeply embedded in our history – it cannot be forgotten and cannot be erased."

Taiwan's ruling government and officials have meanwhile complained of the Friday meeting, "It basically gives China a chance to bully Taiwan behind closed doors."

And Taiwan Deputy Foreign Minister Chen Ming-chi said Friday that China can send a clear message of peace but only if it "stops sending warplanes and ships around Taiwan now."

https://www.zerohedge.com/geopolitical/xi-hosts-taiwan-opposition-leader-rare-meeting-we-will-not-become-chessboard-external

Cal. bill eyes more human operators on robotaxis, Waymo says proposal would be crippling

 A Silicon Valley lawmaker wants to require robotaxis like Google’s Waymo to hire human operators to be on standby locally in case the system goes haywire – like it did last winter when a blackout in San Francisco created a logjam of paralyzed robot cars. 

The legislative push — which Waymo described as potentially crippling — comes after the company’s chief safety officer Mauricio Peña sparked outrage for admitting in US Senate testimony that the crucial human helpers it relies on live in the Philippines. The admission came as lawmakers grilled the company after one of its vehicles struck a child walking to school in Santa Monica.

State Sen. David Cortese, a San Jose Dem, says his new bill would ensure tech companies react more quickly during emergencies and keep robotaxis from blocking the path of emergency vehicles.

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A Silicon Valley lawmaker wants to require robotaxis like Google’s Waymo to hire human operators to be on standby locally.Gado via Getty Images

“Unfortunately, reports of AVs obstructing traffic, competing with first responders, and driving through active law enforcement activities continue to abound,” Cortese said as he introduced the legislation earlier this week.

Humans need to be based nearby to address “ambiguous situations” in real time, he added.

Cortese’s bill would require autonomous-vehicle companies to hire remote drivers and assistants based in the US and licensed in California, and mandate a staffing ratio of one human for every three vehicles.

Under the proposed legislation, a trained autonomous-vehicle worker would be required to arrive on scene within 10 minutes if called. Each robotaxi would also need a manual override option to allow public-safety officials to take over, though similar capabilities already exist.

The proposal advanced out of the state Senate Transportation Committee with a 7-2 vote. 

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State Sen. David Cortese, a San Jose Democrat.Xavier Mascarenas/TNS via ZUMA Press Wire / Shutterstock

Waymo, run by co-CEOs Tekedra Mawakana and Dmitri Dolgov, currently operates about 3,000 vehicles nationwide, while roughly 30 other companies have pending permit applications.  

Waymo and other industry representatives called Cortese’s bill overkill and said they’re already addressing similar safety requirements, the San Francisco Chronicle reported.

Industry lobbyist Sarah Boot said existing California regulations already require companies to continuously monitor each autonomous vehicle, according to the report. She added that starting in July, human operators will be required to respond to emergency personnel within 30 seconds and move a vehicle, if instructed, within two minutes or face a report to the state Department of Motor Vehicles.

“We should not layer on a second overlapping system before the first one is even implemented,” Boot said at a recent hearing, adding that companies have spent the past two years developing compliance programs to meet the new rules.

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Waymo is run by co-CEO Tekedra Mawakana.Getty Images for TechCrunch

She said a provision in Cortese’s bill to halt operations for companies that violate the requirements three times could make for a de-facto ban on the state’s autonomous-vehicle market.

State Sen. Scott Wiener, a Democrat from San Francisco, said requirements like the 10-minute response mandate were overly rigid.

“I wish I could get around San Francisco in 10 minutes,” Wiener said. “I can’t.”

Meagan Subers, a lobbyist for the California Professional Firefighters union, said the bill would help prevent robotaxis from blocking fire station access or parking on fire hoses, according to the Chronicle.

https://nypost.com/2026/04/10/business/california-bill-aims-to-put-more-human-operators-on-robotaxis-like-waymos/

'Google’s AI Overviews spew millions of false answers per hour: study'

 Google’s AI-generated search results are spewing out tens of millions of inaccurate answers per hour – even as the tech giant siphons visitors and ad revenue from cash-strapped news outlets, according to a bombshell analysis.

To test the accuracy of Google’s AI Overviews, startup Oumi reviewed 4,326 Google search results generated by Google’s Gemini 2 model and the same number of results generated by its more advanced Gemini 3 model.

The analysis found that the models were accurate 85% and 91% of the time, respectively.

With Google expected to handle more than 5 trillion searchers in 2026 alone, that means AI Overviews are spitting out fake news at a rate of hundreds of thousands of mistakes every single minute – with users left none the wiser.

The New York Times was first to report on Oumi’s analysis.

“Google AI Overviews have been a disaster for publishers who rely on clicks to fund the production of quality journalism, but they also let down users looking for accurate information,” said Danielle Coffey, president and CEO of the News/Media Alliance, a trade group that represents more than 2,000 news outlets including The Post.

The wrong answers included several basic fumbles, such as misstating the year in which musician Bob Marley’s home was converted into a museum, misstating the year that former MLB relief pitcher Dick Drago died, and claiming there was no record of Yo-Yo Ma being inducted into the Classical Music Hall of Fame even though he was in 2007, according to examples Oumi provided to the Times.

AI Overviews have appeared at the top of Google search results since 2024, while the traditional set of blue links to news outlets are effectively buried out of sight. Publishers have long accused Google, led by CEO Sundar Pichai, of ripping off their work to “train” its AI model without proper credit or compensation.

"Algorithmically-generated responses that pull in data from nearly every source on the internet simply cannot be trusted,” Coffey said.

“Publishers spend enormous amounts of time and money ensuring that the content they deliver to their readers is properly fact-checked, while Google’s AI Overviews are produced with no oversight or accountability.”

AI Overviews also has a penchant for citing information from questionable or easily edited sources, such as Facebook pages, blog posts and Wikipedia entries, as though it is fact.

The feature appears easy to trick into spewing fake news.

The Times cited an example in which BBC podcast host Thomas Germain wrote up a blog post proclaiming himself as one of “The Best Tech Journalists at Eating Hot Dogs.”

Google’s AI summaries had gobbled up the information within a day and began claiming Germain had “gained notoriety for their prowess at the ‘news division’ of competitive eating events.”

Oumi’s analysis was conducted between October and February and utilized a well-known benchmark test called SimpleQA, which was developed by OpenAI and is used to assess the accuracy of AI models.

While the accuracy improved in the jump from Gemini 2 and Gemini 3, Oumi’s research showed that AI Overviews has gotten worse about correctly citing where it found information.

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Google CEO Sundar Pichai appears at an event.Bloomberg via Getty Images

The percentage of AI Overviews answers that were “ungrounded,” or where the links provided by Google did not back up the information included in the AI summary, jumped from 37% in Gemini 2 to 51% in Gemini 3, the report said.

A Google spokesperson said Oumi’s study has “serious holes” – in part because the SimpleQA benchmark test includes inaccurate information within its own dataset.

The company also questioned Oumi’s reliance on its own in-house AI model, dubbed HallOumi, to conduct the analysis, despite the risk that it could also make errors.

“It uses one AI to grade another on an old benchmark that is known for being full of errors, and it doesn’t reflect what people are actually searching on Google,” the spokesperson said. “AI Overviews are built on our Gemini models, which lead the industry in accuracy, and they clear the same high-quality bar that we have for all our Search features.”

As The Post has reported, AI Overviews has struggled to provide accurate information since its launch, previously advising users to add glue to their pizza sauce and touting the “health benefits” of tobacco for kids.

https://nypost.com/2026/04/09/business/googles-ai-overviews-spew-out-millions-of-false-answers-per-hour-bombshell-study/